ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1348

What Influence Do Clinical Domains Other Than Arthritis Have on Composite Clinical Outcomes in Psoriatic Arthritis?: Comparison of Treatment Effects in the SEAM-PsA Trial

Philip Helliwell1, Philip Mease2, Arthur Kavanaugh3, Laura Coates4, Alexis Ogdie5, Atul Deodhar6, Vibeke Strand7, Ervant Maksabedian8, Gregory Kricorian9, Lyrica Liu9, David Collier10 and Dafna Gladman11, 1Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, 2Seattle Rheumatology Associates, P.L.L.C., Seattle, WA, 3UC San Diego Health System, San Diego, CA, 4University of Oxford, Oxford, United Kingdom, 5University of Pennsylvania, Philadelphia, PA, 6Oregon Health & Science University, Portland, OR, 7Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, 8Amgen Inc., LOS ANGELES, CA, 9Amgen Inc., Thousand Oaks, CA, 10Amgen, Thousand Oaks, CA, 11Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada

Meeting: ACR Convergence 2020

Keywords: , , , ,

Session Information

Date: Sunday, November 8, 2020

Title: Spondyloarthritis Including Psoriatic Arthritis – Treatment Poster III

Session Type: Poster Session C

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

Background/Purpose: Psoriatic arthritis is broadly characterized by clinical domains such as enthesitis, dactylitis, nail manifestations, and psoriasis.  How these clinical domains influence the response to MTX and/or TNF inhibitor therapy remains unclear.  Here we report the findings using data from the 48-week, SEAM-PsA trial.

Methods: In the SEAM-PsA trial, MTX and biologic-naïve adult patients with active PsA were randomized to three treatment arms; MTX (20 mg; N=284); ETN (50 mg; N=284); or Combo (ETN 50 mg + MTX 20 mg; N=283), given weekly.  Clinical outcomes (week 24) were measured as a percentage of patients achieving MDA, a change from baseline in PASDAS, and DAPSA scores.  Patient subsets were based on clinical domains such as enthesitis (SPARCC), dactylitis (LDI), nail manifestations (mNAPSI) or psoriasis (BSA).  Analyses comparing the ETN-containing arms with the MTX monotherapy arm used an ANCOVA model and was adjusted for baseline BMI status, prior non-biologic DMARD use, and a disease manifestation baseline status interaction term.  P-values were unadjusted for multiplicity.

Results: The 3 treatment arms had similar baseline values (Table 1).  Among patients with enthesitis, without dactylitis, and BSA< 10%, those patients receiving ETN monotherapy were more likely to achieve MDA compared with MTX monotherapy.  The greater change in PASDAS scores observed in ETN monotherapy compared with MTX monotherapy were not influenced by the presence or absence of enthesitis, dactylitis or BSA>10% (Table 2).  Changes in DAPSA scores were similar across all clinical domains and treatment arms except for those patients with dactylitis in the Combo arm (Table 2).

Conclusion: For clinical domains that demonstrated differences between treatment arms, ETN arms presented better clinical outcomes when compared with MTX monotherapy.  In addition, MDA and PASDAS reported consistent differences between treatment arms and are more sensitive at detecting therapy-mediated changes between clinical domains, whereas no differences were detected with DAPSA, except for dactylitis.

Disclosure: P. Helliwell, AbbVie, 2, 8, Janssen, 2, Pfizer Inc, 8, Celgene, 8, Galapagos, 8, Amgen, 8, Novartis, 2, UCB, 8; 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; A. Kavanaugh, Eli Lilly and Company, 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; A. Ogdie, Amgen Inc., 1, 2, Novartis, 1, 2, Novartis, 1, Pfizer, 1, 2, BMS, 1, Celgene, 1, CORRONA, 1, Janssen, 1, Lilly, 1; A. Deodhar, AbbVie, 2, 5, Eli Lilly, 2, 5, GlaxoSmithKline, 2, 5, Novartis, 2, 5, Janssen, 5, Pfizer, 2, 5, Boehringer Ingelheim, 5, UCB Pharma, 2, 5, Amgen Inc., 5, Celgene, 5, Galapagos, 5, Bristol-Myers Squibb, 2; V. Strand, AbbVie, 5, Amgen, 5, Celltrion, 5, Janssen, 5, Merck, 5, Novartis, 5, Regeneron, 5, Sanofi, 5, UCB, 5, Genentech/Roche, 5, GSK, 5, Pfizer, 5, Bayer, 5, Bristol-Myers Squibb, 5, Boehringer Ingelheim, 5, Galapagos, 5, Lilly, 5, Gilead, 5, Samsung, 5, Servier, 5, Setpoint, 5, Arena, 5, AstraZeneca, 5, Horizon, 5, Ichnos, 5, Inmedix, 5, Sandoz, 5; E. Maksabedian, Amgen Inc., 1, 2; G. Kricorian, Amgen Inc., 1, 2; L. Liu, Amgen Inc., 1, 2; D. Collier, Amgen Inc., 1, 2; 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.

To cite this abstract in AMA style:

Helliwell P, Mease P, Kavanaugh A, Coates L, Ogdie A, Deodhar A, Strand V, Maksabedian E, Kricorian G, Liu L, Collier D, Gladman D. What Influence Do Clinical Domains Other Than Arthritis Have on Composite Clinical Outcomes in Psoriatic Arthritis?: Comparison of Treatment Effects in the SEAM-PsA Trial [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/what-influence-do-clinical-domains-other-than-arthritis-have-on-composite-clinical-outcomes-in-psoriatic-arthritis-comparison-of-treatment-effects-in-the-seam-psa-trial/. Accessed .

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