PMID- 32910531
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240329
IS  - 2578-5745 (Electronic)
IS  - 2578-5745 (Linking)
VI  - 2
IP  - 10
DP  - 2020 Oct
TI  - Tofacitinib in Patients With Psoriatic Arthritis and Metabolic Syndrome: A Post 
      hoc Analysis of Phase 3 Studies.
PG  - 543-554
LID - 10.1002/acr2.11166 [doi]
AB  - OBJECTIVE: Metabolic syndrome (MetS) is a cluster of concurrent risk factors for 
      cardiovascular disease and type 2 diabetes. This post hoc analysis explored key 
      efficacy and safety endpoints in patients with psoriatic arthritis (PsA) and MetS 
      treated with tofacitinib. METHODS: Tofacitinib 5 and 10 mg twice daily and 
      placebo data were pooled from two Phase 3 studies (OPAL Broaden [12 months; 
      ClinicalTrials.gov identifier NCT01877668]; OPAL Beyond [6 months; 
      ClinicalTrials.gov identifier NCT01882439]); patients received one background 
      conventional synthetic disease-modifying antirheumatic drug. Patients were 
      stratified by baseline presence/absence of MetS. Efficacy and safety were 
      reported to month 3 (tofacitinib and placebo) and 6 (tofacitinib only). Efficacy 
      outcomes included: American College of Rheumatology (ACR)20/50/70, Health 
      Assessment Questionnaire-Disability Index (HAQ-DI) response, Psoriasis Area 
      Severity Index (PASI)75 response, and enthesitis/dactylitis resolution rates; and 
      changes from baseline (Delta) in C-reactive protein, HAQ-DI, Patient's/Physician's 
      Global Assessment of Arthritis, and patient-reported outcomes. Safety outcomes 
      included treatment-emergent all-causality adverse events (AEs), Delta in 
      lipid/hepatic values, and liver parameter increases. RESULTS: Of 710 patients, 
      41.4% (n = 294) had baseline MetS. All efficacy outcomes improved with both 
      tofacitinib doses versus placebo, to month 3; tofacitinib efficacy was consistent 
      to month 6, regardless of MetS status. MetS did not appear to affect the 
      incidence of AEs or Delta in lipid/hepatic values with tofacitinib up to month 3 or 
      6. Arterial thromboembolism and myocardial infarction (adjudicated major adverse 
      cardiovascular events) were each reported once in tofacitinib-treated patients 
      with MetS. CONCLUSION: Regardless of baseline MetS status, tofacitinib showed 
      greater efficacy versus placebo in patients with active PsA. The tofacitinib 
      safety profile appeared similar in patients with versus without MetS.
CI  - (c) 2020 The Authors. ACR Open Rheumatology published by Wiley Periodicals LLC on 
      behalf of American College of Rheumatology.
FAU - Ritchlin, Christopher T
AU  - Ritchlin CT
AUID- ORCID: 0000-0002-2602-1219
AD  - University of Rochester Medical Center, Rochester, New York.
FAU - Giles, Jon T
AU  - Giles JT
AD  - Columbia University, New York, New York.
FAU - Ogdie, Alexis
AU  - Ogdie A
AUID- ORCID: 0000-0002-4639-0775
AD  - Perelman School of Medicine at the University of Pennsylvania, Philadelphia, 
      Pennsylvania.
FAU - Gomez-Reino, Juan J
AU  - Gomez-Reino JJ
AD  - Hospital Clinico Universitario, Santiago de Compostela, Spain.
FAU - Helliwell, Philip
AU  - Helliwell P
AUID- ORCID: 0000-0002-4155-9105
AD  - Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, 
      Leeds, UK.
FAU - Young, Pamela
AU  - Young P
AD  - Pfizer Inc, Collegeville, Pennsylvania.
FAU - Wang, Cunshan
AU  - Wang C
AD  - Pfizer Inc, Groton, Connecticut.
FAU - Wu, Joseph
AU  - Wu J
AD  - Pfizer Inc, Groton, Connecticut.
FAU - Romero, Ana Belen
AU  - Romero AB
AD  - Pfizer Inc, Barcelona, Spain.
FAU - Woolcott, John
AU  - Woolcott J
AD  - Pfizer Inc, Collegeville, Pennsylvania.
FAU - Stockert, Lori
AU  - Stockert L
AD  - Pfizer Inc, Collegeville, Pennsylvania.
LA  - eng
SI  - ClinicalTrials.gov/NCT01882439
SI  - ClinicalTrials.gov/NCT01877668
GR  - Pfizer Inc/
PT  - Journal Article
DEP - 20200910
PL  - United States
TA  - ACR Open Rheumatol
JT  - ACR open rheumatology
JID - 101740025
PMC - PMC7571390
EDAT- 2020/09/11 06:00
MHDA- 2020/09/11 06:01
PMCR- 2020/09/10
CRDT- 2020/09/10 12:29
PHST- 2020/02/07 00:00 [received]
PHST- 2020/06/26 00:00 [accepted]
PHST- 2020/09/11 06:00 [pubmed]
PHST- 2020/09/11 06:01 [medline]
PHST- 2020/09/10 12:29 [entrez]
PHST- 2020/09/10 00:00 [pmc-release]
AID - ACR211166 [pii]
AID - 10.1002/acr2.11166 [doi]
PST - ppublish
SO  - ACR Open Rheumatol. 2020 Oct;2(10):543-554. doi: 10.1002/acr2.11166. Epub 2020 
      Sep 10.