ACR Meeting Abstracts

ACR Meeting Abstracts

  • Home
  • Meetings Archive
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018 ACR/ARHP Annual Meeting
    • 2017 ACR/ARHP Annual Meeting
    • 2017 ACR/ARHP PRSYM
    • 2016-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • Register
    • View and print all favorites
    • Clear all your favorites
  • Meeting Resource Center

Abstract Number: L20

A Head-to-Head Comparison of Ixekizumab and Adalimumab in Biologic-Naïve Patients with Active Psoriatic Arthritis: Efficacy and Safety Outcomes from a Randomized, Open-Label, Blinded Assessor Study Through 52 Weeks

Josef Smolen1, Peter Nash 2, Hasan Tahir 3, Hendrik Schulze-Koops 4, Lingnan Li 5, Maja Hojnik 6, Amanda Gellett 5, Soyi Liu-Leage 7, Sreekumar Pillai 7 and Philip J. Mease 8, 1Medical University of Vienna, Vienna, Austria, 2Griffith University, Brisbane, Queensland, Australia, 3Royal Free London NHS Trust, London, United Kingdom, 4Department of Rheumatology/Clinical Immunology, Ludwig-Maximilians-University Munich, Munich, Germany, 5Eli Lilly and Company, Indianapolis, Indiana, 6Eli Lilly and Company, Indianapolis, IN, 7Eli Lilly and Company, Indianapolis, 8Swedish Medical Center and University of Washington, Seattle, Washington

Meeting: 2019 ACR/ARP Annual Meeting

Date of first publication: October 23, 2019

Keywords: Adalimumab, head-to-head, IL-17A, Late-Breaking 2019, Psoriatic arthritis

  • Tweet
  • Email
  • Print
Save to PDF
Session Information

Date: Tuesday, November 12, 2019

Session Title: 5T132: Late-Breaking Abstracts

Session Type: Late-Breaking Abstract Session

Session Time: 4:00PM-6:00PM

Background/Purpose: Multiple biologic DMARDs (bDMARDs) are available for treatment of PsA, but there are few direct comparisons of their efficacy and safety. Furthermore, efficacy of bDMARDs with or without concomitant MTX is one of the most clinically relevant questions for clinicians. Ixekizumab (IXE) was superior to adalimumab (ADA) at Week (Wk) 24 for simultaneous achievement of ACR50 and 100% improvement from baseline in the Psoriasis Area and Severity Index (PASI100) (primary endpoint) in patients (pts) with active PsA (SPIRIT-H2H) (Mease et al, Ann Rheum Dis 2019). We report final 52-wk efficacy and safety, and efficacy in subgroups defined by concomitant MTX use in SPIRIT-H2H.

Methods: Pts with active PsA fulfilling Classification for Psoriatic Arthritis (CASPAR) criteria, ≥3/66 tender and ≥3/68 swollen joints, ≥3% psoriasis body surface area (BSA) involvement, no prior treatment with bDMARDs, and prior inadequate response to ≥1 conventional synthetic DMARD (csDMARD), were randomized 1:1 to open-label IXE or ADA (label dosing according to presence/absence of moderate-to-severe psoriasis [baseline BSA≥10%, PASI≥12, and static Physician’s Global Assessment≥3]) through 52 wks. Outcomes included the percentage of pts achieving both ACR50 + PASI100 simultaneously, ACR20/50/70, PASI75/90/100, Nail Psoriasis Severity Index (NAPSI)=0, Minimal Disease Activity (MDA), Very Low Disease Activity (VLDA, defined as MDA 7/7), Disease Activity in Psoriatic Arthritis Low Disease Activity (DAPSA LDA), DAPSA remission, Leeds Enthesitis Index (LEI)=0, Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index=0, Leeds Dactylitis Index-Basic (LDI-B)=0, and HAQ-Disability Index (HAQ-DI) ≥0.35 change from baseline. Efficacy was also analyzed in subgroups based on concomitant MTX. Efficacy outcomes were analyzed using logistic regression with nonresponder imputation for missing data. There were no adjustments for multiple comparisons. Safety outcomes are summarized for pts who received ≥1 dose of study treatment.

Results: Overall, 87% (246/283) and 84% (237/283) of pts randomized to IXE and ADA, respectively, completed Wk 52. IXE provided significantly greater response than ADA for simultaneous ACR50 + PASI100 through Wk 52 (Figure 1A). IXE performed at least as well as ADA at Wk 52 for all other outcomes (Figure 1B, 1C, Table 1). Simultaneous ACR50 + PASI100 response was numerically greater with IXE than ADA, regardless of concomitant MTX use (Figure 1D). MTX use by treatment interaction was significant for ACR20/50/70 at Wk 52 (Figure 1E-F). Treatment-emergent adverse events (AEs) occurred in 73.9% (IXE) and 68.6% (ADA) of pts. Serious AEs occurred in 4.2% (IXE) and 12.4% (ADA) of pts, and discontinuations due to AEs occurred in 4.2% (IXE) and 7.4% (ADA) of patients; no deaths occurred. (Table 2).

