{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T23:50:38Z","timestamp":1777420238290,"version":"3.51.4"},"reference-count":25,"publisher":"SAGE Publications","issue":"11","license":[{"start":{"date-parts":[[2024,3,27]],"date-time":"2024-03-27T00:00:00Z","timestamp":1711497600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2024,11]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>The aims of this article are to review the clinical aspects of rozanolixizumab, to describe clinical trial results that led to the drug\u2019s approval, and to examine the impact on patient care to aid clinical decision making.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Sources:<\/jats:title>\n                    <jats:p>A PubMed search was conducted using the terms Rystiggo\u2122, rozanolixizumab, rozanolixizumab therapy, and myasthenia gravis. The most recent prescribing information was also used for information relating to the drug and for identification of pertinent studies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study Selection\/Data Extraction:<\/jats:title>\n                    <jats:p>Phase I, II, and III randomized controlled trials were all eligible for inclusion. Meeting abstracts and articles focusing on the use of rozanolixizumab or any indication other than generalized myasthenia gravis were excluded from this article.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Synthesis:<\/jats:title>\n                    <jats:p>Food and Drug Administration approval of rozanolixizumab is based on the phase III MycarinG study in patients with generalized myasthenia gravis. A phase II trial explored initial clinical efficacy and safety pertaining to the dose and frequency of rozanolixizumab across 2 treatment periods in patients with moderate to severe myasthenia gravis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Relevance to Patient Care and Clinical Practice in Comparison to Existing Agents:<\/jats:title>\n                    <jats:p>Rozanolixizumab is the first therapy approved to treat patients positive for both types of antibodies, anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase, in generalized myasthenia gravis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion\/Relevance:<\/jats:title>\n                    <jats:p>The approval of rozanolixizumab represents an advancement in therapy for generalized myasthenia gravis. The provision of individualized, targeted, and well-tolerated treatment is valuable for the patients whose myasthenia gravis is not well controlled and who are seeking a medication with a rapid onset of action to improve their symptoms and overall quality of life.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10600280241239048","type":"journal-article","created":{"date-parts":[[2024,3,27]],"date-time":"2024-03-27T05:39:21Z","timestamp":1711517961000},"page":"1140-1148","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":4,"title":["Rozanolixizumab: A New Therapy in the Treatment of Myasthenia Gravis"],"prefix":"10.1177","volume":"58","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4523-4591","authenticated-orcid":false,"given":"Emily M.","family":"Hitt","sequence":"first","affiliation":[{"name":"Washington State University College of Pharmacy and Pharmaceutical Sciences, Spokane, WA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2024,3,27]]},"reference":[{"key":"bibr1-10600280241239048","unstructured":"National Institute of Neurological Disorders and Stroke. Myasthenia gravis. Accessed October 16, 2023. https:\/\/www.ninds.nih.gov\/health-information\/disorders\/myasthenia-gravis"},{"key":"bibr2-10600280241239048","unstructured":"Howard JF. Clinical overview of MG. Myasthenia Gravis Foundation of America. June 2015. Accessed October 16, 2023. https:\/\/myasthenia.org\/Professionals\/Clinical-Overview-of-MG"},{"key":"bibr3-10600280241239048","unstructured":"Myasthenia gravis\u2014symptoms, causes, treatment. Nord\u2014National Organization for Rare Disorders. January 12, 2023. Accessed October 17, 2023. https:\/\/rarediseases.org\/rare-diseases\/myasthenia-gravis\/"},{"key":"bibr4-10600280241239048","doi-asserted-by":"publisher","DOI":"10.1016\/bs.ircmb.2018.05.008"},{"key":"bibr5-10600280241239048","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2020.00212"},{"key":"bibr6-10600280241239048","doi-asserted-by":"publisher","DOI":"10.3233\/JND-170294"},{"key":"bibr7-10600280241239048","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(15)00145-3"},{"key":"bibr8-10600280241239048","doi-asserted-by":"publisher","DOI":"10.3390\/jcm10071537"},{"key":"bibr9-10600280241239048","doi-asserted-by":"publisher","DOI":"10.1155\/2012\/874680"},{"key":"bibr10-10600280241239048","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000011124"},{"key":"bibr11-10600280241239048","unstructured":"Rystiggo (rozanolixizumab-noli). UCB Inc. 2023. Accessed October 17, 2023. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/761286s000lbl.pdf"},{"key":"bibr12-10600280241239048","doi-asserted-by":"publisher","DOI":"10.1126\/scitranslmed.aan1208"},{"key":"bibr13-10600280241239048","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2020.07.015"},{"key":"bibr14-10600280241239048","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000011108"},{"key":"bibr15-10600280241239048","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(23)00077-7"},{"key":"bibr16-10600280241239048","unstructured":"UCB Biopharma SRL. A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravis. ClinicalTrials.gov identifier: NCT04124965. Updated September 5, 2023. Accessed October 31, 2023. https:\/\/www.clinicaltrials.gov\/study\/NCT04124965?cond=NCT04124965&rank=1&tab=results#outcome-measures"},{"key":"bibr17-10600280241239048","unstructured":"UCB Biopharma SRL. A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravis. ClinicalTrials.gov identifier: NCT04650854. Updated October 6, 2023. Accessed October 31, 2023. https:\/\/www.clinicaltrials.gov\/study\/NCT04650854?cond=NCT04650854&rank=1#study-plan"},{"key":"bibr18-10600280241239048","unstructured":"Puckett Y, Gabbar A, Bokhari A. Prednisone. StatPearls. July 19, 2023. Accessed February 3, 2024. https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK534809\/"},{"key":"bibr19-10600280241239048","unstructured":"Safarini OA, Keshavamurthy C, Patel P. Calcineurin inhibitors. StatPearls. November 12, 2023. Accessed February 3, 2024. https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK558995\/"},{"key":"bibr20-10600280241239048","unstructured":"Vyvgart (efgartigimod alfa-fcab). 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