Assessment of the Safety of Tofacitinib Among Patients With Psoriasis: A Systematic Review and Meta-Analysis

Psoriasis is a clinically heterogeneous, lifelong skin condition. Novel medications such as Janus kinase (JAK) inhibitors have emerged as a promising class of agents that modulate the immune response. Tofacitinib could reduce skin lesions and boost patient-reported clinical outcomes, but its immunosuppressive effects might also increase patients' risk of infections and other adverse effects. To assess the safety outcomes of using Tofacitinib in comparison to placebo in terms of the incidence of serious infections, herpes zoster infection (HZ), upper respiratory tract infections (URTI), nasopharyngitis, and serious adverse events (SAE), this systematic review and meta-analysis followed the Cochrane Handbook for Systematic Reviews and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The search strategy involved five databases. Two authors independently screened and selected studies. Only randomized controlled trials (RCTs) were eligible for inclusion. Data on baseline patient characteristics and outcomes such as serious infections, HZ infections, nasopharyngitis, and URTIs were extracted. The risk of bias was assessed using the revised version of the Cochrane risk of bias (ROB2) tool, and meta-analysis was conducted using Cochrane's Revman web. The OR was employed to estimate outcomes. A probability value of less than 0.05 was considered statistically significant. The search strategy initially identified 998 studies; of these, six RCTs were included with a total of 2516 participants having moderate-to-severe psoriasis and treated with either Tofacitinib or placebo. The meta-analysis results revealed increases in the risks of HZ, URTIs, serious infections, nasopharyngitis, and SAE, but no significant difference was found between the intervention and placebo groups. The risk of bias was assessed using the ROB2 tool, revealing low bias across most domains, with some concerns in certain studies related to deviations from intended interventions and missing outcome data. In conclusion, while Tofacitinib is effective against moderate-to-severe psoriasis with non-significant risks, there are some safety concerns regarding the measured outcomes. Future research is needed concerning the assessment of safety outcomes with long-term use of Tofacitinib among larger populations.