Efficacy and safety of tildrakizumab in patients with active psoriatic arthritis: results of a randomised, double-blind, placebo-controlled, multiple-dose, 52-week phase IIb study
| Autor: | Stephen J. Rozzo, Alan M. Mendelsohn, Alice B. Gottlieb, Siba P. Raychaudhuri, Proton Rahman, Saima Chohan, Philip J. Mease, Richard C Chou, Michael E. Luggen, Ferran J Garcia Fructuoso |
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| Rok vydání: | 2021 |
| Předmět: |
Adult
Male medicine.medical_specialty Psoriatic Arthritis Immunology Tildrakizumab Arthritis Antibodies Monoclonal Humanized Placebo General Biochemistry Genetics and Molecular Biology Dactylitis Psoriatic arthritis Double-Blind Method Rheumatology Internal medicine medicine Humans Immunology and Allergy Adverse effect Glucocorticoids business.industry Arthritis Psoriatic Enthesitis Middle Aged medicine.disease cytokines Sulfasalazine Methotrexate arthritis biological therapy Antirheumatic Agents Drug Therapy Combination Female psoriatic medicine.symptom business Leflunomide |
| Zdroj: | Annals of the Rheumatic Diseases |
| ISSN: | 1468-2060 0003-4967 |
| Popis: | ObjectivesTo evaluate efficacy and safety of the anti-interleukin-23p19 monoclonal antibody tildrakizumab in patients with psoriatic arthritis (PsA).MethodsIn this randomised, double-blind, placebo-controlled, phase IIb study, patients with active PsA were randomised 1:1:1:1:1 to tildrakizumab 200 mg every 4 weeks (Q4W); tildrakizumab 200, 100 or 20 mg Q12W; or placebo Q4W. Patients receiving tildrakizumab 20 mg or placebo switched to tildrakizumab 200 mg Q12W at W24; treatment continued to W52. The primary efficacy endpoint was proportion of patients with ACR20 response (≥20% improvement by American College of Rheumatology criteria) at W24. Secondary efficacy endpoints were assessed without adjustment for multiplicity. Safety was evaluated from treatment-emergent adverse events (TEAEs).Results391/500 patients screened were randomised and treated. At W24, 71.4%–79.5% of tildrakizumab-treated versus 50.6% of placebo-treated patients achieved ACR20 (all pConclusionsTildrakizumab treatment significantly improved joint and skin manifestations of PsA other than dactylitis and enthesitis. Treatment was generally well tolerated through W52. Clinicaltrials.gov NCT02980692. |
| Databáze: | OpenAIRE |
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