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International Journal of Rheumatology
Volume 2015, Article ID 975028, 7 pages
http://dx.doi.org/10.1155/2015/975028
Research Article

Safety, Tolerability, and Efficacy of Tocilizumab in Rheumatoid Arthritis: An Open-Label Phase 4 Study in Patients from the Middle East

1Weill Cornell Medical College in Qatar and Hamad General Hospital, Doha, Qatar
2Department of Medicine, Faculty of Medicine, Kuwait University, Kuwait City, Kuwait
3Rheumatic Disease Unit, Alamiri Hospital, Kuwait City, Kuwait
4Rheumatology Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran
5Rheumatology Ward, Loghman Hakim University Hospital, Shahid Beheshti University of Medical Sciences, Tehran 14155 6153, Iran

Received 12 January 2015; Revised 21 April 2015; Accepted 30 April 2015

Academic Editor: Tim Jansen

Copyright © 2015 Mohammed Hammoudeh et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

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 (). DAS28, CRP, and ESR decreased significantly from baseline at each visit (). 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.