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Secukinumab sustains improvement in signs and symptoms of psoriatic arthritis: 2 year results from the phase 3 FUTURE 2 study
- Source :
- Rheumatology (Oxford, England)
- Publication Year :
- 2017
- Publisher :
- Oxford University Press, 2017.
-
Abstract
- Objectives. To assess long-term efficacy, safety and tolerability of secukinumab up to 104 weeks in\ud patients with active PsA.\ud Methods. Patients with PsA (n = 397) were randomized to s.c. secukinumab 300, 150 or 75 mg or placebo at\ud baseline, weeks 1, 2, 3 and 4 and every 4 weeks thereafter. Placebo-treated patients were re-randomized to\ud receive secukinumab 300 or 150 mg s.c. from week 16 (placebo non-responders) or week 24 (placebo\ud responders). Exploratory endpoints at week 104 included 20, 50 and 70% improvement in ACR criteria\ud (ACR20, 50, 70); 75 and 90% improvement in the Psoriasis Area Severity Index, 28-joint DAS with CRP,\ud presence of dactylitis and enthesitis and other patient-reported outcomes. For binary variables, missing\ud values were imputed; continuous variables were analysed by a mixed-effects model for repeated measures.\ud Results. A total of 86/100 (86%), 76/100 (76%) and 65/99 (66%) patients in the secukinumab 300, 150\ud and 75 mg groups, respectively, completed 104 weeks. At week 104, ACR20 response rates after multiple\ud imputation in the 300, 150 and 75 mg groups were 69.4, 64.4 and 50.3%, respectively. Sustained clinical\ud improvements were observed through week 104 with secukinumab across other clinically important domains\ud of PsA. Responses were sustained through week 104 regardless of prior anti-TNF-a use. Over the\ud entire treatment period the incidence, type and severity of adverse events were consistent with those\ud reported previously.\ud Conclusion. Secukinumab provided sustained improvements in signs and symptoms and multiple clinical\ud domains in patients of active PsA through 2 years of therapy. Secukinumab was well tolerated, with a\ud safety profile consistent with that reported previously.\ud Trial registration: ClinicalTrials.gov (https://clinicaltrials.gov), NCT01752634
- Subjects :
- 0301 basic medicine
efficacy
Severity of Illness Index
Dactylitis
swelling
0302 clinical medicine
biological therapies
Pharmacology (medical)
Longitudinal Studies
Respiratory Tract Infections
psoriatic arthritis
interleukin
Antibodies, Monoclonal
Clinical Science
spondyloarthritis
C-Reactive Protein
Treatment Outcome
Tolerability
Antirheumatic Agents
long term
Drug Therapy, Combination
safety
Diarrhea
medicine.medical_specialty
anti-TNF therapy
Placebo
Antibodies, Monoclonal, Humanized
03 medical and health sciences
Psoriatic arthritis
Rheumatology
Double-Blind Method
Internal medicine
Psoriasis
Severity of illness
medicine
Humans
Patient Reported Outcome Measures
Glucocorticoids
030203 arthritis & rheumatology
business.industry
Arthritis, Psoriatic
Repeated measures design
medicine.disease
Surgery
030104 developmental biology
Logistic Models
Methotrexate
joints
Nasopharyngitis
Quality of Life
Secukinumab
business
Subjects
Details
- Language :
- English
- ISSN :
- 14620332, 14620324, and 01752634
- Volume :
- 56
- Issue :
- 11
- Database :
- OpenAIRE
- Journal :
- Rheumatology (Oxford, England)
- Accession number :
- edsair.doi.dedup.....584d8230aabcd6d8178343dfd6c15831