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

Abstract

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 numberNCT02721966.

Effectiveness and safety of secukinumab in 608 patients with psoriatic arthritis in real life: a 24-month prospective, multicentre study

“…These findings were in line with Managing AXIal Manifestations in psorIatic arthritis with SEcukinumab, the first RCT who evaluated the efficacy of SEC specifically in the management of the axial manifestations of PsA: SEC 300 mg and 150 mg demonstrated significant improvements across the clinical (ASDAS, ASAS20/40 and BASDAI50) and imaging (Berlin MRI Score) end points at week 12, which were sustained through week 52. 50 Our results confirmed the effectiveness of SEC in multiple aspects of PsA, in accordance with the need to treat the heterogeneous clinical phenotypes. The updated PsA core domains, defined by the GRAPPA/ OMERACT, underline the need to obtain a good treatment response in arthritis, enthesitis, dactylitis and spine involvement, skin disease activity (psoriasis and nail involvement), pain, patient global assessment, physical function, fatigue, health-related quality of life and systemic inflammation.…”

Secukinumab: A Review in Psoriatic Arthritis

“…Secukinumab improved axial manifestations in patients with PsA [17]. An ASAS20 response at week 12 was achieved by 66 and 63% of secukinumab 150 and 300 mg recipients, compared with 31% of placebo recipients; the odds ratios (ORs) for secukinumab 150 and 300 mg versus placebo were 4.4 (95% CI 2.7-7.0) and 3.8 (95% CI 2.4-6.1; both p < 0.0001).…”

“…The efficacy of secukinumab for the treatment of PsA was evaluated in several randomized, double-blind, placebocontrolled, multicentre, phase III trials: FUTURE 1-5 [12][13][14][15][16] (Sect. 2.1.1), MAXIMISE [17] (Sect. 2.1.2) and ULTIMATE [18] (Sect.…”

“…The MAXIMISE trial enrolled patients aged ≥ 18 years with PsA and active spinal disease with a spinal pain VAS score of ≥ 40/100 and a Bath Ankylosing Spondylitis Disease Activity Index score of ≥ 4 despite the use of at least two NSAIDs [17]. Patients were randomized to receive subcutaneous secukinumab 150 mg (n = 165), secukinumab 300 mg (n = 167) or placebo (n = 166) weekly for 4 weeks and then every 4 weeks.…”

“…At week 12, patients in the placebo group were re-randomized to secukinumab 150 or 300 mg. The primary endpoint was the proportion of patients achieving ≥ 20% improvement in the Assessment of Spondyloarthritis International Society response criteria (ASAS20) at week 12 [17].…”