Real-Life Efficacy of Tofacitinib in Various Situations in Ulcerative Colitis: A Retrospective Worldwide Multicenter Collaborative Study.

Autor: Resál T; Division of Gastroenterology, Department of Medicine, Albert Szent-Györgyi Medical School, University of Szeged, Szeged, Hungary., Bacsur P; Division of Gastroenterology, Department of Medicine, Albert Szent-Györgyi Medical School, University of Szeged, Szeged, Hungary., Keresztes C; Department for Medical Communication and Translation Studies, Albert Szent-Györgyi Medical School, University of Szeged, Szeged, Hungary., Bálint A; Division of Gastroenterology, Department of Medicine, Albert Szent-Györgyi Medical School, University of Szeged, Szeged, Hungary., Bor R; Division of Gastroenterology, Department of Medicine, Albert Szent-Györgyi Medical School, University of Szeged, Szeged, Hungary., Fábián A; Division of Gastroenterology, Department of Medicine, Albert Szent-Györgyi Medical School, University of Szeged, Szeged, Hungary., Farkas B; Division of Gastroenterology, Department of Medicine, Albert Szent-Györgyi Medical School, University of Szeged, Szeged, Hungary., Katsanos K; Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, School of Health Sciences, University of Ioannina, Ioannina, Greece., Michalopoylos G; Gastroenterology Department, General Hospital of Athens G. Gennimatas, Athens, Greece., Ribaldone DG; Department of Medical Sciences, University of Turin, Turin, Italy., Attauabi M; Department of Gastroenterology and Hepatology, Copenhagen University Hospital - Herlev and Gentofte, Herlev, Denmark., Zhao M; Gastrounit, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark., Barak HA; Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel., Yanai H; Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel., Bezzio C; IBD Unit/Gastroenterology Unit, Rho Hospital, ASST Rhodense, Rho, Italy., Rispo A; IBD Unit Department, Clinical Medicine and Surgery, Azienda Ospedaliera Universitaria Federico II of Naples, Naples, Italy., Castiglione F; IBD Unit Department, Clinical Medicine and Surgery, Azienda Ospedaliera Universitaria Federico II of Naples, Naples, Italy., Bar-Gil Shitrit A; Digestive Diseases Institute, Shaare Zedek Medical Center, Hebrew University of Jerusalem, Jerusalem, Israel., Pugliese D; 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., Armuzzi A; IBD Center, IRCCS Humanitas Research Hospital, Rozzano, Italy.; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy., Savarino EV; Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy.; Gastroenterology Unit, Azienda Ospedale Università di Padova, Padua, Italy., Kolar M; IVth Medical Department, Charles University in Prague, Prague, Czech Republic., Lukáš M; IVth Medical Department, Charles University in Prague, Prague, Czech Republic., Chashkova E; Irkutsk Scientific Center of Surgery and Traumatology, Irkutsk, Russia., Filip R; Department of Gastroenterology with IBD, Unit of Clinical Hospital No. 2 im. Sw. Jadwigi Królowej, Rzeszow, Poland., Rozieres A; Department of Gastroenterology, Lyon-Sud Hospital, Hospices Civils de Lyon, Lyon, France.; Centre International de Recherche et Infectologie, INSERM U1111, Lyon, France., Nancey S; Department of Gastroenterology, Lyon-Sud Hospital, Hospices Civils de Lyon, Lyon, France.; Centre International de Recherche et Infectologie, INSERM U1111, Lyon, France., Krznarić Ž; Department of Gastroenterology and Hepatology, University Hospital Centre Zagreb, Zagreb, Croatia.; Department of Nutrition, School of Medicine, University of Zagreb, Zagreb, Croatia., Schäfer E; Department of Gastroenterology, Military Hospital Medical Centre, State Health Centre, Budapest, Hungary., Szamosi T; Department of Gastroenterology, Military Hospital Medical Centre, State Health Centre, Budapest, Hungary., Sarlós P; Division of Gastroenterology, First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary.; Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary., Franko M; Department of Gastroenterology, University Medical Centre Ljubljana, Ljubljana, Slovenia., Drobne D; Department of Gastroenterology, University Medical Centre Ljubljana, Ljubljana, Slovenia.; Department of Gastroenterology, University Medical Centre Ljubljana, Medical Faculty, University of Ljubljana, Ljubljana, Slovenia., Knyazev OV; Moscow Clinical Scientific Center named after A. S. Loginov, Moscow, Russia.; National Medical Research Center of Coloproctology named after A. N. Ryzhykh, Moscow, Russia., Kagramanova AV; Moscow Clinical Scientific Center named after A. S. Loginov, Moscow, Russia.; Research Institute of Health Organization and Medical Management, Moscow, Russia., Limdi J; Department of Gastroenterology, Pennine Acute Hospitals NHS Trust, Manchester, United Kingdom., Wetwittayakhlang P; Division of Gastroenterology, McGill University Health Centre, Montreal, Quebec, Canada.; Gastroenterology and Hepatology Unit, Division of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand., Lakatos PL; Division of Gastroenterology, McGill University Health Centre, Montreal, Quebec, Canada.; Department of Internal Medicine and Oncology, Semmelweis University, Budapest, Hungary., Maharshak N; Department of Gastroenterology and Liver Diseases, Tel Aviv Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel., Bannon L; Department of Gastroenterology and Hepatology, Copenhagen University Hospital - Herlev and Gentofte, Herlev, Denmark., Nyári T; Department of Medical Physics and Informatics, Albert Szent-Györgyi Medical School University of Szeged, Szeged, Hungary., Szepes Z; Division of Gastroenterology, Department of Medicine, Albert Szent-Györgyi Medical School, University of Szeged, Szeged, Hungary., Farkas K; Division of Gastroenterology, Department of Medicine, Albert Szent-Györgyi Medical School, University of Szeged, Szeged, Hungary., Molnár T; Division of Gastroenterology, Department of Medicine, Albert Szent-Györgyi Medical School, University of Szeged, Szeged, Hungary.
Jazyk: angličtina
Zdroj: Inflammatory bowel diseases [Inflamm Bowel Dis] 2024 May 02; Vol. 30 (5), pp. 768-779.
DOI: 10.1093/ibd/izad135
Abstrakt: 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.
(© 2023 Crohn’s & Colitis Foundation. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation.)
Databáze: MEDLINE