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RENACER study: Assessment of 12-month efficacy and safety of 168 certolizumab PEGol rheumatoid arthritis-treated patients from a Spanish multicenter national database

2015; Oxford University Press; Volume: 26; Issue: 3 Linguagem: Inglês

10.3109/14397595.2015.1101200

1439-7609

Vicenç Torrente-Segarra, Ana Arana, Amalia Sanchez-Andrade Fernández, J.V. Tovar Beltrán, Alejandro Muñóz, Anna Martínez-Cristóbal, José Antonio González Ferrández, Manuel Fernández Prada, Noelia Vázquez Fuentes, Héctor Corominas, Silvia García-Díaz, Asunción Acosta Pereira, José M. Martín, José Ramón Lamua Riazuelo, Rosa Expósito Moliner, Desireé Ruiz Vilchez, Raúl Veiga Cabello, Jesús Carlos Fernández, José Raúl Noguera Pons, Noemí Patricia Garrido Puñal, Pedro Giralt Celiméndiz, R Verdu, Ángel Aragón Díez, Carlos Tomás Roura, Concepción Moll Turudi, Delia Taverner Torrent, Felipe Joaquín Rivas Santirso, Juan J. Garrido, Rosa García Portales, Sergi Ordóñez Palau, Silvia Paredes González-Albó, Antonio Gracia Pérez, Arantxa Conesa Mateos, Jaime Calvo Alén, Jenaro Graña Gil, María Pilar Navarro Alonso, María Jesús Martínez Blasco,

Systemic Lupus Erythematosus Research

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.Observational longitudinal prospective study of RA patients from 35 sites in Spain. Variables (baseline, 3- and 12-month assessment): sociodemographics, previous Disease Modifying Anti-Rheumatic Drug (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.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.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.