FRI0087 DURABILITY OF CERTOLIZUMAB PEGOL IN PATIENTS WITH RHEUMATOID ARTHRITIS OR PSORIASIS OVER THREE YEARS: AN ANALYSIS OF POOLED CLINICAL TRIAL DATA
Authors: V. Bykerk, A. B. Gottlieb, K. Reich, Y. Tanaka, K. Winthrop, C. Popova, N. Tilt, A. Blauvelt
Journal: Annals of the Rheumatic Diseases (2020)

Background: Durability over time varies according to the safety, tolerability and efficacy of a drug. 1 However, durability may vary between patient (pt) subgroups, 1,2 and 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). 3 However, 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–&lt;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time during the trials, included lack of efficacy (RA 13.5%; PSO 1.8%), adverse events (RA 11.9%; PSO 8.1%), consent withdrawn (RA 6.7%; PSO 6.7%), lost to follow-up (RA 1.8%; PSO 4.3%), protocol violation (RA 1.7%; PSO 0.3%) and other (RA 9.2%; PSO 8.7%).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 &lt;1 yr. In PSO, durability was lower in pts with disease duration &lt;1 yr or prior anti-TNF use. Durability was lower in WoCBA pts than male pts aged 18–&lt;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 % patients RA PSO All 49.2 70.1 Age, yrs 18–&lt;45 52.1 66.3 45–&lt;65 49.4 68.3 ≥65 43.3 69.4 Gender Female 49.3 64.1 Male 48.2 69.2 WoCBA 51.1 62.0 Male aged 18–&lt;45 yrs 56.5 68.3 Prior anti-TNF use Yes 49.3 60.1 No 49.6 68.5 Disease duration, yrs &lt;1 43.2 39.6 1–&lt;5 52.6 63.6 5–&lt;10 51.4 64.4 ≥10 48.7 69.7 Region Asia-Pacific 58.5 Central Europe 61.5 78.8 Eastern Europe 54.2 Latin America 57.1 N America 36.6 53.9 W Europe 33.8 67.7 Rest of the world 66.3 [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. 1 Factors 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. References: [1]Neovius M. Ann Rheum Dis 2015;74:354–60; 2. Lie E. Ann Rheum Dis 2015;74:970–8; 3. EMA. CIMZIA SmPC 2019. Available at: https://www.ema.europa.eu [Last accessed 09/01/20]. Acknowledgments: This study was funded by UCB Pharma. Editorial services were provided by Costello Medical. Disclosure of Interests: Vivian Bykerk: None declared, Alice B Gottlieb Grant/research support from:: Research grants, consultation fees, or speaker honoraria for lectures from: Pfizer, AbbVie, BMS, Lilly, MSD, Novartis, Roche, Sanofi, Sandoz, Nordic, Celltrion and UCB., Consultant of:: Research grants, consultation fees, or speaker honoraria for lectures from: Pfizer, AbbVie, BMS, Lilly, MSD, Novartis, Roche, Sanofi, Sandoz, Nordic, Celltrion and UCB., Speakers bureau:: Research grants, consultation fees, or speaker honoraria for lectures from: Pfizer, AbbVie, BMS, Lilly, MSD, Novartis, Roche, Sanofi, Sandoz, Nordic, Celltrion and UCB., Kristian Reich Grant/research support from: Affibody; Almirall; Amgen; Biogen; Boehringer Ingelheim; Celgene; Centocor; Covagen; Eli Lilly; Forward Pharma; Fresenius Medical Care; GlaxoSmithKline; Janssen; Kyowa Kirin; LEO Pharma; Medac; Merck; Novartis; Miltenyi Biotec; Ocean Pharma; Pfizer; Regeneron; Samsung Bioepis; Sanofi Genzyme; Takeda; UCB; Valeant and Xenoport., Consultant of: Affibody; Almirall; Amgen; Biogen; Boehringer Ingelheim; Celgene; Centocor; Covagen; Eli Lilly; Forward Pharma; Fresenius Medical Care; GlaxoSmithKline; Janssen; Kyowa Kirin; LEO Pharma; Medac; Merck; Novartis; Miltenyi Biotec; Ocean Pharma; Pfizer; Regeneron; Samsung Bioepis; Sanofi Genzyme; Takeda; UCB; Valeant and Xenoport., Speakers bureau: Affibody; Almirall; Amgen; Biogen; Boehringer Ingelheim; Celgene; Centocor; Covagen; Eli Lilly; Forward Pharma; Fresenius Medical Care; GlaxoSmithKline; Janssen; Kyowa Kirin; LEO Pharma; Medac; Merck; Novartis; Miltenyi Biotec; Ocean Pharma; Pfizer; Regeneron; Samsung Bioepis; Sanofi Genzyme; Takeda; UCB; Valeant and Xenoport., Yoshiya Tanaka Grant/research support from: Asahi-kasei, Astellas, Mitsubishi-Tanabe, Chugai, Takeda, Sanofi, Bristol-Myers, UCB, Daiichi-Sankyo, Eisai, Pfizer, and Ono, Consultant of: Abbvie, Astellas, Bristol-Myers Squibb, Eli Lilly, Pfizer, Speakers bureau: Daiichi-Sankyo, Astellas, Chugai, Eli Lilly, Pfizer, AbbVie, YL Biologics, Bristol-Myers, Takeda, Mitsubishi-Tanabe, Novartis, Eisai, Janssen, Sanofi, UCB, and Teijin, Kevin Winthrop Grant/research support from: Bristol-Myers Squibb, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, Galapagos, Gilead, GSK, Pfizer Inc, Roche, UCB, Christina Popova Employee of: UCB Pharma, Nicola Tilt Employee of: UCB Pharma, Andrew Blauvelt Consultant of: AbbVie, Aclaris, Almirall, Arena, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dermira, Eli Lilly, FLX Bio, Forte, Galderma, Janssen, Leo, Novartis, Ortho, Pfizer, Regeneron, Sandoz, Sanofi Genzyme, Sun Pharma, and UCB Pharma, Speakers bureau: AbbVie