Does Continuing 5-ASA During Vedolizumab Treatment Improve IBD Clinical Outcomes?

The concurrent use of oral 5-aminosalicylic acid (5-ASA) following the initiation of intravenous (IV) or subcutaneous (SC) vedolizumab does not have a significant effect on clinical and endoscopic outcomes in patients with inflammatory bowel disease (IBD), according to study results published in the Journal of Crohns and Colitis.

Researchers conducted a post hoc analysis of data from adult patients with moderate to severe ulcerative colitis (UC) and Crohn disease (CD) taking IV or SC vedolizumab and reported on the efficacy and safety of treatment.

The following studies (name, ClinicalTrials.gov Identifier) were included: GEMINI 1, NCT00783718; GEMINI 2, NCT00783692; GEMINI 3, NCT01224171; GEMINI long-term safety study, NCT00790933; VISIBLE 1, NCT02611830; VISIBLE 2, NCT02611817; VISIBLE open-label extension, NCT02620046.

Any dose of 5-ASA treatment, including any mesalamine or sulfasalazine formulation, given to the patient from the beginning to the end of vedolizumab therapy was considered 5-ASA.

Efficacy outcomes included the proportion of patients achieving clinical remission at the end of induction (week 6) and maintenance phase (week 52) and CS-free remission at week 52.

Clinical remission was defined as a complete Mayo score of 2 points or lower and no individual subscore greater than 1 point in patients with UC, or CD activity index score of 150 or lower in patients with CD.

The study analyzed 7 clinical trials of vedolizumab-treated patients with moderate to severe IBD. The researchers studied efficacy data from 4 studies, involving 1070 vedolizumab-treated patients during the induction phase (441 with UC and 629 with CD) and 990 vedolizumab-treated patients during the maintenance phase (407 with UC and 583 with CD).

Baseline demographics and disease characteristics were comparable across groups. There were no significant differences in UC clinical remission rates between groups with and without 5-ASA. This was observed at week 6 (20.7% vs 20.4%) and at week 52 (45.1% vs 40.6%). Similarly, in CD clinical remission rates, no significant differences were found at week 6 (41.4% vs 35.1%) or at week 52 (49.6% vs 37.8%).

In patients with CD, the median duration of disease was shorter (5.84 [range, 0-34] years) for those receiving vedolizumab maintenance treatment with concomitant 5-ASA, compared with those not receiving 5-ASA (8.0 [range, 0-47] years). Similarly, for patients with CD receiving vedolizumab induction, the median duration of disease was 5.8 [range, 0-42] years with 5-ASA and 8.3 [range, 0-51] years without 5-ASA.

The occurrence of adverse events in patients with IBD was similar between those treated with or without 5-ASA. It was also consistent across different subgroups, regardless of 5-ASA co-treatment.

The occurrence of enteric and other infections in patients treated with vedolizumab IV/SC was minimal, regardless of the presence or absence of 5-ASA.

Among deaths reported within 126 days of the last vedolizumab IV dose, 2 were in the concomitant 5-ASA group and 11 were in the group without 5-ASA. No deaths were reported within 126 days of the last SC dose in the group receiving 5-ASA, while 1 death was reported in the group without.

Study limitations include using data from open-label treatment and not performing multiplicity adjustment.

The researchers concluded, “Prospective interventional trials of 5-ASA withdrawal at the time of escalation to advanced therapy are warranted to validate findings from this and other retrospective analyses, and to confirm that patients with IBD who require escalation to advanced therapy can safely discontinue 5-ASA treatment.”

Disclosure: This research was supported by Takeda. Multiple study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.