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width="1.25rem" xmlns="http://www.w3.org/2000/svg"><polyline points="6 9 6 2 18 2 18 9"></polyline><path d="M6 18H4a2 2 0 0 1-2-2v-5a2 2 0 0 1 2-2h16a2 2 0 0 1 2 2v5a2 2 0 0 1-2 2h-2"></path><rect x="6" y="14" width="12" height="8"></rect></svg></a></button></div></div><div><div class="flex flex-wrap"><p class=" text-primary font-semibold">News</p><div class="h-[16px] border-l-2 border-gray-400 mt-1 mx-1"></div><p class=" text-primary font-semibold">Article</p><div class="h-[16px] border-l-2 border-gray-400 mt-1 mx-1 "></div><time class="text-gray-500 " dateTime="2024-05-09T14:47:58.291">Published: May 9, 2024</time><time class="text-gray-500 " dateTime="2024-05-21T13:40:00.000"> | Updated: May 21, 2024</time></div><h1 class="text-[26px] font-medium leading-8">FDA Accepts Nivolumab Subcutaneous Injection Application, With Potential to Boost Access to PD-1 Inhibitors</h1><div class="py-3 text-gray-600 md:flex flex-col md:justify-between"><div class="flex flex-col xs:flex-row"><p class="mr-1 self-start">Author(s):</p><div class="flex flex-col xs:flex-row mb-3 md:mb-0"><div class="flex flex-wrap"><span class="text-md mr-2"><a class="text-author text-gray-500 hover:text-primary underline hover:no-underline decoration-gray-400" href="/authors/mary-caffrey">Mary Caffrey</a></span></div></div></div><div class="max-w-full"><div class="flex flex-wrap sm:flex-nowrap items-center w-fit my-2"></div><div class="w-full flex flex-col sm:flex-row justify-between mt-2"><div class="block md:hidden "><div class="mt-2 flex items-center max-w-fit"><button title="FDA Accepts Nivolumab Subcutaneous Injection Application, With Potential to Boost Access to PD-1 Inhibitors" aria-label="facebook" class="react-share__ShareButton" style="background-color:transparent;border:none;padding:0;font:inherit;color:inherit;cursor:pointer"><svg viewBox="0 0 64 64" width="32" height="32"><circle cx="32" cy="32" r="31" fill="#3b5998"></circle><path 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Subcutaneous Injection Application, With Potential to Boost Access to PD-1 Inhibitors" aria-label="pinterest" class="react-share__ShareButton" style="background-color:transparent;border:none;padding:0;font:inherit;color:inherit;cursor:pointer"><svg viewBox="0 0 64 64" width="32" height="32"><circle cx="32" cy="32" r="31" fill="#cb2128"></circle><path d="M32,16c-8.8,0-16,7.2-16,16c0,6.6,3.9,12.2,9.6,14.7c0-1.1,0-2.5,0.3-3.7 c0.3-1.3,2.1-8.7,2.1-8.7s-0.5-1-0.5-2.5c0-2.4,1.4-4.1,3.1-4.1c1.5,0,2.2,1.1,2.2,2.4c0,1.5-0.9,3.7-1.4,5.7 c-0.4,1.7,0.9,3.1,2.5,3.1c3,0,5.1-3.9,5.1-8.5c0-3.5-2.4-6.1-6.7-6.1c-4.9,0-7.9,3.6-7.9,7.7c0,1.4,0.4,2.4,1.1,3.1 c0.3,0.3,0.3,0.5,0.2,0.9c-0.1,0.3-0.3,1-0.3,1.3c-0.1,0.4-0.4,0.6-0.8,0.4c-2.2-0.9-3.3-3.4-3.3-6.1c0-4.5,3.8-10,11.4-10 c6.1,0,10.1,4.4,10.1,9.2c0,6.3-3.5,11-8.6,11c-1.7,0-3.4-0.9-3.9-2c0,0-0.9,3.7-1.1,4.4c-0.3,1.2-1,2.5-1.6,3.4 c1.4,0.4,3,0.7,4.5,0.7c8.8,0,16-7.2,16-16C48,23.2,40.8,16,32,16z" fill="white"></path></svg></button><button aria-label="email" class="react-share__ShareButton" style="background-color:transparent;border:none;padding:0;font:inherit;color:inherit;cursor:pointer"><svg viewBox="0 0 64 64" width="32" height="32"><circle cx="32" cy="32" r="31" fill="#7f7f7f"></circle><path d="M17,22v20h30V22H17z M41.1,25L32,32.1L22.9,25H41.1z M20,39V26.6l12,9.3l12-9.3V39H20z" fill="white"></path></svg></button><a class="print-wrap flex justify-center items-center cursor-pointer"><svg id="print" xmlns="http://www.w3.org/2000/svg" width="24" height="24" fill="currentColor" class="print bi bi-printer" viewBox="0 0 16 16"> <path d="M2.5 8a.5.5 0 1 0 0-1 .5.5 0 0 0 0 1z"></path> <path d="M5 1a2 2 0 0 0-2 2v2H2a2 2 0 0 0-2 2v3a2 2 0 0 0 2 2h1v1a2 2 0 0 0 2 2h6a2 2 0 0 0 2-2v-1h1a2 2 0 0 0 2-2V7a2 2 0 0 0-2-2h-1V3a2 2 0 0 0-2-2H5zM4 3a1 1 0 0 1 1-1h6a1 1 0 0 1 1 1v2H4V3zm1 5a2 2 0 0 0-2 2v1H2a1 1 0 0 1-1-1V7a1 1 0 0 1 1-1h12a1 1 0 0 1 1 1v3a1 1 0 0 1-1 1h-1v-1a2 2 0 0 0-2-2H5zm7 2v3a1 1 0 0 1-1 1H5a1 1 0 0 1-1-1v-3a1 1 0 0 1 1-1h6a1 1 0 0 1 1 1z"></path></svg></a></div><style> .print-wrap { width: 32px; height: 32px; background: #7F7F7F; border-radius: 100%; } .print { background: #7F7F7F; color: white; padding: 2px; border-radius: 100%; } </style></div></div></div></div><div class=" lg:w-full flex flex-col lg:flex-row lg:items-center lg:justify-end"></div><p class="py-2 mb-2 text-sm italic text-gray-600">Some experts believe offering a subcutaneous version of nivolumab could make PD-1 inhibitors available to new groups of patients who currently lack access, such as those in rural areas.</p><div class="py-2"><div class="blockText_blockContent__TbCXh"><p class="pb-2"><em>This article has been updated to reflect a revised target action date.</em></p><p class="pb-2">FDA has accepted Bristol Myer Squibb’s biologics license application (BLA) for its subcutaneous (SC) formulation of the nivolumab, which company officials say has the “potential” to be the first PD-1 inhibitor administered by subcutaneous injection if approved by its target action date, which has been advanced to December 29, 2024.<sup class="text-inherit">1,2</sup></p><p class="pb-2">Sold as Opdivo, the therapy is formulated with hyaluronidase to create subcutaneous (SC) nivolumab. According to a BMS statement, the BLA covers all previously approved indications for use of intravenous (IV) nivolumab as a monotherapy in adult solid tumors, and all approvals for monotherapy as a maintenance therapy following use of the combination nivolumab plus ipilimumab (Yervoy) or combinations with chemotherapy or cabozantinib (Cabometyx).</p><p class="pb-2">Although some warn it’s too soon to say whether the shift to SC nivolumab will be a game-changer, leaders from BMS are enthusiastic about the BLA.</p><div class=""><div style="width:15%;float:left;max-width:525px;margin:0 1.5rem 1.5rem 0;clear:both;cursor:pointer" class=" figure"><div class="flex-none relative text-center"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%27500%27%20height=%27500%27/%3e"/></span><img alt="Gina Fusaro, PhD | Image credit: LinkedIn" title="Gina Fusaro, PhD | Image credit: LinkedIn" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain"/><noscript><img alt="Gina Fusaro, PhD | Image credit: LinkedIn" title="Gina Fusaro, PhD | Image credit: LinkedIn" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fajmc%2F0e20514b3f4fc8c570e965e47c4c6f01add5d233-500x500.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=640&q=75 1x, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fajmc%2F0e20514b3f4fc8c570e965e47c4c6f01add5d233-500x500.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1080&q=75 2x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fajmc%2F0e20514b3f4fc8c570e965e47c4c6f01add5d233-500x500.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1080&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain" loading="lazy"/></noscript></span></div><div id="image-caption" class="text-gray-500 italic"><div class="blockText_blockContent__TbCXh"><p class="pb-2">Gina Fusaro, PhD | Image credit: LinkedIn</p></div></div><div class="top-[-100%] block w-[1px] transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden"><img class="m-auto absolute inset-0 max-w-[0%] max-h-[0%] border-[3px] border-solid border-white shadow-[0px_0px_8px_rgba(0,0,0,0.3)] box-border transition ease-in-out duration-500" src="https://cdn.sanity.io/images/0vv8moc6/ajmc/0e20514b3f4fc8c570e965e47c4c6f01add5d233-500x500.jpg?fit=crop&auto=format"/></div></div><style> #image-caption p{ font-size: 12px; max-width: 525px; margin: 0 auto; text-align: center; } </style></div><p class="pb-2">“We believe subcutaneous nivolumab has the potential to make a significant difference in the lives of patients, which is reinforced by the FDA’s acceptance of our application,” Gina Fusaro, PhD, vice president, global program lead, BMS, said in the statement. “[Nivolumab] is a foundational PD-1 inhibitor approved for many different types of cancer, and our continued investment in research that puts patients first remains a priority.<sup class="text-inherit">2</sup></p><p class="pb-2"></p><p class="pb-2">“If approved by the FDA, the subcutaneous administration of nivolumab would provide patients and their physicians with a new option that delivers the same well-known benefits as IV [nivolumab] but with the improved convenience of an injection administered in 3-5 minutes rather than a 30-to-60-minute infusion.”<sup class="text-inherit">2</sup></p><p class="pb-2">The BLA is based on results from CheckMate-67T (NCT04810078), a phase 3 randomized trial that compared SC nivolumab and IV nivolumab in patients with advanced or metastatic clear cell renal cell carcinoma who had received prior systemic therapy. A total of 495 patients were evaluated. Coprimary endpoints are time-averaged serum concentration over 28 days and trough serum concentration at steady-state of SC nivolumab vs IV nivolumab. A key secondary endpoint is objective response rate (ORR).