Real-Life Efficacy of Tofacitinib in Various Situations in Ulcerative Colitis: A Retrospective Worldwide Multicenter Collaborative Study-Reference-Cited by-同舟云学术

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

Published:2023-08-05 Issue: Volume: Page:
ISSN:1078-0998
Container-title:Inflammatory Bowel Diseases
language:en
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Author:

Resál Tamás¹,Bacsur Péter¹,Keresztes Csilla²,Bálint Anita¹,Bor Renáta¹,Fábián Anna¹,Farkas Bernadett¹,Katsanos Kostas³,Michalopoylos George⁴,Ribaldone Davide Giuseppe⁵,Attauabi Mohamed⁶,Zhao Mirabella⁷^ORCID,Barak Hadar Amir⁸,Yanai Henit⁸,Bezzio Cristina⁹^ORCID,Rispo Antonio¹⁰,Castiglione Fabiana¹⁰,Bar-Gil Shitrit Ariella¹¹,Pugliese Daniela¹²,Armuzzi Alessandro¹³¹⁴^ORCID,Savarino Edoardo Vincenzo¹⁵¹⁶,Kolar Martin¹⁷,Lukáš Milan¹⁷,Chashkova Elena¹⁸,Filip Rafał¹⁹,Rozieres Aurore²⁰²¹,Nancey Stéphane²⁰²¹,Krznarić Željko²²²³,Schäfer Eszter²⁴,Szamosi ²⁴,Sarlós Patrícia²⁵²⁶,Franko Matej²⁷,Drobne David²⁷²⁸^ORCID,Knyazev Oleg V²⁹⁶,Kagramanova Anna V²⁹³⁰,Limdi Jimmy³¹,Wetwittayakhlang Panu³²³³^ORCID,Lakatos Peter L³²³⁴,Maharshak Nitsan³⁵,Bannon Lian³⁶,Nyári Tibor³⁷,Szepes Zoltán¹,Farkas Klaudia¹,Molnár Tamás¹^ORCID,

Affiliation:

1. Division of Gastroenterology, Department of Medicine, Albert Szent-Györgyi Medical School, University of Szeged , Szeged , Hungary

2. Department for Medical Communication and Translation Studies, Albert Szent-Györgyi Medical School, University of Szeged , Szeged , Hungary

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

4. Gastroenterology Department, General Hospital of Athens G. Gennimatas , Athens , Greece

5. Department of Medical Sciences, University of Turin , Turin , Italy

6. Department of Gastroenterology and Hepatology, Copenhagen University Hospital - Herlev and Gentofte , Herlev , Denmark

7. Gastrounit, Copenhagen University Hospital - Amager and Hvidovre , Hvidovre , Denmark

8. Division of Gastroenterology, Rabin Medical Center , Petah Tikva , Israel

9. IBD Unit/Gastroenterology Unit, Rho Hospital, ASST Rhodense , Rho , Italy

10. IBD Unit Department, Clinical Medicine and Surgery, Azienda Ospedaliera Universitaria Federico II of Naples , Naples , Italy

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

12. 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

13. IBD Center, IRCCS Humanitas Research Hospital , Rozzano , Italy

14. Department of Biomedical Sciences, Humanitas University , Pieve Emanuele , Italy

15. Department of Surgery, Oncology and Gastroenterology, University of Padua , Padua , Italy

16. Gastroenterology Unit, Azienda Ospedale Università di Padova , Padua , Italy

17. IVth Medical Department, Charles University in Prague , Prague , Czech Republic

18. Irkutsk Scientific Center of Surgery and Traumatology , Irkutsk , Russia

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

20. Department of Gastroenterology, Lyon-Sud Hospital, Hospices Civils de Lyon , Lyon , France

21. Centre International de Recherche et Infectologie, INSERM U1111 , Lyon , France

22. Department of Gastroenterology and Hepatology, University Hospital Centre Zagreb , Zagreb , Croatia

23. Department of Nutrition, School of Medicine, University of Zagreb , Zagreb , Croatia

24. Department of Gastroenterology, Military Hospital Medical Centre, State Health Centre , Budapest , Hungary

25. Division of Gastroenterology, First Department of Medicine, Medical School, University of Pécs , Pécs , Hungary

26. Institute for Translational Medicine, Medical School, University of Pécs , Pécs , Hungary

27. Department of Gastroenterology, University Medical Centre Ljubljana , Ljubljana , Slovenia

28. Department of Gastroenterology, University Medical Centre Ljubljana, Medical Faculty, University of Ljubljana , Ljubljana , Slovenia

29. Moscow Clinical Scientific Center named after A. S. Loginov , Moscow , Russia

30. Research Institute of Health Organization and Medical Management , Moscow , Russia

31. Department of Gastroenterology, Pennine Acute Hospitals NHS Trust , Manchester , United Kingdom

32. Division of Gastroenterology, McGill University Health Centre , Montreal, Quebec , Canada

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

34. Department of Internal Medicine and Oncology, Semmelweis University , Budapest , Hungary

35. National Medical Research Сenter of Coloproctology named after A. N. Ryzhykh , Moscow , Russia

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

37. Department of Medical Physics and Informatics, Albert Szent-Györgyi Medical School University of Szeged , Szeged , Hungary

Abstract

Abstract 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.

Funder

Hungarian Scientific Research

National Research, Development and Innovation Office

New National Excellence Program of the Ministry of Human Capacities

Janos Bolyai Research

Géza Hetényi Research

Albert Szent-Györgyi Medical School, University of Szeged

Publisher

Oxford University Press (OUP)

Subject

Gastroenterology,Immunology and Allergy

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