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IntroductionReported rates of extraintestinal manifestations (EIMs) in patients (pts) with Crohn’s disease (CD) are 37%–55%.1,2This post hoc exploratory analysis investigated the effect of vedolizumab (VDZ) treatment on existing and new EIMs in patients with CD enrolled in GEMINI 2 (NCT00783692).MethodOutcomes were sustained resolution of existing EIMs (absence of symptoms, sustained to study end), worsening of existing EIMs and occurrence of new EIMs. For arthritis/arthralgia (ar/ar), Kaplan–Meier estimates were used to describe ‘time to sustained resolution’. A multivariate Cox regression adjusting for confounding factors was conducted. The effect of steroid tapering on new or worsening ar/ar was explored, using prednisone equivalent dose (≤30 mg) as a time-dependent covariate.ResultsPts received VDZ (n=814), VDZ/placebo (VDZ/PLA: VDZ to Week 6, PLA Weeks 6–52; n=153) or PLA only (n=148). Rates of EIMs other than ar/ar were too low for further analysis. Predicted annual rates of sustained resolution of ar/ar were 51% (VDZ), 41% (VDZ/PLA) and 36% (PLA). VDZ pts were 32% more likely to achieve sustained resolution of ar/ar versus PLA pts, and 21% less likely to have a worsening/new occurrence (Table, both non-significant [NS]). In pts receiving corticosteroids (CS; n=530), adjustment for CS withdrawal resulted in an ~4% increased likelihood of new or worsening ar/ar in all groups (30 mg dose reduction hazard ratio [HR] 1.04 [95% CI: 0.67–1.60], NS). Hazard reduction for the VDZ groups versus PLA was similar (VDZ, 0.73 [95% CI: 0.44–1.22], NS; VDZ/PLA, 0.72 [95% CI: 0.37–1.39], NS).Abstract PTH-065 Table 1Arthritis/arthralgia in patients with Crohn’s disease in GEMINI 2VDZ Q4W or Q8W (n=814)VDZ/PLA (n=153)PLA (n=148)Existing at baseline, n (%)367 (45)71 (46)78 (53)Sustained resolution of existing cases, n (%)* HR vs PLA (95% CI)128 (35) 1.32 (0.81–2.16)23 (32) 1.13 (0.61–2.09)18 (23) NANew or worsening ar/arWorsening of existing cases, n (%)57 (16)12 (17)12 (15)New occurrence, n (%)125 (28)21 (26)27 (39)HR†vs PLA (95% CI)0.79 (0.56–1.11)0.66 (0.42–1.06)NA*Sustained to the end of study participation†Time to new or worsening ar/arNA, not applicable; Q4/8W, every 4/8 weeksConclusionIn this post hoc exploratory analysis, there were trends for both a reduced incidence of new or worsening ar/ar and an increased rate of sustained resolution of ar/ar in pts receiving VDZ. CS tapering increased the probability of ar/ar in all groups.References. Lakatos L, et al. World J Gastroenterol2003;9:2300. Zippi M, et al. World J Gastroenterol2014;20:17463Disclosure of InterestB. Feagan Conflict with: Abbott/AbbVie, Amgen, Astra Zeneca, Bristol-Myers Squibb (BMS), Janssen Biotech (Centocor), JnJ/Janssen, Roche/Genentech, Millennium, Pfizer, Receptos, Santarus, Sanofi, Tillotts, UCB Pharma, Conflict with: Abbott/AbbVie, ActoGeniX, Akros, Albireo Pharma, Amgen, Astra Zeneca, Avaxia Biologics Inc., Avir Pharma, Axcan, Baxter Healthcare Corp., Biogen Idec, Boehringer-Ingelheim, Bristol-Myers Squibb, Calypso Biotech, Celgene, Elan/Biogen, enGene, Ferring Pharma, Roche/Genentech, gICare Pharma, Gilead, Given Imaging Inc., GSK, Ironwood Pharma, Janssen Biotech (Centocor), JnJ/Janssen, Kyowa Hakko Kirin Co Ltd., Lexicon, Lilly, Lycera BioTech, Merck, Mesoblast Pharma, Millennium, Nektar, Nestles, Novo Nordisk, Pfizer, Prometheus Therapeutics and Diagnostics, Protagonist, Receptos, Salix Pharma, Serono, Shire, Sigmoid Pharma, Synergy Pharma Inc., Takeda, Teva Pharma, TiGenix, Tillotts, UCB Pharma, Vertex Pharma, VHsquared Ltd., Warner Chilcott, Wyeth, Zealand, Zyngenia, Conflict with: Director of Robarts Clinical Trials Inc.; member of advisory boards Abbott/AbbVie, Amgen, Astra Zeneca, Avaxia Biologics Inc., Bristol-Myers Squibb, Celgene, Centocor Inc., Elan/Biogen, Ferring, JnJ/Janssen, Merck, Nestles, Novartis, Novo Nordisk, Pfizer, Prometheus Laboratories, Protagonist, Salix Pharma, Takeda, Teva, TiGenix, Tillotts Pharma AG, UCB Pharma, W Sandborn Conflict with: Janssen, AbbVie, Pfizer, Amgen, Genentech, Conflict with: Janssen, AbbVie, Pfizer, Amgen, Genentech, Takeda, Conflict with: Lecture fee(s): AbbVie, Takeda, J.-F. Colombel Conflict with: Intestinal Biotech Development, Genfit, Conflict with: AbbVie, Janssen and Janssen, Genentech, Takeda, Conflict with: AbbVie, Amgen, Boehringer-Ingelheim, Celgene Corporation, Celltrion, Enterome, Ferring, Genentech, Janssen and Janssen, Medimmune, Merck and Co., Pfizer, Protagonist, Second Genome, Seres, Takeda, Theradiag, Conflict with: Lecture fee(s): AbbVie, Ferring, Takeda, Shire, S O’Byrne Conflict with: Takeda Pharmaceuticals International AG, J Khalid Conflict with: Takeda Development Centre Europe Ltd, N Brayshaw Conflict with: Takeda Development Centre Europe Ltd, P Geransar Conflict with: Takeda Pharmaceuticals International AG, D Rubin Conflict with: AbbVie Inc., Bristol-Myers Squibb, Centocor/Janssen Pharmaceuticals, Inc., Cornerstones Health, Inc., Elan Pharmaceuticals, Emmi, Given Imaging, Ironwood, Lifecore Biomedical, LLC, Prometheus Pharmaceuticals, Santarus, Shire, Takeda-Millennium, Telsar Pharmaceuticals, UCB Pharma, Vertex Pharmaceuticals, Warner Chilcott