</p><p class="pb-2">Results were presented earlier this year at the 2024 <a rel="nofollow" target="_self" href="https://news.bms.com/news/corporate-financial/2024/Bristol-Myers-Squibb-Data-at-ASCO-GU-2024-Showcase-Transformative-Research-in-the-Treatment-of-Genitourinary-Cancers/default.aspx">American Society of Clinical Oncology Genitourinary Cancers Symposium</a> (ASCO GU), where data showed the study met both coprimary pharmacokinetic endpoints and its secondary endpoint of ORR, with response rates of 24.2% (95% CI, 19.0%-30.0%) for subcutaneous nivolumab vs 18.2% (95% CI, 13.6%-23.6%) for IV nivolumab.<sup class="text-inherit">3</sup></p><p class="pb-2">A key advantage of subcutaneous nivolumab, and this administration route generally, is the rapid time to give patients the drug. It only takes an average of 5 minutes to administer subcutaneous nivolumab, compared with 30 minutes for IV administration.</p><p class="pb-2">The possibility of faster administration times—without the need for an infusion center—could make the PD-1 inhibitor available to patients for whom access is difficult, including those in rural areas, an expert told the National Cancer Institute (NCI) earlier this year.<sup class="text-inherit">4</sup></p><p class="pb-2">“Subcutaneous immunotherapy is exciting on many fronts,” Mark Ball, MD, a kidney cancer expert in NCI’s Center for Cancer Research said in March. “We don't know if this is going to end up being a game changer or not, but it definitely has potential.”</p><p class="pb-2"></p><p class="pb-2"><strong>References</strong></p><p class="pb-2">1. Bristol Myers Squibb announced updated action date by the U.S. Food and Drug Administration for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. BMS website. Updated and accessed May 21, 2024. <a rel="nofollow" target="_self" href="https://bit.ly/3K7DO3s">https://bit.ly/3K7DO3s</a></p><p class="pb-2">2. U.S. Food and Drug Administration accepts Bristol Myers Squibb’s application for subcutaneous nivolumab (nivolumab and hyaluronidase). News Release. Bristol Myers Squibb. May 8, 2024. Accessed May 6, 2024. https://news.bms.com/news/details/2024/U.S.-Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-Application-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx</p><p class="pb-2">3. George S, Bourlon MT, Chacon MR, et al. Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): pharmacokinetics (PK), efficacy, and safety results from CheckMate 67T. J Clin Oncol. 2024;42(suppl 4). doi:0.1200/JCO.2024.42.4_suppl.LBA360</p><p class="pb-2">4. Jaber N. Nivolumab injections could make treatment easier for more people with cancer. National Cancer Institute. March 13, 2024. Accessed May 9, 2024. <a rel="nofollow" target="_self" href="https://www.cancer.gov/news-events/cancer-currents-blog/2024/kidney-cancer-subcutaneous-nivolumab">https://www.cancer.gov/news-events/cancer-currents-blog/2024/kidney-cancer-subcutaneous-nivolumab</a></p><p class="pb-2"></p></div></div><div class="flex items-center lg:w-3/4 mb-4 pb-12"></div><div class="jsx-19ede9f0a5a45918 py-4 relative bg-primary md:px-8 -ml-6 xs:ml-0 w-screen xs:w-auto"><div class="jsx-19ede9f0a5a45918 px-4 sm:px-0"><div class="flex justify-between items-center py-1 space-x-4 border-0 select-none sm:border-b border-secondary"><div class="text-3xl text-white text-lg sm:text-3xl">Related Videos</div></div></div><div style="scroll-snap-type:none" class="jsx-19ede9f0a5a45918 flex items-start overflow-x-auto space-x-4 py-4 relative mx-auto w-full pl-4"><a id="" class="w-[200px] h-fit space-y-3 flex-none select-none no-underline" style="scroll-snap-align:center;text-decoration:none" 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loading="lazy"/></noscript></span></div><div class="w-full flex-wrap text-center text-sm mt-4 font-light no-underline text-white"></div></a></div></div><div class="relative block sm:hidden"><div class="mt-4 overflow-hidden"><div class="flex justify-between"><div class="flex items-center clear-both pt-4 pb-2 text-3xl lg:text-2xl xl:text-3xl min-w-fit ">Related Content </div><div class="hidden lg:flex w-full flex-col justify-end items-end"><div class="hidden w-full lg:flex flex-wrap pb-2 gap-x-2 gap-y-1 justify-end items-end"></div></div></div><div class="w-full mb-2 border border-secondary"></div><div class="lg:hidden flex flex-wrap items-center"></div><div class="flex flex-wrap w-full"><div class="jsx-ad50481d5ee26850 w-full h-full"><div><div><div class="text-[8px] text-center text-gray-500 hidden">Advertisement</div><div id="div-gpt-ad-infeed-1"></div></div></div><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/early-palliative-care-linked-to-better-end-of-life-outcomes-in-ovarian-cancer?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/10079312e506a633cf4fcc09d893a56878bf8769-3407x2272.jpg?fit=crop&auto=format" alt="Palliative care | Image Credit: Chinnapong - stock.adobe.com" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">November 22nd 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/early-palliative-care-linked-to-better-end-of-life-outcomes-in-ovarian-cancer?utm_source=www.ajmc.com&utm_medium=relatedContent">Early Palliative Care Linked to Better End-of-Life Outcomes in Ovarian Cancer</a></p><div 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href="/view/frameworks-for-advancing-health-equity-wellness-way?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/a1728e6a06fccde8af20d2308f860344f9776b8f-800x400.jpg?fit=crop&auto=format" alt="Managed Care Cast" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">November 21st 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/frameworks-for-advancing-health-equity-wellness-way?utm_source=www.ajmc.com&utm_medium=relatedContent">Frameworks for Advancing Health Equity: Wellness Way</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/giuliana-grossi">Giuliana Grossi</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/frameworks-for-advancing-health-equity-wellness-way?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">The Wellness Way facility was designed to improve access to comprehensive outpatient care and address social determinants of health for a diverse patient population.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex md:hidden justify-center items-center"></div><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/to-improve-clinical-trial-equity-in-multiple-myeloma-just-ask?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/3e665a0c15a17fc3c7ade987a36f77617f865715-437x115.jpg?fit=crop&auto=format" alt="To Improve Clinical Trial Equity in Multiple Myeloma, Just Ask" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">November 22nd 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/to-improve-clinical-trial-equity-in-multiple-myeloma-just-ask?utm_source=www.ajmc.com&utm_medium=relatedContent">To Improve Clinical Trial Equity in Multiple Myeloma, Just Ask</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/mary-caffrey">Mary Caffrey</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/to-improve-clinical-trial-equity-in-multiple-myeloma-just-ask?utm_source=www.ajmc.com&utm_medium=relatedContent"></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/breaking-the-cycle-the-importance-of-early-intervention-in-hidradenitis-suppurativa?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/4d74ae04b0508977864936ec08f2aaa199758e5c-1000x563.jpg?fit=crop&auto=format" alt="Managed Care Cast" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">October 29th 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/breaking-the-cycle-the-importance-of-early-intervention-in-hidradenitis-suppurativa?utm_source=www.ajmc.com&utm_medium=relatedContent">Breaking the Cycle: The Importance of Early Intervention in Hidradenitis Suppurativa</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/giuliana-grossi">Giuliana Grossi</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/breaking-the-cycle-the-importance-of-early-intervention-in-hidradenitis-suppurativa?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">Prompt care supports mental well-being, as hidradenitis suppurativa is often associated with depression and anxiety due to its physical and social challenges.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/study-finds-obesity-may-worsen-multiple-sclerosis-genetic-analysis-points-to-causal-link?