gms | German Medical Science

Background: The purpose of this study is to demonstrate the efficacy and safety of secukinumab in the management of axial manifestations in patients with psoriatic arthritis (PsA) who have failed to respond to at least 2 NSAIDs over a 4-week period, according to assessment of spondyloarthritis international society (ASAS) recommendations for the treatment of axial spondyloarthritis (axSpA). In particular, the study will provide evidence on the ability of secukinumab to improve clinical and structural outcomes in patients with active axial PsA.

Methods: MAXIMISE is a 52-week, randomized, double-blind, double-dummy, placebo-controlled, multicenter international study consisting of an 8-week screening period, a 12-week placebo-controlled, double-blind treatment period followed by a 40-week double-blind secukinumab treatment period. The study will enroll 495 patients with PsA and axial skeleton involvement. Patients will be randomized 1:1:1 to either placebo, secukinumab 150 mg or secukinumab 300 mg. MRI assessments will be performed at baseline, Week 12 and Week 52 (end of study) and analyzed by central reading.

Results: Enrollment for the study started in October 2016 and estimated study completion date will be in May 2019. First interpretable results are expected for November 2019. As primary objective the study aims to demonstrate that secukinumab 300 mg is superior to placebo in the achievement of ASAS 20 response at Week 12. As main secondary objective the study aims to demonstrate that secukinumab 150 mg is superior to placebo in the achievement of ASAS 20 response at Week 12 after superiority of 300 mg is established. Other secondary objectives evaluate ASAS 40, BASDAI 50, SPARCC enthesitis index and ACR 20 at week 12. MRI scans of the spine and sacroiliac joints will be assessed for any reduction in bone marrow edema by centralized reading (exploratory objective).

Conclusion: MAXIMISE is one of the first trials directly investigating axial skeleton involvement in patients with active PsA, including standardized MRI reading. MAXIMISE will generate data on the efficacy and safety of secukinumab 150 mg and 300 mg in this specific population of active axial PsA patients.