P1061 A matching-adjusted indirect comparison (MAIC) of vedolizumab vs risankizumab in patients with moderately-to-severely active Crohn’s disease
Authors: Jairath V , Dulai P S , Talsma P , Wu J J , Adsul S 
Published: January 2025

Background

Crohn’s disease (CD), a chronic inflammatory bowel disease, requires effective therapies to manage symptoms and prevent complications. Vedolizumab (VDZ; a gut selective anti-α4β7-integrin) and risankizumab (RZB; anti-interleukin-23 p19) are approved for treatment of moderately-to-severely active CD. This matching-adjusted indirect comparison (MAIC) compared the efficacy of VDZ vs RZB using data from 5 phase 3 placebo (PBO)-controlled similarly designed clinical trials (GEMINI 2, VISIBLE 2, ADVANCE, MOTIVATE, FORTIFY).1-4

Methods

Individual patient data from VDZ trials (GEMINI 2, VISIBLE 2)1,2 were adjusted for the observed cross-trial differences in patient baseline characteristics to match the aggregated data from RZB trials (ADVANCE, MOTIVATE, FORTIFY) following MAIC guidance from the National Institute for Health Care Excellence (NICE, 2016) using a method-of-moments-based matching approach.3,4 The baseline covariates used in the matching include potential effect modifiers and clinically relevant covariates that improved the balance across trials. Outcomes compared included Crohn’s Disease Activity Index (CDAI) response (decrease of CDAI of ≥ 100 points from baseline) or remission (CDAI ≤ 150). For induction, the CDAI outcomes were commonly available at Week 4, hence we compared between VDZ and the pooled RZB (ADVANCE + MOTIVATE) on the approved dosage anchoring on PBO as the common comparator. For maintenance, CDAI outcomes at Week 52 of VDZ (pooled GEMINI 2 + VISIBLE 2) were compared with each approved RZB maintenance dose (FORTIFY) anchoring PBO as the common comparator. Outcome differences were reported using the effect measure based on the risk differences in PBO-adjusted response rate.

Results

After matching, baseline characteristics in the induction and maintenance datasets were balanced between VDZ and RZB cohorts (Table). The relative treatment differences were numerically lower with VDZ vs RZB for CDAI response and remission early in induction phase at Week 4 (Figure). At Week 52, the relative treatment effect in CDAI response and remission for VDZ were similar to both RZB doses (Figure). The relative treatment difference in CDAI clinical remission were numerically higher for VDZ than RZB regardless of the dose (180 mg: 2.8% [95% CI -12.3%-18.0%]; 360 mg: 5.4% [-10.1%, 20.9%]).

Conclusion

Despite the numerically lower CDAI outcomes with VDZ early in induction at Week 4, the CDAI outcomes, especially the clinically more meaningful CDAI remission at Week 52 were comparable between VDZ and both RZB doses. Although direct comparisons are warranted to validate these results, this information may help clinicians make informed treatment decisions for patients with CD.

References

1.D’Haens G, et al. Lancet. 2022;399(10340):2015-2030. 2. Ferrante M, et al. Lancet. 2022;399(10340):2031-2046. 3. Sandborn W.J, et al. N Engl J Med. 2013;369(8):711-721. 4. Vermeire S, et al. J Crohns Colitis. 2022;16(1):27-38.