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/f49fc4ae0c0acf600f9f66fb2d4e59bbf7fec0e1-5000x3033.jpg?fit=crop&auto=format" alt="BMI - Olivier Le Moal" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">November 21st 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/study-finds-obesity-may-worsen-multiple-sclerosis-genetic-analysis-points-to-causal-link?utm_source=www.ajmc.com&utm_medium=relatedContent">Study Finds Obesity May Worsen Multiple Sclerosis: Genetic Analysis Points to Causal Link</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/kimberly-rath-pharmd">Kimberly Rath, PharmD</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/study-finds-obesity-may-worsen-multiple-sclerosis-genetic-analysis-points-to-causal-link?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">A new study aimed at exploring the relationship between obesity and multiple sclerosis severity using genetic data finds that higher BMI and other obesity measures were associated with increased disability progression in patients with MS.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/treating-double-exposed-patients-with-cll-a-continued-unmet-need?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/cc6ced98d5b353302d9801257a99e66403d946f7-1200x738.jpg?fit=crop&auto=format" alt="CLL over the image of a stethoscope and red blood cells | Image credit: Saiful52 - stock.adobe.com" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">November 21st 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/treating-double-exposed-patients-with-cll-a-continued-unmet-need?utm_source=www.ajmc.com&utm_medium=relatedContent">Treating Double-Exposed Patients With CLL: A Continued Unmet Need</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/gayle-turim-dickstein">Gayle Turim Dickstein</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/treating-double-exposed-patients-with-cll-a-continued-unmet-need?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">For patients with chronic lymphocytic leukemia (CLL) treated previously with venetoclax and Bruton’s tyrosine kinase inhibitors, many more trials are needed to pinpoint the best next steps </div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div></div></div></div><div class="relative hidden sm:block"><div class="mt-4 overflow-hidden"><div class="flex justify-between"><div class="flex items-center clear-both pt-4 pb-2 text-3xl lg:text-2xl xl:text-3xl min-w-fit ">Related Content </div><div class="hidden lg:flex w-full flex-col justify-end items-end"><div class="hidden w-full lg:flex flex-wrap pb-2 gap-x-2 gap-y-1 justify-end items-end"></div></div></div><div class="w-full mb-2 border border-secondary"></div><div class="lg:hidden flex flex-wrap items-center"></div><div class="flex flex-wrap w-full"><div class="jsx-ad50481d5ee26850 w-full h-full"><div><div><div class="text-[8px] text-center text-gray-500 hidden">Advertisement</div><div id="div-gpt-ad-infeed-1"></div></div></div><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/early-palliative-care-linked-to-better-end-of-life-outcomes-in-ovarian-cancer?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/10079312e506a633cf4fcc09d893a56878bf8769-3407x2272.jpg?fit=crop&auto=format" alt="Palliative care | Image Credit: Chinnapong - stock.adobe.com" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">November 22nd 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/early-palliative-care-linked-to-better-end-of-life-outcomes-in-ovarian-cancer?utm_source=www.ajmc.com&utm_medium=relatedContent">Early Palliative Care Linked to Better End-of-Life Outcomes in Ovarian Cancer</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/brooke-mccormick">Brooke McCormick</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/early-palliative-care-linked-to-better-end-of-life-outcomes-in-ovarian-cancer?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">Initiating palliative care more than 3 months before death improves end-of-life outcomes for patients with ovarian cancer, highlighting the need for earlier interventions.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/frameworks-for-advancing-health-equity-wellness-way?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/a1728e6a06fccde8af20d2308f860344f9776b8f-800x400.jpg?fit=crop&auto=format" alt="Managed Care Cast" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">November 21st 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/frameworks-for-advancing-health-equity-wellness-way?utm_source=www.ajmc.com&utm_medium=relatedContent">Frameworks for Advancing Health Equity: Wellness Way</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/giuliana-grossi">Giuliana Grossi</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/frameworks-for-advancing-health-equity-wellness-way?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">The Wellness Way facility was designed to improve access to comprehensive outpatient care and address social determinants of health for a diverse patient population.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex md:hidden justify-center items-center"></div><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/to-improve-clinical-trial-equity-in-multiple-myeloma-just-ask?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/3e665a0c15a17fc3c7ade987a36f77617f865715-437x115.jpg?fit=crop&auto=format" alt="To Improve Clinical Trial Equity in Multiple Myeloma, Just Ask" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">November 22nd 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/to-improve-clinical-trial-equity-in-multiple-myeloma-just-ask?utm_source=www.ajmc.com&utm_medium=relatedContent">To Improve Clinical Trial Equity in Multiple Myeloma, Just Ask</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/mary-caffrey">Mary Caffrey</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/to-improve-clinical-trial-equity-in-multiple-myeloma-just-ask?utm_source=www.ajmc.com&utm_medium=relatedContent"></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/breaking-the-cycle-the-importance-of-early-intervention-in-hidradenitis-suppurativa?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/4d74ae04b0508977864936ec08f2aaa199758e5c-1000x563.jpg?fit=crop&auto=format" alt="Managed Care Cast" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">October 29th 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/breaking-the-cycle-the-importance-of-early-intervention-in-hidradenitis-suppurativa?utm_source=www.ajmc.com&utm_medium=relatedContent">Breaking the Cycle: The Importance of Early Intervention in Hidradenitis Suppurativa</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/giuliana-grossi">Giuliana Grossi</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/breaking-the-cycle-the-importance-of-early-intervention-in-hidradenitis-suppurativa?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">Prompt care supports mental well-being, as hidradenitis suppurativa is often associated with depression and anxiety due to its physical and social challenges.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/study-finds-obesity-may-worsen-multiple-sclerosis-genetic-analysis-points-to-causal-link?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/f49fc4ae0c0acf600f9f66fb2d4e59bbf7fec0e1-5000x3033.jpg?fit=crop&auto=format" alt="BMI - Olivier Le Moal" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">November 21st 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/study-finds-obesity-may-worsen-multiple-sclerosis-genetic-analysis-points-to-causal-link?utm_source=www.ajmc.com&utm_medium=relatedContent">Study Finds Obesity May Worsen Multiple Sclerosis: Genetic Analysis Points to Causal Link</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/kimberly-rath-pharmd">Kimberly Rath, PharmD</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/study-finds-obesity-may-worsen-multiple-sclerosis-genetic-analysis-points-to-causal-link?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">A new study aimed at exploring the relationship between obesity and multiple sclerosis severity using genetic data finds that higher BMI and other obesity measures were associated with increased disability progression in patients with MS.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/treating-double-exposed-patients-with-cll-a-continued-unmet-need?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/cc6ced98d5b353302d9801257a99e66403d946f7-1200x738.jpg?fit=crop&auto=format" alt="CLL over the image of a stethoscope and red blood cells | Image credit: Saiful52 - stock.adobe.com" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">November 21st 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/treating-double-exposed-patients-with-cll-a-continued-unmet-need?utm_source=www.ajmc.com&utm_medium=relatedContent">Treating Double-Exposed Patients With CLL: A Continued Unmet Need</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/gayle-turim-dickstein">Gayle Turim Dickstein</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/treating-double-exposed-patients-with-cll-a-continued-unmet-need?