1. Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis
- Author
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Désirée van der Heijde, Marleen Nys, Oliver FitzGerald, Philip J. Mease, Alyssa Johnsen, Alice B. Gottlieb, Dafna D. Gladman, and Subhashis Banerjee
- Subjects
0301 basic medicine ,musculoskeletal diseases ,Adult ,Male ,medicine.medical_specialty ,T cell ,Immunology ,T cells ,DMARDs (biologic) ,Placebo ,General Biochemistry, Genetics and Molecular Biology ,Abatacept ,03 medical and health sciences ,Psoriatic arthritis ,Immunocompromised Host ,0302 clinical medicine ,Rheumatology ,Quality of life ,Double-Blind Method ,Psoriasis ,Internal medicine ,medicine ,Clinical endpoint ,Immunology and Allergy ,Humans ,030203 arthritis & rheumatology ,business.industry ,Pneumonia, Pneumocystis ,Arthritis, Psoriatic ,Clinical and Epidemiological Research ,Middle Aged ,medicine.disease ,Surgery ,Treatment ,030104 developmental biology ,medicine.anatomical_structure ,Treatment Outcome ,Antirheumatic Agents ,Quality of Life ,Female ,business ,medicine.drug - Abstract
ObjectivesTo assess the efficacy and safety of abatacept, a selective T-cell costimulation modulator, in a phase III study in psoriatic arthritis (PsA).MethodsThis study randomised patients (1:1) with active PsA (~60% with prior exposure to a tumour necrosis factor inhibitor) to blinded weekly subcutaneous abatacept 125 mg (n=213) or placebo (n=211) for 24 weeks, followed by open-label subcutaneous abatacept. Patients without ≥20% improvement in joint counts at week 16 were switched to open-label abatacept. The primary end point was the proportion of patients with ≥20% improvement in the American College of Rheumatology (ACR20) criteria at week 24.ResultsAbatacept significantly increased ACR20 response versus placebo at week 24 (39.4% vs 22.3%; pConclusionsAbatacept treatment of PsA in this phase III study achieved its primary end point, ACR20 response, showed beneficial trends overall in musculoskeletal manifestations and was well tolerated. There was only a modest impact on psoriasis lesions.Trial registration numberClinicalTrials.gov number, NCT01860976 (funded by Bristol-Myers Squibb).
- Published
- 2017