MIXED TREATMENT COMPARISON OF ADVERSE EVENTS FOR BG-12, GLATIRAMER, AND TERIFLUNOMIDE FOR THE TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS

Author(s)

Zagmutt FJ*1, Carroll CA2 1EpiX Analytics, Boulder, CO, USA, 2Teva Pharmaceuticals, Kansas City, MO, USA

OBJECTIVES: Clinical trials of two new oral treatments (Teriflunomide and BG-12) for relapsing-remitting multiple sclerosis (RRMS) have been recently published. As efficacy is similar between these products and glatiramer, a comparison of their relative safety is relevant to physicians, patients, and providers. Our objective was to conduct a mixed treatment comparison of adverse event (AEs) in placebo-controlled randomized clinical trials of BG-12 240mg BID and TID, Glatiramer 20mg SID, and Teriflunomide 7mg and 14 mg SID in RRMS. METHODS: Articles were selected and reviewed following Cochrane guidelines. Placebo-controlled phase III RRMS clinical trials were eligible for inclusion. Data collected were the total number of patients experiencing at least one AE. The odds ratio (OR) of AEs, Credible Interval (CrI), and confidence in OR >1 for all drug pairs were estimated using a Bayesian random effects network meta-analysis with placebo as baseline comparator, and multi-arm adjustment. The mean rank (1-5) and probability of ranking lowest (PrL) of all treatments were calculated. The Surface Under Cumulative Ranking (SUCRA) summarized overall strength of evidence of the ranking of each treatment (best 100%, worst 0%). RESULTS: A total of 384 studies were identified and reviewed, and 3 studies (3737 patients) were included for analysis. Preliminary results are reported. Glatiramer exhibited the lowest AEs of all treatments (OR >1 for all comparisons with ≥ 90% confidence), except for borderline non-significantly lower AEs vs. placebo (OR=.73;95%CrI=.18-1.98;PL=89.6%). Patients receiving glatiramer had the lowest AEs (rank=1.4,PrL=80.3%,SUCRA=91.7%), followed by placebo (rank=2.9,PrL=4.2%,SUCRA=62.6%), BG-12 240mg TID (rank=3.2,PrL=4.8%,SUCRA=56.8%), Teriflunomide 7mg (rank=4.2,PrL=5.5%,SUCRA=35.3%), BG-12 240mg BID (rank=4.7,PrL=1.2%,SUCRA=26.9%), and Teriflunomide 14mg (rank=4.7,PrL=4.0%,SUCRA=26.7%). CONCLUSIONS: Preliminary results suggest that RRMS patients treated with Glatiramer have the lowest risk of experiencing AEs, while patients taking Teriflunomide 14mg have the highest AEs risk. This evidence may be useful to perform net clinical benefit analyses on alternative RRMS treatments.

Conference/Value in Health Info

2013-09, ISPOR Latin America 2013, Buenos Aires, Argentina

Value in Health, Vol. 16, No. 7 (November 2013)

Code

PND1

Topic

Epidemiology & Public Health

Topic Subcategory

Safety & Pharmacoepidemiology

Disease

Neurological Disorders

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