P188 Secukinumab provides significant improvement of spinal pain and lowers disease activity in patients with axial spondyloarthritis: 24-week results from a randomised controlled Phase 3b trial
Abstract Background/Aims SKIPPAIN (NCT03136861) is the first randomised controlled study involving a biological disease-modifying anti-rheumatic drug, with a primary endpoint of spinal pain at Week 8 in patients with axial spondyloarthritis (axSpA; ankylosing spondylitis [AS] and non-radiographic [...
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Veröffentlicht in: | Rheumatology (Oxford, England) England), 2021-04, Vol.60 (Supplement_1) |
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Format: | Artikel |
Sprache: | eng |
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Zusammenfassung: | Abstract
Background/Aims
SKIPPAIN (NCT03136861) is the first randomised controlled study involving a biological disease-modifying anti-rheumatic drug, with a primary endpoint of spinal pain at Week 8 in patients with axial spondyloarthritis (axSpA; ankylosing spondylitis [AS] and non-radiographic [nr]-axSpA). We present the 24-week results of secukinumab in reducing spinal pain and disease activity following step-up dosing.
Methods
This double-blind, placebo-controlled Phase 3b study enrolled patients (aged ≥18 years) with active disease (BASDAI ≥4; average spinal pain numerical rating scale [NRS] score >4 at baseline; inadequate response to ≥ 2 non-steroidal anti-inflammatory drugs ≥4 weeks). Patients were randomised (3:1) to subcutaneous secukinumab 150 mg or placebo weekly followed by every 4 weeks (Q4W) from Week 4. At Week 8, placebo patients were re-randomised to secukinumab 150 or 300 mg Q4W. Patients originally randomised to secukinumab 150 mg were classified as responders or non-responders (spinal pain NRS score |
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ISSN: | 1462-0324 1462-0332 |
DOI: | 10.1093/rheumatology/keab247.183 |