Introduction Vedolizumab (VDZ), a gut-selective humanised monoclonal antibody that targets α4β7 integrin, is approved for moderately to severely active Crohn’s disease (CD) and ulcerative colitis. The ongoing GEMINI open-label extension (OLE) trial is investigating the long-term safety of VDZ (NCT00790933). We report 5 year exploratory interim analyses of effectiveness and safety in patients (pts) with CD who completed GEMINI 2 and enrolled in GEMINI OLE.
Method Pts who responded to VDZ induction at Week (Wk) 6 received VDZ maintenance (every 8 or 4wks) to Wk 52 of GEMINI 2 and VDZ every 4 wks in GEMINI OLE. In an interim analysis, pts with 248 wks of cumulative VDZ (22 May 2009 to 21 May 2015) were assessed for clinical response (decrease in Harvey–Bradshaw Index [HBI] of 3 points from baseline [BL]), clinical remission (HBI 4), health-related quality of life (HRQoL) and safety.
Results Of 146 pts (anti-tumour necrosis factor-alpha: naïve n=81, failure n=57), 61 had 248 wks’ cumulative VDZ treatment, 58 discontinued (n=11 [19%] due to lack of continued benefit) and a further 27 (18%) had not yet reached 248 wks at data cut-off. Of pts with Wk 248 data, 95% had clinical response and 89% were in remission (Table). HRQoL improvements were observed at Wk 248, with mean change from BL in the Inflammatory Bowel Disease Questionnaire and Euro Quality of Life-5D visual analogue scale scores of 59.4 and 29.8, respectively. In the safety population, 142 pts had adverse events (AEs); 15 discontinued because of AEs. Serious AEs were reported in 49 pts (drug-related n=6; 8 pts discontinued). One death, not drug-related (motor accident), was recorded.
Table Abstract AODWE-003 Table 1 Effectiveness of long-term VDZ in pts with CD
Conclusion Continued clinical response, remission and HRQoL improvements were observed throughout 248 wks (~5 years) of cumulative VDZ therapy in pts with CD who responded at Wk 6, completed GEMINI 2 and enrolled in the OLE. The long-term safety profile of VDZ was consistent with that reported in previous studies.
Disclosure of Interest A Kaser Conflict with: Boehringer Ingelheim, Eisai, Ferring, Genentech, GlaxoSmithKline, Hospira, Janssen J and J, Kymab, Second Genome, Shire, VHsquared, Conflict with: Lecture fee(s): Falk, Ferring, Takeda; serves as course director of the Cambridge – MedImmune PhD programme
- Crohn’s disease
- Long-term effectiveness
- Long-term safety