Safety and Efficacy of Brodalumab for Moderate-to-Severe Plaque Psoriasis: A Systematic Review and Meta-Analysis.

BACKGROUND

Psoriasis is an inflammatory skin disease that affects 2-3% of the worldwide population. The interleukin-17 cytokine family has been proven to play a central role in the pathogenesis of psoriasis. Brodalumab is a novel biologic agent that targets interleukin-17 molecules and their receptors. We aimed to evaluate the safety and efficacy of brodalumab as a therapeutic agent for moderate-to-severe psoriasis in a meta-analysis framework.

METHODS

A computer literature search of PubMed, OVID, Cochrane Central, EMBASE, EBSCO, Scopus, and Web of Science was conducted using relevant keywords. Data were extracted from eligible trials and analyzed using RevMan (Version 5.3 for windows) and OpenMeta [Analyst] software.

RESULTS

Six clinical trials (n = 4118 patients) were pooled in the final analysis. The pooled effect size favored brodalumab over placebo in terms of the Psoriasis Area and Severity Index (PASI) 75 [risk ratio (RR) = 12.61, 95% confidence interval (CI) 9.74-16.34], PASI 90 (RR = 28.72, 95% CI 18.34-44.98), and PASI 100 (RR = 61.23, 95% CI 25.48-147.17). Analysis of secondary outcomes showed that brodalumab was superior to placebo in terms of static physician's global assessment (RR = 32.53, 95% CI 13.80-76.69) and psoriasis symptoms inventory scores (RR = 14.70, 95% CI 8.38-25.78). Meta-regression analysis found a significant linear association between the brodalumab dose and the effect size on PASI and psoriasis symptoms inventory scores. The rate of overall adverse events was slightly higher in the brodalumab group (RR = 1.13, 95% CI 1.06-1.22); however, none of the individual adverse events were significantly higher in the brodalumab group, compared to the placebo group.

CONCLUSION

Brodalumab showed an acceptable safety profile and a robust efficacy in the treatment of moderate-to-severe plaque psoriasis. However, the current evidence is insufficient to confirm maintenance of these results in the long term; therefore, larger studies with longer follow-up periods are required.