ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1528

Resolution of Enthesitis and Dactylitis Is Maintained over Two Years of Ixekizumab Treatment in Patients with Psoriatic Arthritis

Arthur Kavanaugh1, Lihi Eder 2, Josef Smolen 3, Matthew M. Hufford 4, Chen-Yen Lin 4, Aubrey Trevelin Sprabery 4 and Dennis McGonagle 5, 1University of California, San Diego School of Medicine, La Jolla, CA, 2Women’s College Hospital and the Department of Medicine, University of Toronto, Toronto, Canada, 3Medical University of Vienna, Vienna, Austria, 4Eli Lilly and Company, Indianapolis, IN, 5University of Leeds, Leeds, United Kingdom

Meeting: 2019 ACR/ARP Annual Meeting

Keywords:

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: Enthesitis and dactylitis are prominent peri-articular domains of involvement in PsA.1 The activity of enthesitis and dactylitis can vary over time.1 Some conventional and more biologic DMARDs have demonstrated improvements in enthesitis and dactylitis. Ixekizumab (IXE), a high-affinity monoclonal antibody that selectively targets IL-17A, has shown sustained improvement in signs and symptoms of active PsA, including enthesitis and dactylitis.2 The purpose of this study is to examine patients who had resolution of enthesitis and dactylitis with treatment, to see if efficacy was maintained for up to 2 years of IXE treatment.

Methods: Data was integrated from two Phase 3, double-blind, randomized controlled trials in biologic DMARDs-naïve (SPIRIT-P1) and TNF inhibitor (TNFi; SPIRIT-P2) experienced patients who received subcutaneous: placebo, adalimumab (SPIRIT-P1 only; reference arm) 40 mg every 2 weeks, or IXE 80 mg every 2 weeks (Q2W) or every 4 weeks (Q4W) after a 160-mg starting dose. At Week 24, PBO patients were re-randomized to IXEQ2W or IXEQ4W. All patients met the Classification Criteria for PsA. Maintenance primary population included patients who were initially randomized to IXE, completed their Week 24 visit, and had resolution of baseline enthesitis or dactylitis at Week 24. Resolution was defined as Leeds enthesitis index (LEI=0) or Leeds dactylitis index-basic (LDI-B=0). Percentage of patients who maintained LEI and LDI-B resolution were presented up to Week 108 by using the observed method.

Results: In this analysis, we evaluated patients that had enthesitis (LEI >0; N=145) and/or dactylitis (LDI-B >0; N=127) present at baseline that had resolved at Week 24 of IXE treatment. Baseline LEI scores were 2.5 for patients who had resolved their enthesitis, and baseline LDI-B scores were 56.7 for patients who had resolved their dactylitis. Patient demographics and disease characteristics in both groups were similar (Table). Resolution of enthesitis and dactylitis was maintained up to 108 weeks of continuous IXE treatment by LEI=0 ( >80%) and LDI-B=0 (100%) groups, respectively. Responses were similar for both IXE dosing regimens (Figure).

Conclusion: Resolution of enthesitis or dactylitis can be maintained over 2 years of treatment with IXE in patients with PsA.

References:

1Bagel J, et al. Am J Clin Dermatol. 2018; 19(6):839–852.

2Helliwell PS, et al. Arthritis Rheumatol. 2017;69(Suppl 10). Abstract 624.


Table1

Table. Baseline demographics of the maintenance primary population


Layout 1

Disclosure: 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; L. Eder, Abbvie, 2, 5, 8, Celgene, 5, Janssen, 5, Lily, 2, 5, Novartis, 2, 5, Pfizer, 2, 8, UCB, 2; J. Smolen, AbbVie, 2, 5, 8, Abbvie, 2, 5, Amgen, 5, 8, AstraZeneca, 2, 5, 8, Astra-Zeneca, 5, Astro, 5, 8, BMS, 5, Celgene, 5, 8, Celltrion, 5, Celtrion, 5, 8, Chugai, 5, Eli Lilly and Company, 2, 5, Gilead, 5, GlaxoSmithKline, 5, 8, ILTOO, 5, 8, ILTOO Janssen, 5, Janssen, 2, 5, 8, Lilly, 2, 5, 8, Medimmune, 5, 8, MSD, 2, 5, 8, Novartis, 2, 5, Novartis- Sandoz, 5, Novartis-Sandoz, 2, 5, 8, Pfizer, 2, 5, 8, Pfizer Inc, 5, Roche, 2, 5, Roche;, 2, 5, 8, Samsung, 5, 8, Sanofi, 5, 8, Sanofi-Aventis, 5, UCB, 5, 8; M. Hufford, Eli Lilly and Company, 1, 3; C. Lin, Eli Lilly and Company, 1, 3; A. Trevelin Sprabery, Eli Lilly and Company, 1, 3; D. McGonagle, AbbVie, 9, Abbvie, 2, 8, BMS, 9, Celgene, 2, 8, 9, Janssen, 2, 8, Johnson & Johnson, 9, Lilly, 2, 8, MSD, 9, Novartis, 2, 8, 9, Pfizer, 2, 8, 9, UCB, 8, 9.

To cite this abstract in AMA style:

Kavanaugh A, Eder L, Smolen J, Hufford M, Lin C, Trevelin Sprabery A, McGonagle D. Resolution of Enthesitis and Dactylitis Is Maintained over Two Years of Ixekizumab Treatment in Patients with Psoriatic Arthritis [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/resolution-of-enthesitis-and-dactylitis-is-maintained-over-two-years-of-ixekizumab-treatment-in-patients-with-psoriatic-arthritis/. Accessed .

« Back to 2019 ACR/ARP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/resolution-of-enthesitis-and-dactylitis-is-maintained-over-two-years-of-ixekizumab-treatment-in-patients-with-psoriatic-arthritis/