Back to Search
Start Over
Efficacy and safety of olokizumab in patients with rheumatoid arthritis with an inadequate response to TNF inhibitor therapy: outcomes of a randomised Phase IIb study
- Source :
- Annals of the Rheumatic Diseases, Annals of the Rheumatic Diseases, Vol. 73, no. 9, p. 1607-1615 (2014)
- Publication Year :
- 2014
-
Abstract
- OBJECTIVES: The aim of this 12-week Phase IIb study was to assess the efficacy and safety of olokizumab (OKZ), a humanised anti-IL6 monoclonal antibody, in patients with rheumatoid arthritis (RA) with moderate-to-severe disease activity who had previously failed tumour necrosis factor (TNF) inhibitor therapy. The dose-exposure-response relationship for OKZ was also investigated. METHODS: Patients were randomised to one of nine treatment arms receiving placebo (PBO) or OKZ (60, 120 or 240 mg) every 4 weeks (Q4W) or every 2 weeks (Q2W), or 8 mg/kg tocilizumab (TCZ) Q4W. The primary endpoint was change from baseline in DAS28(C-reactive protein, CRP) at Week 12. Secondary efficacy endpoints were American College of Rheumatology 20 (ACR20), ACR50 and ACR70 response rates at Week 12. Exploratory analyses included comparisons of OKZ efficacy with TCZ. RESULTS: Across 221 randomised patients, OKZ treatment produced significantly greater reductions in DAS28(CRP) from baseline levels at Week 12, compared to PBO (p
- Subjects :
- Male
medicine.medical_specialty
Olokizumab
medicine.medical_treatment
Immunology
Sirukumab
Rheumatoid Arthritis
DMARDs (biologic)
Placebo
Antibodies, Monoclonal, Humanized
Gastroenterology
Severity of Illness Index
General Biochemistry, Genetics and Molecular Biology
Drug Administration Schedule
Autoimmune Diseases
Arthritis, Rheumatoid
chemistry.chemical_compound
Tocilizumab
Rheumatology
Double-Blind Method
Internal medicine
medicine
Clinical endpoint
Immunology and Allergy
Humans
Treatment Failure
Disease Activity
Biological Products
Dose-Response Relationship, Drug
business.industry
Interleukin-6
Tumor Necrosis Factor-alpha
Clinical and Epidemiological Research
Middle Aged
medicine.disease
Surgery
TNF inhibitor
Treatment Outcome
chemistry
Rheumatoid arthritis
Pharmacodynamics
Antirheumatic Agents
Female
business
Subjects
Details
- ISSN :
- 14682060
- Volume :
- 73
- Issue :
- 9
- Database :
- OpenAIRE
- Journal :
- Annals of the rheumatic diseases
- Accession number :
- edsair.doi.dedup.....72db8da0988305883926e5f7369d5ec6