Peginterferon beta-1a – nowa postać interferonu beta-1a

• Authors: Zdzisław Maciejek , Anna Niezgodzińska-Maciejek

Title variants

EN

Peginterferon beta-1a – a new form of interferon beta-1a

• Languages of publication: EN PL

Abstracts

EN

In 2014 after phase 3 ADVANCE clinical study was finished, a new, pegylated form of interferon beta-1a with less frequent dosing was accepted for treatment in relapsing-remitting multiple sclerosis. One thousand five hundred and twelve patients with relapsing-remitting multiple sclerosis were enrolled to the ADVANCE study from 183 sites in 26 countries (500 to the placebo group, 512 to the 125 μg subcutaneous peginterferon beta-1a every 2 weeks group and 500 to the 125 μg subcutaneous peginterferon beta-1a every 4 weeks group). The investigated groups were similar in terms of age, sex, duration of the disease and disability rated using the Expanded Disability Status Scale. The primary and secondary endpoints were efficacy and safety of 2-year peginterferon beta-1a treatment in patients with relapsing-remitting multiple sclerosis compared to the placebo group, which after 1 year also received peginterferon beta-1a 125 μg every 2 or every 4 weeks. The results from the 2-year ADVANCE study demonstrate efficacy of treatment with peginterferon beta-1a 125 μg administered subcutaneously every 2 weeks compared with placebo: significantly reduced annualized relapse rate (by 37%), the number of new/newly enlarged T2 lesions (by 67%), the risk of relapse (by 39%) and the risk of 12-week sustained disability progression (by 33%). The most common adverse events (94% of patients) associated with peginterferon beta-1a treatment were: injection site reactions, flu-like symptoms, pyrexia and headache. Sixteen percent of patients taking the study drug every 2 weeks and 22% of patients taking the study drug every 4 weeks reported serious adverse events; relapse, pneumonia and urinary tract infections were the most common. Interpretation: the treatment with peginterferon beta-1a with less frequent administration is effective, well tolerated and safe for patients with relapsing-remitting multiple sclerosis.

PL

W 2014 roku, po zakończeniu próby klinicznej III fazy ADVANCE, do leczenia postaci rzutowo-remisyjnej stwardnienia rozsianego wprowadzono nową pegylowaną postać interferonu beta-1a o wydłużonym czasie działania. Do badania zakwalifikowano 1512 chorych ze 183 ośrodków z 26 krajów (500 uczestników przyjmowało placebo, 512 – peginterferon beta-1a w dawce 125 μg podawany podskórnie co 2 tygodnie, 500 – peginterferon beta-1a w dawce 125 μg podawany podskórnie co 4 tygodnie). Grupy były zbliżone pod względem wieku, płci, czasu trwania choroby i niepełnosprawności ocenianej w Expanded Disability Status Scale. Cel badania stanowiła ocena skuteczności i bezpieczeństwa pegylowanego interferonu beta-1a po 2 latach terapii w porównaniu z grupą placebo, która w drugim roku również otrzymywała ten lek. Skuteczność peginterferonu beta-1a podawanego co 2 tygodnie w porównaniu z placebo przejawiała się redukcją rocznego wskaźnika rzutów (o 37%), liczby nowych lub powiększonych ognisk T2-zależnych (o 67%), ryzyka wystąpienia rzutu (o 39%) i ryzyka utrwalonej 12-tygodniowej progresji niepełnosprawności (o 33%). Najczęstsze działania niepożądane towarzyszące kuracji (94% chorych) to odczyn w miejscu wkłucia, objawy grypopodobne, gorączka i bóle głowy. U 16% osób przyjmujących lek co 2 tygodnie i 22% otrzymujących go co 4 tygodnie odnotowano poważne objawy niepożądane (rzuty, zapalenie płuc, infekcje dróg moczowych). Reasumując: leczenie peginterferonem beta-1a cechowały skuteczność, dobra tolerancja i bezpieczeństwo.

Keywords

EN

MRI; NEDA; RRMS; peginterferon beta-1a

Discipline

• MEDICINE: MEDICINE

• Publisher: Medical Communications
• Journal: Aktualności Neurologiczne
• Year: 2015
• Volume: 15
• Issue: 3
• Pages: 135–138

Contributors

author

Zdzisław Maciejek

• Klinika Neurologiczna, 10. Wojskowy Szpital Kliniczny z Polikliniką SPZOZ w Bydgoszczy, Polska

author

Anna Niezgodzińska-Maciejek

• Klinika Neurologiczna, 10. Wojskowy Szpital Kliniczny z Polikliniką SPZOZ w Bydgoszczy, Polska

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• Document Type: review