Conclusion: IXE provided significantly greater simultaneous joint and skin improvement versus ADA as early as Wk 8 and through Wk 52. IXE performed at least as well as ADA across multiple PsA domains including musculoskeletal and skin domains through Wk 52. Safety outcomes for IXE and ADA were consistent with their previously established safety profiles.

Figure 1: Percentage of patients achieving (A) simultaneous ACR50 and PASI100 response, (B) ACR50 response, and (C) PASI 100 through Week 52. (D) Percentage of patients achieving simultaneous ACR50 and PASI100 response at Week 24 and 52 by concomitant MTX use during the study. Percentage of patients achieving ACR20/50/70 response with (E) no concomitant MTX use or (F) concomitant MTX use through Week 52 of the study. Of 392 patients with concomitant csDMARDs use, 336 patients were on MTX and 56 were on other csDMARDs (leflunomide, sulfasalazine, or cyclosporine). *p<0.05, †p<0.01, ‡p<0.001.

Table 2: Safety outcomes at Week 52


Disclosure: J. Smolen, AbbVie, 2, 5, 8, AstraZeneca, 2, 5, 8, Celgene, 5, 8, Celltrion, 1, 2, Chugai, 1, 2, Eli Lilly and Company, 1, Gilead, 1, 2, ILTOO, 5, 8, Janssen, 1, 2, Novartis-Sandoz, 1, 2, Pfizer, 1, 2, Samsung, 5, 8, Sanofi, 5, 8, Kabi, 1, 2; P. Nash, AbbVie, 1, 2, 3, BMS, 1, 2, 3, Celgene, 1, 2, 3, Eli Lilly, 1, 2, 3, Gilead, 1, 2, 3, Janssen, 1, 2, 3, MSD, 1, 2, 3, Novartis, 1, 2, 3, Pfizer Inc, 1, 2, 3, Roche, 1, 2, 3, Sanofi, 1, 2, 3, UCB, 1; H. Tahir, Novartis, 1, 2, AbbVie, 1, Eli Lilly and Company, 1, 2; H. Schulze-Koops, Eli Lilly and Company, 1, 2, AbbVie, 1, 2, Amgen, 1, 2, Biogen, 1, 2, Hexal-Sandoz, 1, 2; L. Li, Eli Lilly and Company, 1, 2; M. Hojnik, Eli Lilly and Company, 3, 4; A. Gellett, Eli Lilly and Company, 1, 2; S. Liu-Leage, Eli Lilly and Company, 3, 4; S. Pillai, Eli Lilly and Company, 1, 2; P. Mease, AbbVie, 1, 2, 3, Amgen, 1, 2, 3, Bristol-Myers Squibb, 1, 2, 3, Celgene, 1, 2, 3, Eli Lilly, 1, 2, 3, Galapagos, 1, Genentech, 1, Gilead, 1, Janssen, 1, 2, 3, Novartis, 1, 2, 3, Pfizer Inc, 1, 2, 3, Sun, 1, 2, UCB, 1, 2, 3, Boehringer Ingelheim, 1.

To cite this abstract in AMA style:

Smolen J, Nash P, Tahir H, Schulze-Koops H, Li L, Hojnik M, Gellett A, Liu-Leage S, Pillai S, Mease P. A Head-to-Head Comparison of Ixekizumab and Adalimumab in Biologic-Naïve Patients with Active Psoriatic Arthritis: Efficacy and Safety Outcomes from a Randomized, Open-Label, Blinded Assessor Study Through 52 Weeks [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/a-head-to-head-comparison-of-ixekizumab-and-adalimumab-in-biologic-naive-patients-with-active-psoriatic-arthritis-efficacy-and-safety-outcomes-from-a-randomized-open-label-blinded-assessor-study-th/. Accessed April 13, 2021.
  • Tweet
  • Email
  • Print
Save to PDF

« Back to 2019 ACR/ARP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/a-head-to-head-comparison-of-ixekizumab-and-adalimumab-in-biologic-naive-patients-with-active-psoriatic-arthritis-efficacy-and-safety-outcomes-from-a-randomized-open-label-blinded-assessor-study-th/

Advanced Search

Your Favorites

You can save and print a list of your favorite abstracts by clicking the “Favorite” button at the bottom of any abstract. View your favorites »

ACR Convergence: Where Rheumatology Meets. All Virtual. November 5-9.

ACR Pediatric Rheumatology Symposium 2020

© COPYRIGHT 2021 AMERICAN COLLEGE OF RHEUMATOLOGY

Wiley

  • Home
  • Meetings Archive
  • Advanced Search
  • Meeting Resource Center
  • Online Journal
  • Privacy Policy
  • Permissions Policies
loading Cancel
Post was not sent - check your email addresses!
Email check failed, please try again
Sorry, your blog cannot share posts by email.
This site uses cookies: Find out more.