Spondyloarthritis & psoriatic arthritis
A secukinumab dose-escalation study in patients with ankylosing spondylitis not achieving inactive disease after 16 weeks of treatment
Authors' conclusion
Patients with AS who did not achieve ASDAS <1.3 after receiving secukinumab 150 mg for 16 weeks experienced similar clinical response and safety through week 52 regardless of dose escalation.
Study context
- Population
- Patients with AS not achieving inactive disease (AS Disease Activity Score (ASDAS) <1.3) at both week 12 and 16 of open-label secukinumab 150 mg322 treated in Treatment Period 1
- Participants
- 207 patients
- Comparison
- Secukinumab 300 mg vs 150 mg every 4 weeks to week 52 after inadequate response to 16 weeks of open-label 150 mg
- Secukinumab 300 mgn = 101
- Secukinumab 150 mgn = 105reference
- Primary endpoint
- ASDAS <1.3 at week 52 (week 16 as baseline)
- Follow-up
- Week 52
Methodological detailsdouble-blind, parallel-group, multicentre, phase 4, dose-escalation
- Double-blind
- Parallel-group
- Multicentre
- Phase 4
- Dose-escalation
Primary result
As reported in the abstract
ASDAS <1.3
Further findings
Completed the study
Safety
Treatment-emergent adverse events (TEAEs) through week 52
- Incidence of TEAEs similar in both groups; no new safety signals
Original publication
A secukinumab dose-escalation study in patients with ankylosing spondylitis not achieving inactive disease after 16 weeks of treatment. Rheumatology (Oxford). Published 12 August 2024. doi:10.
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