Real-world Effectiveness and Safety of Tofacitinib in Multi-Refractory Ulcerative Colitis: insights from a Belgian Cohort with prior Anti-TNF and Vedolizumab Exposure
| Journal | Volume 88 - 2025 |
| Issue | Fasc.3 - Original articles |
| Author(s) | A. Cremer 1, A. Mansour 1, T. Lobaton 2, P. Bossuyt 3, J. Rahier 4, F. Baert 5, O. Dewit 6, E. Macken 7, A. Vijverman 8, P. Van Hootegem 9, F. Mana 10, B. Willandt 11, E. Humblet 12, F. D’Heygere 13, A. Verreth 14, A. El Nawar 15, J. Coenegrachts 16, S. Dewit 17, S. De Coninck 18, N. Schoofs 19, S. Delen 20, J. Dutre 21, C. Thienpont 22, S. Vanden Branden 23, D. Staessen 24, C. Croonen 25, S. Vieujean 26, D. Franchimont 1 |
| Full article |
 PAGES 229-237 VIEW FREE PDF |
| DOI | 10.51821/88.3.14064 |
|
Affiliations: (1) Erasme University Hospital, Department of Gastroenterology, Brussels, Belgium
(2) University Hospital Ghent, Department of Gastroenterology, Ghent, Belgium (3) Imelda General Hospital, Department of Gastroenterology, Bonheiden, Belgium (4) CHU UCL Namur, Department of Gastroenterology, Yvoir, Belgium (5) AZ Delta, Department of Gastroenterology, Roeselare, Belgium (6) CHU Saint-Luc, Department of Gastroenterology, Brussels, Belgium; (7) University Hospital Antwerp, Department of Gastroenterology, Edegem, Belgium (8) CHR de la Citadelle, Department of Gastroenterology, Liège, Belgium (9) AZ Sint-Lucas, Department of Gastroenterology, Brugge, Belgium (10) Clinique Saint-Jean, Department of Gastroenterology, Brussels, Belgium (11) AZ Sint-Jan, Department of Gastroenterology, Brugge, Belgium (12) Ziekenhuis Oost-Limburg Sint-Jan, Department of Gastroenterology, Genk, Belgium (13) AZ Groeninge, Department of Gastroenterology, Kortrijk, Belgium (14) AZ Voorkempen, Department of Gastroenterology, Malle, Belgium (15) CH Mouscron, Department of Gastroenterology, Mouscron, Belgium (16) Jessa ZH, Department of Gastroenterology, Hasselt, Belgium (17) Maria ZH Noord-Limburg, Department of Gastroenterology, Overpelt, Belgium (18) Sint-Andries ZH, Department of Gastroenterology, Tielt, Belgium (19) Sint-Trudo ZH, Department of Gastroenterology, Sint-Truiden, Belgium (20) ZH Maas en Kempen, Department of Gastroenterology, Maaseik, Belgium (21) ZNA Jan Palfijn, Department of Gastroenterology, Merksem, Belgium (22) ZNA Antwerpen, Department of Gastroenterology, Antwerpen, Belgium (23) Onze-Lieve-Vrouwziekenhuis, Department of Gastroenterology, Aalst, Belgium (24) GZA Sint-Vincentius ZH, Department of Gastroenterology, Antwerpen, Belgium (25) AZ Turnhout, Department of Gastroenterology, Turnhout, Belgium (26) University Hospital CHU of Liège, Department of Gastroenterology, Liège, Belgium |
|
Background and aims: Tofacitinib has expanded treatment options for moderate-to-severe ulcerative colitis (UC). Longterm real-world data on its efficacy and safety remain limited, particularly in multi-refractory populations. This study evaluated the real-world effectiveness and safety of tofacitinib in Belgian UC patients with prior exposure to anti-TNF and vedolizumab. Patients and methods: This retrospective multicentric observational study included consecutive adult UC patients from 26 Belgian centers who initiated tofacitinib through an early access program (November 2018-August 2019). Data were prospectively collected. Primary endpoint was clinical remission (partial adapted Mayo score≤1) at the end of follow-up (predefined as week 52). Secondary endpoints included endoscopic outcomes, treatment retention rate, colectomy-free survival, and adverse events (AEs). Results: Seventy-five patients (59% men, median age 44 years) were included, with a median treatment duration of 45 weeks (IQR:19-51). At baseline, 96% had prior anti-TNF and 97% antiintegrin exposure, while 56% were on concomitant steroids. Clinical remission was achieved by 43% at the end of follow-up. Endoscopic response and remission were observed in 37% and 9% of patients, respectively. Fecal calprotectin <250μg/g at week 16 predicted clinical remission at the end of follow-up (OR:0.03, p=0.01). Overall, 34 patients (45%) discontinued tofacitinib, primarily due to primary non-response (62%). AEs were reported in 33% of patients, with the most common being arthralgia, respiratory tract infections, and herpes zoster. No major cardiovascular events or opportunistic infections occurred. Conclusion: In a real-world Belgian cohort of multi-refractory UC patients, tofacitinib demonstrated effectiveness in achieving clinical remission by the end of follow-up with no new safety signals identified. These findings support its use in this challenging patient population. Keywords: efficacy, inflammatory bowel disease, JAK inhibitor. |
|
© Acta Gastro-Enterologica Belgica. PMID 41083166 |