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Original Article

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

Vicenç Torrente-SegarraRheumatology Department, Hospital General Hospitalet-Sant Joan Despí Moisès Broggi, Catalunya, Spain, Correspondence[email protected] [email protected]

Ana Urruticoechea AranaRheumatology Department, Hospital Can Misses, Ibiza, Spain,

Amalia Sánchez-Andrade FernándezRheumatology Department, Complejo Hospital Universitario Lucus Augusti, Lugo, Spain,

Juan Víctor Tovar BeltránRheumatology Department, Hospital General Universitario de Elche, Elche, Spain,

Alejandro Muñoz JiménezRheumatology Department, Hospital Universitario Virgen del Rocío, Sevilla, Spain,

Anna Martínez-CristóbalRheumatology Department, Hospital de la Ribera, Alzira, Spain,

José Antonio González FerrándezRheumatology Department, Hospital Universitario de Guadalajara, Guadalajara, Spain,

Manuel Fernández PradaRheumatology Department, Hospital Universitario de Ceuta, Ceuta, Spain,

Noelia Vázquez FuentesRheumatology Department, Hospital General Hospitalet-Sant Joan Despí Moisès Broggi, Sant Joan Despí, Spain,

Hèctor CorominasRheumatology Department, Hospital General Hospitalet-Sant Joan Despí Moisès Broggi, Catalunya, Spain,

Sílvia García-DíazRheumatology Department, Hospital General Hospitalet-Sant Joan Despí Moisès Broggi, Sant Joan Despí, Spain,

Asunción Acosta PereiraRheumatology Department, Hospital Santa Creu i Sant Pau, Barcelona, Spain,

José Miguel Ruiz MartínRheumatology Department, Hospital de Viladecans, Viladecans, Spain,

José Ramón Lamua RiazueloRheumatology Department, Hospital Universitario del Henares, Alcalá de Henares, Spain,

Rosa Expósito MolinerRheumatology Department, Hospital Comarcal de Laredo, Laredo, Spain,

Desireé Ruiz VilchezRheumatology Department, Hospital Univeristario Reina Sofia, Córdoba, Spain,

Raúl Veiga CabelloRheumatology Department, Hospital Fuenlabrada, Fuenlabrada, Spain,

Jesús Carlos FernándezRheumatology Department, Complejo Hospital Universitario A Coruña, A Coruña, Spain,

José Raúl Noguera PonsRheumatology Department, Hospital General Universitario de Elche, Elche, Spain,

Noemí Patricia Garrido PuñalRheumatology Department, Hospital Universitario Virgen del Rocío, Sevilla, Spain,

Pedro Giralt CeliméndizRheumatology Department, Hospital Sant Bernabé, Berga, Spain,

Raúl Cortés VerdúRheumatology Department, Hospital Público LluisAlcanyis de Xátiva, Valencia, Spain,

Angel Aragón DíezRheumatology Department, Hospital Universitario de Getafe, Getafe, Spain,

Carlos Tomás RouraRheumatology Department, Hospital Comarcal Mora d’Ebre, Mora d’Ebre, Spain,

Concepción Moll TurudiRheumatology Department, Hospital General MateuOrfila, Mahó, Spain,

Delia Taverner TorrentRheumatology Department, Hospital Universitari de Reus, Reus, Spain,

Felipe Joaquín Rivas SantirsoRheumatology Department, Clínica Dr. Rivas, Segovia, Spain,

Juan José Lerma GarridoRheumatology Department, Hospital General de Castellón, Castellón de la Plana, Spain,

Rosa García PortalesRheumatology Department, Hospital Virgen de la Victoria de Málaga, Málaga, Spain,

Sergi Ordoñez PalauRheumatology Department, Hospital Universitario Arnau de Vilanova, Lleida, Spain,

Silvia Paredes González-AlboRheumatology Department, Hospital Universitari de Reus, Reus, Spain,

Antonio Gracia PérezRheumatology Department, ClinicaQuiron Valencia, Valencia, Spain,

Arantxa Conesa MateosRheumatology Department, Hospital Clínico Valencia, Valencia, Spain,

Jaime Calvo AlénRheumatology Department, Hospital Sierrallana, Torrelavega, Spain,

Jenaro Graña GilRheumatology Department, EOXI CHU A Coruña, A Coruña, Spain,

María Pilar Navarro AlonsoRheumatology Department, Hospital de Fuenlabrada, Madrid, Spain, and

María Jesús Martínez BlascoRheumatology Department, Hospital Universitario de Móstoles, Móstoles, Spain

& (RENACER StudyGroup) show all

Abstract

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords:

Acknowledgements

The authors want to thank all participant patients and Mrs. Patricia Santágueda for their support.

Conflict of interest

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of this article.

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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

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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

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