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">For patients with chronic lymphocytic leukemia (CLL) treated previously with venetoclax and Bruton’s tyrosine kinase inhibitors, many more trials are needed to pinpoint the best next steps </div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div></div></div></div><div class="pb-24"></div></div><script type="application/ld+json">{"@context":"https://schema.org","@type":"NewsArticle","headline":"FDA Accepts Nivolumab Subcutaneous Injection Application, With Potential to Boost Access to PD-1 Inhibitors","datePublished":"2024-05-09T14:47:58.291Z","dateModified":"2024-05-21T13:40:00.000Z","inLanguage":"en-US","image":"https://cdn.sanity.io/images/0vv8moc6/ajmc/020de2a739acebd5b1504eaae11472ee817989eb-880x588.webp?fit=crop&auto=format","mainEntityOfPage":{"@type":"WebPage","@id":"https://www.ajmc.com/view/fda-accepts-nivolumab-subcutaneous-injection-application-with-potential-to-boost-access-to-pd-1-inhibitors"},"publisher":{"@type":"Organization","name":"AJMC","logo":{"@type":"ImageObject","url":"https://www.ajmc.com/ajmc_logo_inverted.png"}},"keywords":"nivolumab,subcutaneous,patient access,PD-1 inhibitors","articleBody":"This article has been updated to reflect a revised target action date.\n\nFDA has accepted Bristol Myer Squibb’s biologics license application (BLA) for its subcutaneous (SC) formulation of the nivolumab, which company officials say has the “potential” to be the first PD-1 inhibitor administered by subcutaneous injection if approved by its target action date, which has been advanced to December 29, 2024.1,2\n\nSold as Opdivo, the therapy is formulated with hyaluronidase to create subcutaneous (SC) nivolumab. According to a BMS statement, the BLA covers all previously approved indications for use of intravenous (IV) nivolumab as a monotherapy in adult solid tumors, and all approvals for monotherapy as a maintenance therapy following use of the combination nivolumab plus ipilimumab (Yervoy) or combinations with chemotherapy or cabozantinib (Cabometyx).\n\nAlthough some warn it’s too soon to say whether the shift to SC nivolumab will be a game-changer, leaders from BMS are enthusiastic about the BLA.\n\n\n\n“We believe subcutaneous nivolumab has the potential to make a significant difference in the lives of patients, which is reinforced by the FDA’s acceptance of our application,” Gina Fusaro, PhD, vice president, global program lead, BMS, said in the statement. “[Nivolumab] is a foundational PD-1 inhibitor approved for many different types of cancer, and our continued investment in research that puts patients first remains a priority.2\n\n\n\n“If approved by the FDA, the subcutaneous administration of nivolumab would provide patients and their physicians with a new option that delivers the same well-known benefits as IV [nivolumab] but with the improved convenience of an injection administered in 3-5 minutes rather than a 30-to-60-minute infusion.”2\n\nThe BLA is based on results from CheckMate-67T (NCT04810078), a phase 3 randomized trial that compared SC nivolumab and IV nivolumab in patients with advanced or metastatic clear cell renal cell carcinoma who had received prior systemic therapy. A total of 495 patients were evaluated. Coprimary endpoints are time-averaged serum concentration over 28 days and trough serum concentration at steady-state of SC nivolumab vs IV nivolumab. A key secondary endpoint is objective response rate (ORR).\n\nResults were presented earlier this year at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), where data showed the study met both coprimary pharmacokinetic endpoints and its secondary endpoint of ORR, with response rates of 24.2% (95% CI, 19.0%-30.0%) for subcutaneous nivolumab vs 18.2% (95% CI, 13.6%-23.6%) for IV nivolumab.3\n\nA key advantage of subcutaneous nivolumab, and this administration route generally, is the rapid time to give patients the drug. It only takes an average of 5 minutes to administer subcutaneous nivolumab, compared with 30 minutes for IV administration.\n\nThe possibility of faster administration times—without the need for an infusion center—could make the PD-1 inhibitor available to patients for whom access is difficult, including those in rural areas, an expert told the National Cancer Institute (NCI) earlier this year.4\n\n“Subcutaneous immunotherapy is exciting on many fronts,” Mark Ball, MD, a kidney cancer expert in NCI’s Center for Cancer Research said in March. “We don't know if this is going to end up being a game changer or not, but it definitely has potential.”\n\n\n\nReferences\n\n1. Bristol Myers Squibb announced updated action date by the U.S. Food and Drug Administration for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. BMS website. Updated and accessed May 21, 2024. https://bit.ly/3K7DO3s\n\n2. U.S. Food and Drug Administration accepts Bristol Myers Squibb’s application for subcutaneous nivolumab (nivolumab and hyaluronidase). News Release. Bristol Myers Squibb. May 8, 2024. Accessed May 6, 2024. https://news.bms.com/news/details/2024/U.S.-Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-Application-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx\n\n3. George S, Bourlon MT, Chacon MR, et al. Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): pharmacokinetics (PK), efficacy, and safety results from CheckMate 67T. J Clin Oncol. 2024;42(suppl 4). doi:0.1200/JCO.2024.42.4_suppl.LBA360\n\n4. Jaber N. Nivolumab injections could make treatment easier for more people with cancer. National Cancer Institute. March 13, 2024. Accessed May 9, 2024. https://www.cancer.gov/news-events/cancer-currents-blog/2024/kidney-cancer-subcutaneous-nivolumab\n\n","description":"Some experts believe offering a subcutaneous version of nivolumab could make PD-1 inhibitors available to new groups of patients who currently lack access, such as those in rural areas.","author":[{"@type":"Person","name":"Mary Caffrey"}]}</script></div></div><div class="flex-none w-[300px] z-[9999] relative hidden md:block"><div style="top:5rem" class="sticky custom-spacing"><div class="collapse-container " style="overflow:hidden;max-height:900px;transition:max-height .4s ease-in-out"></div></div></div></div><div id="div-gpt-ad-pixel" style="width:1px;height:1px" class=""></div><noscript><iframe src="https://www.googletagmanager.com/ns.html?id=GTM-NK5KQXS" height="0" width="0" style="display:none;visibility:hidden"></iframe></noscript><div id="footerOuterWrap" class=" mx-auto flex"><div class="bg-[#00598D] xl:w-[70%] w-[70%] py-12 pl-auto"><div 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A total of 495 patients were evaluated. Coprimary endpoints are time-averaged serum concentration over 28 days and trough serum concentration at steady-state of SC nivolumab vs IV nivolumab. 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","_key":"47b7d9f62cf3","_type":"span","marks":[]},{"_type":"span","marks":["9cd76d57c8d7","em"],"text":"JAMA Network Open","_key":"04a2945091fe1"},{"_type":"span","marks":["em"],"text":".","_key":"04a2945091fe2"},{"_type":"span","marks":["superscript"],"text":"1","_key":"5feef6d76042"}],"_type":"block"},{"_type":"block","style":"normal","_key":"1ee5b3253a12","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"160ef0928d3a0"}]},{"_type":"block","style":"normal","_key":"f32a2dfadafa","markDefs":[{"_key":"3061223e3188","nofollow":true,"blank":true,"_type":"link","href":"https://ascopubs.org/doi/10.1200/JCO.2016.70.1474?url_ver=Z39.88-2003\u0026rfr_id=ori:rid:crossref.org\u0026rfr_dat=cr_pub%20%200pubmed"}],"children":[{"_type":"span","marks":[],"text":"Alongside oncologic treatment, the American Society of Clinical Oncology ","_key":"47b818b3536c"},{"text":"recommends","_key":"400d18f91242","_type":"span","marks":["3061223e3188"]},{"_type":"span","marks":[],"text":" all patients with advanced cancer receive early, dedicated PC within 8 weeks of diagnosis.","_key":"3c3f8c52d151"},{"_type":"span","marks":["superscript"],"text":"2","_key":"10331c1f8bda"},{"_type":"span","marks":[],"text":" PC benefits include prolonged survival, enhanced quality of EOL care, and improved patient and caregiver quality of life (QOL).","_key":"baf479edd562"},{"_key":"4b27a522260c","_type":"span","marks":["superscript"],"text":"1"},{"_type":"span","marks":[],"text":" Early referral to specialist PC is also linked to less aggressive EOL care.","_key":"b06aae173c42"}]},{"style":"normal","_key":"72765f5e4071","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"b1bfc247e90c0"}],"_type":"block"},{"children":[{"_type":"span","marks":[],"text":"Despite experiencing a greater