Safety, Tolerability, and Efficacy of Tocilizumab in Rheumatoid Arthritis: An Open-Label Phase 4 Study in Patients from the Middle East
Joint Authors
Hammoudeh, Mohammed
Al Awadhi, Adel
Akhlaghi, Maassoumeh
Ahmadzadeh, Arman
Sadeghi Abdollahi, Bahar
Hasan, Eman A.
Source
International Journal of Rheumatology
Issue
Vol. 2015, Issue 2015 (31 Dec. 2015), pp.1-7, 7 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2015-05-19
Country of Publication
Egypt
No. of Pages
7
Main Subjects
Abstract EN
This open-label study investigated the safety and efficacy of tocilizumab in Middle Eastern patients with rheumatoid arthritis (RA).
Patients whose Disease Activity Score based on 28 joints (DAS28) was >3.2 received tocilizumab 8 mg/kg intravenously every 4 weeks for 24 weeks.
Patients receiving aTNF ± nonbiologic disease-modifying antirheumatic drug(s) (DMARD(s)) switched to tocilizumab; patients receiving nonbiologic DMARD monotherapy added tocilizumab.
Primary end points were adverse events (AEs), serious AEs (SAEs), and laboratory parameters; secondary end points were DAS28, Health Assessment Questionnaire-Disability Index, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR).
Eighty-eight of 95 patients completed 24 weeks.
Overall, 125 AEs were reported in 43 (45%) patients; the most common were increased hepatic enzymes (16%) and cholesterol (11%).
Eight patients experienced SAEs.
Significant changes from baseline to week 24 occurred for hemoglobin, neutrophils, platelets, total cholesterol, and liver enzymes (P<0.05).
DAS28, CRP, and ESR decreased significantly from baseline at each visit (P<0.0001).
At week 24, the proportions of patients reporting DAS28 clinically meaningful improvement (decrease ≥1.2), low disease activity (DAS28 ≥2.6 to ≤3.2), and remission (DAS28 <2.6) were 92%, 23%, and 64%, respectively.
Safety and efficacy of tocilizumab were consistent with values reported in Western patients.
American Psychological Association (APA)
Hammoudeh, Mohammed& Al Awadhi, Adel& Hasan, Eman A.& Akhlaghi, Maassoumeh& Ahmadzadeh, Arman& Sadeghi Abdollahi, Bahar. 2015. Safety, Tolerability, and Efficacy of Tocilizumab in Rheumatoid Arthritis: An Open-Label Phase 4 Study in Patients from the Middle East. International Journal of Rheumatology،Vol. 2015, no. 2015, pp.1-7.
https://search.emarefa.net/detail/BIM-1066898
Modern Language Association (MLA)
Hammoudeh, Mohammed…[et al.]. Safety, Tolerability, and Efficacy of Tocilizumab in Rheumatoid Arthritis: An Open-Label Phase 4 Study in Patients from the Middle East. International Journal of Rheumatology No. 2015 (2015), pp.1-7.
https://search.emarefa.net/detail/BIM-1066898
American Medical Association (AMA)
Hammoudeh, Mohammed& Al Awadhi, Adel& Hasan, Eman A.& Akhlaghi, Maassoumeh& Ahmadzadeh, Arman& Sadeghi Abdollahi, Bahar. Safety, Tolerability, and Efficacy of Tocilizumab in Rheumatoid Arthritis: An Open-Label Phase 4 Study in Patients from the Middle East. International Journal of Rheumatology. 2015. Vol. 2015, no. 2015, pp.1-7.
https://search.emarefa.net/detail/BIM-1066898
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1066898