Artikel
Secukinumab Reduces Sacroiliac Joint and Spinal Inflammation in Patients with Ankylosing Spondylitis: MRI Data from a Phase 3 Randomized, Double-Blind, Placebo-Controlled Study (MEASURE 1)
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Autoren
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Xenofon Baraliakos
- Rheumazentrum Ruhrgebiet, Herne
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Jürgen Braun
- Rheumazentrum Ruhrgebiet, Herne
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Joachim Sieper
- Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektologie, Rheumatologie, Berlin
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Dominique Baeten
- Academic Medical Center/University of Amsterdam, Clinical Immunology and Rheumatology, Amsterdam, The Netherlands
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Aimee Readie
- Novartis Pharmaceuticals Corporation, NJ, USA, New Jersey, USA
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Gregory Ligozio
- Novartis Pharmaceuticals Corporation, East Hanover, United States of America
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Hanno B. Richards
- Novartis Pharma AG, Basel, Switzerland
| Veröffentlicht: | 1. September 2015 |
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Gliederung
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Introduction: MEASURE 1 (NCT01358175) is a randomized, double-blind, placebo (PBO)-controlled trial that has demonstrated the efficacy and safety of secukinumab, a human anti–interleukin-17A monoclonal antibody, in subjects with active ankylosing spondylitis (AS) [1].
The objective is to investigate the effect of secukinumab on objective signs of inflammation in the sacroiliac (SI) joints and spine at Weeks (Wks) 16 and 52 using magnetic resonance imaging (MRI) in the MEASURE 1 study.
Methods: 371 adults with active AS were randomized to secukinumab or PBO: i.v. secukinumab 10 mg/kg (Wks 0, 2, 4) followed by s.c. secukinumab 75 mg every 4 wks (10 IV → 75 SC); s.c. secukinumab 150 mg every 4 wks (10 IV → 150 SC); or PBO on the same i.v. and s.c. schedules. MRI of the SI joints and spine were performed on a subset of 105 subjects with no prior exposure to therapies targeting tumor necrosis factor (anti–TNF-naïve). Assessments were completed at baseline, Wks 16 and 52. MRI variables were assessed by the Berlin SI joint total edema score, MRI score for spinal activity (ASspi-MRI-a), and the Berlin spine score (derived from the ASspi-MRI-a results). Two experienced readers, blinded to treatment and visit, evaluated all MRIs and their mean scores were used for the final analyses.
Results: Mean baseline ASspi-MRI-a and Berlin spine scores were lower in the secukinumab 10 IV → 150 SC group than in the 10 IV → 75 SC and PBO groups. At Wk 16, improvements were shown in Berlin SI joint total edema score with secukinumab vs PBO (mean change from baseline: –1.30 and –1.05 vs –0.17 in secukinumab 10 IV → 150 SC and 10 IV → 75 SC vs PBO groups, respectively; P < 0.01). Both secukinumab doses also resulted in greater mean percentage improvements from baseline in ASspi-MRI-a and Berlin spine scores vs PBO. Improvements in all MRI measures with secukinumab were sustained through Wk 52.
Conclusion: MRI measures demonstrate that secukinumab provides early reductions in spinal inflammation in subjects with active AS, and that these improvements are sustained through 52 wks of therapy.