symptom burden earlier in their disease course than those with other solid tumors, the optimal timing for early PC initiation in patients with gynecologic cancers remains unclear. Previous studies suggest that increased PC access has not reduced EOL care intensity in this population, and late PC consultations have shown limited impact on EOL quality indicators. To address this, the researchers investigated the relationship between PC timing and EOL care aggression among decedents with ovarian cancer.","_key":"5d0e431a4d3b0"}],"_type":"block","style":"normal","_key":"b079ac496886","markDefs":[]},{"_key":"86cca2536299","disableLightBox":true,"alignment":"right","disableTextWrap":false,"imgcaption":[{"style":"normal","_key":"5a01164c8e9f","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Initiating palliative care more than 3 months before death improves end-of-life outcomes for patients with ovarian cancer. | Image Credit: Chinnapong - stock.adobe.com","_key":"3ced3ddb5ca2"}],"_type":"block"}],"alt":"Palliative care | Image Credit: Chinnapong - stock.adobe.com","widthP":40,"asset":{"_ref":"image-10079312e506a633cf4fcc09d893a56878bf8769-3407x2272-jpg","_type":"reference"},"_type":"figure"},{"children":[{"_type":"span","marks":[],"text":"They used linked administrative Institute for Clinical Evaluative Sciences (ICES) data to identify patients in Ontario, Canada, who died of ovarian cancer between 2006 and 2018, excluding those younger than 18 years or those who had invalid health card numbers. Patient health care numbers were then linked to various administrative databases to analyze diagnoses, procedures, chemotherapy use, and PC services.","_key":"aa20a1cce6620"}],"_type":"block","style":"normal","_key":"8bbc83f5dfec","markDefs":[]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"1876b2db10cb0"}],"_type":"block","style":"normal","_key":"bdb68c0c599c"},{"markDefs":[],"children":[{"marks":[],"text":"The researchers classified PC services as specialist or nonspecialist and institutional or community based, identifying them using validated administrative codes. Also, specialist PC initiation was defined as the first inpatient or outpatient consult, and late PC was defined as services provided within 3 months of death.","_key":"7f9791f6ff270","_type":"span"}],"_type":"block","style":"normal","_key":"afe7d572a8d6"},{"children":[{"_type":"span","marks":[],"text":"","_key":"4839959857c50"}],"_type":"block","style":"normal","_key":"9e1b5eafc0d8","markDefs":[]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Using these data, the researchers assessed EOL care quality indicators, with EOL defined as the final 30 days of life. Indicators were grouped into 2 categories: aggressive (multiple emergency department [ED] visits, hospitalizations, or intensive care unit [ICU] admissions) or supportive (physician house calls or palliative home care) care. They used multivariable logistic regression to examine the link between PC timing and EOL care, adjusting for comorbidities like cancer stage at diagnosis and age at death.","_key":"7a52942c10980"}],"_type":"block","style":"normal","_key":"825b7f599a23"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"e8d6bd7fc6f10"}],"_type":"block","style":"normal","_key":"e1fb240aeb34"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"The study population consisted of 8297 decedents with ovarian cancer. The mean (SD) length of oncologic survival was 2.8 (3.9) years, with the mean age at death being 69.6 (13.1) years. Of 3958 (47.7%) patients with available cancer stage data, 2366 and 1129 presented with stage III and IV disease, respectively.","_key":"1d10a2cf6f5c0"}],"_type":"block","style":"normal","_key":"a85387614c90"},{"_type":"block","style":"normal","_key":"76e57edf0d39","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"cd758292073c0"}]},{"_type":"block","style":"normal","_key":"a458e04b64f7","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Also, 7970 (96.1%) patients initiated PC a median (IQR) of 238 (55-633) days before death. PC was initiated late for 2667 patients (32.1%), with 1304 (15.7%) doing so in the final 30 days of life and 1363 (16.4%) between 1 and 3 months before death.","_key":"412bfdd6d84e0"}]},{"children":[{"text":"","_key":"28a63867284a0","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"27b14e0de596","markDefs":[]},{"_type":"block","style":"normal","_key":"b4632265d2e0","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Compared with those with earlier PC, decedents who initiated PC late had higher rates of the following individual aggressive EOL care quality indicators: ED visits in the final 14 days of life (43.1% vs 25.2%-30.7%), new hospitalization in the final 30 days of life (68.3% vs 42.0%-50.2%), new ICU admission in the final 30 days of life (8.9% vs 2.8%-3.7%), late chemotherapy (7.8% vs 4.2%-4.6%), and death in the hospital (56.3% vs 36.7%-38.3%).","_key":"e68c92bcf8e60"}]},{"children":[{"_type":"span","marks":[],"text":"","_key":"e65a9050f77d0"}],"_type":"block","style":"normal","_key":"ffdbda754636","markDefs":[]},{"children":[{"_type":"span","marks":[],"text":"Overall, 29.7% of those with late PC experienced aggressive EOL care vs 15.8% to 18.2% of those with earlier PC. More specifically, decedents with PC from 3 to 6 months before death were significantly less likely to receive aggressive EOL care (OR, 0.47; 95% CI, 0.37-0.60), be admitted to the ICU in their final 30 days (OR, 0.46; 95% CI, 0.27-0.76), or die in the hospital (OR, 0.54; 95% CI, 0.45-0.65) than those with late PC.","_key":"8c98bed5a39e0"}],"_type":"block","style":"normal","_key":"410418d28c11","markDefs":[]},{"markDefs":[],"children":[{"text":"","_key":"017f716d70c60","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"1f2e03695990"},{"style":"normal","_key":"e18859042cd9","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Only 4298 patients (51.8%) received a specialist PC consultation. Compared with those who received late specialist PC, patients who received specialist PC between 3 to 6 months before death were less likely to receive supportive EOL care (OR, 1.52; 95% CI, 1.23-1.88) and less likely to die in the hospital (OR, 0.66; 95% CI, 0.54-0.79).","_key":"e0f910ebc7480"}],"_type":"block"},{"children":[{"_type":"span","marks":[],"text":"","_key":"e9e230a65fd60"}],"_type":"block","style":"normal","_key":"9bd5016efa45","markDefs":[]},{"_key":"f0c8dbe7d0b5","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Also, only patients who received specialist PC 3 to 6 months before death were significantly less likely to receive late chemotherapy than those who received late specialist PC (OR, 0.46; 95% CI, 0.24-0.88). However, patients who did not receive a specialist PC consultation were at the highest risk of receiving late chemotherapy (OR, 1.78; 95% CI, 1.30-2.42).","_key":"83a0341a44c80"}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"_key":"44fd1b2d87230","_type":"span","marks":[],"text":""}],"_type":"block","style":"normal","_key":"003fc88aebed"},{"_key":"e00c2c9eebfa","markDefs":[],"children":[{"_type":"span","marks":[],"text":"The researchers acknowledged their study’s limitations, one being using data solely on patients within Ontario, Canada. Consequently, their findings may not be generalizable to other health care jurisdictions. However, they expressed confidence in them, suggesting earlier PC initiation for optimized care quality.","_key":"df5de9c70d8d0"}],"_type":"block","style":"normal"},{"children":[{"_type":"span","marks":[],"text":"","_key":"7b64ac6fafe70"}],"_type":"block","style":"normal","_key":"f96540196c48","markDefs":[]},{"children":[{"_type":"span","marks":[],"text":"\"...early PC may be associated with less-aggressive EOL care than late palliative care,” the authors concluded. “Implementation strategies for early PC initiation are needed to optimize care quality and health resource utilization at the EOL.”","_key":"e63726d53c6f0"}],"_type":"block","style":"normal","_key":"1373d244219a","markDefs":[]},{"markDefs":[],"children":[{"marks":[],"text":"","_key":"61af6b5cb8f40","_type":"span"}],"_type":"block","style":"normal","_key":"bb560f93907e"},{"style":"normal","_key":"65b104f3ff4b","markDefs":[],"children":[{"text":"References","_key":"782b8e2a58df0","_type":"span","marks":["strong"]}],"_type":"block"},{"markDefs":[],"children":[{"text":"1. Mah SJ, Carter Ramirez DM, Schnarr K, Eiriksson LR, Gayowsky A, Seow H. Timing of palliative care, end-of-life quality indicators, and health resource utilization. JAMA Netw Open. 2024;7(10):e2440977. doi:10.1001/jamanetworkopen.2024.40977","_key":"935e9b2fd8790","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"dcbb06608d6f"},{"children":[{"_type":"span","marks":[],"text":"2. Ferrell BR, Temel JS, Temin S, et al. Integration of palliative care into standard oncology care: American Society of Clinical Oncology Clinical Practice Guideline update. 