<i>RENACER</i> Study: Assessment of 12-month efficacy and safety of 168 certolizumab-PEGol rheumatoid arthritis treated patients from a Spanish multicenter National database.
V Torrente-Segarra
A Urruticoechea Arana
A Sánchez-Andrade
JV Tovar
A Muñoz
A Martínez
JA González
M Fernández
N. Vázquez
H Corominas
S García-Díaz
A Acosta-Pereira
JM Ruiz Martín
JR Lamua Riazuelo
R Expósito
D Ruiz Vilchez
R Veiga Cabello
J Carlos Fernández
JR Noguera Pons
N Patricia Garrido Puñal
P Giralt Celiméndiz
R Cortés Verdú
A Aragón Díez
C Tomás Roura
C Moll Turudi
D Taverner Torrent
FJ Rivas Santirso
JJ Lerma Garrido
R García Portales
S Ordoñez Palau
S Paredes González-Albo
A Gracia Pérez
A Conesa Mateos
J Calvo Alén
J Graña Gil
MP Navarro Alonso
MJ Martínez Blasco
10.6084/m9.figshare.1569185.v1
https://tandf.figshare.com/articles/journal_contribution/_i_RENACER_i_Study_Assessment_of_12_month_efficacy_and_safety_of_168_certolizumab_PEGol_rheumatoid_arthritis_treated_patients_from_a_Spanish_multicenter_National_database_/1569185
<div><p></p><p><b>Objective:</b> To assess effectiveness and safety of certolizumab PEGol (CZP) in Rheumatoid Arthritis (RA) patients after 12 months of treatment and to detect predictors of response.</p><p><b>Methods:</b> Observational longitudinal prospective study of RA patients from 35 sites in Spain. Variables (baseline, 3- and 12-month assessment): socio-demographics, previous DMARD and previous Biological Therapies (BT) use; TJC, SJC, ESR, CRP, DAS28, SDAI. Response variables: TJC, SJC, CRP, ESR and steroids dose reductions, EULAR Moderate/Good Response, SDAI response and remission, DAS28 remission. Safety variables: discontinuation due to side-effects. Descriptive, comparative and Logistic regression analyses were performed.</p><p><b>Results:</b> We included 168 patients: 79.2% women, mean age 54.5 years (±13.2 SD), mean disease duration 7.5 years (±7.3 SD). Mean number of prior DMARD: 1.4 (±1.2 SD), mean number of prior BT was 0.8 (±1.1). Mean time on CZP was 9.8 months (±3.4 SD). A total of 71.4% were receiving CZP at 12-month assessment. Baseline predictors of response: lower prior number DMARD; low number prior BT; higher CRP, ESR, TJC, SJC, DAS28 and SDAI (p<0.05) scores. A 25/46.4% Moderate/Good Response, a 20% SDAI remission, and a 44% DAS28 remission were observed. We observed 48 discontinuations (28.6%), 31 due to partial or complete ineffectiveness and 17 due to side-effects.</p><p><b>Conclusions:</b> CZP showed benefit in severe RA patients, with significant reduction of all effectiveness parameters, despite the high prevalence of previous BT exposure in our series. We found CRP, ESR, prior DMARD/BT number, TJC, SJC, DAS28, and SDAI as baseline predictors of response. CZP was mostly well tolerated.</p></div>
2015-09-29 00:00:00
bt
crp
safety
Logistic regression analyses
predictor
RA patients
sdai
Assessment
response
SJC
discontinuation
sd
eular
baseline
effectiveness
dmard
esr
variable
steroids dose reductions
DAS 28 remission
TJC
RENACER
CZP
Spanish multicenter National database