Acneiform eruption with deucravacitinib: a systematic review and meta-analysis

Background Deucravacitinib, an oral selective tyrosine kinase 2 (TYK2) inhibitor, is an effective treatment for chronic plaque psoriasis. Its use is expanding to treat other autoinflammatory conditions; however, acneiform eruptions have been increasingly reported. Objectives To explore this, we conducted a systematic review and meta-analysis to quantify the incidence of acneiform eruptions associated with deucravacitinib and compare odds ratios (ORs) vs. placebo, including exploratory analyses by dose and indication. Methods The CENTRAL, Embase and MEDLINE databases were searched for interventional and observational studies. The primary outcome was the incidence of acneiform eruption (including acne, folliculitis, dermatitis acneiform and rosacea). A random-effects meta-analysis was performed to estimate pooled proportions and ORs. Results Of 672 records screened, 14 studies met the inclusion criteria, representing 5280 patients treated with deucravacitinib. Overall, 467/5280 (8.8%) patients developed an acneiform eruption (acne, 71.3%; folliculitis, 23.3%; dermatitis acneiform, 3.2%; and rosacea, 2.1%). Across eight placebo-controlled studies, the pooled incidence was 6.4% [95% confidence interval (CI) 0.05–0.09; I2 = 74.9%]. Events occurred in 145/2539 (5.7%) patients on deucravacitinib vs. 9/1070 (0.8%) in controls (pooled OR, 4.56; 95% CI 2.28–9.12; I2 = 9.4%). Discontinuations for acneiform events were uncommon (n = 7/3317; 0.2%). Dose-specific and indication-specific analyses suggested higher odds of acneiform events at higher total daily doses and in indications such as psoriasis and inflammatory bowel disease. Conclusions Acneiform eruptions are a frequent cutaneous adverse event with deucravacitinib and occur markedly more often than with placebo, yet rarely lead to discontinuation.