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The study, published in ","_key":"07f166e3957e","_type":"span","marks":[]},{"_type":"span","marks":["em","e477b2c0d4c4"],"text":"Annals of Neurology","_key":"c458f39bee97"},{"_type":"span","marks":[],"text":", aimed to build on findings from the largest genome-wide association study (GWAS) of MS severity to date, which provided extensive data but initially found no confirmed link between body mass index (BMI) and MS severity.","_key":"b97401ee75ae"},{"_type":"span","marks":["superscript"],"text":"1","_key":"987d9c9cf5c2"}],"_type":"block","style":"normal","_key":"3085007ac895","markDefs":[{"href":"https://pubmed.ncbi.nlm.nih.gov/39431322/","_key":"e477b2c0d4c4","nofollow":true,"blank":true,"_type":"link"},{"nofollow":false,"blank":true,"_type":"link","href":"https://www.ajmc.com/compendium/multiple-sclerosis","_key":"712b100b2dce"},{"_type":"link","href":"https://www.ajmc.com/compendium/obesity","_key":"21f0c132d592","nofollow":false,"blank":true}]},{"markDefs":[],"children":[{"text":"","_key":"905b9da3c19f","_type":"span","marks":["superscript"]}],"_type":"block","style":"normal","_key":"074fbf772265"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"“Results showed a significant association between higher genetically-determined body mass index and increased MS severity (","_key":"ba9d2f8d910e0"},{"_key":"db363fde6b6f","_type":"span","marks":["em"],"text":"P"},{"_type":"span","marks":[],"text":" = .02),” the researchers noted, adding that “The convergence of this genetic evidence with prior observational studies strengthens the association between obesity and adverse long-term disability in MS.”","_key":"fd902474a8e0"}],"_type":"block","style":"normal","_key":"de1be0fc31c0"},{"children":[{"text":"","_key":"144a87d1c301","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"13219009bc06","markDefs":[]},{"_type":"block","style":"normal","_key":"85aa5e34ee1b","markDefs":[],"children":[{"_type":"span","marks":[],"text":"For this study, researchers updated the statistical power and expanded the analysis of the original GWAS of MS severity data to incorporate a range of obesity measures beyond BMI, providing a more comprehensive view of how different aspects of obesity might impact disease progression in patients with MS .","_key":"d833443126e10"},{"_type":"span","marks":["superscript"],"text":"2","_key":"d45390949133"}]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"c9866c455dd4"}],"_type":"block","style":"normal","_key":"bb2fca8fc541"},{"_type":"block","style":"normal","_key":"1d13d0dd6e31","markDefs":[],"children":[{"_type":"span","marks":[],"text":"A larger GWAS with 806,834 participants was used to identify relevant genetic variants associated with obesity traits, which served as proxies for obesity in the analysis.","_key":"d3378c9c38280"},{"_type":"span","marks":["superscript"],"text":"3","_key":"ac7d68546260"},{"text":" “Mendelian randomization (MR), a technique that uses genetic variants as proxies for risk factors, allowed us to overcome confounding factors and reverse causality,” the authors explained. The original GWAS of 12,584 individuals with MS was then examined using MR to determine the effects of various obesity measures, including adipose distribution, on MS severity and progression.","_key":"ac4220049d12","_type":"span","marks":[]},{"_type":"span","marks":["superscript"],"text":"1","_key":"d1fd4fea426d"}]},{"children":[{"_type":"span","marks":[],"text":"","_key":"5b5df4b8998e"}],"_type":"block","style":"normal","_key":"becdbf145cdc","markDefs":[]},{"style":"normal","_key":"b273141ed207","markDefs":[],"children":[{"text":"The primary analysis showed that each standard deviation increase in BMI was associated with a 0.08-point increase in MS severity scores (","_key":"8d9a4ed165a60","_type":"span","marks":[]},{"_type":"span","marks":["em"],"text":"P","_key":"03574fdcb0c7"},{"_type":"span","marks":[],"text":" = .02). This association was measured using the Age-Related Multiple Sclerosis Severity Score (ARMSS). In addition to BMI, other measures of obesity, such as whole-body fat mass (WBF), body fat percentage (BFP), trunk fat percentage (TFP), and trunk fat mass (TFM), showed a positive correlation with MS severity. However, only WBF had a significant association (β = 0.08, ","_key":"191d3608eaef"},{"_type":"span","marks":["em"],"text":"P","_key":"7879c5db5fe7"},{"_key":"6c3a4575e85c","_type":"span","marks":[],"text":" = .04). “Similar to BMI, we observed no heterogeneity, a null MR-Egger intercept, and a significant RAPS estimate (β = 0.08, "},{"text":"P","_key":"15d80ce6ef6e","_type":"span","marks":["em"]},{"text":" = .039),” the authors noted. The study found no significant association between MS severity and measures of fat distribution, such as waist-hip ratio adjusted for BMI and visceral adipose tissue.","_key":"9744730dec94","_type":"span","marks":[]}],"_type":"block"},{"children":[{"text":"","_key":"b2164f8e325b","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"9f9339e99f50","markDefs":[]},{"_key":"f5e39dd28881","markDefs":[],"children":[{"_type":"span","marks":[],"text":"While the study offers additional insights into the link between obesity and MS severity, the authors note several limitations. First, despite the robust MR approach, the analysis cannot fully eliminate the risk of pleiotropy, where genetic variants may influence MS severity through pathways other than obesity. Additionally, the genetic associations with MS severity were derived from data that did not stratify participants by sex, limiting the ability to examine potential sex-based differences. Collider bias, where obesity influences both MS onset and severity, remains a potential confounding factor despite efforts to account for it.","_key":"c52b260837620"}],"_type":"block","style":"normal"},{"style":"normal","_key":"dc2101b5f307","markDefs":[],"children":[{"marks":[],"text":"","_key":"1b271301d8f7","_type":"span"}],"_type":"block"},{"_key":"0ba1285764fa","markDefs":[],"children":[{"_key":"b66085da2fac0","_type":"span","marks":[],"text":"Obesity, which is a well-known risk factor for several autoimmune and inflammatory diseases, has been associated with MS onset in past research, with adolescent obesity nearly doubling the risk of developing the disease."},{"_key":"dc434601267b","_type":"span","marks":["superscript"],"text":"4"},{"_key":"c1178b76be6a","_type":"span","marks":[],"text":" However, the effect of obesity on MS prognosis and progression has remained less clear."},{"_type":"span","marks":["superscript"],"text":"5","_key":"a9282fbae0a7"},{"marks":[],"text":" The data from this study aligns with a previous prospective longitudinal study of 1,066 MS patients with a BMI ≥30 kg/m² at onset, which linked obesity to higher EDSS scores and a shorter time to reach EDSS 3.","_key":"0a3ffb8068fe","_type":"span"},{"_key":"959538bb7db5","_type":"span","marks":["superscript"],"text":"6"}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"_type":"span","marks":["superscript"],"text":"","_key":"a0f2dbd8d57d"}],"_type":"block","style":"normal","_key":"89d965c0dab1"},{"_key":"6b4b0dca2055","markDefs":[],"children":[{"_type":"span","marks":[],"text":"“This study provides MR evidence that strengthens the association between obesity and greater long-term disability in MS, identifying obesity as a potentially modifiable risk factor whose management could alleviate the severity of MS,\" the original authors wrote.","_key":"48526c7548d30"},{"_type":"span","marks":["superscript"],"text":"1","_key":"40f0d7aaeb33"},{"_type":"span","marks":[],"text":" \"To this end, the emergence of drug therapies targeting obesity presents a potential strategy for people with MS and co-morbid obesity.\"","_key":"08bdedb61c67"}],"_type":"block","style":"normal"},{"children":[{"_type":"span","marks":[],"text":"","_key":"28f4d4d7da39"}],"_type":"block","style":"normal","_key":"152050a98420","markDefs":[]},{"children":[{"_type":"span","marks":["strong"],"text":"References","_key":"5d84b981d0370"}],"_type":"block","style":"normal","_key":"8dfbf59698cf","markDefs":[]},{"_type":"block","style":"normal","_key":"e6c99f6f5182","markDefs":[],"children":[{"_type":"span","marks":[],"text":"1. Alzamanan F, Ding Y, Harroud A. Obesity and multiple sclerosis severity: a Mendelian randomization study. Ann Neurol. Published online October 21, 2024. doi:10.1002/ana.27112","_key":"6dfc1d91c59e0"}]},{"markDefs":[],"children":[{"text":"2. International Multiple Sclerosis Genetics Consortium; MultipleMS Consortium. Locus for severity implicates CNS resilience in progression of multiple sclerosis. Nature. 