PMID- 37059507 OWN - NLM STAT- MEDLINE DCOM- 20230418 LR - 20231205 IS - 1474-4465 (Electronic) IS - 1474-4422 (Linking) VI - 22 IP - 5 DP - 2023 May TI - Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study. PG - 383-394 LID - S1474-4422(23)00077-7 [pii] LID - 10.1016/S1474-4422(23)00077-7 [doi] AB - BACKGROUND: Generalised myasthenia gravis is a chronic, unpredictable, and debilitating autoimmune disease. New treatments for this disease are needed because conventional therapies have limitations, such as side-effects (eg, increased infection risk) or inadequate control of symptoms. Rozanolixizumab is a neonatal Fc receptor blocker that might provide a novel therapeutic option for myasthenia gravis. We aimed to assess the safety and efficacy of rozanolixizumab for generalised myasthenia gravis. METHODS: MycarinG is a randomised, double-blind, placebo-controlled, adaptive phase 3 study done at 81 outpatient centres and hospitals in Asia, Europe, and North America. We enrolled patients (aged >/=18 years) with acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) autoantibody-positive generalised myasthenia gravis (Myasthenia Gravis Foundation of America class II-IVa), a Myasthenia Gravis Activities of Daily Living (MG-ADL) score of at least 3 (non-ocular symptoms), and a quantitative myasthenia gravis score of at least 11. Patients were randomly assigned (1:1:1) to receive subcutaneous infusions once a week for 6 weeks of either rozanolixizumab 7 mg/kg, rozanolixizumab 10 mg/kg, or placebo. Randomisation was stratified by AChR and MuSK autoantibody status. Investigators, patients, and people assessing outcomes were masked to random assignments. The primary efficacy endpoint was change from baseline to day 43 in MG-ADL score, assessed in the intention-to-treat population. Treatment-emergent adverse events (TEAEs) were assessed in all randomly assigned patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov (NCT03971422) and EudraCT (2019-000968-18); an open-label extension study has been completed (NCT04124965; EudraCT 2019-000969-21) and another is underway (NCT04650854; EudraCT 2020-003230-20). FINDINGS: Between June 3, 2019, and June 30, 2021, 300 patients were assessed for eligibility, of whom 200 were enrolled. 66 (33%) were randomly assigned to rozanolixizumab 7 mg/kg, 67 (34%) to rozanolixizumab 10 mg/kg, and 67 (34%) to placebo. Reductions in MG-ADL score from baseline to day 43 were greater in the rozanolixizumab 7 mg/kg group (least-squares mean change -3.37 [SE 0.49]) and in the rozanolixizumab 10 mg/kg group (-3.40 [0.49]) than with placebo (-0.78 [0.49]; for 7 mg/kg, least-squares mean difference -2.59 [95% CI -4.09 to -1.25], p<0.0001; for 10 mg/kg, -2.62 [-3.99 to -1.16], p<0.0001). TEAEs were experienced by 52 (81%) of 64 patients treated with rozanolixizumab 7 mg/kg, 57 (83%) of 69 treated with rozanolixizumab 10 mg/kg, and 45 (67%) of 67 treated with placebo. The most frequent TEAEs were headache (29 [45%] patients in the rozanolixizumab 7 mg/kg group, 26 [38%] in the rozanolixizumab 10 mg/kg group, and 13 [19%] in the placebo group), diarrhoea (16 [25%], 11 [16%], and nine [13%]), and pyrexia (eight [13%], 14 [20%], and one [1%]). Five (8%) patients in the rozanolixizumab 7 mg/kg group, seven (10%) in the rozanolixizumab 10 mg/kg group, and six (9%) in the placebo group had a serious TEAE. No deaths occurred. INTERPRETATION: Rozanolixizumab showed clinically meaningful improvements in patient-reported and investigator-assessed outcomes in patients with generalised myasthenia gravis, for both 7 mg/kg and 10 mg/kg doses. Both doses were generally well tolerated. These findings support the mechanism of action of neonatal Fc receptor inhibition in generalised myasthenia gravis. Rozanolixizumab