AB0909 Certolizumab pegol’s effectiveness, retention rate and safety in psoriatic arthritis. routine clinical practice data
Authors: A. Conesa Mateos, M. Fernandez-Prada, R. Expósito-Molinero, J. Campos Esteban, P. Rubio Muñoz, J.R. Lamua-Riazuelo, P. Navarro-Alonso, P. Ahijado Guzmán, C.M. Gonzalez Fernandez
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Certolizumab pegol (CZP) is the only antiTNF pegylated without Fc available for patients with psoriatic arthritis (PsA). The efficacy and safety of CZP in clinical trials is known, but there are few published data on the effectiveness of CZP in a setting of usual clinical practice. <h3>Objectives</h3> To evaluate the effectiveness and safety of Certolizumab Pegol (CZP) in a real in PsA patients. <h3>Methods</h3> Multicentric cohort of PsA patients treated with CZP according routine clinical practice. Study approved by local Ethics Committee. Maximum time of observation was 12 months. Effectiveness variables: SJC, TJC, PtGA (Patient Global Assesment) and DAS28-CRP. Safety variables: discontinuation rate. <h3>Results</h3> 262 patients with PsA were included: 43.5% male, mean (SD) age 49.9 (11.9) years, mean (Q1-Q3) disease duration 6.9 (1.9–9.3) years, 14.9% of patients HLAB27 positive, mean (SD) IMC (kg/m<sup>2</sup>) 26.9 (4.7), never smokers 70.3%. Extra-articular manifestations ever: Psoriasis (90%; PASI≥10 40.9%), enthesitis (44.4%), dactilytis (41.9%), nail disease (32%), inflammatory bowel diseases (4.9%). 37.3% of the PsA patients had bone erosions and 3% arthritis mutillans. 48.9 patients received 1 prior csDMARD and 52.1% at least 2 csDMARD. Prior bDMARD: 28.4% none; 38.1% 1, 33.5%≥2. 29.6% of PsA patients received CZP in monotherapy. Mean time on treatment with CZP 10 months. Statistically significant differences in SJC, TJC and DAS28-CRP were observed at the last visit comparing with baseline (table 1). Percentage of patients with enthesitis at baseline (25.4%) decrease to 9.5% at the last visit; 73.2% of the patients had a resolution of the enthesitis (MASES=0). The percentage of patients with dactilytis at baseline (29.1%) decrease to 8.6% in the last visit; 82.5% of these patients had a resolution of the dactilytis. Statistically significant reduction of patients with nail disease was observed from 30.6% to 16.4%. According to Kaplan-Meier analysis, the drug survival of CZP was 78.2%, and no differences were observed in patients who received CZP as first/second biologic or after more than 1 failure to other biologicals agents (Figure1). 262 patients were included in the safety analysis, 21.8% withdrawn treatment: 12.6% due to lack of effectiveness, 5.3% due to intolerance and 3.8% other reasons. <h3>Conclusions</h3> In this study of routine clinical practice CZP was effective in patients with PsA, with a significant decrease in DAS28-CRP and the percentage of patients with enthesitis and dactylitis. The retention rate of certolizumab pegol was not affected by the number of previous biological treatments. <h3>Disclosure of Interest</h3> A. Conesa Mateos: None declared, M. Fernandez-Prada: None declared, R. Expósito-Molinero: None declared, J. Campos Esteban: None declared, P. Rubio Muñoz: None declared, J. R. Lamua-Riazuelo: None declared, P. Navarro-Alonso: None declared, P. Ahijado Guzmán: None declared, C. Gonzalez Fernandez Consultant for: Celgene, MSD, Novartis, Janssen, Speakers bureau: UCB, Abbvie, Pfizer, BMS, Roche, Celgene, Janssen