Meta‐analysis: Real‐world effectiveness and safety of ustekinumab in patients with ulcerative colitis

Summary Background Evidence on real‐world outcomes of ustekinumab for ulcerative colitis (UC) patients is needed. Aims To summarise evidence on the real‐world outcomes of ustekinumab for UC and conduct a meta‐analysis of effectiveness and safety data. Methods A systematic search was conducted through September 2022 in electronic databases for observational studies evaluating ustekinumab for UC. A random‐effects meta‐analysis model was used to calculate the pooled effect sizes (percentages or incidence rates [IRs]) of effectiveness and safety outcomes. Results In all, 19 studies were included with 3786 patients. More than 92% of patients were previously treated with any biologic, 61.1% with both anti‐TNF and vedolizumab and 16.4% with any biologic and tofacitinib. Clinical remission was achieved in 45.4% at week 8 (95% CI: 30.1%–60.6%), 43.8% (38.4%–49.2%) at weeks 12–16, 44.6% (35.9%–53.3%) at month 6, and 50.6% (36.3%–64.8%) at month 12. Response was achieved in 61.2%, 59.4%, 65.2% and 76.8% at weeks 8, 12–16, month 6 and 12, respectively. CS‐free remission was achieved in 18.7%, 36.8%, 34.5% and 39% at weeks 8, 12–16, month 6 and 12, respectively. Overall, 58.2% of patients had endoscopic improvement at month 12. Almost 30% of the patients needed dose escalation, which was effective in 40% of these patients. The IRs of colectomy, adverse events (AEs), serious AEs and serious infections were 4.8, 7.9, 0.8 and 0.3 per 100 patient‐years, respectively. Conclusions This meta‐analysis confirms the effectiveness and safety of ustekinumab in a highly treatment‐refractory population of UC patients. The results of the meta‐analysis of observational studies confirm the effectiveness of ustekinumab in a highly treatment‐refractory population of patients with active moderate‐to‐severe ulcerative colitis (UC). The acceptable safety data support the positive long‐term benefit–risk profile of ustekinumab in the treatment of UC.