Patient-Reported Outcomes for Patients Treated with Peginterferon Beta-1a: Plegridy Observational Program Interim Analysis

Background: Assessment of patient-reported outcomes (PROs) is important for monitoring patients receiving disease modifying therapies (DMTs) for multiple sclerosis (MS). The Plegridy Observational Program (POP) explores the real-world safety and effectiveness of peginterferon beta-1a in patients with relapsing MS (RMS).

Objectives: To describe the impact of peginterferon beta-1a on PROs for patients enrolled in POP.

Methods: POP is fully enrolled and ongoing in approximately 130 sites across 14 countries. Data reflect the 5th interim data cut as of February 2021. Newly diagnosed (ND) patients were defined as those diagnosed with RMS ≤1 year prior to consent and no prior DMT treatment. Non-newly diagnosed (NND) patients were defined as those diagnosed >1 year prior to study consent and/or with prior DMT treatment. PROs were assessed using the EQ-5D-3L Health Questionnaire which includes 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with three levels per dimension (no problems, some problems, and extreme problems). Current overall health status was rated using a calibrated visual analog scale (EQ-VAS) with 0=worst and 100=best.

Results: The effectiveness analysis population included 1168 patients (ND 292 [25.0%]; NND 876 [75.0%]). Baseline (BL) demographic and disease characteristics were similar, although ND patients had shorter mean (standard deviation [SD]) time since MS symptom onset (4.2 [6.45] vs 12.7 [8.87] years) and more mean [SD] relapses in the 12 months prior to enrollment (0.9 [0.66] vs 0.3 [0.64]) compared with NND patients. At BL, among patients who completed the EQ-5D-3L, 5.4% (13/240) of ND and 8.1% (56/688) of NND patients reported “extreme problems” for ≥1 dimension, with those proportions decreasing to 2.7% (1/37) and 2.8% (3/106) for ND and NND patients, respectively, at year 5. At BL, overall health status, assessed by mean (SD) EQ-VAS scores, was similar for the ND and NND groups (77.9 [17.71] vs 77.4 [16.72]; P=0.4181). At year 5, mean (SD) EQ-VAS scores had increased in both groups (ND 81.9 [10.72]; NND 79.4 [16.61]; P=0.9353).

Conclusions: Over 5 years, patient reported health outcomes remained stable for ND and NND patients, as shown by numerical decreases in proportions of patients with “extreme problems” and by increases in overall health status score. These results indicate that peginterferon beta-1a can provide improvements in outcomes important for both ND and NND patients.

Support: Biogen