PREVENT

PREVENT studied 90% biologic-naive patients and 10% anti–TNF-α inadequate responders with nr-axSpA⁸

• The primary end point (ASAS40 at 1 year) was achieved by 40% of biologic-naive patients on COSENTYX 150 mg no load (n=166) vs 20% on placebo (n=171) (NRI; P<0.05)⁹

PREVENT study design

PREVENT is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial evaluating 555 adult patients with active nr-axSpA who met the ASAS classification criteria for axSpA and had abnormal hsCRP and/or evidence of sacroiliitis on MRI. Participants were randomized to receive 1 of 3 treatments subcutaneously: COSENTYX 150 mg load, COSENTYX 150 mg no load, or placebo. Patients were treated with COSENTYX 150 mg with load or placebo (Weeks 0, 1, 2, 3, and 4) or COSENTYX 150 mg without load (Weeks 0 and 4), followed by the same dose every 4 weeks thereafter. Starting at Week 16, dose adjustment or addition of concomitant NSAIDs and DMARDs was permitted. Starting at Week 20, patients were allowed to switch to open-label COSENTYX 150 mg monthly or local standard of care if the patient was considered an inadequate responder for 2 consecutive visits by the discretion of the investigator and patient. The primary end point was the percentage of biologic-naive patients who achieved ASAS40 response at Week 52 in the no-load arm. The core phase of the trial ran through Week 104, with an extension phase through Week 208. Most patients (90%) were biologic-naive in this study.^1,8,9

ASAS, Assessment of SpondyloArthritis international Society criteria; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; DMARDs, disease-modifying antirheumatic drugs; FACIT, Functional Assessment of Chronic Illness Therapy; hsCRP, high-sensitivity C-reactive protein; MRI, magnetic resonance imaging; NRI, nonresponder imputation; NSAIDs, nonsteroidal anti-inflammatory drugs; TNF, tumor necrosis factor.