Contributions
Abstract: EP1627
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Subcutaneous peginterferon beta-1a 125 mcg every 2 weeks is approved for the treatment of relapsing-remitting multiple sclerosis (RRMS). The 5-year observational Phase IV Plegridy Observational Study (POP) provides an opportunity to explore the long-term safety and effectiveness of peginterferon beta-1a in a real-world setting.
Objectives: Report interim data on baseline, adverse events (AEs), and clinical effectiveness from the POP study.
Methods: The POP study is ongoing in over 150 sites in 14 countries. Patients who initiated peginterferon beta-1a treatment either after or within 31 days prior to date of consent (Naïve subgroup) and patients treated with peginterferon beta-1a more than 31 days prior to date of consent (Experienced subgroup) will be followed for up to 5 years.
Results: Data from 467 patients treated with peginterferon beta-1a were analysed. At the time of this first interim analysis, 409 patients (88%) had been followed for 12-24 months. A total of 153 patients (31%) discontinued treatment, primarily due to AEs (55%) and lack of efficacy (13%). At on-study baseline, mean age was 44.9 years, 76% were female, and the mean Expanded Disability Status Scale (EDSS) score was 1.9. Of the 370 patients (79%) previously treated with a disease-modifying therapy, 217 (46%) had been treated with intramuscular interferon beta-1a. There were more patients in the Naïve subgroup than in the Experienced subgroup (60% vs 40%, respectively). Overall, AEs were more common in the Naïve subgroup compared with the Experienced subgroup (35% vs 20%). Serious AEs were reported in 5% and 9% of the Naïve and Experienced subgroups, respectively. AEs leading to treatment discontinuation were also more common in the Naïve subgroup (29% vs 15%). The most commonly reported AEs leading to treatment discontinuation in both groups were injection-site erythema and influenza-like illness. A high proportion of patients in both groups were reported to be relapse-free (84.4% and 81.5%; Naïve and Experienced, respectively).
Conclusions: The safety profile reported in this first interim analysis of the POP study was consistent with that observed in the pivotal Phase 3 trial of peginterferon beta-1a. No new safety signals were observed. Patients who had been naïve to peginterferon beta-1a were more likely to experience AEs and discontinue treatment due to injection site reactions and flu-like symptoms, highlighting a need for prophylactic mitigation strategies.
Disclosure:
Marco Salvetti has received grant support and speaker honoraria from Biogen.
Andrew. Pachner has been a PI on clinical trials funded by: Biogen, EMD Serono, Genzyme, Novartis, Genentech, and Roche; as well as a PI on basic research studies funded by: Acorda, Biogen, EMD Serono and Genzyme. He has received consulting fees for participation in advisory boards from Biogen, Genzyme, and Novartis.
Jang Yun, David Appiah-Badu, Guido Sabatella, and Maria L. Naylor are employees and stockholders of Biogen.
Abstract: EP1627
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Subcutaneous peginterferon beta-1a 125 mcg every 2 weeks is approved for the treatment of relapsing-remitting multiple sclerosis (RRMS). The 5-year observational Phase IV Plegridy Observational Study (POP) provides an opportunity to explore the long-term safety and effectiveness of peginterferon beta-1a in a real-world setting.
Objectives: Report interim data on baseline, adverse events (AEs), and clinical effectiveness from the POP study.
Methods: The POP study is ongoing in over 150 sites in 14 countries. Patients who initiated peginterferon beta-1a treatment either after or within 31 days prior to date of consent (Naïve subgroup) and patients treated with peginterferon beta-1a more than 31 days prior to date of consent (Experienced subgroup) will be followed for up to 5 years.
Results: Data from 467 patients treated with peginterferon beta-1a were analysed. At the time of this first interim analysis, 409 patients (88%) had been followed for 12-24 months. A total of 153 patients (31%) discontinued treatment, primarily due to AEs (55%) and lack of efficacy (13%). At on-study baseline, mean age was 44.9 years, 76% were female, and the mean Expanded Disability Status Scale (EDSS) score was 1.9. Of the 370 patients (79%) previously treated with a disease-modifying therapy, 217 (46%) had been treated with intramuscular interferon beta-1a. There were more patients in the Naïve subgroup than in the Experienced subgroup (60% vs 40%, respectively). Overall, AEs were more common in the Naïve subgroup compared with the Experienced subgroup (35% vs 20%). Serious AEs were reported in 5% and 9% of the Naïve and Experienced subgroups, respectively. AEs leading to treatment discontinuation were also more common in the Naïve subgroup (29% vs 15%). The most commonly reported AEs leading to treatment discontinuation in both groups were injection-site erythema and influenza-like illness. A high proportion of patients in both groups were reported to be relapse-free (84.4% and 81.5%; Naïve and Experienced, respectively).
Conclusions: The safety profile reported in this first interim analysis of the POP study was consistent with that observed in the pivotal Phase 3 trial of peginterferon beta-1a. No new safety signals were observed. Patients who had been naïve to peginterferon beta-1a were more likely to experience AEs and discontinue treatment due to injection site reactions and flu-like symptoms, highlighting a need for prophylactic mitigation strategies.
Disclosure:
Marco Salvetti has received grant support and speaker honoraria from Biogen.
Andrew. Pachner has been a PI on clinical trials funded by: Biogen, EMD Serono, Genzyme, Novartis, Genentech, and Roche; as well as a PI on basic research studies funded by: Acorda, Biogen, EMD Serono and Genzyme. He has received consulting fees for participation in advisory boards from Biogen, Genzyme, and Novartis.
Jang Yun, David Appiah-Badu, Guido Sabatella, and Maria L. Naylor are employees and stockholders of Biogen.