Comparison of the Effects of Secukinumab and Adalimumab Biosimilar on Radiographic Progression in Patients with Ankylosing Spondylitis: Design of a Randomized, Phase IIIb Study (SURPASS).
Abstract | BACKGROUND AND OBJECTIVE: METHODS: Overall, 858 biologic-naïve patients with AS with elevated high-sensitivity C-reactive protein (≥ 5 mg/L) and/or at least one syndesmophyte in the cervical/lumbar spine at baseline (without total ankylosis) were randomized (1:1:1) to subcutaneous (sc) secukinumab (300 or 150 mg) or SDZ- ADL (40 mg). Secukinumab will be administered at baseline, weeks 1, 2, 3, and 4, and then every 4 weeks until week 100. SDZ- ADL will be administered every 2 weeks from baseline until week 102. Patients and investigators will be unblinded to drug but blinded to secukinumab doses. Spinal X-rays will be obtained at baseline, and weeks 52 and 104, sacroiliac joint (SIJ) X-rays at baseline and week 104, and magnetic resonance imaging (MRI) of SIJs and spine at baseline, weeks 16, 52, and 104. The primary endpoint is to demonstrate superiority of secukinumab (300 or 150 mg) treatment versus SDZ- ADL regarding proportion of patients with no radiographic progression (change from baseline in modified Stoke Ankylosing Spondylitis Spinal Score [mSASSS] ≤ 0.5) at week 104. Secondary endpoints include change from baseline in mSASSS, proportion of patients with syndesmophyte at baseline who develop no new syndesmophytes, reduction of osteitis on MRI of SIJs and spine (Berlin method). Assessment of SpondyloArthritis International Society (ASAS) 20/40 responses, ASAS partial remission, and AS Disease Activity Score (ASDAS) inactive disease (ASDAS < 1.3) in secukinumab- versus SDZ- ADL-treated patients at week 104. CONCLUSION: This is the first study designed to evaluate superiority of an IL-17A inhibitor, secukinumab, over a TNF inhibitor, SDZ- ADL, in reducing spinal radiographic progression in AS. STUDY REGISTRATION: ClinicalTrials.gov, NCT03259074.
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Authors | Xenofon Baraliakos, Mikkel Østergaard, Lianne S Gensler, Denis Poddubnyy, Eun Young Lee, Uta Kiltz, Ruvie Martin, Hiroshi Sawata, Aimee Readie, Brian Porter, SURPASS Study Group |
Journal | Clinical drug investigation
(Clin Drug Investig)
Vol. 40
Issue 3
Pg. 269-278
(Mar 2020)
ISSN: 1179-1918 [Electronic] New Zealand |
PMID | 31983056
(Publication Type: Clinical Trial Protocol, Journal Article, Multicenter Study)
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Chemical References |
- Adalimumab
- Antibodies, Monoclonal, Humanized
- Antirheumatic Agents
- Biosimilar Pharmaceuticals
- GP2017
- IL17A protein, human
- Interleukin-17
- secukinumab
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Topics |
- Humans
- Adalimumab
(administration & dosage)
- Antibodies, Monoclonal, Humanized
(administration & dosage)
- Antirheumatic Agents
(therapeutic use)
- Biosimilar Pharmaceuticals
(administration & dosage)
- Disease Progression
- Interleukin-17
(antagonists & inhibitors)
- Magnetic Resonance Imaging
- Radiography
- Spondylitis, Ankylosing
(drug therapy)
- Randomized Controlled Trials as Topic
- Clinical Trials, Phase III as Topic
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