EVALUATING TREATMENT BENEFITS AND SAFETY PROFILE OF ANIFROLUMAB IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) -A SYSTEMATIC REVIEW AND META-ANALYSIS

Abstract

disease predominantly affecting women of reproductive age. Current therapies, including corticosteroids and immunosuppressants, have limited long-term safety. Anifrolumab, a monoclonal antibody targeting the type I interferon receptor, is a novel therapeutic option.

Objectives: To evaluate the efficacy and safety of Anifrolumab at 150 mg, 300 mg, and 1000 mg doses in patients with SLE through a systematic review and meta-analysis.

Methods: Five randomized controlled trials (Furie 2017, Furie 2019, Morand 2020, Bruce 2021, Morand 2023), encompassing 2,055 patients, were analyzed. Outcomes included SRI(4) response, BILAG-based Major Clinical Response, SLEDAI scores, and adverse events (herpes zoster, sinusitis, diarrhea, cough, infusion reactions). Data were pooled using random-effects meta-analysis (RevMan 5.4), with calculation of risk ratios, mean differences, heterogeneity (I²), and study weights.

Results: Anifrolumab 300 mg consistently improved SRI(4) response and BILAG scores versus placebo. The 1000 mg dose offered no additional benefit and had increased adverse event rates. The 150 mg dose showed inconsistent efficacy. The 300 mg dose was associated with higher herpes zoster risk (up to 9.4%) and mild to moderate events like sinusitis and infusion reactions. Moderate to high heterogeneity was observed in some outcomes.

Conclusions: Anifrolumab 300 mg offers optimal efficacy and an acceptable safety profile for moderate to severe SLE. Higher doses do not enhance efficacy and may increase toxicity. Findings support the 300 mg dose as the preferred therapeutic strategy.