Background Treatment with rituximab (RTX), a chimeric CD20 monoclonal antibody, has demonstrated efficacy for patients with several autoimmune diseases. There is a growing concern, however, safety evidence of RTX is still lacking.
Objectives We conducted to evaluate the safety of rituximab (RTX) for autoimmune diseases.
Methods A literature review was performed based on the randomized clinical trials (RCTs) that assessed adverse events by comparing RTX and placebo or no treatment for autoimmune diseases. The same add-on treatment for both arms were allowed. Study selection and data extraction were independently conducted in duplicate. Meta-analyses were performed for each outcome separately using fixed model and generic inverse variance method.
Results In the primary analysis, 16 eligible RCTs, with a total of 4147 patients for five autoimmune diseases (n=8: rheumatoid arthritis, n=3: Sjogren syndrome, n=1: systemic lupus erythematosus, multiple sclerosis, ulcerative colitis, Graves orbitopathy, immune thrombocytopenia) were analyzed. The incidence of infusion related reactions and the human antichimeric antibody (HACA) were higher in RTX group than placebo/no treatment group (OR 1.49, 95% CI 1.25–1.77 and OR 2.25, 95% CI 1.35–3.76, respectively). However, there were no significant differences the odds of total adverse events, serious adverse events, withdrawal for adverse events, infections, serious infections, malignancy, and all-cause death between two groups.
Conclusions Our meta-analysis revealed that RTX was not associated with an increased risk of adverse events except for infusion related reactions and the incidence of HACA compared with placebo.
Disclosure of Interest None declared