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Secukinumab provides rapid and persistent relief in pain and fatigue symptoms in patients with ankylosing spondylitis irrespective of baseline C-reactive protein levels or prior tumour necrosis factor inhibitor therapy: 2-year data from the MEASURE 2 stud

1, 2, 3, 4, 5, 6, 7, 8; on behalf of the MEASURE 2 study group

  1. Oregon Health and Science University, Portland, OR, USA. deodhara@ohsu.edu
  2. Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds, UK.
  3. Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
  4. Stanford University School of Medicine, Palo Alto, CA, USA.
  5. RTI Health Solutions, Research Triangle Park, NC, USA.
  6. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
  7. Novartis Pharma AG, Basel, Switzerland.
  8. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.

CER11119 Submission on line
2019 Vol.37, N°2 - PI 0260, PF 0269
Full Papers

Rheumatology Article

 

Abstract

OBJECTIVES:
To evaluate improvement in pain and fatigue in ankylosing spondylitis (AS) patients treated with secukinumab over 2 years (MEASURE 2 study).
METHODS:
Patients with active AS were randomised to receive secukinumab 150 mg, 75 mg, or placebo weekly until Week 4, and every 4 weeks thereafter. This post hoc analysis included assessment of spinal and nocturnal back pain, FACIT-Fatigue, and association between pain and either FACIT-Fatigue or ASQoL item 5 (sleep quality) for the approved secukinumab 150 mg dose in the overall population, and stratified by baseline high-sensitivity C-reactive protein (hsCRP) levels (normal [<5 mg/L] or elevated [≥5 mg/L]) or prior TNF inhibitor therapy status (TNFi-naïve or inadequate response [TNFi-IR]).
RESULTS:
Secukinumab-treated patients reported rapid improvement in pain and fatigue scores in overall population by Weeks 1 and 4, respectively; this trend of improvement was also observed irrespective of baseline hsCRP levels or prior TNFi therapy. Mean change at Week 16 in spinal/nocturnal pain (secukinumab vs. placebo) for the subgroups were -34.6/-30.2 vs. -16.6/-10.0, p<0.05/0.01 (normal hsCRP); -26.7/-31.6 vs. -7.8/-9.3, p<0.001/0.0001 (elevated hsCRP); -33.2/-35.4 vs. -13.2/-14.9, both p<0.0001 (TNFi-naïve); and -22.5/-22.8 vs. -9.4/-4.0, p=0.06/p<0.01 (TNFi-IR). FACIT-Fatigue was 7.1 vs. 3.3, p=0.15 (normal hsCRP); 8.7 vs. 3.6, p<0.05 (elevated hsCRP); 10.0 vs. 5.2, p<0.05 (TNFi-naïve); and 5.7 vs. 0.5, p=0.06 (TNFi-IR). These improvements were sustained or further improved through Week 104.
CONCLUSIONS:
Secukinumab provides rapid and sustained relief of pain and fatigue over 2 years in patients with AS regardless of baseline hsCRP levels and prior TNFi therapy.

PMID: 30148436 [PubMed]

Received: 19/01/2018 - Accepted : 29/05/2018 - In Press: 19/07/2018 - Published: 19/03/2019