1. RENACER study: Assessment of 12-month efficacy and safety of 168 certolizumab PEGol rheumatoid arthritis-treated patients from a Spanish multicenter national database
- Author
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Jenaro Graña Gil, Hèctor Corominas, Felipe Joaquín Rivas Santirso, Desireé Ruiz Vilchez, Silvia Garcia-Diaz, María Pilar Navarro Alonso, Jesús Carlos Fernández, Anna Martínez-Cristóbal, Rosa Expósito Moliner, Juan Víctor Tovar Beltrán, José Raúl Noguera Pons, Antonio Gracia Pérez, José Ramón Lamua Riazuelo, Arantxa Conesa Mateos, Jaime Calvo Alén, Delia Taverner Torrent, Raúl Cortés Verdú, Rosa García Portales, Alejandro Muñoz Jiménez, Juan José Lerma Garrido, Concepción Moll Turudi, Angel Aragón Díez, Ana Urruticoechea Arana, José Miguel Ruiz Martín, María Jesús Martínez Blasco, Amalia Sánchez-Andrade Fernández, RENACER StudyGroup, Sergi Ordoñez Palau, Noemí Patricia Garrido Puñal, Vicenç Torrente-Segarra, Noelia Vázquez Fuentes, Manuel Fernandez Prada, Carlos Tomás Roura, José Antonio González Ferrández, Raúl Veiga Cabello, Pedro Giralt Celiméndiz, Asunción Acosta Pereira, Silvia Paredes González-Albo, [Torrente-Segarra, Vicenc] Hosp Gen Hospitalet St Joan Despi Moises Broggi, Dept Rheumatol, C Avinguda Josep Molins 29-41, Lhospitalet De Llobregat 08906, Catalunya, Spain, [Corominas, Hector] Hosp Gen Hospitalet St Joan Despi Moises Broggi, Dept Rheumatol, C Avinguda Josep Molins 29-41, Lhospitalet De Llobregat 08906, Catalunya, Spain, [Urruticoechea Arana, Ana] Hosp Can Misses, Dept Rheumatol, Ibiza, Spain, [Sanchez-Andrade Fernandez, Amalia] Complejo Hosp Univ Lucus Augusti, Dept Rheumatol, Lugo, Spain, [Tovar Beltran, Juan Victor] Hosp Gen Univ Elche, Dept Rheumatol, Elche, Spain, [Noguera Pons, Jose Raul] Hosp Gen Univ Elche, Dept Rheumatol, Elche, Spain, [Munoz Jimenez, Alejandro] Hosp Univ Virgen del Rocio, Dept Rheumatol, Seville, Spain, [Garrido Punal, Noemi Patricia] Hosp Univ Virgen del Rocio, Dept Rheumatol, Seville, Spain, [Martinez-Cristobal, Anna] Hosp Ribera, Dept Rheumatol, Alzira, Spain, [Gonzalez Ferrandez, Jose Antonio] Hosp Univ Guadalajara, Dept Rheumatol, Guadalajara, Spain, [Fernandez Prada, Manuel] Hosp Univ Ceuta, Dept Rheumatol, Ceuta, Spain, [Vazquez Fuentes, Noelia] Hosp Gen Hospitalet St Joan Despi Moises Broggi, Dept Rheumatol, St Joan Despi, Spain, [Garcia-Diaz, Silvia] Hosp Gen Hospitalet St Joan Despi Moises Broggi, Dept Rheumatol, St Joan Despi, Spain, [Acosta Pereira, Asuncion] Hosp Santa Creu & Sant Pau, Dept Rheumatol, Barcelona, Spain, [Ruiz Martin, Jose Miguel] Hosp Viladecans, Dept Rheumatol, Viladecans, Spain, [Lamua Riazuelo, Jose Ramon] Hosp Univ Henares, Dept Rheumatol, Alcala De Henares, Spain, [Exposito Moliner, Rosa] Hosp Comarcal Laredo, Dept Rheumatol, Laredo, Spain, [Ruiz Vilchez, Desiree] Hosp Univ Reina Sofia, Dept Rheumatol, Cordoba, Spain, [Veiga Cabello, Raul] Hosp Fuenlabrada, Dept Rheumatol, Fuenlabrada, Spain, [Carlos Fernandez, Jesus] Complejo Hosp Univ A Coruna, Dept Rheumatol, La Coruna, Spain, [Giralt Celimendiz, Pedro] Hosp St Bernabe, Dept Rheumatol, Berga, Spain, [Cortes Verdu, Raul] Hosp Publ LluisAlcanyis de Xativa, Dept Rheumatol, Valencia, Spain, [Aragon Diez, Angel] Hosp Univ Getafe, Dept Rheumatol, Getafe, Spain, [Tomas Roura, Carlos] Hosp Comarcal Mora dEbre, Dept Rheumatol, Mora Debre, Spain, [Moll Turudi, Concepcion] Hosp Gen MateuOrfila, Dept Rheumatol, Maho, Spain, [Taverner Torrent, Delia] Hosp Univ Reus, Dept Rheumatol, Reus, Spain, [Paredes Gonzalez-Albo, Silvia] Hosp Univ Reus, Dept Rheumatol, Reus, Spain, [Rivas Santirso, Felipe Joaquin] Clin Dr Rivas, Dept Rheumatol, Segovia, Spain, [Lerma Garrido, Juan Jose] Hosp Gen Castellon, Dept Rheumatol, Castellon De La Plana, Spain, [Garcia Portales, Rosa] Hosp Virgen de la Victoria Malaga, Dept Rheumatol, Malaga, Spain, [Ordonez Palau, Sergi] Hosp Arnau Vilanova, Dept Rheumatol, Lleida, Spain, [Gracia Perez, Antonio] Clin Quiron Valencia, Dept Rheumatol, Valencia, Spain, [Conesa Mateos, Arantxa] Hosp Clin Valencia, Dept Rheumatol, Valencia, Spain, [Calvo Alen, Jaime] Hosp Sierrallana, Dept Rheumatol, Torrelavega, Spain, [Grana Gil, Jenaro] EOXI CHU A Coruna, Dept Rheumatol, La Coruna, Spain, [Navarro Alonso, Maria Pilar] Hosp Fuenlabrada, Dept Rheumatol, Madrid, Spain, and [Martinez Blasco, Maria Jesus] Hosp Univ Mostoles, Dept Rheumatol, Mostoles, Spain
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musculoskeletal diseases ,medicine.medical_specialty ,Survival rate ,Efficacy ,College-of-rheumatology ,Clinical practice ,Logistic regression ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Long-term ,Internal medicine ,medicine ,030212 general & internal medicine ,Certolizumab pegol ,Rheumatoid arthritis ,skin and connective tissue diseases ,Prospective cohort study ,030203 arthritis & rheumatology ,Gisea registry ,Clinical-practice ,Danish danbio registry ,business.industry ,Certolizumab PEGol ,Adalimumab ,Alpha agents ,medicine.disease ,Discontinuation ,Japanese patients ,Anti-tnf therapy ,Plus methotrexate ,Physical therapy ,National database ,Observational study ,Safety ,business ,medicine.drug ,Spanish population - Abstract
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.
- Published
- 2016