PMID- 30539030 OWN - NLM STAT- MEDLINE DCOM- 20190111 LR - 20220331 IS - 2314-7156 (Electronic) IS - 2314-8861 (Print) IS - 2314-7156 (Linking) VI - 2018 DP - 2018 TI - Safety and Efficacy of Rituximab in Multiple Sclerosis: A Retrospective Observational Study. PG - 9084759 LID - 10.1155/2018/9084759 [doi] LID - 9084759 AB - OBJECTIVE: To evaluate the efficacy and safety of rituximab in multiple sclerosis in a clinical practice setting. METHODS: Clinical data for all adult patients with multiple sclerosis (MS) treated with off-label rituximab at a single MS center in Lebanon between March 2008 and April 2017 were retrospectively collected from medical charts. The main efficacy outcomes assessed were annualized relapse rate (ARR) and proportion of patients free from relapses, disability progression, or magnetic resonance imaging (MRI) activity. RESULTS: A total of 89 rituximab-treated patients were included: 59 relapsing-remitting MS (RRMS) and 30 progressive MS (PMS). Patients were treated with 1000 or 2000 mg rituximab IV every 6-12 months for a mean duration of 22.2 +/- 24.8 months. The subjects were 65.2% females with a mean age of 40.5 +/- 12.3 years and a mean disease duration of 7.9 +/- 6.2 years. During treatment, the ARR decreased from 1.07 at baseline to 0.11 in RRMS (p < 0.0001) and from 0.25 to 0.16 in PMS patients (p = 0.593). The mean Expanded Disability Status Scale (EDSS) remained unchanged in both RRMS and PMS patients. Between baseline and the last follow-up, the percent of patients free from any new MRI lesions increased from 18.6% to 92.6% in the RRMS group and from 43.3% to 82% in the PMS group. No evidence of disease activity (NEDA) was achieved in 74% of patients at 1 year of treatment. A total of 64 adverse events (AEs) (71.9%) were recorded with the most common being infusion-related reactions in 25.8% of patients, all mild in nature. Two of our rituximab-treated patients experienced serious AEs requiring surgical interventions: pyoderma gangrenosum vaginalis with perianal abscess and fistula and an increase in the size of a meningioma. No case of progressive multifocal leukoencephalopathy (PML) was detected. CONCLUSION: In our real-world cohort, rituximab was well-tolerated and effective in reducing relapse rate and disability progression in relapsing-remitting and progressive MS patients. FAU - Yamout, Bassem I AU - Yamout BI AD - Nehme and Therese Tohme Multiple Sclerosis Center, American University of Beirut Medical Center, Beirut, Lebanon. FAU - El-Ayoubi, Nabil K AU - El-Ayoubi NK AD - Nehme and Therese Tohme Multiple Sclerosis Center, American University of Beirut Medical Center, Beirut, Lebanon. FAU - Nicolas, Johny AU - Nicolas J AD - Faculty of Medicine, American University of Beirut, Lebanon. FAU - El Kouzi, Yehya AU - El Kouzi Y AD - Nehme and Therese Tohme Multiple Sclerosis Center, American University of Beirut Medical Center, Beirut, Lebanon. FAU - Khoury, Samia J AU - Khoury SJ AUID- ORCID: 0000-0003-3198-6063 AD - Nehme and Therese Tohme Multiple Sclerosis Center, American University of Beirut Medical Center, Beirut, Lebanon. FAU - Zeineddine, Maya M AU - Zeineddine MM AD - Nehme and Therese Tohme Multiple Sclerosis Center, American University of Beirut Medical Center, Beirut, Lebanon. LA - eng PT - Journal Article PT - Observational Study DEP - 20181112 PL - Egypt TA - J Immunol Res JT - Journal of immunology research JID - 101627166 RN - 0 (Antigens, CD20) RN - 0 (Immunologic Factors) RN - 4F4X42SYQ6 (Rituximab) SB - IM MH - Adult MH - Antigens, CD20/immunology MH - Brain/diagnostic imaging/*pathology MH - Cohort Studies MH - Disease Progression MH - Female MH - Follow-Up Studies MH - Humans MH - Immunologic Factors/adverse effects/*therapeutic use MH - Injection Site Reaction/etiology MH - Lebanon MH - Magnetic Resonance Imaging MH - Male MH - Middle Aged MH - Multiple Sclerosis/*diet therapy MH - Off-Label Use MH - Retrospective Studies MH - Rituximab/adverse effects/*therapeutic use PMC - PMC6260423 EDAT- 2018/12/13 06:00 MHDA- 2019/01/12 06:00 PMCR- 2018/11/12 CRDT- 2018/12/13 06:00 PHST- 2018/05/09 00:00 [received] PHST- 2018/08/31 00:00 [revised] PHST- 2018/09/16 00:00 [accepted] PHST- 2018/12/13 06:00 [entrez] PHST- 2018/12/13 06:00 [pubmed] PHST- 2019/01/12 06:00 [medline] PHST- 2018/11/12 00:00 [pmc-release] AID - 10.1155/2018/9084759 [doi] PST - epublish SO - J Immunol Res. 2018 Nov 12;2018:9084759. doi: 10.1155/2018/9084759. eCollection 2018.