Background

Peginterferon (pegIFN) beta-1a with a prolonged half-life and increased systemic exposure was developed for the treatment (tx) of relapsing-remitting multiple sclerosis (RRMS) resulting in less frequent dosing intervals without attenuating the biological or pharmacodynamic properties associated with existing IFN treatments. Real-world data with pegIFN beta-1a in clinical practice are limited. NeuroTransData GmbH (NTD) is a Germany-wide network of neurologists and psychiatrists. The NTD MS registry is a database capturing demographic, clinical history, and clinical variables from MS patients in a real-world setting.

Objectives

To compare pegIFN beta-1a populations with populations using the following injectables: SC IFN beta-1a, IM IFN beta-1a, SC IFN beta-1b, glatiramer acetate (GA).

Methods

NTD registry data from adult patients with RRMS who initiated tx no earlier than 2014, had ≥12 months of tx exposure, and ≥1 EDSS measurement or a relapse after index therapy initiation were retrospectively analyzed. Primary endpoints were annualized relapse rate (ARR) and time to first relapse. The secondary endpoint was time to confirmed disability progression (CDP). Patient characteristics between treatment groups were compared using propensity-score matching (PSM).

Results

In total, 175 pegIFN beta-1a patients, 308 from the IFN group (SC IFN beta-1a, IM IFN beta-1a, SC IFN beta-1b), and 287 GA patients were included in the analysis set. Mean tx duration was 2.5, 2.7, and 2.4 years, respectively. After PSM, no difference was found in the ARR and time to relapse between pegIFN beta-1a patients and patients from the IFN group (estimated ARR ratio 1.18; 95% CI 0.72, 1.94; p= 0.5047; relapse hazard ratio [HR] 1.14; 95% CI 0.71, 1.84; p=0.5790) or the GA group (estimated ARR ratio 0.74; 95% CI 0.45, 1.24; p=0.2608; relapse HR 0.76; 95% CI 0.47, 1.25; p=0.2813). For time to CDP, a significantly higher estimated treatment effect in favor of pegIFN beta-1a was found compared to both, the IFN (CDP HR 0.43; 95% CI 0.21, 0.89; p=0.0234) and the GA group (CDP HR 0.46; 95% CI 0.22, 0.97; p=0.0425).

Conclusions

Statistically significant superiority of pegIFN beta-1a was demonstrated for time to CDP. However, the current analysis is limited by small sample sizes and follow-up time. Updated results with larger sample sizes and longer follow-up time will be presented in order to assess if superiority of pegIFN beta-1a in other endpoints can be supported by statistical evidence.

This study was funded by Biogen.

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).