- In patients with ankylosing spondylitis (AS), secukinumab 150 mg provided sustained efficacy and a favourable and consistent safety profile through 5 years of treatment
- In more than 50% of patients, 75 mg dose was found to be suboptimal, dose escalation to 150 mg improved efficacy.
Why this matters
- Besides tumour necrosis factor (TNF) inhibitors, secukinumab (150 mg) is the only approved biological standard disease-modifying anti-rheumatic drug for AS.
- Findings support evidence for the use of secukinumab as a long-term treatment option for both biologic-naïve patients and those who experience an inadequate response or intolerance to anti-TNF agents.
- Safety and efficacy of secukinumab in AS were evaluated in this phase 3 study (2-year core MEASURE 1 trial, n=371; 3-year extension study, n=230/371).
- Dose escalation from 75 to 150 mg at or after 156 weeks was allowed after the approval of treating physician.
- Primary outcome: Assessment of SpondyloArthritis international Society (ASAS) 20/40 criteria and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score at 5 years.
- Funding: Novartis Pharma.
- At 5 years
- ASAS 20 and 40 responses were 78.6% and 65.2%, respectively.
- BASDAI 50 response was 63.4%.
- The mean BASDAI total score at 5 years with secukinumab 150 mg was 2.6.
- The dose was escalated from 75 to 150 mg in 56.2% patients at week 168; in these patients, ASAS40, ASAS-partial remission, ASAS 5/6 and BASDAI50 responses improved.
- Secukinumab was well tolerated; most common adverse events (relative frequency >2%) were nasopharyngitis, headache, diarrhoea and upper respiratory tract infection.
- Treatment-emergent anti-drug antibodies were detected in one patient in the secukinumab 150 mg group
- 4 deaths occurred during the 5-year treatment, none of them was treatment related.
- Pharmaceutical company sponsored.