Contributions
Abstract: P1236
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: Peginterferon beta-1a every 2 weeks is approved for the treatment of relapsing-remitting multiple sclerosis (RRMS). The phase-3 ADVANCE study and the ATTAIN extension study established long-term safety and efficacy. The 5-year phase-4 Plegridy Observational Program (POP) study explores long-term safety and effectiveness of peginterferon beta-1a in a real-world setting.
Objectives: Report data from the second interim analysis on baseline (BL) characteristics, adverse events (AEs), and clinical effectiveness in newly diagnosed (ND) and non-newly diagnosed (NND) patients in POP.
Methods: POP is fully enrolled and ongoing in approximately 150 sites across 14 countries. Patients diagnosed < 1 year prior to POP study consent and naïve to MS disease-modifying therapy (DMT) were considered ND.
Results: This analysis included data as of Sep 2017 from 963 patients who had received ≥1 peginterferon beta-1a dose; 690 (72%) were ongoing in the study. Nearly all patients (>99%) were followed for ≤36 months. Of the 963 patients, 242 (25%) were ND. BL characteristics were generally balanced between the subgroups; however, ND patients were generally younger (mean age: ND, 37.7 years, NND, 46.0 years); had less disability (mean EDSS score: ND, 1.5; NND, 2.0); and had more relapses in the prior year (mean, ND, 1.0; NND, 0.3) than NND patients. Treatment discontinuation rates for ND and NND patients were similar (31% vs 32%). Among these patients, the most commonly cited reasons for discontinuation were AEs (60% ND, 65% NND) and lack of efficacy (24% ND, 15% NND). The most commonly reported AEs leading to discontinuation across groups were injection site erythema and influenza-like illness. Most ND patients who discontinued switched to either glatiramer acetate (24%) or an oral therapy (49%); most NND patients switched to either intramuscular interferon beta-1a (34%) or an oral therapy (39%). Patients who discontinued due to an AE were more likely to switch to another injectable therapy than those who discontinued due to lack of efficacy. A high proportion of ND (82%) and NND (85%) patients were relapse free up to 2 years.
Conclusions: The safety profile in this analysis of POP was consistent with that in ADVANCE/ATTAIN; no new safety signals were observed. The high proportion of relapse-free ND and NND patients demonstrates peginterferon beta-1a may be an effective therapy in RRMS patients, including ND patients who may benefit from early treatment initiation.
Disclosure: Supported by Biogen.
MS: received grant support and/or speaker honoraria from Biogen, Merck, Novartis, Roche, Sanofi, and Teva.
SW: paid consultant, speaker, and/or contract researcher for Acorda, Bayer, Biogen, EMD Serono, Genzyme, Novartis, Questcor, Receptos, Genentech/Roche, and Teva.
OM, DAB, MLN: employees of and may hold stock and/or stock options in Biogen.
Abstract: P1236
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: Peginterferon beta-1a every 2 weeks is approved for the treatment of relapsing-remitting multiple sclerosis (RRMS). The phase-3 ADVANCE study and the ATTAIN extension study established long-term safety and efficacy. The 5-year phase-4 Plegridy Observational Program (POP) study explores long-term safety and effectiveness of peginterferon beta-1a in a real-world setting.
Objectives: Report data from the second interim analysis on baseline (BL) characteristics, adverse events (AEs), and clinical effectiveness in newly diagnosed (ND) and non-newly diagnosed (NND) patients in POP.
Methods: POP is fully enrolled and ongoing in approximately 150 sites across 14 countries. Patients diagnosed < 1 year prior to POP study consent and naïve to MS disease-modifying therapy (DMT) were considered ND.
Results: This analysis included data as of Sep 2017 from 963 patients who had received ≥1 peginterferon beta-1a dose; 690 (72%) were ongoing in the study. Nearly all patients (>99%) were followed for ≤36 months. Of the 963 patients, 242 (25%) were ND. BL characteristics were generally balanced between the subgroups; however, ND patients were generally younger (mean age: ND, 37.7 years, NND, 46.0 years); had less disability (mean EDSS score: ND, 1.5; NND, 2.0); and had more relapses in the prior year (mean, ND, 1.0; NND, 0.3) than NND patients. Treatment discontinuation rates for ND and NND patients were similar (31% vs 32%). Among these patients, the most commonly cited reasons for discontinuation were AEs (60% ND, 65% NND) and lack of efficacy (24% ND, 15% NND). The most commonly reported AEs leading to discontinuation across groups were injection site erythema and influenza-like illness. Most ND patients who discontinued switched to either glatiramer acetate (24%) or an oral therapy (49%); most NND patients switched to either intramuscular interferon beta-1a (34%) or an oral therapy (39%). Patients who discontinued due to an AE were more likely to switch to another injectable therapy than those who discontinued due to lack of efficacy. A high proportion of ND (82%) and NND (85%) patients were relapse free up to 2 years.
Conclusions: The safety profile in this analysis of POP was consistent with that in ADVANCE/ATTAIN; no new safety signals were observed. The high proportion of relapse-free ND and NND patients demonstrates peginterferon beta-1a may be an effective therapy in RRMS patients, including ND patients who may benefit from early treatment initiation.
Disclosure: Supported by Biogen.
MS: received grant support and/or speaker honoraria from Biogen, Merck, Novartis, Roche, Sanofi, and Teva.
SW: paid consultant, speaker, and/or contract researcher for Acorda, Bayer, Biogen, EMD Serono, Genzyme, Novartis, Questcor, Receptos, Genentech/Roche, and Teva.
OM, DAB, MLN: employees of and may hold stock and/or stock options in Biogen.