Short-term effectiveness and safety of tofacitinib in ulcerative colitis - real world data from tertiary medical centers in Israel: Tofacitinib in ulcerative colitis

Irit Avni-Biron*, Ariella Bar-Gil Shitrit, Benjamin Koslowsky, Asaf Levartovsky, Uri Kopylov, Roni Weisshof, Nathaniel Aviv Cohen, Nitsan Maharshak, David Hovel, Eran Israeli, Timna Naftali, Idan Goren, Yfat Snir, Jacob E. Ollech, Hagar Banai-Eran, Yelena Broitman, Tali Sharar-Fischler, Iris Dotan, Henit Yanai

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Background: We sought to define the effectiveness and safety of tofacitinib in a real-world (RW) cohort of Israeli patients with moderate to severe ulcerative colitis (UC). Methods: This was a multi-center retrospective observational cohort study (2019–2020) to assess the effectiveness and safety of tofacitinib induction and maintenance therapy up to 26 weeks. Clinical response and remission were defined as a reduction in Simple Clinical Colitis Activity Index (SCCAI) or partial Mayo score (PMS) of ≥3 points, and SCCAI ≤2 or a PMS ≤1, respectively. Results: We included 73 patients, 47% male; median age 26 years [IQR: 19.5–39.5], disease duration 7 years [IQR: 2.5–14.5], follow-up 7.1 months [IQR: 3–12], 91% biologics-experienced, and 74% ≥ 2-biologics. Half of patients used concomitant corticosteroids (CS). Overall, 56.1% discontinued therapy due to either lack of response and/or adverse events (AEs), median time to discontinuation - 9.7 months [IQR 3.4–16]. Overall, response, remission, and CS-free-remission were achieved in 47.6%, 20.6%, and 17.5% of patients, respectively. At early maintenance (week 26), response, remission, and CS-free-remission were achieved in 65%, 22.5%, and 20% of patients, respectively. At week 26, tofacitinib 10 mg BID was still used in 43%. Seventeen patients (23.2%) had an adverse event including herpes zoster- 2.7%, hospitalization- 12.3%, and colectomy- 2.7%. Conclusions: Tofacitinib was effective in achieving CS-free-remission in about 1/5 of highly biologics –experienced patients with UC. Despite a considerable proportion of patients maintained on tofacitinib 10 mg bid, it was well tolerated and safe. Earlier positioning of tofacitinib in the therapeutic algorithm may result in improved outcomes.

Original languageEnglish
Pages (from-to)192-197
Number of pages6
JournalDigestive and Liver Disease
Volume54
Issue number2
DOIs
StatePublished - Feb 2022

Funding

FundersFunder number
Corundum Innovation Ltd
MSD Medtronic
Takeda Medtronic
Bristol-Myers Squibb
Pfizer
AbbVie
Takeda Pharmaceutical Company
Janssen Pharmaceuticals

    Keywords

    • Real-world data
    • Tofacitinib
    • Ulcerative colitis

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