PLEGRIDY (peginterferon beta-1a) is indicated for the treatment of patients with relapsing forms of multiple sclerosis.
They have attached a polyethylene glycol (PEG) polymer chain to an existing therapeutic molecule to make it bigger so it might disguise itself from the immune system response and last longer. (I think)
Sounds similar to Interferon Beta 1a products.
*The interferon beta-1a portion of PLEGRIDY is produced as a glycosylated protein using genetically-engineered Chinese hamster ovary cells into which the human interferon beta gene has been introduced. The amino acid sequence of the recombinant interferon beta-1a is identical to that of the human interferon beta counterpart.
*PLEGRIDY 125 micrograms contains approximately 12 MIU of antiviral activity.
*The mechanism by which PLEGRIDY exerts its effects in patients with multiple sclerosis is unknown.
*A prefilled syringe of PLEGRIDY for subcutaneous injection contains 0.5 mL of a sterile solution in water for injection of 63, 94, or 125 micrograms of peginterferon beta-1a, 15.8 mg of L-arginine HCl, 0.79 mg of sodium acetate trihydrate, 0.25 mg of glacial acetic acid, and 0.025 mg of polysorbate 20. The pH is approximately 4.8.
*The efficacy of PLEGRIDY was demonstrated in the randomized, double-blind, and placebo-controlled phase (year 1) of Study 1. The trial compared clinical and MRI outcomes at 48 weeks in patients who received PLEGRIDY 125 micrograms (n=512) or placebo (n=500) by the subcutaneous route, once every 14 days.
*The primary outcome was the annualized relapse rate over 1 year. Secondary outcomes included the proportion of patients relapsing, number of new or newly enlarging T2 hyperintense lesions, and time to confirmed disability progression.
*The study started with 500 patients on placebo and 512 on Plegridy. After 24 weeks (so 12 injections) the placebo group had fallen by 20.4% and the Plegridy group had dropped 19.14%. After 48 weeks (24 injections) the placebo group fell a further 29.64% and the Plegridy group fell a further 23.188%. So 37.89% had dropped out of Plegridy use by 48 weeks. The note does not detail why but makes many references to Interferon Beta 1a as a comparator for experiences.
The time to relapse outcome was better than the placebo. (do nothing)
I have no view.