represents a potential additional treatment option for patients with generalised myasthenia gravis. FUNDING: UCB Pharma. CI - Copyright (c) 2023 Elsevier Ltd. All rights reserved. FAU - Bril, Vera AU - Bril V AD - University Health Network, Toronto, ON, Canada. Electronic address: vera.bril@utoronto.ca. FAU - Druzdz, Artur AU - Druzdz A AD - Department of Neurology, Municipal Hospital, Poznan, Poland. FAU - Grosskreutz, Julian AU - Grosskreutz J AD - Precision Neurology, Department of Neurology, University of Lubeck, Lubeck, Germany. FAU - Habib, Ali A AU - Habib AA AD - MDA ALS and Neuromuscular Center, University of California, Irvine, CA, USA. FAU - Mantegazza, Renato AU - Mantegazza R AD - Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale Neurologico Carlo Besta, Milan, Italy. FAU - Sacconi, Sabrina AU - Sacconi S AD - Universite Cote d'Azur, Peripheral Nervous System and Muscle Department, Pasteur 2 Hospital, Centre Hospitalier Universitaire de Nice, Nice, France. FAU - Utsugisawa, Kimiaki AU - Utsugisawa K AD - Department of Neurology, Hanamaki General Hospital, Hanamaki, Japan. FAU - Vissing, John AU - Vissing J AD - Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. FAU - Vu, Tuan AU - Vu T AD - Department of Neurology, University of South Florida Morsani College of Medicine, Tampa, FL, USA. FAU - Boehnlein, Marion AU - Boehnlein M AD - UCB Pharma, Monheim, Germany. FAU - Bozorg, Ali AU - Bozorg A AD - UCB Pharma, Morrisville, NC, USA. FAU - Gayfieva, Maryam AU - Gayfieva M AD - UCB Pharma, Slough, UK. FAU - Greve, Bernhard AU - Greve B AD - UCB Pharma, Monheim, Germany. FAU - Woltering, Franz AU - Woltering F AD - UCB Pharma, Monheim, Germany. FAU - Kaminski, Henry J AU - Kaminski HJ AD - George Washington University, Washington, DC, USA. CN - MG0003 study team LA - eng SI - ClinicalTrials.gov/NCT03971422 SI - ClinicalTrials.gov/NCT04124965 SI - ClinicalTrials.gov/NCT04650854 SI - EudraCT/2019-000968-18 SI - EudraCT/EudraCT 2019-000969-21 SI - EudraCT/2020-003230-20 GR - R41 NS110331/NS/NINDS NIH HHS/United States GR - U54 NS115054/NS/NINDS NIH HHS/United States PT - Clinical Trial, Phase III PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't PL - England TA - Lancet Neurol JT - The Lancet. Neurology JID - 101139309 RN - P7186074QC (rozanolixizumab) RN - 0 (Receptors, Cholinergic) RN - 0 (Autoantibodies) SB - IM CIN - Lancet Neurol. 2023 May;22(5):368-369. PMID: 37059497 CIN - Nat Rev Neurol. 2023 Jul;19(7):393-394. PMID: 37253854 EIN - Lancet Neurol. 2023 Oct;22(10):e11. PMID: 37739577 MH - Infant, Newborn MH - Humans MH - Adolescent MH - Adult MH - *Activities of Daily Living MH - *Myasthenia Gravis/drug therapy MH - Receptors, Cholinergic MH - Autoantibodies MH - Double-Blind Method MH - Treatment Outcome COIS- Declaration of interests VB is a consultant for Grifols, CSL, UCB, argenx, Takeda, Alnylam, Octapharma, Pfizer, Powell Mansfield, Akcea, Ionis, Immunovant, Sanofi, Momenta (now J&J), Roche, Janssen, Alexion, and NovoNordisk. She has received research support from Alexion, Grifols, CSL, UCB, argenx, Takeda, Octapharma, Akcea, Momenta, Immunovant, Ionis, and Viela Bio (now Horizon). JG has served as a consultant for Biogen, Alexion, and UCB, and his institution has received research support from the Boris Canessa Foundation. AAH has received research support from argenx, Alexion, Cabaletta Bio, Viela Bio, UCB Pharma, Genentech, Regeneron, Sanofi, and Immunovant. He has received consulting fees or honoraria from argenx, Alexion, Immunovant, Regeneron, and UCB Pharma. RM has received funding for travel and meeting attendance or advisory board participation from Alexion, argenx, Biomarin, Catalyst, Sanofi, Regeneron, and UCB. KU has served as a paid Consultant for UCB Pharma, argenx, Janssen