Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis and current skin involvement: a phase III, randomised, controlled trial (PALACE 3)

Autor: Janusz Jaworski, Xiaojiang Zhan, R. Stevens, Paul Bird, Adele R. Vessey, Christopher J Edwards, C. Birbara, Jeffrey Crowley, Francisco J. Blanco, Jacob A. Aelion
Rok vydání: 2016
Předmět:
Adult
Male
medicine.medical_specialty
Ankylosing Spondylitis
Psoriatic Arthritis
Immunology
Placebo
Severity of Illness Index
General Biochemistry
Genetics and Molecular Biology
law.invention
030207 dermatology & venereal diseases
03 medical and health sciences
Psoriatic arthritis
0302 clinical medicine
Double-Blind Method
Rheumatology
Randomized controlled trial
law
Psoriasis
Internal medicine
medicine
Humans
Immunology and Allergy
Skin
030203 arthritis & rheumatology
Ankylosing spondylitis
Dose-Response Relationship
Drug
business.industry
Anti-Inflammatory Agents
Non-Steroidal
Arthritis
Psoriatic
Middle Aged
Clinical and Epidemiological Research
medicine.disease
Thalidomide
3. Good health
Surgery
Treatment
Treatment Outcome
Female
Phosphodiesterase 4 Inhibitors
Apremilast
business
medicine.drug
Zdroj: Annals of the Rheumatic Diseases
RUC. Repositorio da Universidade da Coruña
instname
ISSN: 1468-2060
0003-4967
Popis: ObjectiveTo evaluate apremilast treatment in patients with active psoriatic arthritis, including current skin involvement, despite prior therapy with conventional disease-modifying antirheumatic drugs and/or biologic agents.MethodsPatients (N=505) were randomised (1:1:1) to placebo, apremilast 20 mg twice daily, or apremilast 30 mg twice daily. Rescue therapy with apremilast was designated at week 16 for placebo patients not achieving 20% improvement in swollen and tender joint counts. At week 24, the remaining placebo patients were then randomised to apremilast 20 mg twice daily or 30 mg twice daily. The efficacy and safety of apremilast were assessed over 52 weeks.ResultsAt week 16, significantly more patients receiving apremilast 20 mg twice daily (28%) and 30 mg twice daily (41%) achieved 20% improvement in American College of Rheumatology response criteria versus placebo (18%; p=0.0295 and pConclusionsApremilast demonstrated clinically meaningful improvements in psoriatic arthritis and psoriasis at week 16; sustained improvements were seen with continued treatment through 52 weeks. Apremilast was generally well tolerated and demonstrated an acceptable safety profile.Trial registration numberNCT01212770.
Databáze: OpenAIRE
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