Introduction
Tofacitinib (TFB) is suggested to be an effective therapeutic option for ulcerative colitis (UC) and has even been implicated in the treatment of acute UC (ASUC). However, available data on the efficacy of TFB in the above indications from real-world studies are limited by cohort size.
Aims & Methods
We aimed to investigate the effectiveness and safety of TFB in moderate to severe colitis and ASUC. A retrospective, international, multicenter cohort study, enrolling UC patients with ≥6-week follow-up period was conducted between February 1 and July 31, 2022. Indications for TFB were categorized to ASUC and chronic activity (CA). Baseline demographic and clinical data were obtained. Primary outcome was steroid-free remission (SFR), defined as partial Mayo score ≤ 1, no rectal bleeding and no steroid admission. Major secondary outcome was colectomy, and safety data were also analyzed.
Results
A total of 391 UC patients (median age 38 [IQR: 28-47] years; follow-up period 26 [IQR:14-52] weeks) were included. 27.1% of the patients received TFB for ASUC. SFR, as primary outcome, was achieved in 23.7% (ASUC: 26.0%, CA: 22.8%) at week 12 and 41.1% (ASUC: 34.2%, CA: 43.5%) at week 52. Baseline pMayo (OR: 0.850; p=0.006) was negatively associated with SFR at week 12. Biologic naive patients (OR: 2.078; p=0.04) more likely achieved week 52 SFR (56.8 % vs. 38.7 %). The colectomy rate at week 52 was significantly higher in the ASUC group (17.6% vs. 5.7%; p<0.001). Risk factor of colectomy was decreased with age (OR: 0.94; p=0.013). 67 adverse events were reported, and 17.9% resulted in the cessation of TFB. Thromboembolic event was reported in one patient.
Conclusion
TFB is equally effective in ASUC and chronic activity both in short-term and long-term. Higher baseline disease activity and previous biological therapy decreased the therapeutic efficacy. No new adverse event signals was found.
Disclosure
Daniela Pugliese received speaker fees from MSD, Takeda, Galapagos and Janssen, Pfizer; advisory board fees from Pfizer.
David Drobne is a speaker, consultant and an advisory board member for MSD, Abbvie, Takeda, Pfizer, Janssen, Amgen, Biogen and Krka.
Lukas Milan has been a speaker for: Abbvie, Takeda, Celltrion, Biogen, Janssen Cilag.
Peter L. Lakatos has been a speaker and/or advisory board member: AbbVie, Amgen, BioJamp, Bristol Myers Squibb, Fresenius Kabi, Genetech, Gilead, Janssen, Merck, Mylan, Organon, Pendopharm, Pfizer, Roche, Sandoz, Takeda ,Tillots and Viatris and has received unrestricted research grant: AbbVie, Gilead, Takeda and Pfizer.
George Michalopoylos has received speaker fees from Abbvie, Takeda, Janssen, and Pfizer.
Klaudia Farkas has received speaker’s honoraria from AbbVie, Janssen, Ferring, Takeda, and Goodwill Pharma.
Tamás Molnár has received speaker’s honoraria from MSD, AbbVie, Egis, Goodwill Pharma, Takeda, Pfizer, Janssen, Sandoz, MundiPharma, Phytotec, Roche, Fresenius, and Teva.
Nitsan Maharshak has received speaking and/ or consulting fees from Pfizer, Takeda, Janssen, Ferring, BiomX, BMS, Nestle, Trobix and grant support from Takeda, Janssen, Abbott, Abbvie, Pfizer, BMS, Corundum Innovation Ltd, Nestle.
