FRI0333 ACHIEVEMENT OF VERY LOW DISEASE ACTIVITY AND REMISSION TREATMENT TARGETS IS ASSOCIATED WITH REDUCED RADIOGRAPHIC PROGRESSION IN PATIENTS WITH PSORIATIC ARTHRITIS TREATED WITH CERTOLIZUMAB PEGOL
Authors: L. C. Coates, J. F. Merola, A. Kavanaugh, P. J. Mease, O. Davies, O. Irvin-Sellers, T. Nurminen, D. Van der Heijde
Journal: Annals of the Rheumatic Diseases (2020)

Background: Several disease activity measures and thresholds have been recommended as psoriatic arthritis (PsA) treatment targets, although consensus on the most appropriate assessment tool is lacking. 1 Reports suggest low disease activity (LDA) and remission may be associated with minimal structural progression in PsA. 2 Objectives: To report the relationship between PsA disease activity and structural progression over 216 weeks’ (wks) treatment with certolizumab pegol (CZP), an Fc-free, PEGylated, tumour necrosis factor inhibitor (TNFi) that has shown long-term efficacy and safety in PsA. 3 Methods: Patients (pts) enrolled in RAPID-PsA ( NCT01087788 ) with active PsA (≥3 tender joints; ≥3 swollen joints; ESR ≥28 mm/hour and/or CRP &gt;upper limit of normal) who had failed treatment with ≥1 csDMARD were randomised 1:1:1 to CZP 200 mg every 2 wks (Q2W), CZP 400 mg every 4 wks (Q4W), or placebo (PBO). All CZP pts received CZP 400 mg at Wks 0/2/4. PBO pts were re-randomised to CZP 200 mg Q2W or 400 mg Q4W at Wk 16 or 24. 3 Pts were heterogenous for structural damage and disease duration at baseline. Disease activity was assessed using minimal disease activity (MDA) criteria (MDA: 5–6/7 criteria; very LDA [VLDA]: 7/7 criteria), Psoriatic Arthritis Disease Activity Score (PASDAS) (LDA: &gt;1.9–≤3.2; remission: ≤1.9), or Disease Activity Index for Psoriatic Arthritis (DAPSA) (LDA: &gt;4–≤14; remission: ≤4). Radiographs were read in four reading campaigns using the van der Heijde modified Total Sharp Score (mTSS) for PsA. A risk of structural progression (RSP) subgroup (baseline mTSS &gt;median for all pts) was also assessed. Mean change from baseline (CFB) in mTSS and associations with disease activity states were estimated using a hierarchical linear mixed effects model (fixed effects: reading campaign/interactions of concurrent disease activity levels with time; random effects: pt/reading campaign nested within pt) which allowed mean mTSS trajectory, and impact of disease activity levels on this, to differ over time. Results: 407/409 randomised pts were assessed for mTSS at least once. At Wk 0, mean (standard deviation) DAPSA=44.5 (22.7), PASDAS=6.0 (1.1). 3/409 (0.7%) pts reported MDA. The proportion of pts achieving remission/VLDA states increased to Wk 216, as did estimated mean mTSS. Estimated mean mTSS CFB remained low overall (0.46 at Wk 216; standard error 0.16; Figure ). Across disease activity measures, remission/VLDA states were associated with mTSS estimated mean CFB ≤0 in both the overall group and RSP subgroup ( Table ). Conclusion: These data indicate that achievement of remission in PsA is important to prevent further structural damage, particularly in pts with pre-existing structural changes. This supports the rationale for strict disease activity targets. References: [1]Coates L. Arthritis Rheumatol 2018;70:345–55; 2. Tucker LJ. Curr Rheumatol Rep 2018;20:71; 3. van der Heijde D. RMD Open 2018;4:e000582. Table. Estimated mTSS (mixed effects model) mTSS estimated mean CFB (standard error) All patients (N=407) RSP (n=202) PASDAS Remission -0.20 (0.25) -0.55 (0.49) LDA 0.01 (0.23) -0.07 (0.47) &gt;LDA 1.31 (0.22) 2.54 (0.43) DAPSA Remission -0.34 (0.23) -0.67 (0.46) LDA 0.40 (0.22) 0.81 (0.44) &gt;LDA 1.37 (0.24) 2.46 (0.48) MDA VLDA -0.40 (0.28) -0.84 (0.55) MDA 0.39 (0.24) 0.55 (0.48) &gt;MDA 0.89 (0.20) 1.73 (0.39) mTSS estimated mean CFB: ≤0; ≤0.5; &gt;0.5. Data to Wk 216 pooled for all pts randomised. Acknowledgments: This study was funded by UCB Pharma. Editorial services were provided by Costello Medical. Disclosure of Interests: Laura C Coates: None declared, Joseph F. Merola Consultant of: Merck, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB Pharma, Celgene, Sanofi, Regeneron, Arena, Sun Pharma, Biogen, Pfizer, EMD Sorono, Avotres and LEO Pharma, Arthur Kavanaugh Grant/research support from: Abbott, Amgen, AstraZeneca, BMS, Celgene Corporation, Centocor-Janssen, Pfizer, Roche, UCB – grant/research support, Philip J Mease Grant/research support from: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – grant/research support, Consultant of: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – consultant, Speakers bureau: Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB – speakers bureau, Owen Davies Employee of: UCB Pharma, Oscar Irvin-Sellers Employee of: UCB Pharma, Tommi Nurminen Employee of: UCB Pharma, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV