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

Laura Coates¹, Joseph Merola ², Arthur Kavanaugh ³, Philip Mease ⁴, Owen Davies ⁵, Oscar Irvin-Sellers ⁶, Tommi Nurminen ⁷ and Désirée van der Heijde ⁸, ¹University of Oxford, Oxford, United Kingdom, ²Harvard Medical School, Brigham and Women’s Hospital, Boston, MA, ³University of California, San Diego School of Medicine, La Jolla, CA, ⁴Swedish Medical Center/Providence St Joseph Health, and University of Washington, Seattle, WA, ⁵UCB Pharma, Slough, England, United Kingdom, ⁶UCB Pharma, Slough, UK, Slough, United Kingdom, ⁷UCB Pharma, Monheim, Germany, ⁸Leiden University Medical Center, Leiden, Netherlands

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: certolizumab pegol, Disease Activity, psoriatic arthritis and remission

Session Information

Date: Monday, November 11, 2019

Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster II: Treatment of Axial Spondyloarthritis & Psoriatic Arthritis

Session Type: Poster Session (Monday)

Session Time: 9:00AM-11:00AM

Background/Purpose: 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 Initial reports suggest low disease activity (LDA) and remission may be associated with minimal structural progression in PsA. Here we evaluate the relationship between PsA disease activity and structural progression over 216 weeks’ (wks’) treatment with certolizumab pegol (CZP), an Fc-free, PEGylated, anti-TNF that has shown long-term efficacy and safety in PsA.²

Methods: Patients (pts) enrolled in RAPID-PsA (NCT01087788) with active PsA (≥3 tender joints; ≥3 swollen joints; ESR≥28 mm/hour and/or CRP >upper limit of normal) who had failed treatment with ≥1 conventional synthetic DMARD were randomized 1:1:1 to CZP 200 mg every 2 wks (Q2W), CZP 400 mg every 4 wks (Q4W) (all CZP pts received CZP 400 mg at Wks 0/2/4) or placebo. CZP-randomized pts received the same dose to Wk 216; placebo-pts were re-randomized to CZP 200 mg Q2W or 400 mg Q4W at Wk 16 or 24.²

Pts were heterogenous for structural damage and disease duration at baseline. Disease activity was assessed using 3 disease activity measures: minimal disease activity (MDA) criteria (achievement of MDA=5–6/7 MDA criteria; achievement of very LDA [VLDA]=7/7 MDA criteria), Psoriatic Arthritis Disease Activity Score (PASDAS [LDA=score of >1.9–≤3.2; remission=≤1.9]), Disease Activity Index for Psoriatic Arthritis (DAPSA [LDA= >4–≤14; remission=≤4]). Radiographs taken through Wks 0–216 were read in 4 reading campaigns using van der Heijde modified Total Sharp Score (mTSS) for PsA. A subgroup of pts considered at highest risk of structural progression (baseline mTSS >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, and reading campaign nested within pt) which allowed the trajectory of mean mTSS, and impact of disease activity levels on this, to be different between each timepoint at which radiographs were taken.

Results: Of 409 randomized pts, 407 were assessed for mTSS at least once. At Wk 0, mean (standard deviation) DAPSA was 44.5 (22.7), PASDAS was 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, although overall progression was low (Wk 216 estimated mean mTSS CFB: 0.46; standard error: 0.16) (Figure). For all disease activity measures, remission/VLDA states were associated with mTSS estimated mean CFB ≤0 in both the overall group of pts and those considered at highest risk of structural progression at baseline (Table).

Conclusion: These data indicate that achievement of remission in PsA is important to prevent further structural damage, particularly when pts have pre-existing structural changes. This supports the rationale for strict disease activity targets.

References:

1. Coates L. Arthritis Rheumatol 2018;70:345–55; 2. van der Heijde D. RMD Open 2018;4:e000582.

Disclosure: L. Coates, Abbvie, 2, 5, 8, AbbVie, 2, 5, 8, AbbVie, Amgen, BMS, Celgene Corporation, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Prothena, Sun Pharma, UCB, 5, Abbvie, Amgen, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, UCB, 5, Abbvie, Amgen, Lilly, Novartis, Pfizer, UCB, 8, AbbVie, Celgene Corporation, Eli Lilly, Janssen, Novartis, UCB, 8, AbbVie, Celgene Corporation, Eli Lilly, Novartis, Pfizer, 2, AbbVie, Celgene Corporation, Novartis, Pfizer, 2, Abbvie, Celgene, Novartis, Pfizer, Lilly, 2, Amgen, 5, 8, Biogen, 8, Bristol-Myers Squibb, 5, Celgene, 2, 5, 8, Eli Lilly, 2, 5, 8, Galapagos, 5, Gilead, 5, Janssen, 2, 5, 8, Janssen Research & Development, LLC, Lilly, 2, 5, 8, MSD, 5, Novartis, 2, 5, 8, Pfizer, 2, 5, 8, Pfizer Inc, 2, 5, 8, Prothena, 5, Sun Pharma, 5, UCB, 5, 8, UCB Pharma, 5; J. Merola, AbbVie, 2, 5, 8, Aclaris, 2, 5, Almirall, 2, 5, Amgen, 5, Biogen, 2, 5, Biogen Idec, 2, 5, Biogen IDEC, 5, Brigham and Women's Hospital, Harvard, 3, Burrage Capital Management Boston Advisory Board, 6, Celgene, 2, 5, Dermavant, 2, 5, Eli Lilly, 2, 5, Eli Lilly and Company, 5, GlaxoSmithKline, 5, GSK, 2, 5, Incyte, 2, 5, Janssen, 2, 5, Leo Pharma, 2, 5, Lilly, 5, Merck, 5, Merck Research Laboratories, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, Regeneron, 5, Samumed, 2, 5, Sanofi, 5, Sanofi Regeneron, 2, 5, Science 37, 5, Sun Pharma, 2, 5, UCB, 2, 5; A. Kavanaugh, Abbott, 2, Abbott, Amgen, AstraZeneca, BMS, Celgene Corporation, Centocor-Janssen, Pfizer, Roche, UCB, 2, Amgen, 2, Bristol-Myers Squibb, 2, Eli Lilly, 5, Eli Lilly and Company, 5, Gilead Sciences, Inc., 2, Janssen, 2, Janssen Research & Development, LLC, 2, Novartis, 2, 5, Pfizer, 2, Pfizer Inc, 2, Roche, 2, UCB Pharma, 2; P. Mease, Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Genentech, Janssen, Novartis, Pfizer, Roche, UCB, 2, 5, Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB, 8, AbbVie, 2, 5, 8, Abbvie, 2, 5, 8, Abbvie, Amgen, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, 5, Abbvie, Amgen, Bristol Myers Squibb, Celgene, Genentech, Janssen, Lilly, Novartis, Pfizer, UCB, 8, Abbvie, Amgen, Bristol Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, 2, AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Janssen, Leo, Merck, Novartis, Pfizer and UCB., 5, 8, AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Leo, Eli Lilly, Merck, Novartis, Pfizer, Sun Pharmaceutical Industries, Inc., and UCB, 2, Abbvie, Amgen, Brsitol Myers Squibb, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, 5, Abbvie, Amgen, Brsitol Myers Squibb, Celgene, Genentech, Janssen, Lilly, Novartis, Pfizer, UCB, 8, Abbvie, Amgen, Brsitol Myers Squibb,Celgene, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, 2, Amgen, 2, 5, 6, 8, Amgen, Bristol-Myers Squibb, Celgene, Galapagos, Gilead, GSK, Janssen, Leo, Eli Lilly, Merck, Novartis, Pfizer, Sun Pharmaceutical Industries, and UCB, 5, BMS, 2, 5, 8, Boehringer Ingelheim, 2, 5, Boerhinger Ingelheim, 5, Bristol Myers Squibb, 2, 5, 8, Bristol Myers Squibb Co., 2, 5, 8, Bristol-Myers Squibb, 2, 5, 6, 8, Celgene, 2, 5, 6, 8, Celgene Corp., 2, 5, 8, CORRONA, 5, Eli Lilly, 2, 5, 8, Galapagos, 2, 5, 8, Genentech, 2, 5, 6, 8, Gilead, 2, 5, 8, Janssen, 2, 5, 6, 8, Janssen Inc, 2, 5, 8, Leo, 2, 5, 8, Lilly, 2, 5, 6, 8, Merck, 2, 5, 8, Novartis, 2, 5, 6, 8, Pfizer, 2, 5, 8, Pfizer Inc, 2, 5, 6, Sun, 2, 5, SUN, 2, 5, Sun Pharma, 2, 5, Sun Pharmaceutical Industries, 2, 5, Sun Pharmaceutical Industries, Inc., 2, 5, 8, UCB, 2, 5, 6, 8, UCB Pharma, 2, 5, 8; O. Davies, UCB Pharma, 1, 3; O. Irvin-Sellers, UCB Pharma, 3; T. Nurminen, UCB Pharma, 3; D. van der Heijde, AbbVie, 5, AbbVie, Amgen, Astellas, AstraZeneca, BMS, 5, Amgen, 5, Astellas, 5, 9, Astellas Pharma, 5, AstraZeneca, 5, BMS, 5, Boehringer Ingelheim, 5, Boehringer Ingelheim, Celgene, Daiichi, Eli-Lilly, Galapagos, Gilead, GSK, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB, 5, Boehringer-Ingelheim, 5, Bristol-Myers Squibb, 5, Celgene, 5, Daiichi, 5, 9, Daiichi Sankyo, 5, Director of Imaging Rheumatology, 6, Director of Imaging Rheumatology bv, 9, Eli Lilly, 5, Eli Lilly and Company, 5, Eli-Lilly, 5, Galapagos, 5, Gilead, 5, Gilead Sciences, Inc., 5, GlaxoSmithKline, 5, Glaxo-Smith-Kline, 5, GSK, 5, 8, Imaging Rheumatology bv, 9, Imaging Rheumatology BV, 9, Imaging Rheumatology bv., 9, Janssen, 5, 8, Janssen Pharmaceutica, 5, Merck, 5, 8, Novartis, 5, 8, Pfizer, 5, 8, Pfizer Inc, 5, Regeneron, 5, 8, Rheumatology bv, 4, 9, Roche, 5, 8, Sanofi, 5, 8, Takeda, 5, 8, Takeda Pharmaceutical Company, 5, UCB, 5, 8, UCB Pharma, 5.

To cite this abstract in AMA style:

Coates L, Merola J, Kavanaugh A, Mease P, Davies O, Irvin-Sellers O, Nurminen T, van der Heijde D. 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 [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/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/. Accessed .

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