Artikel
Effect of Secukinumab, an Interleukin-17A inhibitor, on Spinal Radiographic Changes Through 2 Years in Patients with Active Ankylosing Spondylitis: Results of the Phase 3 Study, MEASURE 1
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Autoren
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Jürgen Braun
- Rheumazentrum Ruhrgebiet, Herne
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Xenofon Baraliakos
- Rheumazentrum Ruhrgebiet, Herne
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Joachim Sieper
- Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektologie, Rheumatologie, Berlin
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Paul Emery
- University of Leeds, Leeds Institute of Molecular Medicine and LMBRU, Leeds, UK
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Zsolt Talloczy
- Novartis Pharmaceuticals Corporation, East Hanover, USA
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Ruvie Martin
- Novartis Pharmaceuticals Corporation, New Jersey, USA
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Hanno B. Richards
- Novartis Pharma AG, Basel, Switzerland
| Veröffentlicht: | 29. August 2016 |
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Gliederung
Text
Background: Inhibition of radiographic spinal changes, (primarily osteoproliferative) in active AS represents a main goal of therapy.
Objective: To assess the effects of secukinumab on radiographic progression up to 104 wks in the MEASURE 1 trial.
Methods: 371 pts with active AS were randomized to secukinumab or pbo. Pts on secukinumab received a 10 mg/kg i.v. loading dose at BL, Wks 2 and 4, and then 150 or 75 mg s.c. every q4w from Wk 8. Pbo was given on the same schedule. Pbo pts were re-randomized to secukinumab 150 or 75 mg s.c. q4w based on ASAS20 response at Wk 16 (non-responders) or Wk 24 (responders). Lateral radiographs of the cervical and lumbar spine performed at BL and Wk 104 were read centrally by two independent readers applying the mSASSS. 168 pts were included in this analysis.
Results: Data were pooled for both doses as there were no major differences in radiographic results between them. At BL, 104/168 (62%) pts had syndesmophytes, 105/168 (63%) had elevated (>5 mg/L) CRP levels, 42/168 (25%) were smokers, and 123/168 (73%) were male. The mean (±SD) mSASSS at BL was 10.22±16.62; mean change was 0.30±2.53. Approximately 80% of pts showed no radiographic progression (mSASSS change ≤0). New syndesmophytes were found in 3/64 (5%) pts without syndesmophytes at BL. Approximately 70% of pts with syndesmophytes at BL developed no additional syndesmophytes. Overall, BL mSASSS and mean mSASSS change at Wk 104 were higher in males (0.38±2.79 vs 0.08±1.58 in females), those with BL syndesmophytes (0.47±3.20 vs 0.02±0.26 in pts with no BL syndesmophytes), or elevated CRP levels at BL (0.47±2.66 vs 0.02±2.27 in pts with normal CRP levels). Inter- and intra-reader agreement on mSASSS scores was 85% (Kappa 0.70) for both.
Conclusion: In secukinumab-treated pts, the mean change in mSASSS was low, with no major difference between doses. Changes were higher in pts who were male, had BL syndesmophytes, or elevated BL CRP. No radiographic progression was observed in ~80% of the pts receiving secukinumab over 104 wks. This is the first report of interleukin-17A inhibition on structural changes in patients with AS.
Figure 1 [Fig. 1]
