{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,2]],"date-time":"2026-11-02T16:39:11Z","timestamp":1793637551847,"version":"4.5.1"},"reference-count":27,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2025,3,1]],"date-time":"2025-03-01T00:00:00Z","timestamp":1740787200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,3,1]],"date-time":"2025-03-01T00:00:00Z","timestamp":1740787200000},"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":["Journal of Neuromuscular Diseases"],"published-print":{"date-parts":[[2025,3]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Generalized myasthenia gravis (gMG) is a rare, chronic, fluctuating and heterogeneous autoimmune disease requiring lifelong treatment. The Phase 3 MycarinG study demonstrated the efficacy and safety of one 6-week cycle of weekly rozanolixizumab in adult patients with gMG. Open-label extension studies demonstrated consistent symptom improvement over additional treatment cycles.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To present findings from pooled analyses on the long-term safety of repeated cycles of rozanolixizumab.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Data from the Phase 3 randomized MycarinG study (NCT03971422) and the ongoing open-label extension study MG0007 (NCT04650854) were pooled to assess safety outcomes during cyclical treatment, including incidence of any treatment-emergent adverse events (TEAEs), severe TEAEs, serious TEAEs and TEAEs leading to discontinuations. Additional analyses were performed for TEAEs, including headache, infections, and hypersensitivity reactions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>At data cutoff (July 8, 2022), a total of 188 patients in MycarinG and MG0007 had received \u22651 treatment cycle with rozanolixizumab; total time in studies was 174.71 patient-years. Overall, 169\/188 (89.9%) patients experienced any TEAE: 89\/188 (47.3%) experienced any headache (including migraine, migraine with aura); 85\/188 (45.2%) experienced an infection; 25\/188 (13.3%) experienced a hypersensitivity reaction. One patient experienced an event of aseptic meningitis. The majority of AEs were mild-to-moderate in intensity, and incidence did not increase with repeated cyclic treatment. A total of 50\/188 (26.6%) patients experienced severe TEAEs, the most common of which were MG worsening in 4\/133 (3.0%) and 7\/131 (5.3%) patients in the rozanolixizumab 7 mg\/kg and rozanolixizumab 10 mg\/kg groups, respectively, MG crisis in 0 and 4\/131 (3.1%) patients, and headache in 1\/133 (0.8%) and 7\/131 (5.3%) patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>These pooled results, representing 174.71 patient-years in the studies, demonstrate that treatment with rozanolixizumab in patients with gMG was well tolerated, and TEAEs were consistent and did not increase in incidence over repeated cycles in this patient population.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/22143602241308181","type":"journal-article","created":{"date-parts":[[2025,3,4]],"date-time":"2025-03-04T14:11:37Z","timestamp":1741097497000},"page":"231-243","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":15,"title":["Long-term safety of cyclical rozanolixizumab in patients with generalized myasthenia gravis: Results from the Phase 3 MycarinG study and an open-label extension"],"prefix":"10.1177","volume":"12","author":[{"given":"Ali A","family":"Habib","sequence":"first","affiliation":[{"name":"MDA ALS and Neuromuscular Center, Department of Neurology, University of California, Irvine, Orange, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Artur","family":"Dru\u017cd\u017c","sequence":"additional","affiliation":[{"name":"Department of Neurology, Municipal Hospital Pozna\u0144, Pozna\u0144, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julian","family":"Grosskreutz","sequence":"additional","affiliation":[{"name":"Precision Neurology of Neuromuscular Diseases, Department of Neurology, University of L\u00fcbeck, L\u00fcbeck, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renato","family":"Mantegazza","sequence":"additional","affiliation":[{"name":"Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale Neurologico Carlo Besta, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabrina","family":"Sacconi","sequence":"additional","affiliation":[{"name":"Universit\u00e9 C\u00f4te d\u2019Azur, Peripheral Nervous System and Muscle Department, Pasteur 2 Hospital, Centre Hospitalier Universitaire de Nice, Nice, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimiaki","family":"Utsugisawa","sequence":"additional","affiliation":[{"name":"Department of Neurology, Hanamaki General Hospital, Hanamaki, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tuan","family":"Vu","sequence":"additional","affiliation":[{"name":"Department of Neurology, University of South Florida, Morsani College of Medicine, Tampa, FL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Vissing","sequence":"additional","affiliation":[{"name":"Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maryam","family":"Gayfieva","sequence":"additional","affiliation":[{"name":"UCB, Slough, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irene","family":"Pulido-Valdeolivas","sequence":"additional","affiliation":[{"name":"UCB, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tha\u00efs","family":"Taranc\u00f3n","sequence":"additional","affiliation":[{"name":"UCB, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Franz","family":"Woltering","sequence":"additional","affiliation":[{"name":"UCB, Monheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vera","family":"Bril","sequence":"additional","affiliation":[{"name":"University Health Network, Toronto, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the MycarinG and MG0007 study investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2025,3,4]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41572-019-0079-y"},{"key":"e_1_3_3_3_2","article-title":"Treatment standards and individualized therapy of myasthenia gravis","volume":"2","author":"Urban PP","year":"2018","unstructured":"Urban PP, Jacobi C, Jander S. 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