Contributions
Abstract: P662
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: The pivotal Phase 3 ADVANCE study evaluated the efficacy of subcutaneous peginterferon beta-1a 125 mcg every 2 weeks in patients with relapsing-remitting multiple sclerosis (RRMS), approximately 45% of whom were newly diagnosed and had no prior treatment with a disease-modifying therapy (DMT). While peginterferon beta-1a demonstrated a significant treatment effect vs placebo, the impact of treatment on newly diagnosed patients was not evaluated.
Objectives: Evaluate the effect of peginterferon beta-1a on clinical and radiological disease activity in the subgroup of newly diagnosed, treatment-naïve patients from ADVANCE.
Methods: ADVANCE was a 2-year double-blinded study, in which patients were randomised to receive peginterferon beta-1a every 2 weeks, every 4 weeks, or placebo in Year 1. In Year 2, placebo patients were re-randomised to peginterferon beta-1a every 2 or 4 weeks (delayed-treatment group). Here, the subgroup of patients who were diagnosed ≤1 year prior to study enrolment and had never received a DMT for RRMS were analysed. Annualised relapse rate (ARR), time to first relapse, 24-week confirmed disability worsening (CDW), MRI endpoints, and safety were compared between the every2-weeks group and the delayed-treatment group.
Results: Over 2 years, the adjusted ARR in newly diagnosed patients was reduced by 32.3% for the peginterferon beta-1a every-2-weeks group (n=231), compared with the delayed-treatment group (n=229; p=0.0352). Time to first relapse was delayed in the every-2-weeks group compared with the delayed-treatment group (p=0.0101), and the proportion of patients with 24-week CDW was numerically lower in the every-2-weeks group compared with the delayed-treatment group. At Year 2 the number of new/newly enhancing T2 lesions was lower in the every-2-weeks vs the delayed-treatment group (p< 0.0001), although there appeared to be no difference between the groups in the number of gadolinium-enhancing (Gd+) lesions. The safety profile in newly diagnosed patients was similar to what was observed in the overall patient population.
Conclusions: Newly diagnosed, treatment-naïve patients displayed significantly reduced disease activity when administered peginterferon beta-1a every 2 weeks compared with delayed-treatment patients. These results are generally consistent with what was observed in the previously reported overall population in ADVANCE, and highlight the benefits of initiating therapy early following diagnosis with RRMS.
Disclosure:
Scott D. Newsome has received research support (paid directly to institution) from Biogen, Novartis, Genentech, and the National MS society, and has participated in scientific advisory boards for Biogen and Genentech.
Douglas L. Arnold reports an equity interest in NeuroRx during the conduct of the study and personal fees from Biogen, EMD Serono, Genentech, Genzyme, Hoffman-La Roche, Innate Immunotherapy, MedImmune, Mitsubishi, Novartis, Receptos, Acorda, Sanofi-Aventis, and Teva outside the submitted work, as well as grants from Biogen and Novartis.
Jang Yun, Matthias Meergans, and Maria L. Naylor are employees and stockholders of Biogen.
Abstract: P662
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: The pivotal Phase 3 ADVANCE study evaluated the efficacy of subcutaneous peginterferon beta-1a 125 mcg every 2 weeks in patients with relapsing-remitting multiple sclerosis (RRMS), approximately 45% of whom were newly diagnosed and had no prior treatment with a disease-modifying therapy (DMT). While peginterferon beta-1a demonstrated a significant treatment effect vs placebo, the impact of treatment on newly diagnosed patients was not evaluated.
Objectives: Evaluate the effect of peginterferon beta-1a on clinical and radiological disease activity in the subgroup of newly diagnosed, treatment-naïve patients from ADVANCE.
Methods: ADVANCE was a 2-year double-blinded study, in which patients were randomised to receive peginterferon beta-1a every 2 weeks, every 4 weeks, or placebo in Year 1. In Year 2, placebo patients were re-randomised to peginterferon beta-1a every 2 or 4 weeks (delayed-treatment group). Here, the subgroup of patients who were diagnosed ≤1 year prior to study enrolment and had never received a DMT for RRMS were analysed. Annualised relapse rate (ARR), time to first relapse, 24-week confirmed disability worsening (CDW), MRI endpoints, and safety were compared between the every2-weeks group and the delayed-treatment group.
Results: Over 2 years, the adjusted ARR in newly diagnosed patients was reduced by 32.3% for the peginterferon beta-1a every-2-weeks group (n=231), compared with the delayed-treatment group (n=229; p=0.0352). Time to first relapse was delayed in the every-2-weeks group compared with the delayed-treatment group (p=0.0101), and the proportion of patients with 24-week CDW was numerically lower in the every-2-weeks group compared with the delayed-treatment group. At Year 2 the number of new/newly enhancing T2 lesions was lower in the every-2-weeks vs the delayed-treatment group (p< 0.0001), although there appeared to be no difference between the groups in the number of gadolinium-enhancing (Gd+) lesions. The safety profile in newly diagnosed patients was similar to what was observed in the overall patient population.
Conclusions: Newly diagnosed, treatment-naïve patients displayed significantly reduced disease activity when administered peginterferon beta-1a every 2 weeks compared with delayed-treatment patients. These results are generally consistent with what was observed in the previously reported overall population in ADVANCE, and highlight the benefits of initiating therapy early following diagnosis with RRMS.
Disclosure:
Scott D. Newsome has received research support (paid directly to institution) from Biogen, Novartis, Genentech, and the National MS society, and has participated in scientific advisory boards for Biogen and Genentech.
Douglas L. Arnold reports an equity interest in NeuroRx during the conduct of the study and personal fees from Biogen, EMD Serono, Genentech, