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Abstract Number: 0909

Residual Disease Activity in Psoriatic Arthritis Patients Treated with Secukinumab and Adalimumab Who Achieved Remission or Low Disease Activity: Results from a Phase 3b, Randomized, Double-blinded, Active-controlled, Head-to-head Study

Iain McInnes1, Philip Mease2, Dafna Gladman3, Laura Coates4, Peter Nash5, Alexis Ogdie6, Frank Behrens7, Philippe Goupille8, Arthur Kavanaugh9, Ruvie Martin10, Erhard Quebe-Fehling11 and Corine Gaillez11, 1Institute of Infection, Immunity, and Inflammation, University of Glasgow, Glasgow, United Kingdom, 2Seattle Rheumatology Associates, P.L.L.C., Seattle, WA, 3Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada, 4University of Oxford, Oxford, United Kingdom, 5School of Medicine Griffith University, Brisbane, Queensland, Australia, 6University of Pennsylvania, Philadelphia, PA, 7CIRI/Rheumatology & Fraunhofer IME, Research Division Translational Medicine and Pharmacology, Goethe University Hospital, Frankfurt, Hessen, Germany, 8CHU Tours, department of rheumatology, Tours, France, 9Division of Rheumatology, Allergy, & Immunology, University of California San Diego Medical School, San Diego, CA, 10Novartis Pharmaceuticals Corporation, East Hanover, NJ, 11Novartis Pharma AG, Basel, Switzerland

Meeting: ACR Convergence 2020

Keywords: Anti-TNF Drugs, Biologicals, Outcome measures, Psoriatic arthritis, Response Criteria

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Session Information

Date: Saturday, November 7, 2020

Title: Spondyloarthritis Including Psoriatic Arthritis – Treatment Poster II

Session Type: Poster Session B

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

Background/Purpose: Recent EULAR recommendations propose that treatment of psoriatic arthritis (PsA) should seek remission (REM) or alternatively low disease activity (LDA) by regular disease activity assessments using composite indices targeting one or several key manifestations in PsA.1,2  The EXCEED study compared secukinumab (SEC) and adalimumab (ADA) monotherapy in patients with active PsA with inadequate response/intolerance to csDMARDs. We present a post hoc analysis of patients who achieved LDA and/or REM at Week 24 and 52 with their respective levels of residual disease activity (RDA) in the core components of the various composite indices.

Methods: Head-to-head, phase-3b, randomized, double-blind trial: biologic naïve active PsA patients were randomized to receive SEC 300 mg subcutaneous at baseline, Week 1-4, and then every 4wks (q4w) until Week 48 or ADA 40 mg subcutaneous at baseline and then q2w until Week 50. The primary and key secondary endpoints at Week 52 were previously reported.3 LDA and REM were assessed using MDA, VLDA, DAPSA REM/LDA and PASDAS REM/LDA. The proportions of RDA were established for clinical domains of PsA (articular, enthesitis, and psoriasis), HAQ, VAS pain, patient global assessment (PtGA) and Physician’s global assessment (PhGA) of disease activity. The composite indices were analyzed using logistic regression and missing data was handled using multiple imputation. RDA levels are presented in patients who achieved either LDA and/or REM.

Results: A similar proportion of patients receiving SEC and ADA achieved LDA and REM at Week 24. Further increase from Week 24 in LDA/REM was observed in both treatment groups through Week 52. VLDA was achieved by a lower proportion of patients than PASDAS LDA+REM/REM and DAPSA LDA+REM/REM at Week 24 and 52 (Table 1). The proportion of patients achieving VLDA, PASDAS REM and DAPSA REM in the treatment groups at Week 24 had low RDA (10%-19%) across core components except for PhGA and PASI ≤1 (Table 2). At least 66%, 59% and 49% of the patients achieving MDA, PASDAS LDA+REM and DAPSA LDA+REM, respectively, across both treatment groups had no RDA at Week 24 suggesting that MDA was the most stringent composite index. Further decrease in RDA was observed among patients who achieved either REM or LDA at Week 52 across all composite indices in both treatment groups (Table 2 and 3).

Conclusion: A comparable proportion of patients achieved LDA and/or REM at Week 24 across the two treatment groups with further improvements in response/targets at Week 52. Patients who achieved VLDA or MDA tended to have a lower residual disease activity than those who achieved PASDAS REM/LDA+REM or DAPSA REM/LDA+REM. Residual disease activity was lower in patients reaching REM than LDA and somewhat lower in patients who achieved VLDA than PASDAS REM or DAPSA REM.

