Phase 3
Completed N=226
16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients
Spondylitis, Ankylosing
Source: ClinicalTrials.gov NCT02008916 ↗
Enrolled (actual)
226
Serious AEs
8.6%
Results posted
Dec 2018
Primary outcomePrimary: Number of Participants With 20% Improvement in the Assessment of Spondyloarthritis International Society Criteria Scale / ASAS 20 Response — 43; 46; 28; 31 Participants — p=0.0093
◆ Published Evidence
Established
70citations · ~18 / year
Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications.
Summary
The purpose of this study was to generate 16-week efficacy data, as well as up to 3-year efficacy, safety and tolerability data in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF therapy.
Linked Publications (5)
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Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications.
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Incidence of Uveitis in Secukinumab-treated Patients With Ankylosing Spondylitis: Pooled Data Analysis From Three Phase 3 Studies.
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A Pooled Analysis Reporting the Efficacy and Safety of Secukinumab in Male and Female Patients with Ankylosing Spondylitis.
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Secukinumab Efficacy on Enthesitis in Patients With Ankylosing Spondylitis: Pooled Analysis of Four Pivotal Phase III Studies.
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Nonsteroidal anti-inflammatory drug-sparing effect of secukinumab in patients with radiographic axial spondyloarthritis: 4-year results from the MEASURE 2, 3 and 4 phase III trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With 20% Improvement in the Assessment of Spondyloarthritis International Society Criteria Scale / ASAS 20 Response |
43; 46; 28; 31; 30; 48 | 0.0093 sig |
| SECONDARY ASAS 40 Response |
30; 32; 16; 44; 44; 60 | 0.0100 sig |
| SECONDARY Serum hsCRP |
15.79; 11.08; 13.91; 7.68; 4.34; 15.34 | <0.0001 sig |
| SECONDARY ASAS 5/6 Response |
31; 30; 11; 43; 46; 65 | 0.0002 sig |
| SECONDARY Bath Ankylosing Spondylitis Disease Activity Index / BASDAI |
6.958; 6.963; 6.907; 4.451; 4.178; 5.369 | 0.0347 sig |
| SECONDARY Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe) |
72; 73; 71; 0; 0; 1 | — |
| SECONDARY Pre-filled Syringe Possible Hazard |
0; 0; 0; 73; 73; 72 | — |
| SECONDARY Prefilled Syringe Patient Satisfaction Assessment |
7.97; 7.66; 8.01; 7.96; 7.68; 8.24 | — |
| SECONDARY ASAS Partial Remission |
7; 16; 1; 67; 60; 75 | 0.0593 |
Eligibility Criteria
Inclusion criteria: moderate to severe AS, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response to NSAIDs. -- Exclusion criteria: pregnancy or lactation, on-going infectious or malignant process on a chest X-ray or MRI, previous exposure to IL-17 or IL-17R targeting therapies, previous exposure to any biological immunomodulating agent excluding TNF antagonists, previous cell depleting therapy.
Data sourced from ClinicalTrials.gov (NCT02008916) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.