PMID- 37286268
OWN - NLM
STAT- MEDLINE
DCOM- 20230609
LR  - 20230609
IS  - 2173-5743 (Electronic)
IS  - 2173-5743 (Linking)
VI  - 19
IP  - 6
DP  - 2023 Jun-Jul
TI  - Patient-reported outcomes in RA patients treated with tofacitinib or bDMARDs in 
      real-life conditions in two Latin American countries.
PG  - 319-327
LID - S2173-5743(23)00078-3 [pii]
LID - 10.1016/j.reumae.2023.02.006 [doi]
AB  - OBJECTIVE: To describe efficacy, safety, and patient-reported outcomes (PROs) in 
      patients with rheumatoid arthritis (RA) with an inadequate response to 
      conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) treated 
      with tofacitinib or biological DMARDs (bDMARDs) in real-life conditions. METHODS: 
      A noninterventional study was performed between March 2017 and September 2019 at 
      13 sites in Colombia and Peru. Outcomes measured at baseline and at the 6-month 
      follow-up were disease activity (RAPID3 [Routine Assessment of Patients Index 
      Data] score), functional status (HAQ-DI [Health Assessment Questionnaire] score), 
      and quality of life (EQ-5D-3L [EuroQol Questionnaire]). The Disease Activity 
      Score-28 (DAS28-ESR) and frequency of adverse events (AEs) were also reported. 
      Unadjusted and adjusted differences from baseline were estimated and expressed as 
      the least squares mean difference (LSMD). RESULTS: Data from 100 patients treated 
      with tofacitinib and 70 patients with bDMARDs were collected. At baseline, the 
      patients' mean age was 53.53 years (SD 13.77), the mean disease duration was 6.31 
      years (SD 7.01). The change from baseline at month 6 was not statistically 
      significant different in the adjusted LSMD [SD] for tofacitinib vs. bDMARDs for 
      RAPID3 score (-2.55[.30] vs. -2.52[.26]), HAQ-DI score (-.56[.07] vs. -.50[.08]), 
      EQ-5D-3L score (.39[.04] vs. .37[.04]) and DAS28-ESR (-2.37[.22] vs. -2.77[.20]). 
      Patients from both groups presented similar proportions of nonserious and serious 
      AEs. No deaths were reported. CONCLUSION: Changes from baseline were not 
      statistically significantly different between tofacitinib and bDMARDs in terms of 
      RAPID3 scores and secondary outcomes. Patients from both groups presented similar 
      proportions of nonserious and serious AEs. CLINICAL TRIAL NUMBER: NCT03073109.
CI  - Copyright (c) 2023 The Author(s). Published by Elsevier Espana, S.L.U. All rights 
      reserved.
FAU - Reyes, J M
AU  - Reyes JM
AD  - Pfizer, Bogota, Colombia. Electronic address: JuanManuel.Reyes@pfizer.com.
FAU - Gutierrez, M V
AU  - Gutierrez MV
AD  - Pfizer, Santiago, Chile.
FAU - Madariaga, H
AU  - Madariaga H
AD  - Centro Especializado de enfermedades neoplasicas (CEEN), Arequipa, Peru.
FAU - Otero, W
AU  - Otero W
AD  - Centro Servimed, Bucaramanga, Colombia.
FAU - Guzman, R
AU  - Guzman R
AD  - Instituto de Enfermedades Autoinmunes Renato Guzman (IDEARG), Bogota, Colombia.
FAU - Izquierdo, J
AU  - Izquierdo J
AD  - Clinica del Occidente, Cali, Colombia.
FAU - Abello, M
AU  - Abello M
AD  - Centro Integral de Reumatologia Circaribe, Barranquilla, Colombia.
FAU - Velez, P
AU  - Velez P
AD  - Centro de Investigacion en Reumatologia y Especialidades Medicas (CIREEM), 
      Bogota, Colombia.
FAU - Castillo, D
AU  - Castillo D
AD  - Clinica del Occidente, Cali, Colombia.
FAU - Ponce de Leon, D
AU  - Ponce de Leon D
AD  - Pfizer, Lima, Peru.
FAU - Lukic, T
AU  - Lukic T
AD  - Pfizer Inc, New York, USA.
FAU - Amador, L
AU  - Amador L
AD  - Pfizer, Bogota, Colombia.
LA  - eng
SI  - ClinicalTrials.gov/NCT03073109
PT  - Journal Article
PL  - Spain
TA  - Reumatol Clin (Engl Ed)
JT  - Reumatologia clinica
JID - 101717526
RN  - 87LA6FU830 (tofacitinib)
RN  - 0 (Pyrroles)
RN  - 0 (Antirheumatic Agents)
SB  - IM
MH  - Humans
MH  - Middle Aged
MH  - Quality of Life
MH  - Latin America
MH  - Treatment Outcome
MH  - Pyrroles/therapeutic use
MH  - *Antirheumatic Agents/therapeutic use
MH  - *Arthritis, Rheumatoid/drug therapy
MH  - Patient Reported Outcome Measures
OTO - NOTNLM
OT  - Agentes antirreumaticos
OT  - Antirheumatic agents
OT  - Artritis reumatoide
OT  - Desenlaces reportados por pacientes
OT  - Latin America
OT  - Latinoamerica
OT  - Patient reported outcome measures
OT  - Rheumatoid arthritis
OT  - Tofacitinib
EDAT- 2023/06/08 01:08
MHDA- 2023/06/09 06:42
CRDT- 2023/06/07 21:00
PHST- 2022/07/19 00:00 [received]
PHST- 2023/02/03 00:00 [accepted]
PHST- 2023/06/09 06:42 [medline]
PHST- 2023/06/08 01:08 [pubmed]
PHST- 2023/06/07 21:00 [entrez]
AID - S2173-5743(23)00078-3 [pii]
AID - 10.1016/j.reumae.2023.02.006 [doi]
PST - ppublish
SO  - Reumatol Clin (Engl Ed). 2023 Jun-Jul;19(6):319-327. doi: 
      10.1016/j.reumae.2023.02.006.