2023;619(7969):323-331. doi:10.1038/s41586-023-06250-x","_key":"c56ac1301fe90","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"222ab0807944"},{"markDefs":[],"children":[{"text":"3. Pulit SL, Stoneman C, Morris AP, et al; GIANT Consortium. Meta-analysis of genome-wide association studies for body fat distribution in 694,649 individuals of European ancestry. Hum Mol Genet. 2019;28(1):166-174. doi:10.1093/hmg/ddy327","_key":"d17b6ca627860","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"98c447a2eac1"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"4. Munger KL, Chitnis T, Ascherio A. Body size and risk of MS in two cohorts of US women. Neurology. 2009;73:1543-1550. doi:10.1212/WNL.0b013e3181c0d6e0","_key":"caae1ddcbfce0"}],"_type":"block","style":"normal","_key":"c0df065eea04"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"5. Manuel Escobar J, Cortese M, Edan G, et al. Body mass index as a predictor of MS activity and progression among participants in BENEFIT. Mult Scler. 2022;28(8):1277-1285. doi:10.1177/13524585211061861","_key":"8d4bcbc03a2a0"}],"_type":"block","style":"normal","_key":"2afdef395764"},{"markDefs":[],"children":[{"text":"6. Lutfullin I, Eveslage M, Bittner S, et al. Association of obesity with disease outcome in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2023;94(1):57-61. doi:10.1136/jnnp-2022-329685","_key":"b27a363ed1320","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"9d86f9bb458b"}],"factCheckAuthors":null,"documentGroupMapping":null,"ExcludeFromPubMedXML":false,"authors":[{"displayName":"Kimberly Rath, PharmD","url":"kimberly-rath-pharmd"}],"factCheckAuthorMapping":null,"documentGroup":null,"_type":"article","_id":"790a2cba-4686-416c-93be-f95308611e1a","gptSummary":"A recent study from McGill University establishes a link between obesity and increased severity of multiple sclerosis (MS). Utilizing Mendelian randomization, researchers found a significant association between higher genetically-determined body mass index (BMI) and MS severity. The study expanded on previous genome-wide association studies (GWAS) by incorporating various obesity measures, revealing that whole-body fat mass (WBF) significantly correlates with MS severity. Despite limitations like potential pleiotropy and collider bias, the findings suggest obesity as a modifiable risk factor, highlighting the potential of obesity-targeting therapies in managing MS severity.","articleType":"News","url":"study-finds-obesity-may-worsen-multiple-sclerosis-genetic-analysis-points-to-causal-link","authorMapping":[{"_createdAt":"2024-04-12T12:56:17Z","_rev":"qNe2e9NrqyCsTecezTdgy6","_type":"author","_id":"9b4faadd-6cd1-4c3e-8bc2-48c752241cea","biography":[{"children":[{"_type":"span","marks":[],"text":"Kimberly Rath, PharmD, is a freelance health writer who previously worked as a clinical pharmacist with Elevance Health for a decade. She has also worked for Amerigroup and Sentara Group.","_key":"19953fe47e02"}],"_type":"block","style":"normal","_key":"7a10018db04a","markDefs":[]}],"_updatedAt":"2024-04-12T12:56:17Z","url":{"current":"kimberly-rath-pharmd","_type":"slug"},"displayName":"Kimberly Rath, PharmD"}],"_rev":"EbkpNMUbiIwDU1ASli3bby","gptTakeaways":"• Mendelian randomization revealed a significant link between higher genetically-determined BMI and increased MS severity, strengthening previous observational findings.\n\n• Expanded analysis included various obesity measures, with whole-body fat mass showing a significant correlation with MS severity.\n\n• Limitations include potential pleiotropy, lack of sex-based stratification, and collider bias, which may confound results.\n\n• Obesity is identified as a modifiable risk factor, suggesting potential benefits of obesity-targeting therapies in managing MS severity.","_createdAt":"2024-11-21T17:17:27Z","taxonomyMapping":[{"name":"News","_updatedAt":"2022-01-19T10:20:16Z","_createdAt":"2020-03-30T18:05:45Z","_rev":"OU32WOWh4YetHW0RkWbkso","parent":null,"_type":"taxonomy","_id":"39be7351-bd4c-4e98-82b3-0d675ae4671b","identifier":"news","pixelTrackingCode":null},{"_rev":"J9E0v654gKdSlGLhTDBh6q","identifier":"multiple-sclerosis","_id":"compendium_multiple-sclerosis","pixelTrackingCode":null,"name":"Multiple Sclerosis","_updatedAt":"2023-11-03T18:04:41Z","perKeywordMapping":["Neurology","Health Equity Diversity \u0026 Inclusion"],"cmeType":"per","_createdAt":"2020-04-14T15:02:13Z","_type":"taxonomy","summary":[{"_key":"a7e5eacaeb67","markDefs":[],"children":[{"marks":[],"text":"The ","_key":"4f2a0e6ffbb0","_type":"span"},{"_type":"span","marks":["em"],"text":"AJMC","_key":"5a5093331326"},{"_type":"span","marks":["superscript"],"text":"®","_key":"558548d9e407"},{"_type":"span","marks":[],"text":" Multiple Sclerosis compendium is a comprehensive resource for clinical news and expert insights for the disabling disease that impacts the brain and spinal cord.","_key":"171e0c38af85"}],"_type":"block","style":"normal"}],"parent":{"_rev":"oruil6rlosjyltJbhrNMGF","_type":"taxonomy","parent":null,"isMainTopic":true,"_createdAt":"2020-03-30T18:16:46Z","name":"Compendium","_id":"297fa3d1-5216-46eb-bf51-66c5f77c3c8a","_updatedAt":"2024-04-09T09:14:18Z","identifier":"compendium"}},{"summary":[{"children":[{"_key":"e80c79954e08","_type":"span","marks":[],"text":"The "},{"_type":"span","marks":["em"],"text":"AJMC","_key":"a8e0f75c5d05"},{"_type":"span","marks":["superscript"],"text":"®","_key":"f7d4dddf7edd"},{"_type":"span","marks":[],"text":" clinical page includes all the published content across AJMC.com, ","_key":"0f03d46e3b3a"},{"_type":"span","marks":["em"],"text":"The American Journal of Managed Care","_key":"cc409f2da7da"},{"_key":"2babb3e59bb3","_type":"span","marks":["superscript"],"text":"®"},{"_type":"span","marks":[],"text":" and ","_key":"d86a5bb12052"},{"text":"Evidence-Based Oncology","_key":"40b2eaba6c17","_type":"span","marks":["em"]},{"_type":"span","marks":[],"text":"™ on a variety of specialties, including dermatology, cardiology, oncology, and rheumatology.","_key":"b59bef533cdf"}],"_type":"block","style":"normal","_key":"dd8ad578cd0b","markDefs":[]}],"identifier":"clinical","parent":{"parent":null,"_createdAt":"2020-03-31T14:24:50Z","_rev":"SpZIJtjiAn4ebHE4u6sWYc","_type":"taxonomy","name":"Topic","_id":"15012229-f713-4f0a-8f82-7667530bb382","_updatedAt":"2021-10-21T10:15:35Z","identifier":"topic","isMainTopic":true},"pixelTrackingCode":null,"_createdAt":"2020-05-04T23:46:13Z","_id":"topic_clinical","name":"Clinical","_updatedAt":"2022-02-18T12:13:55Z","_rev":"HexDiduX8d6Nqnq1ECriVF","_type":"taxonomy"}],"contentCategory":{"_id":"3f4b3ced-7c9d-4fc4-967f-fe993087cce2","_updatedAt":"2023-09-29T14:32:27Z","_createdAt":"2020-04-03T20:03:53Z","_rev":"Q2ZL7ihdIB33NiMMcGccmh","_type":"contentCategory","name":"Articles"},"drugMentions":"{\"drug_mentions\": []}","targeting":{"content_placement":["news","compendium/multiple-sclerosis","topic/clinical"],"document_url":["study-finds-obesity-may-worsen-multiple-sclerosis-genetic-analysis-points-to-causal-link"],"document_group":null,"rootDocumentGroup":[],"issue_url":"","publication_url":""},"relatedArticles":[{"title":"In-Room Air Purifiers Could Impact RSV Incidence Among Older Adults","url":{"current":"in-room-air-purifiers-could-impact-rsv-incidence-among-older-adults","_type":"slug"},"thumbnail":{"alt":"Air purifier | Image credit: Prathankarnpap - 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These clinical data are very limited, though, the authors noted.","_key":"acd8cd0adc760"}],"_type":"block","style":"normal","_key":"ad9f777e254c"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"2ce8644fb5b80"}],"_type":"block","style":"normal","_key":"1b97c0da7d64"},{"_type":"block","style":"normal","_key":"db120b9e001d","markDefs":[],"children":[{"_type":"span","marks":[],"text":"“Available treatment options for patients who fail on BTKi and BCL2 inhibitors highlight a significant unmet need,” they emphasized, echoing previous researchers.","_key":"73f41ad4ed750"},{"text":"2,3","_key":"e98f391998d2","_type":"span","marks":["superscript"]},{"_type":"span","marks":[],"text":" “Carefully designed clinical trials with balanced treatment groups should be commissioned to better understand the efficacy outcomes in double-exposed patients.”","_key":"9bca0777a650"}]},{"_type":"block","style":"normal","_key":"85d1830766a7","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"1a762a86ed470"}]},{"markDefs":[],"children":[{"_key":"a69b22afb0f00","_type":"span","marks":[],"text":"What the Literature Revealed"}],"_type":"block","style":"h3","_key":"9c8c6cc1f60b"},{"_key":"fed462a09a87","markDefs":[],"children":[{"_type":"span","marks":[],"text":"An exhaustive database search resulted in 13 publications based on 9 different studies: 5 single-arm