Similar Local Tolerability Profiles Following Double-Blind Treatment With Generic or Branded Glatiramer Acetate in Multiple Sclerosis (P3.256)

Abstract

BACKGROUND: GTR (Synthon) is the first generic glatiramer acetate with a demonstrated equivalent efficacy and safety profile to branded glatiramer acetate (GA, Copaxone®, Teva). Because local injection site reactions (LISRs) are common adverse reactions for GA, these were further investigated. OBJECTIVE: To evaluate local tolerability following treatment of relapsing remitting multiple sclerosis (RRMS) patients with GTR or GA. DESIGN/METHODS: RRMS patients aged 18-55 years with 蠅1 relapse in the year prior to screening and 1-15 gadolinium-enhanced brain lesions were randomized to receive daily subcutaneous injections of 20 mg GTR, 20 mg GA, or placebo in a double-blind trial for 9 months. The presence and severity of LISRs 5 minutes and 24 hours after injection were recorded for 14 days at Day 1 and Month 3. The LISR presence score ranges from 0 to 5 based on the number of symptoms (pain, redness, swelling, itching, lumps), the severity score ranges from 0 (none) to 3 (severe). RESULTS: 794 randomized patients were treated with GTR (n=353), GA (n=357), or placebo (n=84). During the first period LISR presence scores at 5 minutes (mean±SD) were similar in the active groups: 2.13±1.26 (GTR) and 2.14±1.29 (GA). After 24 hours, LISR scores decreased similarly to 0.49±0.68 (GTR) and 0.51±0.81 (GA). Pain was the most relevant LISR: 5 minutes after injection, 62[percnt] (GTR) and 65[percnt] (GA) of patients reported moderate or severe pain at least once. Mean pain severity scores were similar during this period. They decreased from 1.13±0.73 (GTR) and 1.12±0.69 (GA) at 5 minutes to 0.33±0.49 and 0.32±0.52, respectively, at 24 hours. Month 3 results were similar. Local symptomatology in the placebo group was mild with a mean LISR score <0.40 and a maximum severity score 0.24. CONCLUSIONS: Similar local tolerability further supports equivalence of generic GTR to the branded product. Study supported by: Synthon

Disclosure: Dr. Selmaj has received personal compensation for activities with Genzyme Corporation, Novartis, Ono Pharmaceutical, Roche Diagnostics Corporation, Synthon, Teva Neuroscience, and Biogen Idec. as a consultant and/or speaker. Dr. Barkhof has received personal compensation for activities with Bayer Schering Pharma, Sanofi, Genzyme, Biogen Idec, Teva, Merck Serono, Novartis, Roche, Synthon BV, and Janssen Research as a consultant. Dr. Wolf has received personal compensation for activities with Novartis, Synthon, Teva Neuroscience, and BBB as a consultant. Dr. Belova has received research support from Synthon. Dr. Oberye has received personal compensation for activities with Synthon as an employee. Dr. van den Tweel has received personal compensation for activities with Synthon. Dr. Mulder has received research support for activities with Synthon as an employee. Dr. Koper has received personal compensation for activities with Synthon as an employee. Dr. Voortman has received personal compensation for activities with Synthon as an employee. Dr. Cohen has received personal compensation for activities with Biogen Idec, Eli Lilly, Novartis, and Vaccinex as a consultant and/or speaker.