ACR 2019

ACR/ARP HIGHLIGHTS

Conference summaries


Spondyloarthritis Including Psoriatic Arthritis

Ixekizumab Demonstrates Improvement Comparable to Adalimumab Across ACR Components in Biologic-Naïve Patients with Psoriatic Arthritis

Presented by: M. Elaine Husni, MD, MPH
Dept. of Rheumatologic and Immunologic Diseases, Cleveland Clinic, Cleveland, OH, USA
  • In bDMARD-naïve patients with PsA and active plaque PsO, ixekizumab and adalimumab showed comparable efficacy at Week 24 in terms of percentage of patients achieving ≥50% or ≥70% improvement in clinical components, and in patient-reported outcomes of the ACR composite measure.

Head-to-head studies may provide valuable guidance to physicians in selecting optimal treatment and allow to formulate more precise evidence-based treatment guidelines. [1] Ixekizumab is a high-affinity monoclonal antibody selectively targeting interleukin-17A [2] that is approved for the treatment of moderate-to-severe plaque psoriasis (PsO), active psoriatic arthritis (PsA), and active ankylosing spondylitis. [3,4] SPIRIT-H2H is the first head-to-head (H2H) superiority trial in active PsA, which demonstrated the superiority of ixekizumab over adalimumab on a combined endpoint at Week 24. [5]

  • To assess and compare the individual American College of Rheumatology (ACR) components (tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP), HAQ-Disability Index (HAQ-DI), joint pain by visual analog scale (VAS), physician and patient global assessment) at Week 24 of ixekizumab and adalimumab treatment arms (SPIRIT-H2H trial).
  • An open-label study design with blinded outcome assessments was chosen to reduce the heavy burden of placebo injections on patients.
  • To be qualified as blinded assessor, physicians were required to have a minimum of 1 year of experience in TJC and SJC.
  • A total of 566 patients were randomized to receive either ixekizumab (n=283) or adalimumab (n=283) and followed up for 24 weeks.
    • The starting dose of ixekizumab was 160 mg at week 0. Pateints with moderate-to-severe plaque psoriasis were treated with ixekizumab Q2W from Weeks 2 to 12, and ixekizumab Q4W thereafter (N=65); participants not meeting criteria for moderate-to-severe plaque psoriasis were treated with ixekizumab Q4W from Week 4 (N=218).
    • For adalimumab, the starting dose at week 0 was 80 mg in patients with moderate-to-severe plaque psoriasis (N=64), or 40 mg in those not meeting criteria for moderate-to-severe plaque psoriasis (N=219); the maintenance dose was 40 mg every 2 weeks.
  • The primary outcome was the percentage of pts meeting ≥50% or ≥70% improvement in each ACR component at Week 24

Main inclusion criteria

  • PsA lasting for at least 6 months and fulfilling Classification Criteria for Psoriatic Arthritis (CASPAR) criteria.
  • Active PsA (≥3/68 tender and ≥3/66 swollen joints at screening and baseline).
  • Active plaque psoriasis (body surface area ≥3% at screening and baseline).
  • Inadequate response to ≥1 conventional synthetic disease modifying anti-rheumatic drug (csDMARD).
  • There were no significant differences in the percentage of patients achieving ≥50% improvement from baseline in ACR components (except CRP) between the ixekizumab and adalimumab groups (Figure).
  • A significantly higher number of patients treated with adalimumab had ≥50% improvement from baseline in CRP compared with ixekizumab.
  • There were no significant differences in the percentage of patients achieving ≥70% improvement from baseline in any of the ACR components between the ixekizumab and adalimumab groups.
  • In bDMARD-naïve patients with PsA and active plaque psoriasis, ixekizumab and adalimumab had comparable efficacy at Week 24 across ACR components as determined by the percentage of patients achieving ≥50% or ≥70% improvement in clinical components, and in patient-reported outcomes of the ACR composite measure.

Key messages/Clinical perspectives

  • This study provides important information with regard to the selection among different biologic DMARDs in active PsA.

