Higher secukinumab dose yields no clinical difference after inadequate response in AS
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Key takeaways:
- Patients with ankylosing spondylitis who had an inadequate response to secukinumab at 16 weeks saw no benefit at 52 weeks from an escalated dose.
- No new safety signals were observed.
Increasing the dosage of secukinumab failed to improve ankylosing spondylitis outcomes among patients who initially demonstrated an inadequate treatment response, according to data published in Rheumatology.
“Diagnostic delays of 8-14years are frequently observed in patients with AS, and failure to adequately treat AS early in the course of disease can result in greater disease activity, radiographic damage, poorer quality of life and increased economic burden,” Atul Deodhar, MD, MRCP, FACR, FACP, professor of medicine at Oregon Health & Science University, and colleagues wrote.
“Inactive disease, defined as AS Disease Activity Score (ASDAS) <1.3, has been recommended as a treatment target reflecting optimal disease control for patients with AS,” they added. “... Secukinumab doses of 150 mg and 300 mg are approved for the treatment of AS, although no previous dose-escalation studies have been performed in patients who do not achieve a predefined treatment target.”
The current study followed up on a previous phase 4 trial, ASLeap, in which 64.3% (n = 207) of patients with AS demonstrated inadequate response — defined as inactive disease according to the ASDAS — after 16 weeks of open-label secukinumab (Cosentyx, Novartis) 150 mg. To examine subsequent clinical responses after dose escalation, Deodhar and colleagues randomly assigned participants with prior inadequate response to either increase their dose to 300 mg or continue at 150 mg, every 4 weeks, until week 52.
The primary efficacy outcome was inactive disease at week 52, defined as a ASDAS score of 1.3 or less. Safety was assessed based on the appearance of treatment-emergent adverse events.
A total of 101 patients on the escalated dose, and 105 patients on the stable dose, completed the study. At week 52, inactive disease was achieved by 8.8% of those on 300 mg secukinumab and by 6.7% of those on 150 mg, according to the researchers. The groups also demonstrated similar rates of treatment-emergent adverse events — with 63.4% among those who received an escalated dose, and 68.6% for the stable dose — throughout the study. No new safety signals were observed.
“The response rates at week 52 show no clinically important differences between the secukinumab 300 and 150 mg groups,” Deodhar and colleagues wrote. “Patients who did not achieve inactive disease by week 16 showed similar clinical response and safety profile at week 52 irrespective of dose escalation to 300 mg or continued treatment with 150 mg.
“The safety profile was consistent with previous studies, with no new safety findings,” they added. “While not all patients with AS who have an inadequate response would benefit from dose escalation, it may be appropriate for some patient subsets, including those with moderate responses to lower doses.”
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