DOP019 Effect of vedolizumab treatment on extraintestinal manifestations in patients with Crohn's disease: a GEMINI 2 post hoc analysis

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Background: Extraintestinal manifestations (EIMs) pose an additional burden to patients with IBD (reported frequency: 6–47%) [1]. Vedolizumab (VDZ) is approved for the treatment of moderately to severely active Crohn's disease (CD) and ulcerative colitis. This post hoc exploratory analysis investigated the effect of VDZ treatment on existing and new EIMs in patients with CD enrolled in GEMINI 2 (NCT00783692).

Methods: Data were collected on 5 categories of EIM and assessed using the following definitions: sustained resolution (absence of an EIM symptom, sustained to study end), worsening of existing EIM and occurrence of new EIM. For the category of arthritis/arthralgia (ar/ar), Kaplan–Meier (KM) estimates were used to describe “time to sustained resolution”. A multivariate Cox regression adjusting for potential baseline confounding factors was conducted. In patients receiving corticosteroids (CS), the influence of steroid tapering on the occurrence of new or worsening ar/ar was explored, with prednisone equivalent dose (≤30 mg) as a time-dependent covariate.

Results: Patients (pts) received VDZ (n=814), VDZ/placebo (VDZ/PLA; VDZ to Week 6, PLA Week 6–52; n=153) or PLA only (n=148). Baseline EIM incidence was similar across treatment groups (Table). Further analyses focussed on ar/ar as the most common EIM. Predicted annual rates of sustained resolution of ar/ar were 51% (VDZ), 41% (VDZ/PLA) and 36% (PLA; Figure). VDZ pts were 32% more likely to achieve sustained resolution of ar/ar versus PLA (not significant [NS], Table) and 21% less likely to have a worsening/new occurrence (NS, Table). In pts receiving CS (n=530), adjustment for CS withdrawal resulted in ∼4% increased likelihood of new or worsening ar/ar in all groups over time (30 mg dose reduction HR 1.04 [95% CI: 0.67–1.60], NS). Hazard reduction for the VDZ groups versus those on PLA was similar (VDZ, 0.73 [95% CI: 0.44–1.22], NS; VDZ/PLA, 0.72 [95% CI: 0.37–1.39], NS).

Conclusions: In this post hoc exploratory analysis there was a trend for both reduced incidence of new or worsening ar/ar and increased rates of sustained resolution of ar/ar in pts receiving VDZ. CS tapering increased the probability of ar/ar in all groups. GEMINI 2 was not sufficiently powered to assess worsening/new occurrences of other EIMs.


[1] Vavricka SR, Schoepfer A, Scharl M, et al., (2015), Extraintestinal Manifestations of Inflammatory Bowel Disease, Inflamm Bowel Dis, 1982–92

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