Background/Purpose: To evaluate the effectiveness and safety of Certolizumab Pegol (CZP) in a real word setting in Psoriatic Arthritis (PsA) patients.

Methods: Multicentric cohort of PsA patients treated with CZP according to routine clinical practice. Study approved by local Ethics Committee. Maximum time of observation is 12 months. Effectiveness variables: SJC, TJC, PtGA, PhGA and DAS28-CRP. Safety variables: discontinuation rate.

Results: 262 patients with PsA were included: 43.5% male, mean (SD) age 49.9 (±11.9) years, median disease duration 5.0 (0, 40.2) years, 14.9% of patients were HLAB27 positive, BMI (kg/m²) 26.9 (±4.7) and never smokers 70.3%.  Regarding extra-articular manifestations ever: Psoriasis (90%; PASI≥10 4.9%), enthesitis (44.4%), dactilytis (41.9%), nail disease (32%), inflammatory bowel diseases (4.9%). 37.3% of the PsA patients had erosions and a 3% arthritis mutillans (N=8). 48.9% patients received 1 prior csDMARDs and 52.1% at least 2 csDMARDs. Prior bDMARD received (28.4% none; 38.1% 1, 33.5% ≥2). 29.6% of PsA patients received CZP in monotherapy. Mean duration on treatment with CZP 10 m (78.2%).

Statistically significant differences in SJC, TJC and DAS28[CRP] were observed at the last visit comparing with baseline (Table 1). In the last observation, 47.1% of the patients had a DAS28 response (reduction of ≥1.2 from baseline). The percentage of patients with enthesitis at baseline (25.4%) was reduced to 9.5% at the end of the observation; 73.2% of the patients had a total resolution of the enthesitis (MASES=0). The percentage of patients with dactilytis at baseline (29.1%) decreased to 8.6% in the last observation; 82.5% of these patients had a total resolution of the dactilytis.

Table 1. Evolution of clinical variables of activity

*p<0,001, Wilcoxon’s test

The drug survival of CZP is 78.2% (Figure1), and similar retention rates were observed independently if CZP were used as monotherapy (79.2%) or in combination with DMARDs (78.9%).

Figure 1.

262 patients were included in the safety analysis, 21.8% withdrawn treatment: 12.6% due to lack of efficacy, 5.3% due to intolerance and 3.8% other reasons.

Conclusion:  Real life experience from this nationwide study, demonstrated the effectiveness and safety of CZP in PsA patients (bionaïve only: 28.4%), with a significant reduction of DAS28, enthesitis and dactilytis. CZP survival seems to be similar regardless of csDMARDs concomitant use.  

This publication has been possible thanks to a grant of UCB Pharma to the technical companies which have been managing the data collection and the statistical analyses. The results are independent of UCB Pharma