title: Safety, Tolerability, and Efficacy of Tocilizumab in Rheumatoid Arthritis: An Open-Label Phase 4 Study in Patients from the Middle East.
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 (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.
authors.affiliation: Weill Cornell Medical College in Qatar and Hamad General Hospital, Doha, Qatar.
authors.forename: Mohammed
authors.initials: M
authors.lastname: Hammoudeh
authors.affiliation: Department of Medicine, Faculty of Medicine, Kuwait University, Kuwait City, Kuwait.
authors.forename: Adel
authors.initials: A
authors.lastname: Al Awadhi
authors.affiliation: Rheumatic Disease Unit, Alamiri Hospital, Kuwait City, Kuwait.
authors.forename: Eman Haji
authors.initials: EH
authors.lastname: Hasan
authors.affiliation: Rheumatology Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Maassoumeh
authors.initials: M
authors.lastname: Akhlaghi
authors.affiliation: Rheumatology Ward, Loghman Hakim University Hospital, Shahid Beheshti University of Medical Sciences, Tehran 14155 6153, Iran.
authors.forename: Arman
authors.initials: A
authors.lastname: Ahmadzadeh
authors.affiliation: Rheumatology Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Bahar
authors.initials: B
authors.lastname: Sadeghi Abdollahi