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Multicenter Study
. 2024 May 2;30(5):768-779.
doi: 10.1093/ibd/izad135.

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

Tamás Resál  1 , Péter Bacsur  1 , Csilla Keresztes  2 , Anita Bálint  1 , Renáta Bor  1 , Anna Fábián  1 , Bernadett Farkas  1 , Kostas Katsanos  3 , George Michalopoylos  4 , Davide Giuseppe Ribaldone  5 , Mohamed Attauabi  6 , Mirabella Zhao  7 , Hadar Amir Barak  8 , Henit Yanai  8 , Cristina Bezzio  9 , Antonio Rispo  10 , Fabiana Castiglione  10 , Ariella Bar-Gil Shitrit  11 , Daniela Pugliese  12 , Alessandro Armuzzi  13   14 , Edoardo Vincenzo Savarino  15   16 , Martin Kolar  17 , Milan Lukáš  17 , Elena Chashkova  18 , Rafał Filip  19 , Aurore Rozieres  20   21 , Stéphane Nancey  20   21 , Željko Krznarić  22   23 , Eszter Schäfer  24 , Tamás Szamosi  24 , Patrícia Sarlós  25   26 , Matej Franko  27 , David Drobne  27   28 , Oleg V Knyazev  29   30 , Anna V Kagramanova  29   31 , Jimmy Limdi  32 , Panu Wetwittayakhlang  33   34 , Peter L Lakatos  33   35 , Nitsan Maharshak  36 , Lian Bannon  6 , Tibor Nyári  37 , Zoltán Szepes  1 , Klaudia Farkas  1 ; TFB Study Group; Tamás Molnár  1
Collaborators, Affiliations
Multicenter Study

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

Tamás Resál et al. Inflamm Bowel Dis. .

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.

Keywords: acute severe ulcerative colitis; moderate-to severe ulcerative colitis; tofacitinib.

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Conflict of interest statement

G.M. has received speaker fees from AbbVie, Takeda, Janssen, and Pfizer. N.M. has received speaking and/or consulting fees from Pfizer, Takeda, Janssen, Ferring, BiomX, BMS, Nestlé, and Trobix; and grant support from Takeda, Janssen, Abbott, AbbVie, Pfizer, BMS, Corundum Innovation Ltd, and Nestlé. L.M. has served as a speaker for AbbVie, Takeda, Celltrion, Biogen, and Janssen Cilag. C.B. has received lecture fees and served as a consultant for Takeda, MSD, Ferring, Galapagos, and Janssen. S.S. has received lecture fees and served as a consultant and advisory board member for AbbVie, Arena, Ferring, Gilead, Janssen, MSD, and Takeda. D.D. has served as a speaker, consultant, and an advisory board member for MSD, AbbVie, Takeda, Pfizer, Janssen, Amgen, Biogen, and Krka. E.V.S. has served as a speaker for AbbVie, AGPharma, Alfasigma, Dr Falk, EG Stada Group, Fresenius Kabi, Grifols, Janssen, Innovamedica, Malesci, Pfizer, Reckitt Benckiser, Sandoz, SILA, Sofar, Takeda, Unifarco; served as a consultant for Alfasigma, Amgen, Biogen, Bristol-Myers Squibb, Celltrion, Diadema Farmaceutici, Dr Falk, Fresenius Kabi, Janssen, Merck & Co, Reckitt Benckiser, Regeneron, Sanofi, Shire, SILA, Sofar, Synformulas GmbH, Takeda, and Unifarco; and received research support from Pfizer, Reckitt Benckiser, SILA, Sofar, and Unifarco. D.P. has received speaker fees from MSD, Takeda, Galapagos, and Janssen, Pfizer; advisory board fees from Pfizer. A.A. has received consulting and/or advisory board fees from AbbVie, Allergan, Amgen, Arena, Biogen, Bristol-Myers Squibb, Celgene, Celltrion, Eli Lilly, Ferring, Galapagos, Gilead, Janssen, MSD, Mylan, Pfizer, Protagonist Therapeutics, Roche, Samsung Bioepis, Sandoz, Takeda; lecture and/or speaker bureau fees from AbbVie, Amgen, Arena, Biogen, Ferring, Galapagos, Gilead, Janssen, MSD, Mitsubishi-Tanabe, Nikkiso, Novartis, Pfizer, Sandoz, Samsung Bioepis, Takeda; and research grants from MSD, Pfizer, Takeda and Biogen. P.L.L. has served as a speaker and/or advisory board member for AbbVie, Amgen, BioJamp, Bristol Myers Squibb, Fresenius Kabi, Genetech, Gilead, Janssen, Merck, Mylan, Organon, Pendopharm, Pfizer, Roche, Sandoz, Takeda, Tillots, and Viatris; and received unrestricted research grant support from AbbVie, Gilead, Takeda, and Pfizer. K.F. has received speaker honoraria from AbbVie, Janssen, Ferring, Takeda, and Goodwill Pharma. T.M. has received speaker’s honoraria from MSD, AbbVie, Egis, Goodwill Pharma, Takeda, Pfizer, Janssen, Sandoz, MundiPharma, Phytotec, Roche, Fresenius, and Teva.

Figures

Figure 1.
Figure 1.
Study flowchart of included patients. AE, adverse event; IPAA, ileal pouch–anal anastomosis; IR, ineffective response; LOR, loss of response; PNR, primary nonresponse; UC, ulcerative colitis; w, week.
Figure 2.
Figure 2.
Week 12 (w12) and w52 steroid-free remission (SFR) rates in our cohort. ASUC, acute severe ulcerative colitis; CA, chronic activity.
Figure 3.
Figure 3.
Survival analysis regarding week 52 colectomy rates between the chronic activity and acute severe ulcerative colitis groups (P = .06).
Figure 4.
Figure 4.
Drug persistence between various indications of tofacitinib (P = .056).
See this image and copyright information in PMC

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