gms | German Medical Science

Background: According to the ASAS treatment recommendations for axial spondyloarthritis, NSAIDs build the backbone of the pharmacotherapy. After failure of 2 NSAIDs, initiation of biologic immunomodulating therapy is recommended. There is so far no general guidance when, how, and how fast NSAIDs should be reduced after biologic initiation.

This German Phase IV study will compare the efficacy (ASAS20) and extent of NSAID reduction between Secukinumab 150 mg and Placebo over 20 weeks.

Methods: This study will enroll 204 patients with active AS (BASDAI ≥4) and inadequate response to at least 2 different NSAIDs at the highest recommended dose in ~40 sites across Germany. Patients who are naïve to/or inadequate responders / intolerant to max. 2 TNF-α inhibitors may be enrolled.

Patients will be randomized (1:1:1) to receive Secukinumab 150 mg sc from week 0 (delayed tapering), Secukinumab 150 mg sc from week 4 (early tapering), or Placebo (Figure 1). Starting at week 4 patients in all groups are advised to reduce NSAID intake and capture the level of their spinal pain in a patient diary.

The primary endpoint of this trial is to show superiority of Secukinumab 150 mg delayed tapering vs placebo based on the proportion of patients achieving ASAS20 response. Key secondary endpoints include change in ASAS-NSAID score, BASDAI and SF-36PCS. As the time of onset of Secukinumab therapy is blinded a comparison of endpoints for patients reducing NSAIDs immediately after start of secukinumab vs. NSAID reduction after 4 weeks of secukinumab therapy will be possible. After 4 weeks ASAS20 response rates were already at 52.8% for Secukinumab in the MEASURE2 trial.

Results: to be reported in 2018

Conclusion: This is the first randomized, controlled study of Secukinumab to evaluate efficacy under altered NSAID intake. The study started in Q2/2016 and results are expected for early 2018.