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Observational Study
. 2025 Mar 18;25(1):184.
doi: 10.1186/s12876-025-03656-x.

Tofacitinib for ulcerative colitis in Brazil: a multicenter observational study on effectiveness and safety

Rogério Serafim Parra  1 , Renata de Sá Brito Fróes  2 , Daniela Oliveira Magro  3 , Sandro da Costa Ferreira  4 , Munique Kurtz de Mello  5 , Matheus Freitas Cardoso de Azevedo  6 , Aderson Omar Mourão Cintra Damião  6 , Alexandre de Sousa Carlos  6 , Luísa Leite Barros  6 , Maria Luiza Queiroz de Miranda  7 , Andrea Vieira  7 , Marcos Paulo Moraes Sales  8 , Gilmara Pandolfo Zabot  9 , Ornella Sari Cassol  10 , Antonio José Tiburcio Alves Jr  11 , Márcio Lubini  12 , Marta Brenner Machado  13 , Cristina Flores  14 , Fabio Vieira Teixeira  15 , Claudio Saddy Rodrigues Coy  3 , Cyrla Zaltman  16 , Liliana Andrade Chebli  8 , Ligia Yukie Sassaki  17 , Omar Féres  18 , Júlio Maria Fonseca Chebli  8
Affiliations
Observational Study

Tofacitinib for ulcerative colitis in Brazil: a multicenter observational study on effectiveness and safety

Rogério Serafim Parra et al. BMC Gastroenterol. .

Abstract

Aim: To assess the real-life, long-term effectiveness and safety of tofacitinib in a large cohort of patients with refractory or difficult-to-treat ulcerative colitis (UC).

Methods: This multicenter, retrospective, observational cohort study included patients with moderately to severely active UC who received tofacitinib for at least 8 weeks. Clinical remission and response, endoscopic response and remission, biochemical response and remission, steroid-free clinical remission, primary and secondary loss of response, drug discontinuation, the need for dose optimization, the need for colectomy, and adverse events were evaluated over up to 30 months.

Results: We included 127 patients with UC, with a mean age of 40.3 ± 14.2 years; 58.2% were male, 75.6% had pancolitis, and 79.5% had previously failed at least one biological therapy, predominantly anti-TNF agents (70.1%). Clinical remission was observed in 31.5% of patients at weeks 12-16, 46.5% at 26 ± 4 weeks, and 37.0% at 1 year. Steroid-free clinical remission was achieved in 28.6%, 44.8%, and 37.1% of patients at the same time points, respectively. Biochemical remission was achieved in 33.6% of patients at 26 ± 4 weeks and 29.3% at 1 year. Endoscopic response and endoscopic remission within 1 year were observed in 46.0% and 15.3% of patients, respectively. Ten patients (7.9%) required colectomy, and 13 patients (10.2%) required hospitalization, all of whom had been previously exposed to biologics. The colectomy rate was significantly greater in patients with serum albumin levels ≤ 3.5 g/dL (21.4% vs. 4.1%, p = 0.013).

Conclusion: In this large, long-term real-world study involving patients with predominantly biologically refractory UC, tofacitinib effectively induced clinical remission and endoscopic improvement and prevented colectomy for more than 30 months, with a favorable safety profile. Notably, baseline hypoalbuminemia was associated with higher colectomy rates.

Keywords: Inflammatory bowel disease; Jak inhibitors; Tofacitinib; Real-world; Ulcerative colitis.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The study was approved by the Ethics Committee of the coordinating site, the Hospital das Clínicas of the Ribeirão Preto Medical School at the University of São Paulo, with the following approval details: CAAE 71008923.0.1001.5440; Ethics Committee Number 6.171.795/2023. Based on this ethical approval, we are authorized to retrospectively collect data from all patients receiving treatment with small molecules, such as tofacitinib. All procedures were conducted in accordance with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. Consent for publication: Not Applicable. Competing interests: Parra RS has received fees for serving as a speaker and/or an advisory board member for Takeda, Janssen, Abbvie, Celltrion and Pfizer. Fróes RSB has received fees for serving as a speaker and/or an advisory board member for Takeda, Janssen, Abbvie, and is a speaker for Celltrion, Nestle, Ferring, Pfizer, and CSL Vifor. Ferreira SC has received fees for serving as a speaker and/or an advisory board member for Janssen, Takeda, and Pfizer. Mello MK has received fees for serving as a speaker and/or an advisory board member for Takeda, Janssen, Abbvie, Sandoz and Ferring. Azevedo MFC has received fees for serving as a speaker and/or an advisory board member for Takeda, Abbvie, Pfizer and Janssen. Damião AOMC has received fees for serving as a speaker and/or an advisory board member for Takeda, Abbvie, Ferring, and Janssen Carlos AS has received fees for serving as a speaker and/or an advisory board member for Takeda, Janssen, Abbvie Miranda MLQ has received fees for serving as speaker for Takeda, Janssen and Abbvie Zabot GP has received fees for serving as a speaker and/or an advisory board member for Janssen, Abbvie, and Takeda. Cassol OS has received fees for serving as a speaker and/or an advisory board member for Nestle, Abbvie, Janssen, Takeda, and Buhlmann. Alves Junior AJT has received fees for serving as a speaker and/or an advisory board member for Janssen, Takeda, UCB, and Abbvie. Machado MB has received fees for serving as a speaker and/or na Advisory board for Takeda, Jassen, Abbvie, Ferring and Pfizer. Teixeira FV is a speaker and an advisory board member of Takeda. Chebli JMF has received fees for serving as a speaker and/or an advisory board member for Takeda, Janssen, AbbVie, Abbott, and Sandoz. Magro, DO, Sales MPM, Barros LL, Sassaki LY, Flores C, Vieira A, Lubini M, Coy CSR, Zaltmann C, and Féres O report no conflicts of interest.

Figures

Fig. 1
Fig. 1
Clinical Remission After Induction, at 6 Months and at 1 Year, and Endoscopic Response and Remission Rates within 1 Year of Treatment with Tofacitinib
Fig. 2
Fig. 2
Bar Graph Depicting Rates of Clinical Response and Biochemical Response After Induction (Weeks 12–16) and at 6 Months, Steroid-Free Clinical Remission after Induction, at 6 Months and at 1 Year, and Biochemical Remission at 6 Months and at 1 Year
Fig. 3
Fig. 3
Kaplan–Meier Curve for Tofacitinib Persistence in the Whole Cohort of Patients with Ulcerative Colitis Over the 30 Months of Follow-Up
Fig. 4
Fig. 4
Kaplan–Meier Curve Showing Colectomy-Free Survival in a 30 Months-Long Follow-up Between 127 Patients with Ulcerative Colitis Under Treatment with Tofacitinib
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