Effectiveness and safety of tofacitinib for ulcerative colitis: two-year results of the ICC Registry

Tessa Straatmijer, Fiona D.M. van Schaik, Alexander G.L. Bodelier, Marijn Visschedijk, Annemarie C. de Vries, Cyriel Y. Ponsioen, Marieke Pierik, Ad A. van Bodegraven, Rachel L. West, Nanne K.H. de Boer, Nidhi Srivastava, Tessa E.H. Romkens, Jildou Hoekstra, Bas Oldenburg, Gerard Dijkstra, Janneke C. van der Woude, Mark Löwenberg, Zlatan Mujagic, Vince B.C. Biemans, Andrea E. van der Meulen-de JongMarjolijn Duijvestein*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

Background: Tofacitinib is an oral Janus kinase (JAK) inhibitor and is registered for the treatment of ulcerative colitis (UC). The effectiveness of tofacitinib has been evaluated up to 12 months of treatment. Aim: The aim of this study was to assess the effectiveness and safety of 24 months of tofacitinib use in UC patients in the Netherlands. Methods: Patients initiating tofacitinib treatment were included in the ICC Registry, a nationwide, observational registry. Patients were prospectively evaluated for up to 24 months. The primary outcome was corticosteroid-free clinical remission (CSFR, Simple Clinical Colitis Activity Index [SCCAI] ≤2) at week 104. Secondary outcomes included biochemical remission (C-reactive protein (CRP) ≤5 mg/L and faecal calprotectin (FC) ≤250 μg/g), safety, and discontinuation rate. Results: We included 110 patients of whom 104 (94.5%) were anti-TNF experienced. After 104 weeks of tofacitinib, 31.8% (34/107) were in CSFR, 23.4% (25/107) in biochemical remission and 18.7% (20/107) in combined clinical and biochemical remission. Of the patients in CSFR at week 52, 76.5% (26/34) remained so after 104 weeks of treatment. Sixty-one patients (55.5%) discontinued tofacitinib after a median duration of 13 weeks (IQR 7–34). The main reasons for discontinuation were non-response (59%), loss of response (14.8%), and adverse events (18%). There were 33.9 possible tofacitinib-related adverse events per 100 patient-years during follow-up. Adverse events most probably related to tofacitinib were skin reactions and headaches. There were 6.4 herpes zoster infections per 100 patient-years. Conclusion: Tofacitinib was effective in 31.8% of patients after 24 months of treatment.

Original languageEnglish
Pages (from-to)117-126
Number of pages10
JournalAlimentary Pharmacology and Therapeutics
Volume57
Issue number1
Early online date25 Oct 2022
DOIs
Publication statusPublished - Jan 2023

Bibliographical note

N de Boer has served as a speaker for AbbVie, Takeda and MSD. He has served as a consultant and principal investigator for Takeda and/or TEVA Pharma B.V. He has received research grants from Dr. Falk, MLDS and Takeda. All outside the submitted work. A.C. de Vries served as an advisory board member of Jansen, Abbvie, Galapagos and Takeda. ISR grant from Pfizer, Jansen and Takeda. Mark Löwenberg has served as a speaker and/or principal investigator for: Abbvie, Alimentiv, Bristol Myers Squibb, Celgene, Covidien, Dr. Falk, Ferring Pharmaceuticals, Galapagos, Gilead, GlaxoSmithKline, Janssen-Cilag, Merck Sharp & Dohme, Pfizer, Protagonist therapeutics, Receptos, Takeda, Tillotts, Tramedico. He has received research grants from AbbVie, Merck Sharp & Dohme, Dr Falk, Achmea healthcare, Galapagos and ZonMW. Marijn Visschedijk has served as speaker for Janssen-Cilag. N de Boer has served as a speaker for AbbVie, Takeda and MSD. He has served as a consultant and principal investigator for Takeda and/or TEVA Pharma B.V. He has received research grants from Dr. Falk, MLDS and Takeda. All outside the submitted work. Fiona DM van Schaik served as a consultant for Takeda, Galapagos and Dr Falk. AAvB has received speaker or consultancy or advisory board fees from AbbVie, BMS/Celgene, Ferring, Janssen/J&J, Galapagos, Pfizer, Takeda, and TEVA. Ferring, Janssen, and Takeda supported educational programmes. He participated in Tofacitinib phase 2 and phase 3 registration studies. Research grants were provided by Pfizer, TEVA, Zon-MW and Zuyderland MC. Vince B.C. Biemans: none.

The ICC fellowship is sponsored by AbbVie, Pfizer, Takeda, Celgene, Janssen Pharmaceutica, MLDS Teva Pharmaceutical Industries, Cablon Medical, Ferring pharmaceuticals, Mundipharma, Dr. Falk Pharma, Sandoz and Tramedico.

Independent Investigator Sponsored Research Grant (Pfizer Tracking Number #57944353).


Publisher Copyright:
© 2022 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.

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