A RANDOMIZED, DOUBLE-BLIND TRIAL COMPARING SECUKINUMAB 300 MG AND 150 MG AT WEEK 52 IN PATIENTS WITH ANKYLOSING SPONDYLITIS WHO DID NOT ACHIEVE INACTIVE DISEASE DURING AN INITIAL 16 WEEKS OF OPEN-LABEL TREATMENT WITH SECUKINUMAB 150 MG
Authors: A. Deodhar et al.
Secukinumab is licensed for ankylosing spondylitis in the 150mg as well as the 300mg dose. This randomized double blind study compared the efficacy of the 300mg dose versus 150mg in patients that failed to reach inactive disease (ASDAS<1.3) at 16 weeks of open label treatment with 150mg. The primary endpoint was ASDAS<1.3 at week 52. Of 279 patients that were treated with 150mg in the open label phase, 207 did not achieve inactive disease and were randomized to continuation of 150mg or escalation to 300mg. At 52 weeks no differences of the percentage of patients with inactive disease were seen between the groups. Also, no significant changes in secondary outcomes such as BASDAI50, ASAS20 and ASAS40 were observed. There were no differences in treatment associated adverse events.
The study shows that in patients with ankylosing spondylitis that partially respond to Secukinumab 150mg, a dose increase to 300mg is not improving the therapeutic response. Thus, in AS patients with insufficient response to Secukinumab 150mg a change of therapy should be considered rather than a dose increase.