Vedolizumab treatment persistence and safety in a 2-year data analysis of an extended access programme

Abstract

Background: Vedolizumab was shown to be effective and safe for patients with ulcerative colitis (UC) or Crohn's disease (CD) in the GEMINI phase 3 and long-term safety (LTS) studies.

Aim: To report treatment persistence and safety results up to 2 years after enrolment in the vedolizumab extended access programme (XAP) METHODS: Vedolizumab XAP is a phase 3b/4, prospective, open-label, multinational, interventional study. At rollover from GEMINI LTS, patients who were experiencing continued clinical benefit with vedolizumab received reduced dosing frequency from every 4 weeks (Q4W) to every 8 weeks (Q8W). Patient persistence on Q8W dosing, incidence of relapse, and safety 2 years after enrolment were investigated.

Results: We enrolled 311 patients (142 UC and 169 CD). At baseline, 93.7% (UC) and 89.3% (CD) of patients were in clinical remission; 93.0% (UC) and 84.6% (CD) reduced dosing frequency to Q8W at enrolment. Of those who reduced dosing frequency to Q8W at enrolment, 93.9% (UC) and 91.6% (CD) remained on Q8W dosing; 6.1% (UC) and 8.4% (CD) re-escalated to Q4W dosing. Relapse was reported in 9.1% (UC) and 14.0% (CD) of patients who reduced dosing to Q8W. Adverse events related to vedolizumab were infrequent; no new events were reported.

Conclusion: We observed high patient persistence on vedolizumab Q8W in the first 2 years after the reduction of dosing frequency in the XAP along with low rates of Q4W dose re-escalation and relapse. The safety profile was consistent with previous reports. ClinicalTrials.gov: NCT02743806.

FIGURE 1

Time to re‐escalation to Q4W dosing and relapse. (A) Time to dosing re‐escalation was defined as the time from the last vedolizumab dose during GEMINI LTS to the date of the first dose on the Q4W regimen. (B) Time to relapse is defined as the time from the last vedolizumab dose during GEMINI LTS to the date of relapse. Relapse was considered any of the following events: vedolizumab re‐escalation from Q8W to Q4W dosing, study withdrawal due to AE indicating the worsening of UC or CD, loss of adequate benefit from vedolizumab, commencement or increased dose of corticosteroid or immunomodulator therapy due to the worsening of UC or CD, or serious AE indicating the worsening of UC or CD. Only patients starting the study on Q8W dosing were included. AE, adverse event; CD, Crohn's disease; LTS, long‐term safety; Q4W, every 4 weeks; Q8W, every 8 weeks; UC, ulcerative colitis