Concomitant 5-ASA treatment does not affect efficacy, safety of vedolizumab in IBD
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Key takeaways:
- There were no significant differences in rates of clinical remission at weeks 6 or 52 in IBD patients receiving vedolizumab with or without 5-aminosalicylic acid.
- Adverse events were similar between groups.
Concomitant use of 5-aminosalicylic acid did not affect the overall safety and efficacy of IV or subcutaneous vedolizumab in patients with inflammatory bowel disease, according to a post hoc analysis in the Journal of Crohn’s and Colitis.
“Professional guidelines recommend 5-ASA therapy as a first-line treatment in mild to moderate ulcerative colitis,” Ryan C. Ungaro, MD, MS, associate professor of gastroenterology at the Icahn School of Medicine at Mount Sinai, and colleagues wrote. “However, 5-ASA is not recommended for induction or maintenance of remission in mild to moderate Crohn’s disease, and there is an ongoing debate as to the benefit of 5-ASA in CD management.”
They continued: “As the therapeutic armamentarium for IBD expands, it is important to understand if there is any benefit to continuing 5-ASA in patients escalated to other advanced therapies that have differing mechanisms of action.”
In a post hoc analysis of data from GEMINI, VISIBLE and open-label studies, Ungaro and colleagues assessed the effect of 5-aminosalicylic acid (5-ASA) treatment on the safety and efficacy of IV or subcutaneous vedolizumab in patients with moderate to severely active IBD. Researchers evaluated 5-ASA co-treatment on clinical and endoscopic outcomes at weeks 6 and 52.
Efficacy data analysis included 1,070 vedolizumab-treated patients from the induction phase (629 with CD; 441 with UC) and 990 vedolizumab-treated patients from the maintenance phase (583 with CD; 407 with UC).
Ulcerative colitis
At week 6, 75% of patients with UC treated with vedolizumab and 5-ASA achieved clinical response compared with 61.9% who did not receive 5-ASA. Researchers reported no significant differences in clinical remission among those treated with vs. without 5-ASA at week 6 (20.7% vs. 20.4%; adjusted OR = 0.77; 95% CI, 0.43-1.38) or week 52 (45.1% vs. 40.6%; aOR = 1.14; 95% CI, 0.7-1.86).
Corticosteroid-free remission was achieved at week 52 in 34.3% of patients who received 5-ASA co-treatment vs. 39.5% who did not.
Crohn’s disease
In patients with CD, clinical remission was achieved at week 6 in 41.4% of those treated with 5-ASA vs. 35.1% without (aOR = 1.26; 95% CI, 0.86-1.85). Clinical response was achieved in 70.3% vs. 61.9%, respectively, at week 6.
The proportion of those in clinical remission at week 52 was 49.6% in the 5-ASA group vs. 37.8% (aOR = 1.35; 95% CI, 0.91-1.99), while clinical response was 56.4% vs. 42.4% (aOR = 1.5; 95% CI, 1.03-2.21), respectively.
Researchers reported adverse events were comparable between groups who did or did not receive 5-ASA co-treatment.
“Concomitant 5-ASA does not appear to impact the efficacy of vedolizumab IV or SC treatment in patients with IBD,” Ungaro and colleagues concluded. “Although there were limited data for some subgroups, there was no evidence to suggest that concomitant 5-ASA use impacted adverse event rates.”
They continued: “These data will be useful to inform benefit-risk assessments of concomitant 5-ASA treatment in patients initiating vedolizumab therapy.”
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