Pharma, Viela Bio, Chugai Pharma, Hanall BioPharma, and Mitsubishi Tanabe Pharma, and has received speaker honoraria from argenx, Alexion Pharmaceuticals, and the Japan Blood Products Organization. JV has been a consultant on advisory boards for Sanofi Genzyme, Sarepta Therapeutics, Viela Bio, Novartis Pharma, Fulcrum Therapeutics, Stealth Biotherapeutics, Roche, Biogen, Lupin, Genethon, Amicus Therapeutics, Zogenix, Regeneron, UCB Biopharma, Arvinas, ML Biopharma, Horizon Therapeutics, Pfizer, and Lundbeck Pharma; has received research, travel support, or speaker honoraria from Sanofi Genzyme, argenx, Alexion Pharmaceuticals, Biogen, Lupin, Stealth Biotherapeutics, Edgewise Therapeutics, Fulcrum Therapeutics, and UCB Biopharma, and is a principal investigator in clinical trials for Sanofi Genzyme, Roche, Horizon Therapeutics, argenx, Novartis Pharma, Alexion Pharmaceuticals, Stealth Biotherapeutics, Spark Pharmaceuticals, UCB Biopharma, Genethon, ML Biopharma, Reneo Pharma, Pharnext, Janssen Pharmaceuticals, Khondrion, Regeneron, Atamyo therapeutics, and Dynacure. TV is the USF site principal investigator for MG clinical trials sponsored by Alexion, argenx, Ra-UCB, Horizon-Viela Bio, Janssen-Momenta, Sanofi, Regeneron, and Cartesian Therapeutics, and receives speaking and consulting honoraria from Alexion, argenx, and UCB. HJK is a consultant for Roche, Cabeletta Bio, Lincoln Therapeutics, Takeda, and UCB Pharmaceuticals, and is CEO and CMO of ARC Biotechnology on the basis of US Patent 8,961,98; he is principal investigator of the Rare Disease Network for Myasthenia Gravis, National Institute of Neurological Disorders & Stroke, U54 NS115054, and Targeted Therapy for Myasthenia Gravis; and has received R41 NS110331-01 to ARC Biotechnology. MB, MG, BG, and FW are employees and shareholders of UCB Pharma. AB was an employee and shareholder of UCB Pharma during the conduct of the study, but is currently employed at Otsuka Pharmaceutical Commercialization and Development. AD and SS have nothing to disclose. 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Strittmatter B FIR - Mozaffar, Tahseen IR - Mozaffar T FIR - Habib, Ali A IR - Habib AA FIR - Hernandez, Isela IR - Hernandez I FIR - Moulton, Kelsey IR - Moulton K FIR - Karam, Chafic IR - Karam C FIR - Ravikumar, Pranali IR - Ravikumar P FIR - Lomen-Hoerth, Catherine IR - Lomen-Hoerth C FIR - Rosow, Laura IR - Rosow L FIR - George, Hannah IR - George H FIR - Irodenko, Viktoriya IR - Irodenko V FIR - Denny, Carol IR - Denny C FIR - Hanson, Bart IR - Hanson B FIR - Klein, Sara IR - Klein S FIR - Martinez-Thompson, Jennifer IR - Martinez-Thompson J FIR - Naddaf, Elie IR - Naddaf E FIR - Padgett, Denny IR - Padgett D FIR - Sorenson, Eric IR - Sorenson E FIR - L Sultze, Jane IR - L Sultze J FIR - Weis, Delena IR - Weis D FIR - Rezania, Kourosh IR - Rezania K FIR - Thonhoff, Jason IR - Thonhoff J FIR - Shroff, Sheetal IR - Shroff S FIR - Pascuzzi, Robert IR - Pascuzzi R FIR - Micheels, Angela IR - Micheels A FIR - Bodkin, Cynthia IR - Bodkin C FIR - Comer, Adam IR - Comer A FIR - Baras, Gelasio IR - Baras G FIR - Wagner, Renee IR - Wagner R FIR - Mahuwala, Zabeen IR - Mahuwala Z FIR - Ryan, Stephen IR - Ryan S FIR - Su, Kai IR - Su K FIR - Sharma, Khema IR - Sharma K FIR - Brown, Andrew IR - Brown A FIR - Liow, Kore IR - Liow K EDAT- 2023/04/15 06:00 MHDA- 2023/04/18 10:16 CRDT- 2023/04/14 20:58 PHST- 2022/11/11 00:00 [received] PHST- 2023/02/07 00:00 [revised] PHST- 2023/02/10 00:00 [accepted] PHST- 2023/04/18 10:16 [medline] PHST- 2023/04/14 20:58 [entrez] PHST- 2023/04/15 06:00 [pubmed] AID - S1474-4422(23)00077-7 [pii] AID - 10.1016/S1474-4422(23)00077-7 [doi] PST - ppublish SO - Lancet Neurol. 2023 May;22(5):383-394. doi: 10.1016/S1474-4422(23)00077-7.