FRI0087 DURABILITY OF CERTOLIZUMAB PEGOL IN PATIENTS WITH RHEUMATOID ARTHRITIS OR PSORIASIS OVER THREE YEARS: AN ANALYSIS OF POOLED CLINICAL TRIAL DATA

Abstract

Background:Durability over time varies according to the safety, tolerability and efficacy of a drug.1However, durability may vary between patient (pt) subgroups,1,2and physicians should consider pt characteristics when making treatment decisions. Certolizumab pegol (CZP) is an anti-tumour necrosis factor (anti-TNF) agent approved for the treatment of chronic inflammatory diseases, including rheumatoid arthritis (RA) and plaque psoriasis (PSO).3However, little is known about the impact of pt baseline characteristics on long-term CZP durability.Objectives:To investigate the durability of CZP and reasons for discontinuation over 3 years (yrs) in subgroups of pts with RA or PSO using pooled clinical trial data.Methods:27 RA and 3 PSO clinical trials were pooled for indication-specific analyses. Kaplan-Meier curves were calculated to estimate CZP durability for pt subgroups by age, gender, disease duration, prior anti-TNF use and geographic region. Reasons for CZP discontinuation were investigated.Results:6927 RA and 1112 PSO pts were included; mean ages were 53.0 yrs (standard deviation [SD]: 12.2 yrs) and 45.4 (13.0) yrs, respectively. 79.3% RA pts were female (of all patients, 19.4% were women of childbearing age [18–<45 yrs; WoCBA]) compared with 33.5% (15.2% WoCBA) in PSO. Mean disease durations were 6.4 (6.9) yrs for RA and 18.4 (12.3) yrs for PSO. 18.5% RA and 13.3% PSO pts had prior anti-TNF use. Maximum CZP exposure was ~8 yrs for RA and ~3 yrs for PSO. At 1 yr, 63.4% of RA pts remained on CZP vs 80.3% PSO pts, decreasing to 49.2% RA pts and 70.1% PSO pts at 3 yrs (Table 1). Reasons for discontinuation, at any time during the trials, included lack of efficacy (RA 13.5%; PSO 1.8%), adverse events (RA 11.9%; PSO 8.1%), consent withdrawn (RA 6.7%; PSO 6.7%), lost to follow-up (RA 1.8%; PSO 4.3%), protocol violation (RA 1.7%; PSO 0.3%) and other (RA 9.2%; PSO 8.7%). In RA pts, CZP durability was lower in the elderly and in pts with disease duration <1 yr. In PSO, durability was lower in pts with disease duration <1 yr or prior anti-TNF use. Durability was lower in WoCBA pts than male pts aged 18–<45 yrs for both indications. CZP durability was lower in Western Europe and North America compared to other regions.Table 1.CZP durability at 3 years,[a] by patient subgroup% patientsRAPSOAll49.270.1Age, yrs 18–<4552.166.3 45–<6549.468.3 ≥6543.369.4Gender Female49.364.1 Male48.269.2 WoCBA51.162.0 Male aged 18–<45 yrs56.568.3Prior anti-TNF use Yes49.360.1 No49.668.5Disease duration, yrs <143.239.6 1–<552.663.6 5–<1051.464.4 ≥1048.769.7Region Asia-Pacific58.5 Central Europe61.578.8 Eastern Europe54.2 Latin America57.1 N America36.653.9 W Europe33.867.7 Rest of the world66.3[a] For PSO, the 3 year analysis was calculated with Week 144 data. CZP: certolizumab pegol; N: North; PSO: psoriasis; RA: rheumatoid arthritis; TNF: tumour necrosis factor; W: Western; yrs: years.Conclusion:Overall, CZP durability was similar to that reported for other anti-TNFs with some differences between indication and subgroups.1Factors influencing durability included age, disease duration and geographic region. Gender differences were observed in the 18–45 yrs age group, however, both male and female CZP durability was higher than in older RA pts.