Pubmed- Worldwide post-marketing safety surveillance experience with tofacitinib in ulcerative colitis - IBD Reporter Newsfeed - IBD Support Group Forums -


Jump to content

- - - - -

Pubmed- Worldwide post-marketing safety surveillance experience with tofacitinib in ulcerative colitis

  • Please log in to reply
No replies to this topic

#1 Health Reporter

Health Reporter


  • RSS
  • PipPipPipPip
  • 20864 posts
  • Country:United States

Posted 10 October 2021 - 07:25 AM


Aliment Pharmacol Ther. 2021 Oct 9. doi: 10.1111/apt.16619. Online ahead of print.


BACKGROUND: Tofacitinib is an oral Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Post-marketing surveillance (PMS) is an important part of monitoring adverse events (AEs).

AIMS: To report an analysis of PMS case safety reports for tofacitinib in patients with UC METHODS: Worldwide tofacitinib PMS reports received in the Pfizer safety database from 30 May 2018 (first regulatory approval) to 25 August 2020 were analysed. The type and estimated reporting rate (RR) of serious AEs of interest, including infection, gastrointestinal, vascular, respiratory, neoplasm and cardiac events, were reviewed. Patient-years of exposure (PY) was estimated based on worldwide sales data and the calculated daily regimens of tofacitinib 5 or 10 mg twice daily, immediate- or extended-release formulations.

RESULTS: During the 27-month reporting period, worldwide post-marketing exposure to tofacitinib was 8916 PY. Overall, 4226 case reports were received and included 12 103 AEs, of which 1839 were serious AEs (SAEs). Among the cases reported, 1141 (27.0%) included an SAE and 18 (0.4%) were fatal. The RR (per 100 PY) for SAEs of interest by Medical Dictionary for Regulatory Activities System Organ Class were 3.28 for infections, 1.26 for vascular disorders, 0.74 for respiratory disorders, 0.55 for neoplasms and 0.50 for cardiac disorders.

CONCLUSIONS: The types of AEs were consistent with those reported in tofacitinib clinical trials. Most reported AEs were non-serious. Limitations of PMS reports and reliance on estimated RRs due to lack of precise values for exposure, required for incidence rate calculation, should be considered when interpreting these results.

PMID:34626429 | DOI:10.1111/apt.16619

View the full article


© Copyright 1995-2014 IBD Support All rights reserved.

About Us | Contact Us | Advertise With Us | Disclaimer | Terms of Service | Crisis Resources

This website is certified by Health On the Net Foundation. Click to verify. We comply with the HONcode standard for trustworthy health information: verify here