clinical trials (all phase I or II) and 4retrospective observational studies. Each clinical trial included between 4 and 100 patients (generally, the double-exposed cohort was a subgroup) and the observational studies each included between11 and 125.","_key":"c2fe208eaafe0"}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"f32d2a7838b00"}],"_type":"block","style":"normal","_key":"cd40c107e88e"},{"children":[{"_type":"span","marks":[],"text":"The authors reported their findings organized by the 9 classes of treatment received by the double-exposed patients with CLL or small lymphocytic lymphoma.The overall poor prognoses exist no matter what the reasons were for discontinuation of venetoclax or BTKi, said the authors. They added that since the results they presented were all from either single-arm or observational studies, outcomes could be confounded by patient characteristics.","_key":"de9a1e523c750"}],"_type":"block","style":"normal","_key":"56ef87465aeb","markDefs":[]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"66f1ee0d55c40"}],"_type":"block","style":"normal","_key":"b528a4af4bd2"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"The 9 studies covered these treatments:","_key":"dad886db7f7a0"}],"_type":"block","style":"normal","_key":"df88236c606d"},{"markDefs":[],"children":[{"_key":"f4816cfa09220","_type":"span","marks":[],"text":""}],"_type":"block","style":"normal","_key":"15e1b383167f"},{"children":[{"_type":"span","marks":["strong"],"text":"Noncovalent BTKi.","_key":"cd9f3d261f920"},{"_type":"span","marks":[],"text":" One clinical trial each assessed the efficacy of pirtobrutinib and nemtabrutinib, both noncovalent BTKi. With pirtobrutinib, after a median follow-up of 18.2 months, the patients’ median progression-free survival (PFS) was 16.8 months. The overall response rate (ORR) was 70%.In the nemtabrutinib trial, at the 8.1-month follow-up, the patients’ median PFS was 10.1 months; the ORR was 58%.","_key":"f0a75260084b"}],"_type":"block","style":"normal","_key":"03b846108942","markDefs":[]},{"markDefs":[],"children":[{"_key":"555d1a7292f80","_type":"span","marks":[],"text":""}],"_type":"block","style":"normal","_key":"89c10238d451"},{"children":[{"_key":"7ad1670528a30","_type":"span","marks":["strong"],"text":"Chimeric antigen receptor T-cell therapy (CAR T)."},{"_key":"83627f54f85f","_type":"span","marks":[],"text":" Two clinical trials and 3 observational studies assessed the efficacy and effectiveness of CAR T in this population. In the first clinical trial, assessing lisocabtagene maraleucel, the ORR was 80% (complete response [CR], 60%; partial response [PR], 20%). At 11 months of follow-up, the median PFS was 13 months.The second clinical trial’s results showed that the ORR of patients treated with anti-CD19 CAR T cells was 50% (all PRs)."}],"_type":"block","style":"normal","_key":"65f97f7d9c11","markDefs":[]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"c656313014720"}],"_type":"block","style":"normal","_key":"f2a0a8465706"},{"markDefs":[],"children":[{"marks":[],"text":"No survival outcomes were reported in the 3 observational studies. Regarding response outcomes, in the first, the ORR was 85.7% at 3 months follow-up.The second reported a CR in 50% of the patients. The ORR was 66.6% (CR, 33.3%; PR, 33.3%) in the third.","_key":"8b5674b468ec0","_type":"span"}],"_type":"block","style":"normal","_key":"691d1f022398"},{"style":"normal","_key":"c2acefc12c85","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"5ea226db2ea00"}],"_type":"block"},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Retreatment with BTKi.","_key":"497c525682dd0"},{"_key":"c05df9860490","_type":"span","marks":[],"text":" Two retrospective studies sought to ascertain the effectiveness of retreatment with drugs in this category.In one, patients treated with BTKi that included ibrutinib, acalabrutinib, and noncovalent BTKi had a collective ORR of 53.7%. In the other, PFS was 12 months and theORR was 53.4% (CR, 10%; PR, 26.7%)."}],"_type":"block","style":"normal","_key":"2a063c2ba09c"},{"children":[{"text":"","_key":"ca29dfb9dd620","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"72500a5f1fc3","markDefs":[]},{"_key":"b14717c89325","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"PI3K inhibitors.","_key":"c673e807eee00"},{"_type":"span","marks":[],"text":" Two observational studies reported effectiveness results. In one, at 4 months follow-up, the PFS was 5 months and the ORR was 40.9%. In the other, a retrospective study, the median PFS was5 months and the ORR was 44.6% (CR, 5.9%; PR, 35.2%).","_key":"0e285d48626b"}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"870bcc9b28940"}],"_type":"block","style":"normal","_key":"70e79532fb7a"},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"BTKi combination retreatment. ","_key":"bb07b99167550"},{"_type":"span","marks":[],"text":"Again, 2 observational studies reported effectiveness results. A retrospective study assessed the effectiveness of ibrutinib with venetoclax combination retreatment in these double-exposed patients.At a median follow-up of 23.8 months, the median OS was 27 months, and all patients had a response (CR, 55%; PR, 45%). A second retrospective study, of just 2 patients, assessed the effectiveness of acalabrutinib plus obinutuzumab and found that 1 patient had an objective response.","_key":"f9526eb9d07e"}],"_type":"block","style":"normal","_key":"2fc74e3bfc19"},{"children":[{"_type":"span","marks":[],"text":"","_key":"b8a6139971ea0"}],"_type":"block","style":"normal","_key":"9b42f22b189e","markDefs":[]},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"BCL2 retreatment.","_key":"514b8254af420"},{"_type":"span","marks":[],"text":" In a study assessing effectiveness of venetoclax retreatment,the medianPFS was 14 months and the ORR was 40%.","_key":"29a6fd1f4a21"}],"_type":"block","style":"normal","_key":"bd693443191e"},{"markDefs":[],"children":[{"text":"","_key":"6b5d1aa9f6490","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"13e173023196"},{"markDefs":[],"children":[{"_key":"ce0d8453cb900","_type":"span","marks":["strong"],"text":"Allogeneic stem cell transplantation. "},{"_type":"span","marks":[],"text":"A study following patients who had undergone this treatment found that after 6.5 months, the median PFS was 11 months and the ORR was 76.5%.","_key":"4a57174822a0"}],"_type":"block","style":"normal","_key":"51376008dce0"},{"_key":"ad20097a0df9","markDefs":[],"children":[{"_key":"d2a38834336a0","_type":"span","marks":[],"text":""}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Chemoimmunotherapy.","_key":"3b98cee8f65a0"},{"_type":"span","marks":[],"text":" One observational study reported the effectiveness of chemoimmunotherapy in this population, finding that at a median follow-up of 2 months, the ORR was 31.8%.","_key":"c9e49172c1a9"}],"_type":"block","style":"normal","_key":"9635ee9a4eee"},{"_type":"block","style":"normal","_key":"d934ae78ee13","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"465b54af01e70"}]},{"style":"normal","_key":"e388c25456e4","markDefs":[],"children":[{"_key":"e2d442c3b04d0","_type":"span","marks":["strong"],"text":"Bispecific CD20-directed CD3 T-cell engager. "},{"_type":"span","marks":[],"text":"Efficacy results for subcutaneous epcoritamab were explored in a study that found that at 9.3 months of follow-up, the ORR was 53% (CR,27%; PR, 26%).","_key":"9f0b9c7650ba"}],"_type":"block"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"88e8253cb0be0"}],"_type":"block","style":"normal","_key":"b884d9a22f36"},{"_key":"436263b6effe","markDefs":[],"children":[{"marks":[],"text":"","_key":"a8a3bc4460a70","_type":"span"}],"_type":"block","style":"normal"},{"_key":"4c435c4446aa","markDefs":[],"children":[{"_type":"span","marks":[],"text":"References","_key":"de4d29c64e580"}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"1. Zuber M, Akkala S, Li N, Veettil SK, Tan CJ, Zapata LV. Efficacy and effectiveness outcomes of treatments for double-exposed chronic lymphocytic leukemia and small lymphocytic lymphoma patients: a systematic literature review. Cancer Med. 2024;13(18):e70258.doi:10.1002/cam4.70258","_key":"f5cbc3a303520"}],"_type":"block","style":"normal","_key":"fd1ef7fad0ce"},{"style":"normal","_key":"16e082b16ca5","markDefs":[],"children":[{"text":"2. Aronson JH, Skånland SS, Roeker LE, Thompson MC, Mato AR. Approach to a patient with “double refractory” chronic lymphocytic leukemia: “double, double toil and trouble” (Shakespeare).Am J Hematol. 2022:97 Suppl 2:S19-S25. doi:10.1002/ajh.26682","_key":"2132d6e1fa8b0","_type":"span","marks":[]}],"_type":"block"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"3. Zygmunciak P, Robak T, Puła B. 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