Friday, 24 May 2013

3X per week glatiramer acetate

3X a week glatiramer acetate (Copaxone); innovation or life-cycle management? #MSBlog #MSResearch

Epub
: Khan et al. Three times weekly glatiramer acetate in relapsing-remitting multiple sclerosis. Ann Neurol. 2013 May 20. doi: 10.1002/ana.23938.

Objective: To assess the efficacy and safety of glatiramer acetate (GA) 40 mg administered three times weekly (tiw) compared with placebo in RRMSers. 

Methods: This randomized, double-blind study was conducted in 142 sites in 17 countries. RRMSers with at least one documented relapse in the 12 months before screening, or at least two documented relapses in the 24 months before screening, and an Expanded Disability Status Scale score ≤5.5, were randomized 2:1 to receive either subcutaneous (sc) GA 40 mg tiw (1 mL) or placebo for 12 months. 

Results: Of 1524 MSers screened, 1404 were randomized to receive GA 40 mg sc tiw (n=943) or placebo (n=461). Ninety-three percent and 91% of MSers in the placebo and GA groups, respectively, completed the 12-month study. GA 40 mg tiw was associated with a 34.0% reduction in risk of confirmed relapses compared with placebo (mean annualized relapse rate 0.331 vs 0.505; p< 0.0001). MSers who received GA 40 mg tiw experienced highly significant reduction (p< 0.0001) in the cumulative number of gadolinium (Gd)-enhancing T1 (44.8%) and new or newly enlarging T2 lesions (34.7%), at months 6 and 12. GA 40 mg tiw was safe and well tolerated. The most common adverse events in the GA group were injection-site reactions (35.5% with GA vs 5.0% with placebo). 

Interpretation: GA 40 mg sc tiw is a safe and effective regimen for the treatment of RRMS, providing the convenience of fewer sc injections per week. 


"Two days ago it was a new interferon preparation that could be given every 2 weeks or possibly every 4 weeks and now its double-dose glatiramer acetate (Copaxone) that can be give 3X times a week instead of every day. Is this innovation or life-cycle management of blockbuster drugs that are beginning to get ready for the invasion of cheaper biosimilars?"

CoI: multiple

Other posts of interest:

24 Feb 2013
OBJECTIVE: A double-blind, randomized, controlled study to determine if combined use of interferon beta-1a (IFN) 30ug IM weekly and glatiramer acetate (GA) 20mg daily is more efficacious than either agent alone in ...
08 Feb 2013
Research: Glatiramer acetate and the neuroprotective effects. Epub: Gentile et al. Glatiramer Acetate Protects Against Inflammatory Synaptopathy in Experimental Autoimmune Encephalomyelitis. J Neuroimmune Pharmacol.
25 Dec 2012
RESULTS: Early glatiramer acetate treatment reduced CDMS conversion risk by 41% (hazard ratio 0.59, 95% confidence interval 0.44-0.80; p=0.0005) versus delayed-treatment, and was associated with a 972-day delay ...
18 Nov 2012
Research: glatiramer acetate in EAE again. Epub: Aharoni et al. Magnetic resonance imaging characterization of different experimental autoimmune encephalomyelitis models and the therapeutic effect of glatiramer acetate.

25 Oct 2012
BACKGROUND: Only few studies have assessed safety of in utero exposure to glatiramer acetate (GA). Following a previous study assessing the safety of interferon beta (IFNB) pregnancy exposure in MS, these investigators ...
18 Apr 2013
The phase III, multicenter, randomized, placebo-controlled PreCISe trial assessed glatiramer acetate (GA) effects in patients with clinically isolated syndromes (CIS) suggestive of multiple sclerosis (MS). To assess the ...
12 Aug 2012
Glatiramer acetate and liver problems. Subramaniam et al. Glatiramer acetate induced hepatotoxicity. Curr Drug Saf 2012 Apr 1;7(2):186-8. Introduction: Glatiramer acetate (Copaxone), a polypeptide has been approved for ...
28 Jun 2012
Research: skin reactions to glatiramer acetate. Mayorga et al. Immunological mechanisms underlying delayed-type hypersensitivity reactions to glatiramer acetate. Ann Allergy Asthma Immunol. 2012;109(1):47-51.

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