Efficacy and safety of rituximab for the treatment of systemic lupus erythematosus

ABSTRACT

Strength of recommendations: Strong against the technology

Technology: Rituximab

Indication: Refractory systemic lupus treatment

Characterization of the technology: Rituximab targets a specific protein known as CD20 on the surface of B-cells resulting in cell death.

Question: Is the use of rituximabe as adjuvant treatment effective and safe for patients with refractory systemic lupus?

Search and analysis of scientific evidence: We searched the Medline (via Pubmed), The Cochrane Library (via Bireme), Lilacs and the Centre for Reviews Dissemination (CRD). Systematic Reviews (SR) and Randomized Controlled Trials (RCT) of clinical trials comparing the use of rituximabe plus standard treatment with standard treatment at refractory systemic lupus treatment were included. The quality of evidence and strength of recommendation were assessed using the GRADE system and its variance.

Summary of results of selected studies: Three SR with metanalysis and three RCT were included whose quality ranged from very low to moderate quality. Most of them showed no significantly superior efficacy to decrease the disease activity index of rituximabe in systemic lupus treatment when compared to standard treatments, despite the significant improved in serological markers of disease activity index (most of them with p value >0.05, against rituximab utilization). Unexpected adverse events, severe and non-severe, were not observed when compared to standard treatment.

Recommendations: The strength of recommendation is strong against rituximabe for systemic lupus treatment, considering the quality of the evidence and the higher cost of treatment compared to standard treatment. However, more randomized controlled trials are needed to evaluate its effectiveness with higher precision.

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