Plegridy (peginterferon beta-1a)

– a pegylated beta-interferon1

Indication

PLEGRIDY is indicated in adults for the treatment of relapsing remitting multiple sclerosis (RRMS).1

Posology

The recommend dosage for PLEGRIDY is 125 μg subcutaneous injection every 2 weeks.1 It is recommended that dosing should be titrated at initiation: The first dose should be 63 μg (day 0); the second dose should be 94 μg (day 14); and then 125 μg (day 28) and every 2 weeks there after.1 An Initiation Pack is available with the 63 μg and 94 μg doses.1

Efficacy

Results from ADVANCE, a pivotal phase III study: PLEGRIDY has demonstrated efficacy across measures of annualised relapse rate (ARR), disability progression and MRI indicators of disease activity compared with placebo and post-hoc analysis of ADVANCE (ATTAIN ITT population) also support better no-evidence-of-disease-activity (NEDA) outcomes for PLEGRIDY versus placebo. 1-4

Significant results in all clinical and neuroradiological endpoints at year 1 2,4

Safety profile

PLEGRIDY has an established and mangageable tolerability and safety profile.1,5 The majority of adverse events (AEs) reported in the clinical trial were mild to moderate.1-3 The most common AEs are injection site reactions and flu-like symptoms. PLEGRIDY is associated with low rates of immunogencity.5

The long-term safety profile of PLEGRIDY has also been investigated. There were no marked changes in any AE rates in years 3–6 (n=547) of treatment compared with years 0–2 (n=512).5

See the SmPC (UK), (ROI) and PI for more information

Study design: ADVANCE: An international, 2-year, double-blind, parallel group, phase 3 study, with placebo-controlled design for the first 48 weeks. 1,512 RRMS patients (aged 18-65 with EDSS ≤5) were randomly assigned to receive placebo, PLEGRIDY 125 μg every two weeks, or peginterferon beta-1a 125 μg every four weeks. For year two, patients originally randomised to placebo were re-randomised to PLEGRIDY 125 μg two-weekly or peginterferon beta-1a four-weekly. The primary endpoint of the study was: ARR at 48 weeks. The secondary endpoints were: number of new or newly enlarging T2 hyperintense lesions, proportion of patients who relapsed and proportion of patients with 12-week disability progression,1 all at year 1.

ATTAIN:4 A 2-year extension study of ADVANCE with the objective of determining the long-term safety and efficacy PLEGRIDY. Patients who had successfully completed the ADVANCE 2-year trial were eligible to enter the ATTAIN study.

Abbreviations: AE: Adverse Event; ARR: Annualised Relapse Rate; CDP: Confirmed Disability Progression; EDSS: Expanded Disability Status Scale; Gd+: Gadolinium Enhancing; MRI: Magnetic Resonance Imaging; ITT: Intention-to-treat; NEDA: No Evidence of Disease Activity; RRMS: Relapsing Remitting Multiple Sclerosis

Biogen-11457 Date of prep: May 2019