Related Experiment Video
Updated: Nov 12, 2025
Author Spotlight: Liujunzi Decoction as a Traditional Chinese Treatment for Coloproctitis Cancer
Published on: October 13, 2023
Tofacitinib for the Treatment of Ulcerative Colitis: Analysis of Nonmelanoma Skin Cancer Rates From the Ulcerative
Bruce E Sands1, Millie D Long2, Walter Reinisch3
1Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Background:
Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We present integrated analyses of nonmelanoma skin cancer (NMSC) incidence in the tofacitinib UC clinical program.
Methods:
Nonmelanoma skin cancer events were evaluated from 3 randomized, placebo-controlled studies: 2 identical, 8-week induction studies (NCT01465763, NCT01458951), a 52-week maintenance study (NCT01458574), and an open-label, long-term extension study (NCT01470612). Cohorts analyzed were: Induction, Maintenance, and Overall (patients receiving ≥1 dose of tofacitinib 5 mg or 10 mg twice daily [BID]). An independent adjudication committee reviewed potential NMSC. Proportions and incidence rates (IRs; unique patients with events per 100 patient-years of exposure) for NMSC were evaluated. A Cox proportional hazards model was used for risk factor analysis.
Results:
Nonmelanoma skin cancer was evaluated for 1124 patients (2576.4 patient-years of tofacitinib exposure; ≤6.8 years' treatment). In the Induction Cohort, NMSC IR was 0.00 for placebo and 1.26 for 10 mg BID. Nonmelanoma skin cancer IR was 0.97 for placebo, 0.00 for 5 mg BID and 1.91 for 10 mg BID in the Maintenance Cohort, and 0.73 (n = 19) in the Overall Cohort. No NMSC was metastatic or led to discontinuation. In the Overall Cohort, Cox regression identified prior NMSC (hazard ratio [HR], 9.09; P = 0.0001), tumor necrosis factor inhibitor (TNFi) failure (3.32; P = 0.0363), and age (HR per 10-year increase, 2.03; P = 0.0004) as significant independent NMSC risk factors.
Conclusions:
For patients receiving tofacitinib, NMSC occurred infrequently. Older age, prior NMSC, and TNFi failure, which are previously reported NMSC risk factors in patients with UC, were associated with increased NMSC risk.
Insights
Tofacitinib treatment for ulcerative colitis showed infrequent nonmelanoma skin cancer (NMSC) events. Prior NMSC, older age, and TNFi failure were identified as key risk factors for NMSC in patients with UC.
Area of Science:
- Immunology
- Dermatology
- Gastroenterology
Background:
- Tofacitinib is an oral Janus kinase inhibitor used to treat ulcerative colitis (UC).
- Integrated analyses of nonmelanoma skin cancer (NMSC) incidence within the tofacitinib UC clinical program were conducted.
- Understanding NMSC risk is crucial for patients with UC treated with immunomodulatory therapies.
Purpose of the Study:
- To evaluate the incidence of nonmelanoma skin cancer (NMSC) in patients with ulcerative colitis (UC) treated with tofacitinib.
- To identify risk factors associated with NMSC development in this patient population.
- To provide integrated safety data on NMSC from a comprehensive clinical program.
Main Methods:
- Analysis of data from 3 randomized, placebo-controlled studies and an open-label extension study.
- Evaluation of NMSC events by an independent adjudication committee.
- Utilized Cox proportional hazards modeling to identify significant risk factors for NMSC.
Main Results:
- Nonmelanoma skin cancer (NMSC) occurred infrequently across all treatment groups.
- Incidence rates (IRs) for NMSC varied by cohort and dosage, with higher rates observed in the 10 mg BID tofacitinib group compared to placebo in the Maintenance Cohort.
- Prior NMSC, tumor necrosis factor inhibitor (TNFi) failure, and older age were identified as significant independent risk factors for NMSC.
Conclusions:
- Nonmelanoma skin cancer (NMSC) events were infrequent in patients receiving tofacitinib for ulcerative colitis (UC).
- Established risk factors including older age, previous NMSC, and TNFi failure were associated with an increased risk of NMSC.
- These findings reinforce the importance of monitoring for NMSC in UC patients, particularly those with identified risk factors.
More Related Videos
09:29Development and Maintenance of a Preclinical Patient Derived Tumor Xenograft Model for the Investigation of Novel Anti-Cancer Therapies
Published on: September 30, 2016
10:21Mechanistic Insight into the Development of TNBS-Mediated Intestinal Fibrosis and Evaluating the Inhibitory Effects of Rapamycin
Published on: September 12, 2019
Related Concept Videos
01:29Drugs for Treatment of Ulcerative Colitis in IBD
01:27Inflammatory Bowel Disease I: Ulcerative Colitis
Inflammatory bowel disease, or IBD, encompasses a group of disorders characterized by chronic inflammation or ulceration of the gastrointestinal tract.
Risk Factors
The exact cause of IBD remains unclear, although it is believed to be due to a mix of genetic, environmental, microbial, and immune factors. Genetic factors are significant in determining susceptibility to IBD, with family history being a critical risk factor. Individuals with a first-degree relative who has IBD are at...
01:29Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents
01:24Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF
01:21Drugs for Treatment of Crohn's Disease in IBD Using Glucocorticoids
01:30Inflammatory Bowel Disease II: Crohn's Disease
Inflammatory bowel disease, commonly known as IBD, refers to a collection of disorders that lead to persistent inflammation of the gastrointestinal tract. The two types of IBD are ulcerative colitis, which impacts the colon, and Crohn's disease, which can involve any part of the gastrointestinal segment.
Crohn's disease
Crohn's disease is a chronic, systemic inflammatory bowel disease (IBD) that predominantly affects the gastrointestinal tract. It is marked by...