ACR 2019

ACR/ARP HIGHLIGHTS

Conference summaries


Spondyloarthritis Including Psoriatic Arthritis

Secukinumab 150 mg Significantly Improved Signs and Symptoms of Non-radiographic Axial Spondyloarthritis: Results from a Phase 3 Double-blind, Randomized, Placebo-controlled Study

Presented by: Atul Deodhar, MD, MRCP
Oregon Health & Science University, Portland, OR, USA
  • The phase 3 PREVENT trial evaluated the efficacy of SEC in patients with nr-axSpA, and met the primary endpoint (ASAS40 at week 16), with a safety profile that was consistent with previous reports.

Non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS) are considered part of the spectrum of axSpA. Patients are classified as nr-axSpA due to the absence of definitive radiographic sacroiliitis, but suffer from similar disease burden as those with AS. NSAIDs are first-line therapy, and only one anti-TNF therapy is approved in the US for nr-axSpA pts with objective signs of inflammation. [1] Secukinumab (SEC) provides significant and sustained improvement in signs and symptoms of patients with AS2. [2] PREVENT is the first phase 3 study evaluating the efficacy and safety of SEC 150 mg with (LD) or without loading (NL) in patients with nr-axSpA.

  • To assess efficacy and safety of secukinumab in patients with nr-axSpA.
  • This phase 3, double blind, placebo (PBO)-controlled, multicenter trial included 555 pts (aged ≥18 years) fulfilling the ASAS (Assessment of SpondyloArthritis International Society) classification criteria for axSpA but not the modified New York Criteria, plus abnormal C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), with no radiographic changes in the sacroiliac joints.
  • Patients were randomized (1:1:1) to subcutaneous SEC 150 mg LD, 150 mg NL, or PBO.
  • The LD group received SEC 150 mg at baseline, weeks 1, 2, 3, and 4, and then every 4 weeks (q4wk) through week 52.
  • The NL group received SEC 150 mg at baseline and PBO at weeks 1, 2, and 3, and then SEC 150 mg q4wk starting at week 4.
  • Analysis used the Net Reclassification Index for binary and the Mixed Model for Repeated Measures for continuous variables.
  • Endpoints were analyzed according to a statistical hierarchy.

Primary outcome

  • The primary endpoint was ASAS40 response with SEC 150 mg LD in anti-TNF-naïve patients at week 16.
  • Secondary endpoints included ASAS40 response rates, total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BASDAI50, Bath Ankylosing Spondylitis Functional Index (BASFI), Short Form-36 physical component summary (SF-36 PCS), Ankylosing Spondylitis Quality of Life (ASQoL), and ASAS partial remission in the overall population.
  • 94.6% (150 mg LD), 96.2% (150 mg NL), and 94.1% (PBO) patients completed 24 weeks of treatment.
  • Demographic and baseline disease characteristics were comparable across groups.
  • The primary and all secondary endpoints were met.
  • At week 16, ASAS40 in anti-TNF-naïve pts was significantly higher in the SEC 150 mg LD group than PBO patients (Figure).
  • SEC 150 mg LD and NL also showed significant improvement vs. PBO in all secondary endpoints (BASDAI, BASDAI50, BASFI, sacroiliac joint edema on MRI, high sensitivity-CRP, ASAS partial remission) as well as physical function and quality of life.
  • Three cases of serious infections/infestations (0.8%), and 1 case of Crohn’s disease (0.3%) were reported with SEC.
  • No cases of esophageal candidiasis, major adverse cardiovascular events, malignancy or death were reported on any SEC dose up to week 20.
  • SEC 150 mg LD provided significant improvement in signs and symptoms of nr-axSpA through week 16.
  • The safety profile of SEC was consistent with the established safety profile across indications

Key messages/Clinical perspectives

  • PREVENT is the first randomized controlled trial evaluating the efficacy and safety of SEC in patients with nr-axSpA, met the primary endpoint (ASAS40 at week 16) and confirmed the good safety profile of SEC

 

Trial: NCT02696031



References

References


  1. van der Heijde D, Ramiro S, Landewé R, et al. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheu Dis. 2017;76:978-91
  2. Lubrano E and Perrotta FM. Secukinumab for ankylosing spondylitis and psoriatic arthritis. Ther Clin Risk Manag. 2016;12:1587-92.

Presenter disclosure: The presenter has reported relationships with Abbvie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, GlaxoSmithKline, Galapagos, Janssen, Janssen Research & Development, LLC, Novartis, Pfizer, UCB Pharma.

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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