What is Plegridy - peginterferon beta-1a and what is it used for?
Plegridy is a medicine that contains the active substance peginterferon beta-1a . It is indicated for the treatment of multiple sclerosis (MS), a disease in which inflammation destroys the protective sheath that covers the nerve fibers. It is particularly indicated in adult patients with a form of multiple sclerosis known as "relapsing-remitting" (that is when the patient suffers from exacerbations of symptoms (relapses) followed by periods of recovery (remissions).
How is Plegridy used - peginterferon beta-1a?
Plegridy can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in the treatment of MS. Plegridy is available as a solution for injection in pre-filled pens containing 63, 94 or 125 micrograms of peginterferon beta-1a. Treatment should start with a dose of 63 micrograms, followed by a dose of 94 micrograms after two weeks, then continuing with a dose of 125 micrograms every two weeks. Plegridy is given by subcutaneous injection in the abdomen, arm or thigh. The patient can inject himself the medicine after receiving appropriate instructions. For more information, see the package leaflet.
How does Plegridy work - peginterferon beta-1a?
In multiple sclerosis the body's immune system does not function properly and attacks certain parts of the central nervous system (consisting of brain and spinal cord), causing inflammation that damages nerve sheaths. The mechanism of action of Plegridy in MS is not yet fully known but the active ingredient contained in the medicine, peginterferon beta 1-a, appears to reduce the activity of the immune system (the body's natural defenses) and prevent relapses of MS. Interferon beta 1-a is a form of protein that is naturally produced by the body. The interferon present in Plegridy is produced by a method known as "recombinant DNA technology": that is, it is obtained from cells in which a gene (DNA) has been introduced that allows them to produce human interferon. The interferon is then "pegylated" (ie linked to a chemical called "polyethylene glycol"). This treatment reduces the rate at which the substance is eliminated from the body and allows the medicine to be administered less often.
What benefit has Plegridy - peginterferon beta-1a shown during the studies?
As part of a two-year main study involving 1, 516 patients, Plegridy has been shown to reduce the percentage of relapses in patients with relapsing-remitting MS. During the first year, patients were treated with Plegridy or placebo (a dummy treatment) every two or four weeks; the second year, all patients were treated with Plegridy every two or four weeks. The main measure of effectiveness was the number of relapses reported by patients over 1 year, although the study also examined other parameters including the rapidity of progression of disability. In the first year, patients treated with Plegridy every two or four weeks reported on average less recurrence than placebo-treated patients: 0.26 and 0.29 relapses, respectively, compared to 0.40. Disability progression decreased in subjects treated with Plegridy every two weeks, while the data appears less clear in patients treated every four weeks. In the second year of therapy Plegridy continued to produce benefits. The study was extended for another two years to examine the safety and efficacy of Plegridy over the long term, and the data from this second phase available at the time of the authorization were consistent with the results of the main study.
What is the risk associated with Plegridy - peginterferon beta-1a?
The most common side effects with Plegridy (which may affect more than 1 in 10 people) are headache, myalgia (muscle pain), arthralgia (joint pain), flu-like symptoms, pyrexia (fever), chills, asthenia (weakness) and erythema (redness of the skin), pain or itching at the injection site. Treatment with Plegridy should not be started during pregnancy. Furthermore, Plegridy should not be used in patients with severe depression or suicidal thoughts. For the full list of all side effects and restrictions with Plegridy, see the package leaflet.
Why has Plegridy - peginterferon beta-1a been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Plegridy's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that Plegridy given every two weeks has been shown to induce a reduction of about 30% in the number of relapses in patients with relapsing-remitting MS compared to placebo, a result that is comparable to that seen with other medicines used in the treatment of MS containing non-pegylated beta interferon, and which is therefore considered clinically relevant. Furthermore, the CHMP is of the opinion that Plegridy offers patients greater benefits when administered every two weeks compared to the less frequent administrations tested in the study. When Plegridy was given every four weeks, its positive effect was lower and it was not possible to identify a group of patients in whom this less frequent dosage could be considered adequate. As for the safety profile, the most common adverse events observed during treatment with Plegridy are considered manageable and, in general, are consistent with the events observed with the use of non-pegylated interferon-based medicines.
What measures are being taken to ensure the safe and effective use of Plegridy - peginterferon beta-1a?
A risk management plan has been developed to ensure that Plegridy is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Plegridy, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
Other information on Plegridy - peginterferon beta-1a
On 18 July 2014, the European Commission issued a marketing authorization for Plegridy, valid throughout the European Union. For more information about treatment with Plegridy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 07-2014.
