BACKGROUND AND AIMS: Tofacitinib (TFB) appears to be effective in the treatment of ulcerative colitis (UC); however, available real-world studies are limited by cohort size. TFB could be an option in the treatment of acute severe ulcerative colitis (ASUC). We aimed to investigate efficacy and safety of TFB in moderate-to-severe colitis and ASUC. METHODS: This retrospective, international cohort study enrolling UC patients with ≥6-week follow-up period was conducted from February 1 to July 31, 2022. Indications were categorized as ASUC and chronic activity (CA). Baseline demographic and clinical data were obtained. Steroid-free remission (SFR), colectomy, and safety data were analyzed. RESULTS: A total of 391 UC patients (median age 38 [interquartile range, 28-47] years; follow-up period 26 [interquartile range, 14-52] weeks) were included. A total of 27.1% received TFB in ASUC. SFR rates were 23.7% (ASUC: 26.0%, CA: 22.8%) at week 12 and 41.1% (ASUC: 34.2%, CA: 43.5%) at week 52. The baseline partial Mayo score (odds ratio [OR], 0.850; P = .006) was negatively associated with week 12 SFR, while biologic-naïve patients (OR, 2.078; P = .04) more likely achieved week 52 SFR. The colectomy rate at week 52 was higher in ASUC group (17.6% vs 5.7%; P < .001) and decreased with age (OR, 0.94; P = .013). A total of 67 adverse events were reported, and 17.9% resulted in cessation of TFB. One case of thromboembolic event was reported. CONCLUSIONS: TFB is effective in both studied indications. TFB treatment resulted in high rates of SFR in the short and long terms. Higher baseline disease activity and previous biological therapies decreased efficacy. No new adverse event signals were found.

4th Medical Department Charles University Prague Prague Czech Republic

Centre International de Recherche et Infectologie INSERM U1111 Lyon France

Department for Medical Communication and Translation Studies Albert Szent Györgyi Medical School University of Szeged Szeged Hungary

Department of Biomedical Sciences Humanitas University Pieve Emanuele Italy

Department of Gastroenterology and Hepatology Copenhagen University Hospital Herlev and Gentofte Herlev Denmark

Department of Gastroenterology and Hepatology University Hospital Centre Zagreb Zagreb Croatia

Department of Gastroenterology and Liver Diseases Tel Aviv Medical Center Sackler Faculty of Medicine Tel Aviv University Tel Aviv Israel

Department of Gastroenterology Lyon Sud Hospital Hospices Civils de Lyon Lyon France

Department of Gastroenterology Military Hospital Medical Centre State Health Centre Budapest Hungary

Department of Gastroenterology Pennine Acute Hospitals NHS Trust Manchester United Kingdom

Department of Gastroenterology University Medical Centre Ljubljana Ljubljana Slovenia

Department of Gastroenterology University Medical Centre Ljubljana Medical Faculty University of Ljubljana Ljubljana Slovenia

Department of Gastroenterology with IBD Unit of Clinical Hospital No 2 im Sw Jadwigi Królowej Rzeszow Poland

Department of Internal Medicine and Oncology Semmelweis University Budapest Hungary

Department of Medical Physics and Informatics Albert Szent Györgyi Medical School University of Szeged Szeged Hungary

Department of Medical Sciences University of Turin Turin Italy

Department of Nutrition School of Medicine University of Zagreb Zagreb Croatia

Department of Surgery Oncology and Gastroenterology University of Padua Padua Italy

Digestive Diseases Institute Shaare Zedek Medical Center Hebrew University of Jerusalem Jerusalem Israel

Division of Gastroenterology 1st Department of Medicine Medical School University of Pécs Pécs Hungary

Division of Gastroenterology Department of Internal Medicine Faculty of Medicine School of Health Sciences University of Ioannina Ioannina Greece

Division of Gastroenterology Department of Medicine Albert Szent Györgyi Medical School University of Szeged Szeged Hungary

Division of Gastroenterology McGill University Health Centre Montreal Quebec Canada

Division of Gastroenterology Rabin Medical Center Petah Tikva Israel

Gastroenterology and Hepatology Unit Division of Internal Medicine Faculty of Medicine Prince of Songkla University Songkhla Thailand

Gastroenterology Department General Hospital of Athens G Gennimatas Athens Greece

Gastroenterology Unit Azienda Ospedale Università di Padova Padua Italy

Gastrounit Copenhagen University Hospital Amager and Hvidovre Hvidovre Denmark

IBD Center Centro Malattie Apparato Digerente Unità Operativa Complessa di Medicina Interna e Gastroenterologia Dipartimento di Scienze Mediche e Chirurgiche Fondazione Policlinico Universitario A Gemelli IRCCS Rome Italy

IBD Center IRCCS Humanitas Research Hospital Rozzano Italy

IBD Unit Department Clinical Medicine and Surgery Azienda Ospedaliera Universitaria Federico 2 of Naples Naples Italy

IBD Unit Gastroenterology Unit Rho Hospital ASST Rhodense Rho Italy

Institute for Translational Medicine Medical School University of Pécs Pécs Hungary

Irkutsk Scientific Center of Surgery and Traumatology Irkutsk Russia

Moscow Clinical Scientific Center named after A S Loginov Moscow Russia

National Medical Research Center of Coloproctology named after A N Ryzhykh Moscow Russia

Research Institute of Health Organization and Medical Management Moscow Russia

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