PMID- 34377385 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220429 IS - 2040-6223 (Print) IS - 2040-6231 (Electronic) IS - 2040-6223 (Linking) VI - 12 DP - 2021 TI - Rituximab versus mitoxantrone: comparing effectiveness and safety in advanced relapsing multiple sclerosis. PG - 20406223211024366 LID - 10.1177/20406223211024366 [doi] LID - 20406223211024366 AB - BACKGROUND: Rituximab (RTX), a CD20 depleting agent, is a frequently used off-label treatment for multiple sclerosis (MS), while mitoxantrone (MTX) is approved, albeit rarely used for active relapsing MS (RMS). However, observational data comparing RTX and MTX effectiveness and safety are scarce. OBJECTIVE: We aimed to compare effectiveness and safety of MTX and RTX in patients with active RMS. METHODS: From combined retrospective clinical data of three MS centers, we selected patients who had received at least one infusion of RTX or MTX and had at least a 6-month clinical follow-up available. Treatment groups were compared by propensity score (PS)-adjusted regression and inverse PS-weighted generalized estimated equation models regarding disability progression, relapse activity, and adverse events (AEs). RESULTS: We included 292 RMS patients (mean age 41.8 years, 71.6% female) who received RTX (119 patients, mean age 36.8 years, 74.8% female) or MTX (173 patients mean age 45.3 years, 69.4% female). Using both PS methods, we did not find a significant effect favoring RTX or MTX treatment regarding the probability of disability worsening or relapse occurrence. However, RTX treatment was associated with a significantly lower probability of severe AEs and AEs. CONCLUSIONS: RTX shows comparable effectiveness but a favorable safety profile compared with MTX in active RMS. CI - (c) The Author(s), 2021. FAU - Zrzavy, Tobias AU - Zrzavy T AUID- ORCID: 0000-0001-8909-1591 AD - Department of Neurology, Medical University of Vienna, Vienna, Austria. FAU - Daniels, Esther AU - Daniels E AD - Department of Neurology, Rostock University Medical Center, Rostock, Germany. FAU - Stuka, Niklas AU - Stuka N AD - Department of Neurology, Medical University of Vienna, Vienna, Austria. FAU - Weber, Dennis AU - Weber D AD - Department of Neurology, Medical University of Vienna, Vienna, Austria. FAU - Winkelmann, Alexander AU - Winkelmann A AD - Department of Neurology, Rostock University Medical Center, Rostock, Germany. FAU - Rauschka, Helmut AU - Rauschka H AD - Department of Neurology, Karl Landsteiner Institute for Neuroimmunological and Neurodegenerative Disorders and Diseases, Klinik Donaustadt, Vienna, Austria. FAU - Hecker, Michael AU - Hecker M AD - Department of Neurology, Rostock University Medical Center, Rostock, Germany. FAU - Aboulenein-Djamshidian, Fahmy AU - Aboulenein-Djamshidian F AD - Department of Neurology, Karl Landsteiner Institute for Neuroimmunological and Neurodegenerative Disorders and Diseases, Klinik Donaustadt, Vienna, Austria. FAU - Meister, Stefanie AU - Meister S AD - Department of Neurology, Rostock University Medical Center, Rostock, Germany. FAU - Leutmezer, Fritz AU - Leutmezer F AD - Department of Neurology, Medical University of Vienna, Vienna, Austria. FAU - Berger, Thomas AU - Berger T AD - Department of Neurology, Medical University of Vienna, Vienna, Austria. FAU - Bsteh, Gabriel AU - Bsteh G AD - Department of Neurology, Medical University of Vienna, Waehringer Guertel 18-20, Vienna, 1090, Austria. FAU - Zettl, Uwe Klaus AU - Zettl UK AD - Department