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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
A. Deodhar1, P.G. Conaghan2, T.K. Kvien3, V. Strand4, B. Sherif5, B. Porter6, S.M. Jugl7, K.K. Gandhi8
- Oregon Health and Science University, Portland, OR, USA. deodhara@ohsu.edu
- Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds, UK.
- Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
- Stanford University School of Medicine, Palo Alto, CA, USA.
- RTI Health Solutions, Research Triangle Park, NC, USA.
- Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
- Novartis Pharma AG, Basel, Switzerland.
- Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
on behalf of the MEASURE 2 study group
CER11119
2019 Vol.37, N°2
PI 0260, PF 0269
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PMID: 30148436 [PubMed]
Received: 19/01/2018
Accepted : 29/05/2018
In Press: 19/07/2018
Published: 19/03/2019
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.