Sunday, 9 August 2015

Efficacy and safety of copaxone three times a week

Wolinsky JS, Borresen TE, Dietrich DW, Wynn D, Sidi Y, Steinerman JR, Knappertz V, Kolodny S; GLACIER Study Group.
GLACIER: An open-label, randomized, multicenter study to assess the safety and tolerability of glatiramer acetate 40mg three-times weekly versus 20mg daily in patients with relapsing-remitting multiple sclerosis. Mult Scler Relat Disord. 2015;4(4):370-6.

BACKGROUND: The efficacy and safety of glatiramer acetate (GA) 20mg/mL once-daily subcutaneous injections (GA20) in relapsing-remittingmultiple sclerosis (RRMS) is well-established. However, injection-related adverse events (IRAEs) may impede treatment adherence and tolerability. GA 40mg/mL three-times weekly (GA40) also has a favourable efficacy and safety profile.
OBJECTIVE: To evaluate the safety, tolerability, and patient experience when converting from GA20 to GA40.
METHODS/TRIAL DESIGN: GLACIER was an open-label, randomized, parallel-group trial conducted at 31 sites in the US between June 2013 and December 2013. Stable RRMS patients on GA20 were randomized in a 1:1 ratio to continue with GA20 or convert to GA40. The adjusted mean annualized rate of IRAEs was the primary endpoint for this study. Additionally, the severity of IRAEs, rate of injection-site reactions (ISRs), and patient-reported MS impact and treatment satisfaction were compared for the two treatment groups over the 4-month core study.
RESULTS: A total of 209 patients were randomized to convert to GA40 (n=108) or continue with GA20 (n=101). The adjusted mean annualized rate of IRAEs was reduced by 50% with GA40 (35.3 events per year; n=108) versus GA20 (70.4 events per year; n=101) (risk ratio (RR)=0.50; 95% confidence interval [CI]=0.34-0.74; p=0.0006). There was a 60% reduction in the rate of moderate/severe events (GA40 (n=108): 0.9 events per year versus GA20 (n=101): 2.2 events per year; RR=0.40; p=0.0021). Perception of treatment convenience improved for GA40-treated patients soon after converting and was sustained.
CONCLUSIONS: The GLACIER study demonstrates a favorable IRAE and convenience profile of GA40 for RRMS patients.


This study examines copaxone once a day verses three times a week and finds that it is better tolerated and seems to have better efficacy.  

CoI None;

However are we surprised? Is this new news. 

It is therefore no wonder that word on the street is that neuros/COPers are/have being convinced to swop from once a day to three times a week treatment. 3 x 40mg = 120mg copaxone verses 7 x 20mg = 140mg copaxone. Is this because it is more convenient and effective that this was developed.

In contrast is this because the once a day patent has run out and this will stop you avoiding you using generic copaxone. 

How long until the three times a week patent runs out?, but as this drug makes $4 billion a year even protection for 6 months generates $2 billion. When the patent run outs will we see 120mg once a week arrive, and then  240mg every 2 weeks, because it is not really clear to me why injections need to be once a day, as in the animal studies the copaxone was often given once only.

However, if making money is the name of the game, hats off to Teva for keeping this product top of the crop for so long, how do they do it

3 comments:

  1. Remember the WiFi password at ECTRIMS in Boston? Apparently free Wifi was sponsored by Teva, and whoever wanted to connect to th eInternet, had to use password "copaxone40"

    ReplyDelete
  2. lol, can't believe they do product placement on a wifi password...yikes.

    ReplyDelete
    Replies
    1. I think the novartis footsteps from the underground to the bar er hotel were good:-)

      Delete

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