Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial
| Autor: | Xenofon Baraliakos, Michael Rissler, Sławomir Jeka, Effie Pournara, Antonio Mera-Varela, Laura C Coates, Chiara Perella, Laure Gossec, Salvatore D'Angelo, Kriti Nagar, Barbara Schulz |
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| Přispěvatelé: | Ruhr University Bochum (RUB), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Consiglio Nazionale delle Ricerche [Potenza] (CNR), Novartis Pharma AG, University of Oxford [Oxford], Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), University of Oxford, Gestionnaire, HAL Sorbonne Université 5 |
| Rok vydání: | 2020 |
| Předmět: |
Adult
Male medicine.medical_specialty antirheumatic agents tumor necrosis factor inhibitors Immunology Psoriatic Arthritis Arthritis Placebo Antibodies Monoclonal Humanized Severity of Illness Index General Biochemistry Genetics and Molecular Biology 03 medical and health sciences Psoriatic arthritis 0302 clinical medicine Rheumatology Double-Blind Method Internal medicine medicine Clinical endpoint Immunology and Allergy Humans BASDAI Axis Cervical Vertebra low back pain 030304 developmental biology 030203 arthritis & rheumatology [SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system 0303 health sciences Ankylosing spondylitis business.industry Arthritis Psoriatic Middle Aged medicine.disease Low back pain 3. Good health Treatment Outcome [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system arthritis biological therapy Secukinumab Female medicine.symptom psoriatic business |
| Zdroj: | Annals of the Rheumatic Diseases Annals of the Rheumatic Diseases, BMJ Publishing Group, 2020, 80 (5), pp.582-590. ⟨10.1136/annrheumdis-2020-218808⟩ Annals of the Rheumatic Diseases, 2020, 80 (5), pp.582-590. ⟨10.1136/annrheumdis-2020-218808⟩ |
| ISSN: | 1468-2060 0003-4967 |
| DOI: | 10.1136/annrheumdis-2020-218808⟩ |
| Popis: | International audience; 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, placebocontrolled, 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 nonsteroidal 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 |
| Databáze: | OpenAIRE |
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