title: RENACER study: Assessment of 12-month efficacy and safety of 168 certolizumab PEGol rheumatoid arthritis-treated patients from a Spanish multicenter national database.
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.
authors.affiliation: a Rheumatology Department , Hospital General Hospitalet-Sant Joan Despí Moisès Broggi , Catalunya , Spain.
authors.forename: Vicenç
authors.initials: V
authors.lastname: Torrente-Segarra
authors.affiliation: b Rheumatology Department , Hospital Can Misses , Ibiza , Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Urruticoechea Arana
authors.affiliation: c Rheumatology Department , Complejo Hospital Universitario Lucus Augusti , Lugo , Spain.
authors.forename: Amalia
authors.initials: A
authors.lastname: Sánchez-Andrade Fernández
authors.affiliation: d Rheumatology Department , Hospital General Universitario de Elche , Elche , Spain.
authors.forename: Juan Víctor
authors.initials: JV
authors.lastname: Tovar Beltrán
authors.affiliation: e Rheumatology Department , Hospital Universitario Virgen del Rocío , Sevilla , Spain.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Muñoz Jiménez
authors.affiliation: f Rheumatology Department , Hospital de la Ribera , Alzira , Spain.
authors.forename: Anna
authors.initials: A
authors.lastname: Martínez-Cristóbal
authors.affiliation: g Rheumatology Department , Hospital Universitario de Guadalajara , Guadalajara , Spain.
authors.forename: José Antonio
authors.initials: JA
authors.lastname: González Ferrández
authors.affiliation: h Rheumatology Department , Hospital Universitario de Ceuta , Ceuta , Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Fernández Prada
authors.affiliation: i Rheumatology Department , Hospital General Hospitalet-Sant Joan Despí Moisès Broggi , Sant Joan Despí , Spain.
authors.forename: Noelia
authors.initials: N
authors.lastname: Vázquez Fuentes
authors.affiliation: a Rheumatology Department , Hospital General Hospitalet-Sant Joan Despí Moisès Broggi , Catalunya , Spain.
authors.forename: Hèctor
authors.initials: H
authors.lastname: Corominas
authors.affiliation: i Rheumatology Department , Hospital General Hospitalet-Sant Joan Despí Moisès Broggi , Sant Joan Despí , Spain.
authors.forename: Sílvia
authors.initials: S
authors.lastname: García-Díaz
authors.affiliation: j Rheumatology Department , Hospital Santa Creu i Sant Pau , Barcelona , Spain.
authors.forename: Asunción
authors.initials: A
authors.lastname: Acosta Pereira
authors.affiliation: k Rheumatology Department , Hospital de Viladecans , Viladecans , Spain.
authors.forename: José Miguel
authors.initials: JM
authors.lastname: Ruiz Martín
authors.affiliation: l Rheumatology Department , Hospital Universitario del Henares , Alcalá de Henares , Spain.
authors.forename: José Ramón
authors.initials: JR
authors.lastname: Lamua Riazuelo
authors.affiliation: m Rheumatology Department , Hospital Comarcal de Laredo , Laredo , Spain.
authors.forename: Rosa
authors.initials: R
authors.lastname: Expósito Moliner
authors.affiliation: n Rheumatology Department , Hospital Univeristario Reina Sofia , Córdoba , Spain.
authors.forename: Desireé
authors.initials: D
authors.lastname: Ruiz Vilchez
authors.affiliation: o Rheumatology Department , Hospital Fuenlabrada , Fuenlabrada , Spain.
authors.forename: Raúl
authors.initials: R
authors.lastname: Veiga Cabello
authors.affiliation: p Rheumatology Department , Complejo Hospital Universitario A Coruña , A Coruña , Spain.
authors.forename: Jesús Carlos
authors.initials: JC
authors.lastname: Fernández
authors.affiliation: d Rheumatology Department , Hospital General Universitario de Elche , Elche , Spain.
authors.forename: José Raúl
authors.initials: JR
authors.lastname: Noguera Pons
authors.affiliation: e Rheumatology Department , Hospital Universitario Virgen del Rocío , Sevilla , Spain.
authors.forename: Noemí Patricia
authors.initials: NP
authors.lastname: Garrido Puñal
authors.affiliation: q Rheumatology Department , Hospital Sant Bernabé , Berga , Spain.
authors.forename: Pedro
authors.initials: P
authors.lastname: Giralt Celiméndiz
authors.affiliation: r Rheumatology Department , Hospital Público LluisAlcanyis de Xátiva , Valencia , Spain.
authors.forename: Raúl
authors.initials: R
authors.lastname: Cortés Verdú
authors.affiliation: s Rheumatology Department , Hospital Universitario de Getafe , Getafe , Spain.
authors.forename: Angel
authors.initials: A
authors.lastname: Aragón Díez
authors.affiliation: t Rheumatology Department , Hospital Comarcal Mora d'Ebre , Mora d'Ebre , Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Tomás Roura
authors.affiliation: u Rheumatology Department , Hospital General MateuOrfila , Mahó , Spain.
authors.forename: Concepción
authors.initials: C
authors.lastname: Moll Turudi
authors.affiliation: v Rheumatology Department , Hospital Universitari de Reus , Reus , Spain.
authors.forename: Delia
authors.initials: D
authors.lastname: Taverner Torrent
authors.affiliation: w Rheumatology Department , Clínica Dr. Rivas , Segovia , Spain.
authors.forename: Felipe Joaquín
authors.initials: FJ
authors.lastname: Rivas Santirso
authors.affiliation: x Rheumatology Department , Hospital General de Castellón , Castellón de la Plana , Spain.
authors.forename: Juan José
authors.initials: JJ
authors.lastname: Lerma Garrido
authors.affiliation: y Rheumatology Department , Hospital Virgen de la Victoria de Málaga , Málaga , Spain.
authors.forename: Rosa
authors.initials: R
authors.lastname: García Portales
authors.affiliation: z Rheumatology Department , Hospital Universitario Arnau de Vilanova , Lleida , Spain.
authors.forename: Sergi
authors.initials: S
authors.lastname: Ordoñez Palau
authors.affiliation: v Rheumatology Department , Hospital Universitari de Reus , Reus , Spain.
authors.forename: Silvia
authors.initials: S
authors.lastname: Paredes González-Albo
authors.affiliation: aa Rheumatology Department , ClinicaQuiron Valencia , Valencia , Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Gracia Pérez
authors.affiliation: ab Rheumatology Department , Hospital Clínico Valencia , Valencia , Spain.
authors.forename: Arantxa
authors.initials: A
authors.lastname: Conesa Mateos
authors.affiliation: ac Rheumatology Department , Hospital Sierrallana , Torrelavega , Spain.
authors.forename: Jaime
authors.initials: J
authors.lastname: Calvo Alén
authors.affiliation: ad Rheumatology Department , EOXI CHU A Coruña , A Coruña , Spain.
authors.forename: Jenaro
authors.initials: J
authors.lastname: Graña Gil
authors.affiliation: ae Rheumatology Department , Hospital de Fuenlabrada , Madrid , Spain , and.
authors.forename: María Pilar
authors.initials: MP
authors.lastname: Navarro Alonso
authors.affiliation: af Rheumatology Department , Hospital Universitario de Móstoles , Móstoles , Spain.
authors.forename: María Jesús
authors.initials: MJ
authors.lastname: Martínez Blasco
keywords: Certolizumab PEGol; Clinical practice; Efficacy; Rheumatoid arthritis; Safety; Spanish population; Survival rate