Impact of Concomitant Medications on Advanced Therapies for Ulcerative Colitis
The authors conducted an analysis that pooled individual patient data from 10 clinical trials of biologics and small molecule drugs. The medications evaluated included corticosteroids, immunomodulators, 5-aminosalicylates (5-ASAs), proton pump inhibitors (PPIs), histamine receptor antagonists (H2RAs), opiates, antidepressants, and antibiotics. A modified Poisson regression model was used to assess treatment efficacy and safety outcomes in patients receiving concomitant medications.
The analysis included 6044 patients; 4280 received an active intervention and 1764 received a placebo. Among the participants, 47% used corticosteroids, 28% used immunomodulators, 68% used 5-ASAs, and smaller percentages used other medications.
After adjusting for confounders, the study found no significant impact of concomitant use of corticosteroids (ratio of relative risk [RRR], 0.81; 95% confidence interval [CI], 0.63–1.06); 5-ASAs (RRR, 1.04; 95% CI, 0.78–1.39); PPIs (RRR, 0.87; 95% CI, 0.61–1.22); H2RAs (RRR, 1.72; 95% CI, 0.97–14.29); opiates (RRR, 0.90; 95% CI, 0.54–1.49); antidepressants (RRR, 1.02; 95% CI, 0.57–1.83); or antibiotics (RRR, 0.72; 95% CI, 0.44–1.16) on the likelihood of achieving clinical remission. However, concomitant use of immunomodulators was associated with a lower likelihood of clinical remission (RRR, 0.73; 95% CI, 0.55–0.97), particularly with nontumor necrosis factor (TNF) antagonists.
These results could inform future trial designs regarding the management of baseline concomitant medications, the authors concluded.
Reference
Ahuja D, Zou G, Solitano V, Syal G, Lee HH, Ma C, Jairath V, Singh S. No impact of concomitant medications on efficacy and safety of biologics and small molecules for ulcerative colitis. Clin Gastroenterol Hepatol. Published online October 10, 2024. doi: 10.1016/j.cgh.2024.08.040.
