PMID- 28552437
OWN - NLM
STAT- MEDLINE
DCOM- 20190614
LR  - 20210525
IS  - 2173-5743 (Electronic)
IS  - 2173-5743 (Linking)
VI  - 15
IP  - 1
DP  - 2019 Jan-Feb
TI  - Tofacitinib, an oral Janus kinase inhibitor, in patients from Mexico with 
      rheumatoid arthritis: Pooled efficacy and safety analyses from Phase 3 and LTE 
      studies.
PG  - 43-53
LID - S1699-258X(17)30097-9 [pii]
LID - 10.1016/j.reuma.2017.04.006 [doi]
AB  - OBJECTIVES: Tofacitinib is an oral Janus kinase inhibitor for the treatment of 
      rheumatoid arthritis (RA). We characterized efficacy and safety of tofacitinib in 
      Mexican patients from RA Phase 3 and long-term extension (LTE) studies. METHODS: 
      Data from Mexican patients with RA and an inadequate response to 
      disease-modifying antirheumatic drugs (DMARDs) were taken from four Phase 3 
      studies (pooled across studies) and one open-label LTE study of tofacitinib. 
      Patients received tofacitinib 5 or 10mg twice daily, adalimumab (one Phase 3 
      study) or placebo (four Phase 3 studies) as monotherapy or in combination with 
      conventional synthetic DMARDs. Efficacy up to Month 12 (Phase 3) and Month 36 
      (LTE) was assessed by American College of Rheumatology 20/50/70 response rates, 
      Disease Activity Score (erythrocyte sedimentation rate), and Health Assessment 
      Questionnaire-Disability Index. Safety, including incidence rates (IRs; patients 
      with events/100 patient-years) for adverse events (AEs) of special interest, was 
      assessed throughout the studies. RESULTS: 119 and 212 Mexican patients were 
      included in the Phase 3 and LTE analyses, respectively. Tofacitinib-treated 
      patients in Phase 3 had numerically greater improvements in efficacy responses 
      versus placebo at Month 3. Efficacy was sustained in Phase 3 and LTE studies. IRs 
      for AEs of special interest were similar to those with tofacitinib in the global 
      and Latin American RA populations. CONCLUSIONS: In Mexican patients from the 
      tofacitinib global RA program, tofacitinib efficacy was demonstrated up to Month 
      12 in Phase 3 studies and Month 36 in the LTE study, with a safety profile 
      consistent with tofacitinib global population.
CI  - Copyright (c) 2017 Elsevier Espana, S.L.U. and Sociedad Espanola de Reumatologia y 
      Colegio Mexicano de Reumatologia. All rights reserved.
FAU - Burgos-Vargas, Ruben
AU  - Burgos-Vargas R
AD  - Hospital General de Mexico, Ciudad de Mexico, Mexico.
FAU - Cardiel, Mario
AU  - Cardiel M
AD  - Centro de Investigacion Clinica de Morelia, Morelia, Mexico.
FAU - Xibille, Daniel
AU  - Xibille D
AD  - Servicios de Salud de Morelos, Morelos, Mexico.
FAU - Pacheco-Tena, Cesar
AU  - Pacheco-Tena C
AD  - Universidad Autonoma de Chihuahua, Chihuahua, Mexico.
FAU - Pascual-Ramos, Virginia
AU  - Pascual-Ramos V
AD  - Instituto Nacional de Ciencias, Ciudad de Mexico, Mexico.
FAU - Abud-Mendoza, Carlos
AU  - Abud-Mendoza C
AD  - Hospital Central, San Luis Potosi, Mexico.
FAU - Mahgoub, Ehab
AU  - Mahgoub E
AD  - Pfizer Inc., Collegeville, PA, USA.
FAU - Rahman, Mahboob
AU  - Rahman M
AD  - Perelman School of Medicine, Philadelphia, PA, USA.
FAU - Fan, Haiyun
AU  - Fan H
AD  - Pfizer Inc., Groton, CT, USA.
FAU - Rojo, Ricardo
AU  - Rojo R
AD  - Pfizer Inc., Groton, CT, USA.
FAU - Garcia, Erika
AU  - Garcia E
AD  - Pfizer Inc., Collegeville, PA, USA.
FAU - Santana, Karina
AU  - Santana K
AD  - Pfizer Inc., Ciudad de Mexico, Mexico. Electronic address: 
      karina.santana@pfizer.com.
LA  - eng
LA  - spa
PT  - Journal Article
PT  - Meta-Analysis
DEP - 20170525
PL  - Spain
TA  - Reumatol Clin (Engl Ed)
JT  - Reumatologia clinica
JID - 101717526
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Janus Kinase Inhibitors)
RN  - 0 (Piperidines)
RN  - 0 (Pyrimidines)
RN  - 0 (Pyrroles)
RN  - 87LA6FU830 (tofacitinib)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antirheumatic Agents/therapeutic use
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Clinical Trials, Phase III as Topic
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Janus Kinase Inhibitors/*therapeutic use
MH  - Longitudinal Studies
MH  - Male
MH  - Mexico
MH  - Middle Aged
MH  - Piperidines/*therapeutic use
MH  - Pyrimidines/*therapeutic use
MH  - Pyrroles/*therapeutic use
MH  - Randomized Controlled Trials as Topic
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Artritis Reumatoide
OT  - Efficacy
OT  - Eficacia
OT  - Janus kinase
OT  - Mexico
OT  - Mexico
OT  - Quinasa Janus
OT  - Rheumatoid arthritis
OT  - Safety
OT  - Seguridad
EDAT- 2017/05/30 06:00
MHDA- 2019/06/15 06:00
CRDT- 2017/05/30 06:00
PHST- 2016/12/05 00:00 [received]
PHST- 2017/03/10 00:00 [revised]
PHST- 2017/04/12 00:00 [accepted]
PHST- 2017/05/30 06:00 [pubmed]
PHST- 2019/06/15 06:00 [medline]
PHST- 2017/05/30 06:00 [entrez]
AID - S1699-258X(17)30097-9 [pii]
AID - 10.1016/j.reuma.2017.04.006 [doi]
PST - ppublish
SO  - Reumatol Clin (Engl Ed). 2019 Jan-Feb;15(1):43-53. doi: 
      10.1016/j.reuma.2017.04.006. Epub 2017 May 25.