PMID- 29949132
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200929
IS  - 2198-6576 (Print)
IS  - 2198-6584 (Electronic)
IS  - 2198-6576 (Linking)
VI  - 5
IP  - 2
DP  - 2018 Dec
TI  - Tofacitinib, an Oral Janus Kinase Inhibitor: Pooled Efficacy and Safety Analyses 
      in an Australian Rheumatoid Arthritis Population.
PG  - 383-401
LID - 10.1007/s40744-018-0118-2 [doi]
AB  - INTRODUCTION: In Australia, there is an unmet need for improved treatments for 
      rheumatoid arthritis (RA). Tofacitinib is an oral Janus kinase inhibitor for the 
      treatment of RA. To provide an overview of key study outcomes for tofacitinib in 
      Australian patients, we analyzed the efficacy and safety of tofacitinib in the 
      Australian subpopulation of global RA phase III and long-term extension (LTE) 
      studies. METHODS: Data were pooled from the Australian subpopulation of four 
      phase III studies and one LTE study (database not locked at cut-off date: January 
      2016). Patients in the phase III studies received tofacitinib 5 or 10 mg twice 
      daily (BID), placebo (advancing to tofacitinib at months 3 or 6), or adalimumab, 
      with background methotrexate or conventional synthetic disease-modifying 
      antirheumatic drugs. Patients in the LTE study received tofacitinib 5 or 10 mg 
      BID. Efficacy endpoints were American College of Rheumatology (ACR) 20/50/70 
      response rates, and change from baseline in the Disease Activity Score in 28 
      joints, erythrocyte sedimentation rate [DAS28-4(ESR)] and Health Assessment 
      Questionnaire-Disability Index (HAQ-DI) scores. Safety endpoints included 
      incidence of adverse events (AEs), serious AEs, and discontinuations due to AEs. 
      AEs of special interest and laboratory parameters were analyzed in the LTE study. 
      RESULTS: Across phase III studies (N = 100), ACR response rates and improvements 
      in DAS28-4(ESR) and HAQ-DI scores were numerically greater with tofacitinib vs. 
      placebo at month 3, and increased until month 12. The results were sustained in 
      the LTE study (N = 99) after 60 months' observation. In general, the efficacy and 
      safety profiles of tofacitinib were similar to those of the global RA population. 
      CONCLUSIONS: In Australian patients with RA, tofacitinib therapy demonstrated 
      sustained efficacy and consistent safety over >/= 60 months' treatment. FUNDING: 
      Pfizer Inc. TRIAL REGISTRATION NUMBERS (ALL CLINICALTRIALS.GOV): NCT00960440; 
      NCT00847613; NCT00856544; NCT00853385; NCT00413699.
FAU - Hall, Stephen
AU  - Hall S
AD  - Department of Medicine, Cabrini Health and Monash University, Emeritus Research, 
      Melbourne, Australia.
FAU - Nash, Peter
AU  - Nash P
AD  - Department of Medicine, University of Queensland, Brisbane, Australia.
FAU - Rischmueller, Maureen
AU  - Rischmueller M
AD  - Department of Rheumatology, The Queen Elizabeth Hospital and University of 
      Adelaide, Adelaide, Australia.
FAU - Bossingham, David
AU  - Bossingham D
AD  - Cairns Clinical School, James Cook University, College of Medicine and Dentistry, 
      Cairns, Australia.
FAU - Bird, Paul
AU  - Bird P
AD  - Faculty of Medicine, University of New South Wales, Sydney, Australia.
FAU - Cook, Nicola
AU  - Cook N
AD  - Department of Rheumatology, Royal Perth Hospital, Perth, Australia.
FAU - Witcombe, David
AU  - Witcombe D
AD  - Immunology and Inflammation, Pfizer Australia, Sydney, Australia. 
      david.witcombe@pfizer.com.
FAU - Soma, Koshika
AU  - Soma K
AD  - Clinical Research, Pfizer Inc, Groton, CT, USA.
FAU - Kwok, Kenneth
AU  - Kwok K
AD  - Biostatistics, Pfizer Inc, New York, NY, USA.
FAU - Thirunavukkarasu, Krishan
AU  - Thirunavukkarasu K
AD  - Immunology and Inflammation, Pfizer Australia, Sydney, Australia.
LA  - eng
SI  - ClinicalTrials.gov/NCT00853385
SI  - ClinicalTrials.gov/NCT00960440
SI  - ClinicalTrials.gov/NCT00847613
SI  - ClinicalTrials.gov/NCT00856544
SI  - ClinicalTrials.gov/NCT00413699
PT  - Journal Article
DEP - 20180611
PL  - England
TA  - Rheumatol Ther
JT  - Rheumatology and therapy
JID - 101674543
PMC - PMC6251845
OTO - NOTNLM
OT  - Australia
OT  - Efficacy
OT  - Rheumatoid arthritis
OT  - Safety
OT  - Tofacitinib
EDAT- 2018/06/28 06:00
MHDA- 2018/06/28 06:01
PMCR- 2018/06/11
CRDT- 2018/06/28 06:00
PHST- 2018/03/18 00:00 [received]
PHST- 2018/06/28 06:00 [pubmed]
PHST- 2018/06/28 06:01 [medline]
PHST- 2018/06/28 06:00 [entrez]
PHST- 2018/06/11 00:00 [pmc-release]
AID - 10.1007/s40744-018-0118-2 [pii]
AID - 118 [pii]
AID - 10.1007/s40744-018-0118-2 [doi]
PST - ppublish
SO  - Rheumatol Ther. 2018 Dec;5(2):383-401. doi: 10.1007/s40744-018-0118-2. Epub 2018 
      Jun 11.