The efficacy and safety of teriflunomide based therapy in patients with relapsing multiple sclerosis: A meta-analysis of randomized controlled trials |
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| Affiliation: | 1. Department of Neurology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, 1111 XianXia Road, Shanghai 200336, China;2. Department of Neurology, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, 639 Zhizhaoju Road, Shanghai 200011, China;1. St Vincent’s Hospital, Sydney, NSW, Australia;2. Centre for Health Economics Research and Evaluation, University of Technology Sydney, Sydney, NSW, Australia;3. Johns Hopkins University, Baltimore, MD, USA;4. Centre for Cardiovascular & Chronic Care, University of Technology Sydney, Sydney, NSW, Australia;5. Medtronic Inc., Minneapolis, MN, USA;6. iRhythm Technologies Inc., San Francisco, CA, USA;1. Department of Radiation Oncology, Stanford University, Stanford, CA, United States;2. VA Palo Alto Health Care System, Palo Alto, CA, United States;3. Division of Oncology, Department of Medicine, Stanford University, Stanford, CA, United States;4. Institute for Stem Cell Biology and Regenerative Medicine, Stanford University, Stanford, CA 94305, United States;5. Stanford Cancer Institute, Stanford University, Stanford, CA 94305, United States;1. Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy;2. Ospedale Pediatrico Microcitemico “A. Cao,” A.O. “G. Brotzu,” Cagliari, Italy;1. Department of General Surgery, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China;2. Shanghai Research Center of Biliary Tract Disease, Shanghai, China;3. Department of Hepatobiliary Surgery, Nanjing Medical University Affiliated Wuxi No2 Hospital, Jiangsu, China;1. National Centre for Pharmacoeconomics, Dublin, Ireland;2. Health Economics and Evidence Synthesis Research Unit, Department of Population Health, Luxembourg Institute of Health, Luxembourg;3. Department of Neurology, St. Vincent''s University Hospital, Dublin, Ireland;4. Department of Mathematics and Statistics, University of Limerick, Ireland;5. National Centre for Pharmacoeconomics, Dublin, Ireland |
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| Abstract: | The aim of this study was to evaluate the efficacy and safety of teriflunomide in reducing the frequency of relapses and progression of physical disability in patients with relapsing multiple sclerosis (RMS). Literatures were searched in Pubmed, Medline and Embase to screen citations from January 1990 to April 2015. Studies of parallel group design comparing teriflunomide and placebo for RMS were screened. After independent review of 234 citations by two authors, seven studies were identified as meeting the inclusion criteria. The results showed teriflunomide (7 and 14 mg) could significantly reduce annualized relapse rate and teriflunomide at the higher dose could also decrease the disability progression (risk ratio (RR) = 0.69, 95% confidence interval (CI): 0.55–0.87). And teriflunomide significantly reduce annualized rates of relapses with sequelae-EDSS/FS, relapses leading to hospitalization, and relapses requiring IV corticosteroids. Patients treated with teriflunomide 14 mg have a lower annualized rate of relapses with sequelae-investigator (RR = 0.37, 95% CI: 0.26–0.52). Teriflunomide 7 mg has a higher incidence of diarrhea (RR = 1.73, 95% CI: 1.32–2.26) and hair thinning (RR = 1.99, 95% CI: 1.4–2.81), while teriflunomide 14 mg has a higher incidence of diarrhea (RR = 1.71, 95% CI: 1.34–2.18), hair thinning (RR = 2.81, 95% CI: 2.02–3.91) and nausea (RR = 1.65, 95% CI: 1.03–2.31) compared with placebo. The incidence of elevated alanine aminotransferase levels was also higher with teriflunomide than with placebo. However, the incidence of serious adverse events was similar across groups. In conclusion, teriflunomide significantly reduces annualized relapse rates and disability progression with a similar safety and tolerability profile to placebo. |
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| Keywords: | Meta-analysis Multiple sclerosis Randomized controlled trial Teriflunomide |
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