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Tofacitinib for the Treatment of Ulcerative Colitis: Analysis of Infection Rates from the Ulcerative Colitis Clinical

Kevin L Winthrop1, Edward V Loftus2, Daniel C Baumgart3

  • 1Division of Infectious Diseases, Oregon Health & Science University, Portland, OR, USA.

Journal of Crohn'S & Colitis
|November 27, 2020
PubMed
Abstract

Insights

Tofacitinib showed increased serious infections during induction for ulcerative colitis but was infrequent in later stages. Herpes zoster rates were higher with tofacitinib, particularly at higher doses, but remained stable over time.

Area of Science:

  • Gastroenterology
  • Immunology
  • Pharmacology

Background:

  • Tofacitinib is an oral Janus kinase (JAK) inhibitor used to treat ulcerative colitis.
  • Understanding infection risks associated with tofacitinib is crucial for patient safety.
  • This analysis integrates infection data from Phase 2 and 3 OCTAVE clinical trials.

Purpose of the Study:

  • To analyze the incidence of serious infections (SIs), herpes zoster (HZ), and opportunistic infections (OIs) in patients with ulcerative colitis treated with tofacitinib.
  • To compare infection rates between tofacitinib and placebo groups across different treatment phases (induction and maintenance).
  • To evaluate the safety profile regarding infections in a long-term tofacitinib treatment population.

Main Methods:

  • Integrated analysis of three cohorts: Induction (Phase 2/3), Maintenance (Phase 3), and Overall (all tofacitinib-treated patients up to May 2019).
  • Incidence rates (IRs) per 100 patient-years were calculated for SIs, HZ (serious and non-serious), and OIs.
  • Data were censored at the time of the event; analyses included placebo and tofacitinib 5 mg and 10 mg twice daily (BID) dosages.

Main Results:

  • During induction, SIs were more frequent in the tofacitinib 10 mg BID group (0.9%) compared to placebo.
  • In the Maintenance Cohort, SI IRs were low and comparable between tofacitinib doses and placebo. HZ IRs were numerically higher with tofacitinib 10 mg BID.
  • In the Overall Cohort (N=1157), SI IR was 1.70, HZ IR was 3.48, and non-HZ OI IR was 0.15. No SIs led to death.

Conclusions:

  • While SIs were more common during induction with tofacitinib, they were infrequent in maintenance and overall treatment periods.
  • Herpes zoster incidence increased with tofacitinib, particularly at the 10 mg BID dose, but remained stable over time.
  • Non-herpes zoster opportunistic infections and viral infections were rare in the analyzed tofacitinib-treated populations.
Keywords:
Infectionstofacitinibulcerative colitis

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