PMID- 34626429
OWN - NLM
STAT- MEDLINE
DCOM- 20220401
LR  - 20220731
IS  - 1365-2036 (Electronic)
IS  - 0269-2813 (Print)
IS  - 0269-2813 (Linking)
VI  - 55
IP  - 3
DP  - 2022 Feb
TI  - Worldwide post-marketing safety surveillance experience with tofacitinib in 
      ulcerative colitis.
PG  - 302-310
LID - 10.1111/apt.16619 [doi]
AB  - 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.
CI  - (c) 2021 Pfizer Inc. Alimentary Pharmacology & Therapeutics published by John Wiley 
      & Sons Ltd.
FAU - Rubin, David T
AU  - Rubin DT
AUID- ORCID: 0000-0001-5647-1723
AD  - University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL, 
      USA.
FAU - Modesto, Irene
AU  - Modesto I
AD  - Pfizer Inc, New York, NY, USA.
FAU - Vermeire, Severine
AU  - Vermeire S
AD  - Department of Gastroenterology, University Hospitals Leuven, Leuven, Belgium.
FAU - Danese, Silvio
AU  - Danese S
AUID- ORCID: 0000-0001-7341-1351
AD  - Humanitas Clinical and Research Center - IRCCS and Department of Biomedical 
      Sciences, Humanitas University, Milan, Italy.
FAU - Ng, Siew C
AU  - Ng SC
AUID- ORCID: 0000-0002-6850-4454
AD  - Institute of Digestive Disease, Department of Medicine and Therapeutics, LKS 
      Institute of Health Science, The Chinese University of Hong Kong, Hong Kong.
FAU - Kwok, Kenneth K
AU  - Kwok KK
AD  - Pfizer Inc, New York, NY, USA.
FAU - Koram, Nana
AU  - Koram N
AD  - Pfizer Inc, New York, NY, USA.
FAU - Jones, Thomas V
AU  - Jones TV
AD  - Pfizer Inc, Collegeville, PA, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20211009
PL  - England
TA  - Aliment Pharmacol Ther
JT  - Alimentary pharmacology & therapeutics
JID - 8707234
RN  - 0 (Piperidines)
RN  - 0 (Pyrimidines)
RN  - 0 (Pyrroles)
RN  - 87LA6FU830 (tofacitinib)
SB  - IM
CIN - Aliment Pharmacol Ther. 2022 Jan;55(1):131-132. PMID: 34907564
MH  - *Colitis, Ulcerative/chemically induced/drug therapy
MH  - Humans
MH  - Marketing
MH  - Piperidines/adverse effects
MH  - Pyrimidines/adverse effects
MH  - Pyrroles/adverse effects
PMC - PMC9293472
EDAT- 2021/10/10 06:00
MHDA- 2022/04/02 06:00
PMCR- 2022/07/18
CRDT- 2021/10/09 12:13
PHST- 2021/07/25 00:00 [revised]
PHST- 2021/07/01 00:00 [received]
PHST- 2021/09/13 00:00 [accepted]
PHST- 2021/10/10 06:00 [pubmed]
PHST- 2022/04/02 06:00 [medline]
PHST- 2021/10/09 12:13 [entrez]
PHST- 2022/07/18 00:00 [pmc-release]
AID - APT16619 [pii]
AID - 10.1111/apt.16619 [doi]
PST - ppublish
SO  - Aliment Pharmacol Ther. 2022 Feb;55(3):302-310. doi: 10.1111/apt.16619. Epub 2021 
      Oct 9.