References:

  1. Gossec L, et al. Ann Rheum Dis. 2016;75:499-510.
  2. Coates LC, et al. Rheumatology (Oxford). 2017;56:1251-1253.
  3. McInnes IB, et al. LANCET. 2020;395:1496-1505.

Table 1. Proportion of patients achieving LDA and/or REM at Week 24 and 52

Table 2: Proportion of patients with no residual disease activity levels at Week 24

Table 3: Proportion of patients with no residual disease activity levels at Week 52


Disclosure: I. McInnes, Novartis, 9, AbbVie, 9, Celgene, 9, Janssen, 2, 9, UCB, 2, 9, Bristol Myers Squibb, 2, 9, AstraZeneca, 2, Boehringer Ingelheim, 2, Lilly, 9, LEO, 9; P. Mease, Amgen, 2, 5, 8, Bristol-Myers Squibb, 2, 5, Novartis, 2, 5, 8, Pfizer Inc, 2, 5, 8, Sun, 2, 5, UCB, 2, 5, 8, AbbVie, 2, 5, 8, Gilead, 2, 5, Janssen, 2, 5, 8, Eli Lilly, 2, 5, 8, Galapagos, 5, GlaxoSmithKline, 5; D. Gladman, AbbVie, 2, 5, Amgen, 2, 5, Janssen, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, UCB, 2, 5, Bristol-Myers Squibb, 5, Gilead, 5, Galapagos, 5, Celgene, 2, 5, Eli Lilly, 2, 5; L. Coates, AbbVie, 2, 5, 8, Celgene, 2, 5, 8, Novartis, 2, 5, 8, Pfizer, 2, 5, 8, Amgen Inc., 5, 8, Gilead, 5, 8, Janssen, 5, 8, UCB Pharma, 5, 8, Eli Lilly, 2, 5, 8, Biogen, 8, Medac, 8, Boehringer Ingelheim, 5, MSD, 5; P. Nash, AbbVie, 2, 5, 8, Bristol Myers Squibb, 2, 5, 8, Celgene, 2, 5, 8, Eli Lilly, 2, 5, 8, Janssen, 2, 5, 8, Novartis, 2, 5, 8, Pfizer, 2, 5, 8, Roche, 2, 5, 8, Sanofi, 2, 5, 8, UCB, 2, 5, 8; A. Ogdie, Lilly, 5, Amgen, 5, AbbVie, 5, BMS, 5, Celgene, 5, Janssen, 5, Norvatis, 2, 5, Pfizer, 2, 5, Takeda, 5; F. Behrens, Pfizer, 2, 5, 8, Janssen, 2, 5, 8, Chugai, 2, 5, 8, Celgene, 2, 5, 8, Bionorica, 2, Roche, 2, 5, 8, Abbvie, 5, 8, Sanofi, 5, 8, Lilly, 5, 8, Novartis, 5, 8, Genzyme, 5, 8, Boehringer, 5, 8, MSD, 5, 8, Amgen, 5, 8, UCB, 5, 8, Gilead, 5, 8, Sandoz, 5, 8; P. Goupille, MSD France, 1, 2, Abbvie, 1, Amgen, 1, Biogaran, 1, 2, BMS, 1, Celgene, 1, Chugai, 1, Lilly, 1, Hospira, 1, Janssen, 1, Medac, 1, Nordic Pharma, 1, Novartis, 1, Sanofi-Genzyme, 1, Pfizer, 1, UCB Pharma, 1; A. Kavanaugh, AbbVie, 2, 9, Amgen, 2, 9, AstraZeneca, 2, 9, Bristol-Myers Squibb, 2, 9, Celgene, 2, 9, Janssen, 2, 9, Pfizer, 2, 9, Roche, 2, 9, UCB, 2, 9; R. Martin, Novartis, 1, 3; E. Quebe-Fehling, Novartis, 1, 3; C. Gaillez, Novartis, 1, 3.

To cite this abstract in AMA style:

McInnes I, Mease P, Gladman D, Coates L, Nash P, Ogdie A, Behrens F, Goupille P, Kavanaugh A, Martin R, Quebe-Fehling E, Gaillez C. Residual Disease Activity in Psoriatic Arthritis Patients Treated with Secukinumab and Adalimumab Who Achieved Remission or Low Disease Activity: Results from a Phase 3b, Randomized, Double-blinded, Active-controlled, Head-to-head Study [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/residual-disease-activity-in-psoriatic-arthritis-patients-treated-with-secukinumab-and-adalimumab-who-achieved-remission-or-low-disease-activity-results-from-a-phase-3b-randomized-double-blinded-a/. Accessed .
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