Concomitant use of common medications does not significantly affect UC induction therapy
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Key takeaways:
- Concomitant use of common medications did not significantly affect treatment efficacy or safety during UC induction.
- Only immunomodulator use was associated with lower likelihood of clinical remission.
Baseline concomitant exposure to commonly used medications, such as corticosteroids and 5-aminosalicylates, did not significantly affect clinical and endoscopic outcomes during induction therapy in ulcerative colitis, data analysis showed.
“Several medications which may have an impact on IBD-related inflammation are routinely used at trial entry including corticosteroids, immunomodulators and 5-aminosalicylates,” Dhruv Ahuja, MBChB, MBBS, of the department of medicine at Indira Gandhi Hospital, and colleagues wrote in Clinical Gastroenterology and Hepatology. “Some concomitant medications such as opiates and antidepressants may also impact gastrointestinal transit and thus may impact symptoms and patient-reported outcomes.”
They continued, “There has been limited evaluation of the impact of all major classes of background medications on diverse clinical and safety outcomes in patients with UC.”
To address this need, Ahuja and colleagues performed a pooled data analysis of 10 phase 3, placebo-controlled, randomized clinical trials of biologics and small-molecule drugs for treatment of moderate to severe UC.
The primary outcome was induction of clinical remission and endoscopic remission.
According to results, 4,280 patients received active intervention in the trials and 1,764 received placebo, with 47% also receiving concomitant corticosteroids, 28% immunomodulators, 68% 5-aminosalicylates, 14% PPIs, 2% histamine receptor antagonists, 7% opiates, 6% antidepressants and 5% antibiotics.
After adjusting for placebo response and confounders such as prior biologic exposure, endoscopic severity at baseline, sex and race, the researchers reported no significant effect on clinical and endoscopic outcomes with concomitant use of corticosteroids (ratio of RR [RRR] = 0.81; 95% CI, 0.63-1.06), 5-aminosalicylates (RRR = 1.04; 95% CI, 0.78-1.39), PPIs (RRR = 0.87; 95% CI, 0.61-1.22), histamine receptor antagonists (RRR = 1.72; 95% CI, 0.97-14.29), opiates (RRR = 0.9; 95% CI, 0.54-1.49), antidepressants (RRR = 1.02; 95% CI, 0.57-1.83) and antibiotics (RRR = 0.72; 95% CI, 0.44-1.16).
Conversely, use of immunomodulators, specifically non-tumor necrosis factor antagonists, was associated with a decreased likelihood of clinical remission (RRR = 0.73; 95% CI, 0.55-0.97).
Further, the researchers observed no negative impact on the risk for infections or serious adverse events with concomitant corticosteroids, immunomodulators or antibiotics.
“In clinical trials of advanced therapies for UC, baseline concomitant exposure to multiple commonly used class of medications does not impact treatment efficacy or safety,” Ahuja and colleagues wrote. “These findings directly inform design of regulatory clinical trials with respect to managing concomitant medications at baseline.”
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