{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,6]],"date-time":"2026-11-06T00:27:53Z","timestamp":1793924873613,"version":"4.8.0"},"reference-count":28,"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>Myasthenia gravis (MG) is a chronic autoimmune disease causing fluctuating muscle weakness. The MycarinG study showed that rozanolixizumab, a neonatal Fc receptor inhibitor, provided clinically meaningful improvements in MG outcomes in patients with acetylcholine receptor (AChR) and muscle-specific tyrosine kinase (MuSK) autoantibody-positive generalized MG (gMG).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>We assessed efficacy and safety of 6-week rozanolixizumab treatment cycles in patients with gMG.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Following MycarinG, eligible patients enrolled in the open-label extension Phase 3 studies MG0004 (NCT04124965) to receive up to 52 weekly rozanolixizumab infusions or MG0007 (NCT04650854) to receive cycles of 6 weekly rozanolixizumab infusions (initiated on symptom worsening at investigators\u2019 discretion). To assess the effect of repeated cyclical treatment, data were pooled across MycarinG, MG0004 (first 6 weeks) and MG0007 (interim analysis). Efficacy endpoints included change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL), Myasthenia Gravis Composite (MGC) and Quantitative Myasthenia Gravis (QMG) assessed in patients who received \u22652 symptom-driven treatment cycles. Treatment-emergent adverse events (TEAEs) were assessed in patients who received \u22651 cycle and had an (up to) 8-week follow-up period.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>At data cut-off (July 8, 2022), 188\/196 (95.9%) patients received \u22651 treatment cycle with a follow-up period (primary safety pool; MycarinG\/MG0007) and 127 (64.8%) received \u22652 symptom-driven cycles (primary efficacy pool; MycarinG\/MG0004 [first 6 weeks]\/MG0007). Consistent and clinically meaningful improvements in MG-ADL, MGC and QMG scores, and high MG-ADL, MGC and QMG response rates, were observed at the end of the first symptom-driven cycle and subsequent cycles. TEAEs were experienced by 169\/188 (89.9%) patients and were mostly mild to moderate. TEAEs did not increase with repeated cycles.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Repeated cycles of rozanolixizumab resulted in consistent, clinically meaningful improvements across cycles in MG-specific outcomes with an acceptable safety profile, supporting rozanolixizumab as a treatment option for adults with AChR and MuSK autoantibody-positive gMG.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/22143602241305511","type":"journal-article","created":{"date-parts":[[2025,3,4]],"date-time":"2025-03-04T14:11:37Z","timestamp":1741097497000},"page":"218-230","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":19,"title":["Rozanolixizumab in generalized myasthenia gravis: Pooled analysis of the Phase 3 MycarinG study and two open-label extensions"],"prefix":"10.1177","volume":"12","author":[{"given":"Vera","family":"Bril","sequence":"first","affiliation":[{"name":"University Health Network, Toronto, ON, Canada"}],"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, Department of Neurology, University of L\u00fcbeck, L\u00fcbeck, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ali A","family":"Habib","sequence":"additional","affiliation":[{"name":"MDA ALS &amp; Neuromuscular Center, Department of Neurology, University of California, Irvine, Orange, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renato","family":"Mantegazza","sequence":"additional","affiliation":[{"name":"Emeritus and Past Director, Department of Neuroimmunology and Neuromuscular Diseases, 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, Iwate Prefecture, 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":"Marion","family":"Boehnlein","sequence":"additional","affiliation":[{"name":"UCB, Monheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernhard","family":"Greve","sequence":"additional","affiliation":[{"name":"UCB, Monheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maryam","family":"Gayfieva","sequence":"additional","affiliation":[{"name":"UCB, Slough, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Franz","family":"Woltering","sequence":"additional","affiliation":[{"name":"UCB, Monheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tha\u00efs","family":"Taranc\u00f3n","sequence":"additional","affiliation":[{"name":"UCB, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Vissing","sequence":"additional","affiliation":[{"name":"Department of Neurology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the MycarinG, MG0004 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_4_2_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41572-019-0079-y"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.4103\/aian.AIAN_472_19"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40120-021-00285-w"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.autrev.2013.03.001"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.3390\/jcm11061597"},{"key":"e_1_3_4_7_2","unstructured":"Zilbrysq US PI; 2024 [cited November 2024]. 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