Journal article
Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial
- Abstract:
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Objectives: MAXIMISE trial was designed to evaluate the efficacy of secukinumab in the management of axial manifestations of PsA.
Methods: This phase 3b, double-blind, placebo-controlled, multicentre 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 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% versus 31% placebo). The odds ratio (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, 6.1) and 4.4 (2.7, 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.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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(Preview, Version of record, 525.8KB, Terms of use)
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- Publisher copy:
- 10.1136/annrheumdis-2020-218808
Authors
- Publisher:
- BMJ
- Journal:
- Annals of the Rheumatic Diseases More from this journal
- Volume:
- 80
- Issue:
- 5
- Pages:
- 582-590
- Publication date:
- 2020-12-17
- Acceptance date:
- 2020-12-01
- DOI:
- EISSN:
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1468-2060
- ISSN:
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0003-4967
- Language:
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English
- Keywords:
- Pubs id:
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1147537
- Local pid:
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pubs:1147537
- Deposit date:
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2020-12-02
Terms of use
- Copyright holder:
- Baraliakos et al.
- Copyright date:
- 2020
- Rights statement:
- © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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