Rituxan safety in autoimmune diseases - a metastudy

ard.bmj.com/content/76/Suppl_2/1191.1
AB0405 Safety of rituximab therapy in autoimmune diseases:systematic review and meta-analysis
K Kobayashi1, KM Minegishi1, N Horita2, S Ohno1, HN Nakajima3
Abstract
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.

I wonder why there is a 'growing concern'?

Very interesting article. I was pretty surprised in talking with my new doctor regarding Rituxan. He is not a fan, and because I have already had a splenectomy, that treatment is basically off the table for me. He was really interested in ascertaining whether I can still receive vaccines just from having had the surgery, not even throwing such a strong immune-killing treatment like Rituxan in the mix. From reading other stories of various response patterns, I had really been feeling that I was heading there next, so his stand on the topic was surprising.

Maybe as more targeted treatments emerge, the sledgehammer approach of Rituxan will fall out of favor!