Systematic Review with Meta-analysis: Efficacy and Safety of Upadacitinib in Managing Moderate-to-Severe Crohn’s Disease and Ulcerative Colitis

• Published in: Clinical drug investigation 2024-06, Vol.44 (6), p.371-385
• Main Authors: Niu, Chengu, Zhang, Jing, Napel, Mahesh, Boppana, Leela Krishna Teja, Anas, Hashem, Jadhav, Nagesh, Dunnigan, Karin, Okolo, Patrick I.
• Format: Article
• Language: English
• Subjects: Colitis, Ulcerative - drug therapy; Crohn Disease - drug therapy; Crohn's disease; Heterocyclic Compounds, 3-Ring - administration & dosage; Heterocyclic Compounds, 3-Ring - adverse effects; Heterocyclic Compounds, 3-Ring - therapeutic use; Humans; Inflammatory bowel disease; Internal Medicine; Medicine; Medicine & Public Health; Pharmacology/Toxicology; Pharmacotherapy; Remission (Medicine); Severity of Illness Index; Steroids; Systematic Review; Treatment Outcome; Tumor necrosis factor-TNF
• ISSN: 1173-2563; 1179-1918; 1179-1918
• DOI: 10.1007/s40261-024-01364-0

Background In the panorama of therapeutic strategies for inflammatory bowel diseases, oral upadacitinib stands out for its potential to improve short-term and long-term patient outcomes. Objective This meta-analysis aspires to collate and assess the available evidence regarding the efficacy and safety of upadacitinib in managing moderate-to-severe Crohn’s disease and ulcerative colitis. Methods A meta-analysis was conducted using studies sourced from MEDLINE/PubMed, Cochrane Library, Scopus, and Embase, published from January 2010 to March 2024. Peer-reviewed articles that reported data on the effects of upadacitinib in adult patients with Crohn’s disease and ulcerative colitis were included based on established inclusion and exclusion criteria. Results Eight studies, encompassing a total of 2818 patients treated with upadacitinib, were included. In primary outcomes, for patients with Crohn’s disease who were using upadacitinib, the weighted pooled clinical remission rate was found to be 45.8% (95% confidence interval [CI] 0.39–0.52), while for patients with ulcerative colitis who were using upadacitinib, the rate was 25.4% (95% CI 0.17–0.36). The pooled clinical response rate for Crohn’s disease was 53.6% (95% CI 0.50–0.57), and for ulcerative colitis it was 72.6% (95% CI 0.69–0.76). The pooled serious adverse event rate was 6.0% (95% CI 0.07–0.09). Conclusions Upadacitinib demonstrates significant efficacy in achieving clinical remission and response in patients with moderate-to-severe Crohn’s disease and ulcerative colitis, as shown by clinical remission rates of 44.9% and 36.0%, respectively. The treatment also maintains a favorable safety profile with a serious adverse event rate of 7.8%, making it an effective option for those resistant or intolerant to traditional immunosuppressants or tumor necrosis factor antagonists.