Vedolizumab treatment persistence and safety

In an extended access program (XAP), patient persistence on vedolizumab every 8 weeks (Q8W) was high in the first 2 years after reduction of dosing frequency [1]. Overall, there were low rates of dose escalation (to every 4 weeks [Q4W]) and ulcerative colitis (UC) or Crohn’s disease (CD) disease relapse. The safety profile was consistent with previous reports.

The prospective, open-label vedolizumab XAP study enrolled 311 patients (142 UC, 169 CD) who had benefitted from vedolizumab in the GEMINI long-term safety study. They could remain on vedolizumab 300 mg intravenous Q4W if medically indicated. However, the large majority of UC and CD patients (93.0% and 84.6%) reduced dosing frequency at XAP start from Q4W to Q8W; 87.3% and 77.5% were still on Q8W after 2 years. At baseline, 93.0% and 88.2% of UC and CD patients were in corticosteroid-free remission.

Of patients who initiated Q8W dosing at enrolment in the XAP, 95% had no relapse for ≥6 months (97.0% UC, 93.7% CD). Only 7.3% of patients required dose escalation to Q4W. Time to dose escalation and to relapse were similar in UC and CD patients. Adverse events related to vedolizumab were infrequent; no new or serious events attributed to this treatment were reported.

In a binational, multicentre, retrospective case-control study, vedolizumab was found to have similar efficacy rates in young (n=140) vs elderly (n=144) patients with UC or CD [2]. The respective average age was 29.6 and 70.2 years. An increased risk of overall infections in the elderly cohort was noted, but it is unclear whether this was related to vedolizumab treatment.

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   1. Danese S, et al. ECCO-IBD 2020, DOP60.
   2. Cohen NA, et al. ECCO-IBD 2020, DOP57.

Posted on 14 April 20208 April 2024