Biological and target synthetic treatments for chronic spontaneous urticaria: A systematic review and network meta-analysis.

BACKGROUND

Most biological and synthetic target-specific drugs for antihistamine-refractory chronic spontaneous urticaria (CSU) have not been compared head-to-head. This systematic review and network meta-analysis evaluated their relative efficacy and safety.

METHODS

Searches were conducted on PubMed, Embase, Web of Science and Cochrane library databases to March 25, 2024 for randomized trials. A random-effects model was used to calculate the network estimates reported as mean differences (MD) and odds ratios (OR) with corresponding 95% CIs. Main outcomes included the weekly urticaria activity score (UAS7), adverse events (AEs) and serious adverse events (SAEs).

RESULTS

23 randomized clinical trials with 6933 participants that compared 26 different interventions or dosages and placebos were included. Omalizumab 300 mg [MD -10.07, 95% CI (-11.35; -8.82)] continues to demonstrate superior efficacy compared with placebo. Remibrutinib, at doses of 35 mg once daily [MD -7.80, 95% CI (-12.76; -2.51)], 25 mg twice daily [MD -7.69, 95% CI (-9.85; -5.76)], and 10 mg twice daily [MD -7.61, 95% CI (-12.59; -2.47)], had the best overall performance for efficacy and safety. Dupilumab, fenebrutinib, and rilzabrutinib also showed greater efficacy than placebo. The results were similar for the proportion of patients who achieved UAS7 ≤ 6 or UAS7 = 0. No significant differences were found among all treatment comparisons for AEs and SAEs.

CONCLUSION

The findings of this study indicate that the biological agent omalizumab 300 mg and the oral small molecule remibrutinib at doses of 35 mg, 25 mg, or 10 mg are recommended for patients with antihistamine-refractory CSU.

TRIAL REGISTRATION

PROSPERO: CRD42024516289.