Gender-Based Differences in Response to Tumor Necrosis Factor Inhibitor Therapies for Ulcerative Colitis: Individual Participant Data Meta-Analyses of Clinical Trials
| Autor: | Manasi Agrawal, Francesca Petralia, Adam Tepler, Laura Durbin, Walter Reinisch, Jean-Frederic Colombel, Shailja C Shah |
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| Jazyk: | angličtina |
| Rok vydání: | 2022 |
| Předmět: |
Male
therapy Remission Induction Gastroenterology individual participant data meta-analysis Infliximab/therapeutic use Treatment Outcome sex-based Tumor Necrosis Factor Inhibitors/therapeutic use Inflammatory Bowel Diseases/drug therapy clinical trial data gender Humans Immunology and Allergy Female Leading Off tumor necrosis factor inhibitor Colitis Ulcerative/drug therapy ulcerative colitis |
| Zdroj: | Inflamm Bowel Dis Agrawal, M, Petralia, F, Tepler, A, Durbin, L, Reinisch, W, Colombel, J-F & Shah, S C 2023, ' Gender-Based Differences in Response to Tumor Necrosis Factor Inhibitor Therapies for Ulcerative Colitis : Individual Participant Data Meta-Analyses of Clinical Trials ', Inflammatory Bowel Diseases, vol. 29, no. 1, izac067, pp. 1-8 . https://doi.org/10.1093/ibd/izac067 |
| DOI: | 10.1093/ibd/izac067 |
| Popis: | Background Gender-based differences are reported in inflammatory bowel diseases (IBD) pathogenesis, but their impacts on IBD outcomes are not well known. We determined gender-based differences in response to treatment with tumor necrosis factor inhibitor (TNFi) therapies in individuals with ulcerative colitis (UC). Methods We used the Yale University Open Data Access (YODA) platform to abstract individual participant data from randomized clinical trials to study infliximab and golimumab as induction and maintenance therapies in moderately to severely active UC. Using multivariable logistic regression, we examined associations between gender and the endpoints of clinical remission, mucosal healing, and clinical response for each study individually and in a meta-analysis. Results Of 1639 patients included in induction trials (Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment—Subcutaneous [PURSUIT-SC], active ulcerative colitis trials [ACT] 1 and 2) and 1280 patients included in maintenance trials (Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment—Maintenance [PURSUIT-IM], ACT 1 and 2), 696 (42.5%) and 534 (41.7%) were women, respectively. In a meta-analysis of induction trials, the adjusted odds ratios (aORs) of clinical remission (aOR, 0.55; 95% CI, 0.31–0.97), mucosal healing (aOR, 0.47; 95% CI, 0.27–0.83), and clinical response (aOR, 0.51; 95% CI, 0.29–0.90) in the treatment arm and of clinical remission in the placebo arm (aOR, 0.34; 95% CI, 0.15–0.82) were lower in men compared to women. There were no differences in outcomes by gender in the treatment and placebo arms in the meta-analysis of maintenance trials. Conclusions Men are less likely to achieve clinical remission, mucosal healing, and clinical response compared to women during induction treatment with TNFi for UC, but not during the maintenance phase. Future studies delineating the mechanisms underlying these observations would be informative. |
| Databáze: | OpenAIRE |
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