PMID- 29470834
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220410
IS  - 2198-6576 (Print)
IS  - 2198-6584 (Electronic)
IS  - 2198-6576 (Linking)
VI  - 5
IP  - 1
DP  - 2018 Jun
TI  - Worldwide, 3-Year, Post-Marketing Surveillance Experience with Tofacitinib in 
      Rheumatoid Arthritis.
PG  - 283-291
LID - 10.1007/s40744-018-0097-3 [doi]
AB  - INTRODUCTION: Post-marketing surveillance (PMS) is an integral part of monitoring 
      adverse events (AEs) following approval of new drugs. Tofacitinib is an oral 
      Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). An 
      analysis of PMS reports was conducted to evaluate the safety of tofacitinib in a 
      post-marketing setting. METHODS: Worldwide tofacitinib PMS data received in the 
      Pfizer safety database from November 6, 2012 (first marketing authorization of 
      tofacitinib) to November 5, 2015 were analyzed. Serious AEs (SAEs) of interest 
      were reviewed and reporting rates (RRs) were calculated by dividing the number of 
      SAEs by the estimated 100 patient-years of exposure. Patient exposure was 
      calculated based on estimated worldwide sales and an estimated daily regimen of 
      tofacitinib 5 mg twice daily. RESULTS: During the 3-year reporting period, 
      worldwide post-marketing exposure to tofacitinib since approval was estimated to 
      be 34,223 patient-years. In total, 9291 case reports (82.9% non-serious) were 
      received and 25,417 AEs, 102 fatal cases, and 4352 SAEs were reported. The RRs 
      (per 100 patient-years) for SAEs of interest by Medical Dictionary for Regulatory 
      Activities System Organ Class were 2.57 for infections, 0.91 for gastrointestinal 
      disorders, 0.60 for respiratory disorders, 0.45 for neoplasms, 0.43 for cardiac 
      disorders, and 0.12 for hepatobiliary disorders. CONCLUSIONS: Although there are 
      limitations to these data, no new safety risks were revealed in this real-world 
      setting compared with the safety profile identified in the tofacitinib RA 
      clinical development program. Any risks identified through the tofacitinib 
      development program and PMS will continue to be monitored through 
      pharmacovigilance surveillance. FUNDING: Pfizer Inc.
FAU - Cohen, Stanley
AU  - Cohen S
AD  - Metroplex Clinical Research Center, Dallas, TX, USA.
FAU - Curtis, Jeffrey R
AU  - Curtis JR
AD  - University of Alabama at Birmingham, Birmingham, AL, USA.
FAU - DeMasi, Ryan
AU  - DeMasi R
AD  - Pfizer Inc, New York, NY, USA.
FAU - Chen, Yan
AU  - Chen Y
AD  - Pfizer Inc, Collegeville, PA, USA.
FAU - Fan, Haiyun
AU  - Fan H
AD  - Pfizer Inc, Collegeville, PA, USA.
FAU - Soonasra, Arif
AU  - Soonasra A
AD  - Pfizer Inc, Collegeville, PA, USA. arif.soonasra@pfizer.com.
FAU - Fleischmann, Roy
AU  - Fleischmann R
AD  - Metroplex Clinical Research Center, Dallas, TX, USA.
AD  - University of Texas Southwestern Medical Center, Dallas, TX, USA.
LA  - eng
PT  - Journal Article
DEP - 20180222
PL  - England
TA  - Rheumatol Ther
JT  - Rheumatology and therapy
JID - 101674543
PMC - PMC5935628
OTO - NOTNLM
OT  - Disease-modifying antirheumatic drug
OT  - Post-marketing surveillance
OT  - Registry
OT  - Rheumatoid arthritis
OT  - Tofacitinib
EDAT- 2018/02/23 06:00
MHDA- 2018/02/23 06:01
PMCR- 2018/02/22
CRDT- 2018/02/23 06:00
PHST- 2017/11/13 00:00 [received]
PHST- 2018/02/23 06:00 [pubmed]
PHST- 2018/02/23 06:01 [medline]
PHST- 2018/02/23 06:00 [entrez]
PHST- 2018/02/22 00:00 [pmc-release]
AID - 10.1007/s40744-018-0097-3 [pii]
AID - 97 [pii]
AID - 10.1007/s40744-018-0097-3 [doi]
PST - ppublish
SO  - Rheumatol Ther. 2018 Jun;5(1):283-291. doi: 10.1007/s40744-018-0097-3. Epub 2018 
      Feb 22.