Biogen

Author Of 1 Presentation

Observational Studies Poster Presentation

P0914 - Safety and clinical effectiveness of peginterferon beta-1a for relapsing multiple sclerosis: PLEGRIDY Observational Program fourth interim results (ID 1560)

Speakers
Presentation Number
P0914
Presentation Topic
Observational Studies

Abstract

Background

Peginterferon beta-1a every 2 weeks is approved to treat relapsing forms of multiple sclerosis (MS). The 5-year phase 4 PLEGRIDY Observational Program (POP) study explores the real-world safety and effectiveness of peginterferon beta-1a.

Objectives

Report safety, pregnancy outcomes, and clinical effectiveness of peginterferon beta-1a in patients enrolled in POP.

Methods

POP is fully enrolled (n=1208) and ongoing in 128 sites across 14 countries. Data reflect the fourth interim data cut as of September 2019, with the exception of pregnancy outcomes, which are reported as of February 2020. Patients diagnosed <1 year prior to POP study consent and naive to MS disease-modifying therapies were considered newly diagnosed (ND); all others were considered non–newly diagnosed (NND).

Results

Analyses of safety and effectiveness included 1161 (ND, 289; NND, 872) patients and 1160 (ND, 289; NND, 871) patients, respectively. Baseline (BL) characteristics were generally similar between the subgroups, though ND patients were younger than NND patients, had less disability, had more relapses in the prior year, and had a shorter MS treatment duration. Flu-like symptoms (FLS) and injection-site reactions were reported in 51.6% and 37.4% of ND patients, respectively, and 43.8% and 41.4% of NND patients, respectively. Treatment-emergent serious adverse events (AEs) were reported in 5.9% of ND and 8.1% of NND patients. The overall incidence of treatment-emergent AEs was 66.8% in ND patients and 65.0% in NND patients. Of the 32 pregnancies reported, 28 had known outcomes, including 24 live births without congenital anomaly (85.7%), 3 spontaneous abortions (10.7%), and 1 elective termination (3.6%). Adjusted annualized relapse rates in ND and NND patients were 0.11 and 0.12, respectively, with 74.0% of ND and 81.5% of NND patients free of relapse at 3 years. From BL to 3 years, mean Expanded Disability Status Scale scores appeared stable in ND (1.4 [n=118] to 1.5 [n=76]) and NND patients (1.9 [n=297] to 2.1 [n=194]).

Conclusions

These data from POP show a safety profile consistent with clinical trials. ND patients were more likely to experience FLS than NND patients, indicating the importance of FLS mitigation and management in the ND population. The high proportion of relapse-free patients at 3 years in both subgroups indicates the efficacy of peginterferon beta-1a in treatment of relapsing MS, including in ND patients who may benefit from early treatment initiation.

The POP study is funded by Biogen. Biogen funded the analyses and writing support for this abstract. Writing support was provided by Ashfield Healthcare Communications (Middletown, CT, USA).

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