ABSTRACT
Background and objective – Selective IL-12/23p40 receptor antagonists (IL-12/23RA) show promise for treating moderate to severe ulcerative colitis (UC), but their efficacy and safety are not fully understood. Objective: This systematic review and meta-analysis assess the effectiveness and safety of IL-12/23RA in UC. Methods – A systematic search of PubMed, Embase, Cochrane, and ClinicalTrials.gov was performed in December 2024. Randomized controlled trials (RCTs) comparing IL-12/23RA to placebo in moderate to severe UC were included. Outcomes included clinical and endoscopic remission, response rates, and adverse events (AEs). Risk ratios (RR) and mean differences (MD) with 95% confidence intervals (CI) were pooled using a random-effects model. Results – Nine RCTs (3,808 patients in the induction phase; 1,734 in the maintenance phase) were analyzed. IL-12/23RA enhanced clinical remission (induction: RR 2.63; 95%CI 2.05-3.36; maintenance: RR 1.99; 95%CI 1.63-2.44; all P<0.01) and endoscopic remission (induction: RR 2.36; 95%CI 1.70-2.20; maintenance: RR 1.96; 95%CI 1.63-2.37; all P<0.01). IL-12/23RA reduced serious AE in the induction phase (RR 0.40; 95%CI 0.27-0.69; P<0.01), while there was no difference during maintenance (RR 0.75; 95%CI 0.31-1.84; P=0.53). No differences were observed in overall AEs or specific AEs like headache or nasopharyngitis. Trial sequential analysis confirmed sufficient sample size for clinical endpoints. Conclusion – IL-12/23RA showed superior effectiveness and similar safety when compared to placebo in moderate to severe UC.
AUTORES
Wellgner Fernandes Oliveira AMADOR, Isabelle Castro VITOR, Milena Ramos TOMÉ, Diogo Delgado DOTTA and Rodrigo V MOTTA
