Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial

• Published in: Annals of the rheumatic diseases Vol. 80; no. 5; pp. 582 - 590
• Main Authors: Baraliakos, Xenofon, Gossec, Laure, Pournara, Effie, Jeka, Slawomir, Mera-Varela, Antonio, D'Angelo, Salvatore, Schulz, Barbara, Rissler, Michael, Nagar, Kriti, Perella, Chiara, Coates, Laura C
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01.05.2021; BMJ Publishing Group
• Subjects: Ankylosing spondylitis; Arthritis; Biological products; Clinical medicine; Cytokines; Double-blind studies; Human health and pathology; Inflammation; Inflammatory diseases; Life Sciences; Monoclonal antibodies; Nonsteroidal anti-inflammatory drugs; Pain; Placebos; Psoriasis; Psoriatic Arthritis; Rheumatic diseases; Rhumatology and musculoskeletal system; TNF inhibitors; Tumor necrosis factor-TNF; psoriatic; arthritis; tumor necrosis factor inhibitors; antirheumatic agents; biological therapy; low back pain
• ISSN: 0003-4967; 1468-2060
• DOI: 10.1136/annrheumdis-2020-218808

ObjectivesMAXIMISE (Managing AXIal Manifestations in psorIatic arthritis with SEcukinumab) trial was designed to evaluate the efficacy of secukinumab in the management of axial manifestations of psoriatic arthritis (PsA).MethodsThis phase 3b, double-blind, placebo-controlled, multi-centre 52-week trial included patients (≥18 years) diagnosed with PsA and classified by ClASsification criteria for Psoriatic Arthritis (CASPAR) criteria, with spinal pain Visual Analogue Score ≥40/100 and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥4 despite use of at least two non-steroidal anti-inflammatory drugs (NSAIDs). Patients were randomised (1:1:1) to secukinumab 300 mg, secukinumab 150 mg or placebo weekly for 4 weeks and every 4 weeks thereafter. At week 12, placebo patients were re-randomised to secukinumab 300/150 mg. Primary endpoint was ASAS20 (Assessment of SpondyloArthritis international Society) response with secukinumab 300 mg at week 12.ResultsPatients were randomly assigned; 167 to secukinumab 300 mg, 165 to secukinumab 150 mg and 166 to placebo. Secukinumab 300 mg and 150 mg significantly improved ASAS20 response versus placebo at week 12 (63% and 66% vs 31% placebo). The OR (95% CI) comparing secukinumab 300 mg and 150 mg versus placebo, using a logistic regression model after multiple imputation, was 3.8 (2.4 and 6.1) and 4.4 (2.7 and 7.0; p<0.0001).ConclusionsSecukinumab 300 mg and 150 mg provided significant improvement in signs and symptoms of axial disease compared with placebo in patients with PsA and axial manifestations with inadequate response to NSAIDs.Trial registration number NCT02721966.