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Clinical Trial
. 2021 May;80(5):582-590.
doi: 10.1136/annrheumdis-2020-218808. Epub 2020 Dec 17.

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

Xenofon Baraliakos  1 , Laure Gossec  2   3 , Effie Pournara  4 , Slawomir Jeka  5 , Antonio Mera-Varela  6 , Salvatore D'Angelo  7 , Barbara Schulz  4 , Michael Rissler  4 , Kriti Nagar  8 , Chiara Perella  4 , Laura C Coates  9
Affiliations
Clinical Trial

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

Xenofon Baraliakos et al. Ann Rheum Dis. 2021 May.

Abstract

Objectives: MAXIMISE (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).

Methods: This 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.

Results: Patients 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).

Conclusions: Secukinumab 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.

Keywords: antirheumatic agents; arthritis; biological therapy; low back pain; psoriatic; tumor necrosis factor inhibitors.

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Conflict of interest statement

Competing interests: XB: Grant/research support from: AbbVie, and Novartis, Consultant for: AbbVie, BMS, Celgene, Chugai, Galapagos, Gilead, MSD, Novartis, Pfizer, and UCB; Speakers bureau: AbbVie, BMS, Celgene, Chugai, MSD, Novartis, Pfizer, and UCB. LG: Research grants: Amgen, Lilly, Janssen, Pfizer, Sandoz, Sanofi, and Galapagos; consulting fees: AbbVie, Amgen, BMS, Biogen, Celgene, Gilead, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis and UCB. EP: Employee of Novartis with Novartis stock. SJ: Research support/speaker: AbbVie, Pfizer, Roche, Novartis, MSD, Sandoz, Lilly, Egis, UCB and Celgene. AM-V: None declared. SD: Consultant for AbbVie, Biogen, BMS, Celgene, Lilly, MSD, Novartis and UCB; Speakers bureau: AbbVie, BMS and Celgene, Lilly, Novartis, Pfizer and Sanofi. BS: Employee of Novartis. MR: Employee of Novartis with Novartis stock. KN: Employee of Novartis. CP: Employee of Novartis with Novartis stock. LCC: Grant/research support: AbbVie, Janssen, Lilly, Novartis and Pfizer; Consultant for: AbbVie, Amgen, Biogen, Celgene, Pfizer, UCB, Boehringer Ingelheim, Novartis, Lilly, Janssen, Sun Pharma, Prothena and Gilead.

Figures

Figure 1
Figure 1
Patient disposition. *5 patients were mis-randomised and were treated like screen failures for the data analysis. AE, adverse event; ICF, informed consent; Pt, patient; N, total number of randomised patients.
Figure 2
Figure 2
ASAS20 response rates at week 12 (MI). OR secukinumab 300 mg versus placebo: 3.8, p<0.0001 secukinumab 150 mg versus placebo: 4.4, p<0.0001. ASAS, Assessment of SpondyloArthritis International Society; MI, multiple imputation; N, total number of randomised patients (full analysis set); s.c., subcutaneous.
Figure 3
Figure 3
ASAS20 and ASAS40 responses through week 52*. (A) ASAS20. (B) ASAS40. *LOCF data in full analysis set. ASAS, Assessment of SpondyloArthritis international Society; LOCF, last observation carried forward.
See this image and copyright information in PMC

References

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