PMID- 29794874
OWN - NLM
STAT- MEDLINE
DCOM- 20190826
LR  - 20231006
IS  - 1536-7355 (Electronic)
IS  - 1076-1608 (Print)
IS  - 1076-1608 (Linking)
VI  - 25
IP  - 3
DP  - 2019 Apr
TI  - Tofacitinib 5 mg Twice Daily in Patients with Rheumatoid Arthritis and Inadequate 
      Response to Disease-Modifying Antirheumatic Drugs: A Comprehensive Review of 
      Phase 3 Efficacy and Safety.
PG  - 115-126
LID - 10.1097/RHU.0000000000000786 [doi]
AB  - BACKGROUND: Tofacitinib is an oral Janus kinase inhibitor for the treatment of 
      rheumatoid arthritis (RA). We performed a comprehensive review of phase 3 studies 
      of tofacitinib 5 mg twice daily (BID) (approved dose in many countries) in 
      patients with moderate to severe RA and inadequate response to prior 
      disease-modifying antirheumatic drugs. METHODS: A search of PubMed and 
      ClinicalTrials.gov identified 5 studies: ORAL Solo (NCT00814307), ORAL Sync 
      (NCT00856544), ORAL Standard (included adalimumab 40 mg once every 2 weeks; 
      NCT00853385), ORAL Scan (NCT00847613), and ORAL Step (NCT00960440). Efficacy and 
      safety data for tofacitinib 5 mg BID, placebo, and adalimumab were analyzed. 
      RESULTS: Across the 5 studies, 1216 patients received tofacitinib 5 mg BID, 681 
      received placebo, and 204 received adalimumab. At month 3, tofacitinib 
      demonstrated significantly higher 20%, 50%, and 70% improvement in American 
      College of Rheumatology response criteria (ACR20, ACR50, and ACR70, respectively) 
      response rates, greater improvement in Health Assessment Questionnaire-Disability 
      Index, and a higher proportion of Disease Activity Score-defined remission than 
      placebo. Frequencies of adverse events (AEs), serious AEs, and discontinuations 
      due to AEs were similar for tofacitinib and placebo at month 3; serious infection 
      events were more frequent for tofacitinib. In ORAL Standard, although not powered 
      for formal comparisons, tofacitinib and adalimumab had numerically similar 
      efficacy and AEs; serious AEs and serious infection events were more frequent 
      with tofacitinib. CONCLUSIONS: Tofacitinib 5 mg BID reduced RA signs and symptoms 
      and improved physical function versus placebo in patients with inadequate 
      response to prior disease-modifying antirheumatic drugs. Tofacitinib 5 mg BID had 
      a consistent, manageable safety profile across studies, with no new safety 
      signals identified.
FAU - Bird, Paul
AU  - Bird P
FAU - Bensen, William
AU  - Bensen W
AD  - St Joseph's Healthcare, McMaster University, Hamilton, Ontario, Canada.
FAU - El-Zorkany, Bassel
AU  - El-Zorkany B
AD  - Department of Rheumatology, Cairo University, Cairo, Egypt.
FAU - Kaine, Jeffrey
AU  - Kaine J
AD  - Sarasota Arthritis Center, Sarasota, FL.
FAU - Manapat-Reyes, Bernadette Heizel
AU  - Manapat-Reyes BH
AD  - Section of Rheumatology, Department of Medicine, University of the 
      Philippines-Philippine General Hospital, Manila, Philippines.
FAU - Pascual-Ramos, Virginia
AU  - Pascual-Ramos V
AD  - Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Medicas 
      y Nutricion Salvador Zubiran, Mexico City, Mexico.
FAU - Witcombe, David
AU  - Witcombe D
AD  - Pfizer Australia, Sydney, New South Wales, Australia.
FAU - Soma, Koshika
AU  - Soma K
AD  - Pfizer Inc, Groton, CT.
FAU - Zhang, Richard
AU  - Zhang R
AD  - Pfizer Inc, Groton, CT.
FAU - Thirunavukkarasu, Krishan
AU  - Thirunavukkarasu K
AD  - Pfizer Australia, Sydney, New South Wales, Australia.
LA  - eng
SI  - ClinicalTrials.gov/NCT00856544
SI  - ClinicalTrials.gov/NCT00814307
PT  - Journal Article
PT  - Review
PL  - United States
TA  - J Clin Rheumatol
JT  - Journal of clinical rheumatology : practical reports on rheumatic & 
      musculoskeletal diseases
JID - 9518034
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Janus Kinase Inhibitors)
RN  - 0 (Piperidines)
RN  - 0 (Pyrimidines)
RN  - 0 (Pyrroles)
RN  - 87LA6FU830 (tofacitinib)
MH  - *Antirheumatic Agents/classification/therapeutic use
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Clinical Trials, Phase III as Topic
MH  - Humans
MH  - Janus Kinase Inhibitors/administration & dosage/adverse effects
MH  - *Piperidines/administration & dosage/adverse effects
MH  - *Pyrimidines/administration & dosage/adverse effects
MH  - *Pyrroles/administration & dosage/adverse effects
MH  - Treatment Outcome
PMC - PMC6445596
EDAT- 2018/05/26 06:00
MHDA- 2019/08/27 06:00
PMCR- 2019/04/02
CRDT- 2018/05/26 06:00
PHST- 2018/05/26 06:00 [pubmed]
PHST- 2019/08/27 06:00 [medline]
PHST- 2018/05/26 06:00 [entrez]
PHST- 2019/04/02 00:00 [pmc-release]
AID - RHU50536 [pii]
AID - 10.1097/RHU.0000000000000786 [doi]
PST - ppublish
SO  - J Clin Rheumatol. 2019 Apr;25(3):115-126. doi: 10.1097/RHU.0000000000000786.