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Mod Rheumatol. 2016 May;26(3):336-341. doi: 10.3109/14397595.2015.1101200. Epub 2015 Nov 7.

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

Author information

1
a Rheumatology Department , Hospital General Hospitalet-Sant Joan Despí Moisès Broggi , Catalunya , Spain.
2
b Rheumatology Department , Hospital Can Misses , Ibiza , Spain.
3
c Rheumatology Department , Complejo Hospital Universitario Lucus Augusti , Lugo , Spain.
4
d Rheumatology Department , Hospital General Universitario de Elche , Elche , Spain.
5
e Rheumatology Department , Hospital Universitario Virgen del Rocío , Sevilla , Spain.
6
f Rheumatology Department , Hospital de la Ribera , Alzira , Spain.
7
g Rheumatology Department , Hospital Universitario de Guadalajara , Guadalajara , Spain.
8
h Rheumatology Department , Hospital Universitario de Ceuta , Ceuta , Spain.
9
i Rheumatology Department , Hospital General Hospitalet-Sant Joan Despí Moisès Broggi , Sant Joan Despí , Spain.
10
j Rheumatology Department , Hospital Santa Creu i Sant Pau , Barcelona , Spain.
11
k Rheumatology Department , Hospital de Viladecans , Viladecans , Spain.
12
l Rheumatology Department , Hospital Universitario del Henares , Alcalá de Henares , Spain.
13
m Rheumatology Department , Hospital Comarcal de Laredo , Laredo , Spain.
14
n Rheumatology Department , Hospital Univeristario Reina Sofia , Córdoba , Spain.
15
o Rheumatology Department , Hospital Fuenlabrada , Fuenlabrada , Spain.
16
p Rheumatology Department , Complejo Hospital Universitario A Coruña , A Coruña , Spain.
17
q Rheumatology Department , Hospital Sant Bernabé , Berga , Spain.
18
r Rheumatology Department , Hospital Público LluisAlcanyis de Xátiva , Valencia , Spain.
19
s Rheumatology Department , Hospital Universitario de Getafe , Getafe , Spain.
20
t Rheumatology Department , Hospital Comarcal Mora d'Ebre , Mora d'Ebre , Spain.
21
u Rheumatology Department , Hospital General MateuOrfila , Mahó , Spain.
22
v Rheumatology Department , Hospital Universitari de Reus , Reus , Spain.
23
w Rheumatology Department , Clínica Dr. Rivas , Segovia , Spain.
24
x Rheumatology Department , Hospital General de Castellón , Castellón de la Plana , Spain.
25
y Rheumatology Department , Hospital Virgen de la Victoria de Málaga , Málaga , Spain.
26
z Rheumatology Department , Hospital Universitario Arnau de Vilanova , Lleida , Spain.
27
aa Rheumatology Department , ClinicaQuiron Valencia , Valencia , Spain.
28
ab Rheumatology Department , Hospital Clínico Valencia , Valencia , Spain.
29
ac Rheumatology Department , Hospital Sierrallana , Torrelavega , Spain.
30
ad Rheumatology Department , EOXI CHU A Coruña , A Coruña , Spain.
31
ae Rheumatology Department , Hospital de Fuenlabrada , Madrid , Spain , and.
32
af Rheumatology Department , Hospital Universitario de Móstoles , Móstoles , Spain.

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:

Certolizumab PEGol; Clinical practice; Efficacy; Rheumatoid arthritis; Safety; Spanish population; Survival rate

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