of Neurology, Rostock University Medical Center, Rostock, Germany. FAU - Rommer, Paulus AU - Rommer P AD - Department of Neurology, Medical University of Vienna, Vienna, Austria Department of Neurology, Rostock University Medical Center, Rostock, Germany. LA - eng PT - Journal Article DEP - 20210728 PL - United States TA - Ther Adv Chronic Dis JT - Therapeutic advances in chronic disease JID - 101532140 EIN - Ther Adv Chronic Dis. 2021 Sep 14;12:20406223211046076. PMID: 34729146 PMC - PMC8323410 OTO - NOTNLM OT - effectiveness OT - mitoxantrone OT - multiple sclerosis OT - rituximab OT - safety COIS- Conflict of interest statement: Tobias Zrzavy has participated in meetings sponsored by or received travel funding from Biogen, Merck, Novartis, Roche, Sanofi-Genzyme and Teva. Esther Daniels declares no conflict of interest. Alexander Winkelmann participated in meetings sponsored by, received speaker honoraria or travel funding from Celgene, Merck, Novartis, Sanofi-Genzyme and Teva, and received honoraria for consulting Merck, Novartis, Roche, Sanofi-Genzyme and Teva. Helmut Rauschka has participated in meetings sponsored by or received travel funding from Alexion, Biogen, Merck, Novartis, Pfizer, Sanofi-Genzyme and Teva. Michael Hecker received speaking fees and travel funds from Bayer HealthCare, Biogen, Merck, Novartis and Teva. Dennis Weber declares no conflict of interest. Niklas Stuka declares no conflict of interest. Fahmy Aboulenein-Djamshidian declares no conflict of interest. Stefanie Meister declares no conflict of interest relevant to this study. Fritz Leutmezer has received honoraria for consultancy/speaking from Allmiral, Alexion, Biogen, MedDay, Merck, Novartis, Octapharma, Roche, Sanofi-Genzyme, and Teva. Thomas Berger has participated in meetings sponsored by and received honoraria (lectures, advisory boards, consultations) from pharmaceutical companies marketing treatments for MS: Allergan, Bayer, Biogen, Bionorica, Celgene, MedDay, Merck, Novartis, Octapharma, Roche, Sanofi-Genzyme, Teva. His institution has received financial support in the past 12 months by unrestricted research grants (Biogen, Bayer, Merck, Novartis, Sanofi Aventis, Teva) and for participation in clinical trials in multiple sclerosis sponsored by Alexion, Bayer, Biogen, Merck, Novartis, Octapharma, Roche, Sanofi-Genzyme, Teva. Gabriel Bsteh has participated in meetings sponsored by, received speaker honoraria or travel funding from Biogen, Celgene, Lilly, Merck, Novartis, Sanofi-Genzyme and Teva, and received honoraria for consulting Biogen, Celgene, Merck, Novartis, Roche and Teva. Uwe Klaus Zettl received research support as well as speaking fees and travel funds from Almirall, Bayer HealthCare, Biogen, Merck Serono, Novartis, Sanofi-Genzyme and Teva. Paulus Rommer has received honoraria for consultancy/speaking from AbbVie, Allmiral, Alexion, Biogen, Merck, Novartis, Roche, Sandoz, Sanofi-Genzyme, has received research grants from Amicus, Biogen, Merck, Roche. EDAT- 2021/08/12 06:00 MHDA- 2021/08/12 06:01 PMCR- 2021/07/28 CRDT- 2021/08/11 06:38 PHST- 2021/02/23 00:00 [received] PHST- 2021/05/12 00:00 [accepted] PHST- 2021/08/11 06:38 [entrez] PHST- 2021/08/12 06:00 [pubmed] PHST- 2021/08/12 06:01 [medline] PHST- 2021/07/28 00:00 [pmc-release] AID - 10.1177_20406223211024366 [pii] AID - 10.1177/20406223211024366 [doi] PST - epublish SO - Ther Adv Chronic Dis. 2021 Jul 28;12:20406223211024366. doi: 10.1177/20406223211024366. eCollection 2021.