Use of rituximab in adults with relapsing–remitting multiple sclerosis: a systematic literature review
| Autor: | Barinder Singh, Gerard Harty, M.K. Siddiqui, Christiaan Veraart, Schiffon L Wong, Sumeet Attri |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Pediatrics medicine.medical_specialty Disease 030204 cardiovascular system & hematology 03 medical and health sciences 0302 clinical medicine Multiple Sclerosis Relapsing-Remitting immune system diseases hemic and lymphatic diseases medicine Humans 030212 general & internal medicine Randomized Controlled Trials as Topic business.industry Multiple sclerosis General Medicine Glatiramer Acetate medicine.disease Systematic review Relapsing remitting Rituximab Interferons business medicine.drug |
| DOI: | 10.6084/m9.figshare.12011301.v1 |
| Popis: | Objective: Rituximab is used as an off-label treatment for relapsing–remitting multiple sclerosis (RRMS); however, the comparative efficacy and safety of rituximab versus currently licensed disease-modifying drugs (DMDs) for RRMS is unknown. A systematic literature review was conducted to evaluate the available data pertaining to efficacy and safety of rituximab in adult patients with RRMS and highly active relapsing multiple sclerosis (HA-RMS); data quality was critically assessed via risk of bias (RoB) assessment. Methods: Biomedical literature databases were searched until mid-2018 and key proceedings were searched from 2016 to 2018. Critical appraisal of non-randomized studies was conducted using the Cochrane RoB assessment tool; randomized controlled trials (RCTs) were appraised using comprehensive assessment criteria based on the NICE guidelines. Results: Thirty-eight unique studies based on 49 publications were identified: 25 RRMS studies (one RCT) and 13 HA-RMS studies (no RCTs). The evidence among patients with RRMS generally favored rituximab in comparison to placebo (relapse rate) and interferons/glatiramer acetate (relapse rate and disability progression), although much of the non-randomized data were descriptive and/or not statistically significant. In comparison to placebo, rituximab was associated with a greater risk of adverse events. Two-thirds of the non-randomized RRMS studies were associated with critical/serious RoB; the single RCT was associated with low RoB. Furthermore, all of the non-randomized HA-RMS studies were associated with critical/serious RoB. Conclusions: Available evidence of off-label rituximab use for the treatment of patients with RRMS suggests generally favorable efficacy versus placebo and interferons/glatiramer acetate; however, the poor quality of the included studies limits any robust conclusions. |
| Databáze: | OpenAIRE |
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