Logo

Long-term effects of interleukin-17A inhibition with secukinumab in active ankylosing spondylitis: 3-year efficacy and safety results from an extension of the Phase 3 MEASURE 1 trial

1, 2, 3, 4, 5, 6, 7, 8; for the MEASURE 1 Study Group

  1. Rheumazentrum Ruhrgebiet, Herne, Ruhr-University Bochum, Germany. xenofon.baraliakos@elisabethgruppe.de
  2. Altoona Centre for Clinical Research, Duncansville, PA, USA.
  3. Oregon Health & Science University, Portland, OR, USA.
  4. Rheumazentrum Ruhrgebiet, Herne, Ruhr-University Bochum, Germany.
  5. Division of Allergy, Immunology and Rheumatology, Chung Shan Medical University Hospital, Taichung, Taiwan.
  6. Novartis Pharma AG, Basel, Switzerland.
  7. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
  8. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.

CER10351 Submission on line
2018 Vol.36, N°1 - PI 0050, PF 0055
Full Papers

Free to view (click on article PDF icon to read the article)

Rheumatology Article

 

Abstract

OBJECTIVES:
Secukinumab, a fully human anti-IL-17A monoclonal antibody, provided rapid and sustained improvements in signs and symptoms of ankylosing spondylitis (AS) over 2 years in the Phase 3 MEASURE 1 trial. Here, we report efficacy and safety after 3 years of treatment.
METHODS:
AS subjects completing 2 years of treatment every 4 weeks with subcutaneous secukinumab 150 or 75 mg (following intravenous loading or initial placebo treatment to 16/24 weeks) entered a separate 3-year extension study (NCT01863732). Assessments included ASAS20/40, ASAS5/6, BASDAI, BASDAI 50, BASFI, BASMI, SF-36 physical component summary, ASAS partial remission and ASDAS-CRP. Results were also analysed by prior anti-TNF treatment status.
RESULTS:
Among 290 subjects completing the core trial, 274 entered the extension study, with 260 subjects (94.9%) completing 156 weeks of treatment. ASAS20/40 response (observed) was 80.2%/61.6% in the IV→150 mg group and 75.5%/50.0% in the IV→75 mg group after 156 weeks. Sustained improvements were also seen in BASDAI, BASFI, BASMI and across all other endpoints regardless of previous exposure to anti-TNF agents. Mean secukinumab exposure was 964.3 days (137.8 weeks). Discontinuation rates were low, and secukinumab had a favourable safety profile, consistent with previous reports. Exposure-adjusted incidence rates for serious infections, Candida infections, Crohn’s disease, ulcerative colitis, malignant/unspecified tumours, and adjudicated major adverse cardiac events were 1.1, 0.4, 0.5, 0.1, 0.5 and 0.7 per 100 subject-years, respectively.
CONCLUSIONS:
Secukinumab provided sustained efficacy in signs, symptoms and physical function in subjects with AS over 3 years. No new safety signals were observed.

PMID: 28516874 [PubMed]

Received: 21/02/2017 - Accepted : 17/05/2017 - In Press: 15/05/2017 - Published: 05/02/2018