P0844 Comparative short-term effectiveness of tofacitinib and cyclosporine rescue therapy in patients with steroid-refractory, acute severe ulcerative colitis

Abstract Background The effectiveness of tofacitinib (TOFA) and cyclosporine (CsA) as rescue therapy has already been proven, but there are no studies directly comparing the two agents in patients with steroid-refractory, acute severe ulcerative colitis (ASUC). Methods We conducted a single-center, real-life retrospective cohort study to assess and compare the short-term effectiveness of TOFA and CsA in ASUC patients. The co-primary outcomes were week 2 and 8 clinical remission rates defined as partial Mayo score <2 with a rectal bleeding subscore of 0 and C-reactive protein ≤5 mg/L. The secondary outcomes were colectomy and relapse rates within 24 weeks of rescue therapy. Relapse was defined as the need for treatment modification or escalation, IBD-related hospitalization, and/or colectomy. Inverse probability weighting analysis (IPTW) was performed for age, disease extent, baseline pMayo, baseline CRP, as well as concomitant local and/or systemic corticosteroid use between the two treatment groups. Results A total of 198 patients (106 TOFA, 92 CsA; mean age: 34.9 + 14.5 years; 43.9% male) were enrolled in the study. After IPTW analysis, there was no statistically significant difference between TOFA and CsA treated patients regarding the probability of achieving clinical remission at weeks 2 (OR:0.63, 95% CI: 0.39-1.04, p = 0.07) and 8 (OR:1.1, 95% CI: 0.72-1.67, p = 0.66). However, the risk of relapse within 24 weeks of rescue therapy was more than twofold higher in patients receiving CsA compared to those receiving TOFA (OR:2.10, 95% CI: 1.21-3.66, p = 0.01). Furthermore, the risk of early colectomy was also significantly higher among CsA-treated patients than in the TOFA-treated group (OR:2.78, 95% CI: 1.22-6.34, p = 0.02). No new safety signal was noted. Conclusion Based on our real-life data, TOFA rescue treatment might be more effective than CsA in preventing urgent colectomy and early relapse in patients with steroid-refractory ASUC. Conflict of interest: Dr. Farkas, Bernadett: No conflict of interest Resál, Tamás: No conflict of interest Bacsur, Péter: No conflict of interest Ivány, Emese: No conflict of interest Gálfalvi, Noémi: No conflict of interest. Pápista, Máté: I have no Conflict of interest to declare. Farkas, Klaudia: No conflict of interest Molnár, Tamás: Conflict of interest: Tamás Molnár has received speaker’s honoraria from MSD, AbbVie, Egis, Goodwill Pharma, Takeda, Pfizer, Janssen, Sandoz, Phytotec, Roche, Fresenius, Teva, Celltrion, Stada, BMS, Ferring, EwoPharma and SOBI