PMID- 27317492
OWN - NLM
STAT- MEDLINE
DCOM- 20180518
LR  - 20180518
IS  - 1885-1398 (Electronic)
IS  - 1699-258X (Linking)
VI  - 13
IP  - 4
DP  - 2017 Jul-Aug
TI  - Tofacitinib, an oral Janus kinase inhibitor, for the treatment of Latin American 
      patients with rheumatoid arthritis: Pooled efficacy and safety analyses of Phase 
      3 and long-term extension studies.
PG  - 201-209
LID - S1699-258X(16)30040-7 [pii]
LID - 10.1016/j.reuma.2016.04.010 [doi]
AB  - OBJECTIVE: Tofacitinib is an oral Janus kinase inhibitor for the treatment of 
      rheumatoid arthritis (RA). We assessed tofacitinib efficacy and safety in the 
      Latin American (LA) subpopulation of global Phase 3 and long-term extension (LTE) 
      studies. MATERIALS AND METHODS: Data from LA patients with RA and inadequate 
      response to disease-modifying antirheumatic drugs (DMARDs) were pooled across 
      five Phase 3 studies. Phase 3 patients received tofacitinib 5 or 10mg twice daily 
      (BID), adalimumab or placebo; patients in the single LTE study received 
      tofacitinib 5 or 10mg BID; treatments were administered alone or with 
      conventional synthetic DMARDs. Efficacy was reported up to 12 months (Phase 3) 
      and 36 months (LTE) by American College of Rheumatology (ACR) 20/50/70 response 
      rates, Disease Activity Score (DAS)28-4(erythrocyte sedimentation rate [ESR]) and 
      Health Assessment Questionnaire-Disability Index (HAQ-DI). Incidence rates (IRs; 
      patients with event/100 patient-years) of adverse events (AEs) of special 
      interest were reported. RESULTS: The Phase 3 studies randomized 496 LA patients; 
      the LTE study enrolled 756 LA patients from Phase 2 and Phase 3. In the Phase 3 
      studies, patients who received tofacitinib 5 and 10mg BID showed improvements vs 
      placebo at Month 3 in ACR20 (68.9% and 75.7% vs 35.6%), ACR50 (45.8% and 49.7% vs 
      20.7%) and ACR70 (17.5% and 23.1% vs 6.9%) responses, mean change from baseline 
      in HAQ-DI (-0.6 and -0.8 vs -0.3) and DAS28-4(ESR) score (-2.3 and -2.4 vs -1.4). 
      The improvements were sustained up to Month 36 in the LTE study. In the Phase 3 
      studies, IRs with tofacitinib 5 and 10mg BID and placebo were 7.99, 6.57 and 
      9.84, respectively, for SAEs, and 3.87, 5.28 and 3.26 for discontinuation due to 
      AEs. IRs of AEs of special interest in tofacitinib-treated LA patients were 
      similar to the global population. CONCLUSION: In Phase 3 and LTE studies in LA 
      patients with RA, tofacitinib demonstrated efficacy up to 36 months with a 
      manageable safety profile up to 60 months, consistent with the overall 
      tofacitinib study population.
CI  - Copyright (c) 2016 Elsevier Espana, S.L.U. and Sociedad Espanola de Reumatologia y 
      Colegio Mexicano de Reumatologia. All rights reserved.
FAU - Radominski, Sebastiao Cezar
AU  - Radominski SC
AD  - Universidade Federal do Parana, Curitiba, Brazil.
FAU - Cardiel, Mario Humberto
AU  - Cardiel MH
AD  - Centro de Investigacion Clinica de Morelia, Morelia, Mexico.
FAU - Citera, Gustavo
AU  - Citera G
AD  - Instituto de Rehabilitacion Psicofisica, Buenos Aires, Argentina.
FAU - Goecke, Annelise
AU  - Goecke A
AD  - Instituto de Ciencias Biomedicas, Hospital Clinico de la Universidad de Chile, 
      Santiago, Chile.
FAU - Jaller, Juan Jose
AU  - Jaller JJ
AD  - University Metropolitana, Barranquilla, Colombia.
FAU - Lomonte, Andrea Barranjard Vannucci
AU  - Lomonte ABV
AD  - Hospital Heliopolis, Sao Paulo, Brazil.
FAU - Miranda, Pedro
AU  - Miranda P
AD  - Centro de Estudios Reumatologicos, Santiago, Chile.
FAU - Velez, Patricia
AU  - Velez P
AD  - CIREISAS, Bogota, Colombia.
FAU - Xibille, Daniel
AU  - Xibille D
AD  - Hospital General de Cuernavaca, Cuernavaca, Mexico.
FAU - Kwok, Kenneth
AU  - Kwok K
AD  - Pfizer Inc, New York, NY, USA.
FAU - Rojo, Ricardo
AU  - Rojo R
AD  - Pfizer Inc, Groton, CT, USA. Electronic address: Ricardo.Rojo@pfizer.com.
FAU - Garcia, Erika Gabriela
AU  - Garcia EG
AD  - Pfizer Inc, Collegeville, PA, USA.
LA  - eng
LA  - spa
PT  - Journal Article
PT  - Meta-Analysis
DEP - 20160615
PL  - Spain
TA  - Reumatol Clin
JT  - Reumatologia clinica
JID - 101293923
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  - Adolescent
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  - Female
MH  - Humans
MH  - Janus Kinase Inhibitors/*therapeutic use
MH  - Latin America
MH  - Male
MH  - Middle Aged
MH  - Piperidines/*therapeutic use
MH  - Pyrimidines/*therapeutic use
MH  - Pyrroles/*therapeutic use
MH  - Randomized Controlled Trials as Topic
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Artritis reumatoide
OT  - Janus kinase
OT  - Kinasas Janus
OT  - Latin America
OT  - Latinoamerica
OT  - Rheumatoid arthritis
OT  - Tofacitinib
EDAT- 2016/06/19 06:00
MHDA- 2018/05/19 06:00
CRDT- 2016/06/19 06:00
PHST- 2016/01/07 00:00 [received]
PHST- 2016/04/25 00:00 [revised]
PHST- 2016/04/28 00:00 [accepted]
PHST- 2016/06/19 06:00 [pubmed]
PHST- 2018/05/19 06:00 [medline]
PHST- 2016/06/19 06:00 [entrez]
AID - S1699-258X(16)30040-7 [pii]
AID - 10.1016/j.reuma.2016.04.010 [doi]
PST - ppublish
SO  - Reumatol Clin. 2017 Jul-Aug;13(4):201-209. doi: 10.1016/j.reuma.2016.04.010. Epub 
      2016 Jun 15.