 

Trial: NCT03151551



References

References


  1. Singh JA, Guyatt G, Ogdie A, et al. Special Article: 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arth Rheum. 2019;71:5-32.
  2. Liu L, Lu J, Allan BW, et al. Generation and characterization of ixekizumab, a humanized monoclonal antibody that neutralizes interleukin-17A. J Inflamm Res. 2016;9:39-50.
  3. Taltz (ixekizumab) [US Package Insert]. Indianapolis, IN: Eli Lilly and Company, 2018; rev. 08/2019.
  4. European Medicines Agency. Summary of product characteristics (SmPC): Taltz, INN-ixekizumab.
  5. https://clinicaltrials.gov/ct2/show/NCT03151551 (Accessed 11 October 2019).

Presenter disclosure: The presenter has reported relationships with AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Janssen, Janssen Research & Development, LLC, Novartis, PASE questionnaires, Pfizer, Regeneron, Sanofi-Genzyme, UCB.

Written by: Patrick Moore, PhD

Reviewed by: Alessia Alunno, MD, PhD

Local reviewers: Alessia Alunno, MD, PhD (Italian); Aurélie Najm, MD (French); Yukinori Okada, MD, PhD (Japanese); Fabian Proft, MD (German); Javier Rodríguez-Carrio, MD, PhD (Spanish); Priscilla Wong, MD (Chinese)

Scientific Editor:  Leonard H. Calabrese, DO


RHEUMATOID ARTHRITIS

A Comparative Analysis of Upadacitinib Monotherapy and Upadacitinib Combination Therapy for the Treatment of Rheumatoid Arthritis from Two Phase 3 Trials

Presented by: Maya H. Buch, MD, PhD - University of Leeds & NIHR Leeds Biomedical Research Centre, Leeds, United Kingdom

Rheumatoid Arthritis Treatment with Filgotinib: Week 156 Safety and Efficacy Data from a Phase 2b Open-Label Extension Study

Presented by: Arthur Kavanaugh, MD - University of California, San Diego School of Medicine, La Jolla, CA, USA

SYSTEMIC LUPUS ERYTHEMATOSUS

A Phase 1b/2a Trial of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus

Presented by: Sarfaraz Hasni, MD - National Institute of Arthritis, Musculoskeletal, and Skin diseases/ National Institutes of Health, Bethesda, MD, USA

A Phase 3 Randomized Controlled Trial of Anifrolumab in Patients with Moderate to Severe Systemic Lupus Erythematosus

Presented by: Richard A. Furie, MD - Zucker School of Medicine at Hofstra/Northwell, New York, NY, USA

EPIDEMIOLOGY AND PUBLIC HEALTH

The Burden of Comorbidity in Patients with RA, PsA or SPA in a General Practice Registry

Presented by: Diederik De Cock, PhD - KU Leuven, Leuven, Belgium

SJÖGREN’S SYNDROME

SPONDYLOARTHRITIS INCLUDING PSORIATIC ARTHRITIS

Ixekizumab Demonstrates Improvement Comparable to Adalimumab Across ACR Components in Biologic-Naïve Patients with Psoriatic Arthritis

Presented by: M. Elaine Husni, MD, MPH - Dept. of Rheumatologic and Immunologic Diseases, Cleveland Clinic, Cleveland, OH, USA

Tildrakizumab Efficacy on Psoriasis in Patients with Psoriatic Arthritis—An Analysis from a Phase 2 Study

Presented by: Alan M. Mendelsohn, MD - Sun Pharmaceutical Industries, Inc., Princeton, NJ, USA, Princeton, NJ, USA

Development of a Set of ASAS Quality Standards for Adults with Axial Spondyloarthritis

Presented by: Uta Kiltz, MD - Rheumazentrum Ruhrgebiet/Ruhr University Bochum, Herne, Germany

Ixekizumab in Non-Radiographic Axial Spondyloarthritis: Primary Results from a Phase 3 Trial

Presented by: Atul Deodhar, MD, MRCP - Oregon Health & Science University, Portland, OR, USA

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