ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0319

Target Outcomes in Psoriatic Arthritis: Simultaneous Achievement of ACR50-Psoriasis Area and Severity Index 100 and Beyond: Insights from Open-Label, Assessor-Blinded Study at Week 24

Josef Smolen1, Frank Behrens2, Soyi Liu-Leage3, Christophe Sapin3, Inmaculada de la Torre3, Gabriella Meszaros3, Georg Schett4, Laure Gossec5, Andrew Östör6, Bernard Combe7 and Filip Van den Bosch8, 1Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria, 2CIRI/Rheumatology & Fraunhofer IME, Research Division Translational Medicine and Pharmacology, Goethe University Hospital, Frankfurt, Hessen, Germany, 3Eli Lilly and Company, Indianapolis, IN, 4Friedrich-Alexander-Universität Erlangen- Nuremberg, Erlangen, Germany, 5Sorbonne Université and Hôpital Universitaire Pitié Salpêtrière, Paris, France, 6Cabrini Medical Center, Monash University, Malvern, Victoria, Australia, 7University of Montpellier, Montpellier, France, 8Ghent University Hospital, Ghent, Belgium

Meeting: ACR Convergence 2020

Keywords:

Session Information

Date: Friday, November 6, 2020

Title: Spondyloarthritis Including Psoriatic Arthritis – Diagnosis, Manifestations, & Outcomes Poster I: Psoriatic Arthritis

Session Type: Poster Session A

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

Background/Purpose: Psoriatic Arthritis (PsA) treatment should aim to achieve robust improvement of arthritis as well as control of extra-articular manifestations like the skin. SPIRIT-H2H evaluated the efficacy of ixekizumab (IXE) and adalimumab (ADA) in patients with active PsA and psoriasis, and naïve to biologic Disease-Modifying Anti-Rheumatic Drugs (bDMARDs). At Week 24, IXE showed superiority to ADA in simultaneous achievement of ACR50 and Psoriasis Area and Severity Index (PASI) 100 as well as significant improvement of treat-to-target and other extra-articular outcomes. The objective is to examine and to compare PsA efficacy outcomes in patients beyond achievement of the primary endpoint of the SPIRIT-H2H trial at Week 24, irrespective of treatment allocation.

Methods: All patients recruited had active PsA (defined as tender joint count ≥3/68, swollen joint count ≥3/66 and body surface area [BSA] ≥3%), and inadequate response to conventional synthetic (cs)-DMARDs. Patients were randomized 1:1 to open-label, assessor-blinded IXE or ADA. We conducted post-hoc analysis of SPIRIT-H2H (NCT03151551), categorizing patients into four independent groups based on the achievement of the primary outcomes (ACR50 and PASI 100), ACR50 only, PASI 100 only or none of them, after 24 weeks of treatment. Statistical analyses consisted of mixed model for repeated measurement and logistic regression models using non-response imputation.

Results: At Week 24, patients reaching simultaneously ACR50 and PASI 100 had a statistically significant higher response in most treat-to-target endpoints than those meeting ACR50 only (p< 0.05). In this latter group, a high response rate was observed in ACR70, minimal disease activity (MDA), Disease Activity in Psoriatic Arthritis (DAPSA) remission and PASI 90 response (48.9%, 60.6%, 35.1%, 36.2%, respectively). In patients that did not achieve either ACR50 or PASI 100, up to 1/3 of the patients did achieve ACR20, DAPSA score ≤14, or no physical impairment.

Conclusion: Reflecting the complexity of PsA, different degrees of improvement were observed across all treat-to-target outcomes with greater improvements in patients that met ACR50 response regardless of skin resolution. These findings at Week 24 need to be confirmed with a longer duration of treatment. 

Disclosure: J. Smolen, AbbVie, 2, 5, 8, AstraZeneca, 2, 5, 8, Eli Lilly, 2, 5, 8, Celgene, 5, 8, Celltrion, 5, 8, Chugai, 5, 8, Gilead, 5, 8, ILTOO, 5, 8, Janssen, 5, 8, Kabi, 5, 8, Novartis-Sandoz, 5, 8, Pfizer Inc, 5, 8, Samsung, 5, 8, Sanofi, 5, 8; 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; S. Liu-Leage, Eli Lilly and Company, 3, 4; C. Sapin, Eli Lilly and Company, 1, 3; I. de la Torre, Eli Lilly and Company, 3; G. Meszaros, Eli Lilly and Company, 1, 3; G. Schett, None; L. Gossec, Sandoz, 1, AbbVie, 5, 8, Amgen Inc., 5, 8, Biogen, 5, 8, Janssen, 5, 8, Celgene, 5, 8, Eli Lilly, 1, 5, 8, Novartis, 5, 8, Pfizer, 1, 5, 8, UCB Pharma, 5, 8, Sanofi, 5, 8; A. Östör, AbbVie, 5, Roche, 5, Janssen, 5, Eli Lilly, 5, Novartis, 5, Pfizer, 5, Gilead, 5, Paradigm, 5, UCB Pharma, 5, Bristol-Myers Squibb, 5; B. Combe, AbbVie, 5, 8, Janssen, 5, Eli Lilly, 2, 5, 8, Novartis, 2, Gilead Sciences, Inc., 5, 8, Roche-Chugai, 5, 8, Sanofi, 5, Pfizer, 2, 8, MSD, 8, Bristol-Myers Squibb, 8; F. Van den Bosch, AbbVie, 5, 8, Celgene, 5, 8, Eli Lilly, 5, 8, Galapagos, 5, 8, Novartis, 5, 8, Pfizer, 5, 8, UCB, 5, 8, Gilead, 5, Merck, 5, 8.

To cite this abstract in AMA style:

Smolen J, Behrens F, Liu-Leage S, Sapin C, de la Torre I, Meszaros G, Schett G, Gossec L, Östör A, Combe B, Van den Bosch F. Target Outcomes in Psoriatic Arthritis: Simultaneous Achievement of ACR50-Psoriasis Area and Severity Index 100 and Beyond: Insights from Open-Label, Assessor-Blinded Study at Week 24 [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/target-outcomes-in-psoriatic-arthritis-simultaneous-achievement-of-acr50-psoriasis-area-and-severity-index-100-and-beyond-insights-from-open-label-assessor-blinded-study-at-week-24/. Accessed .

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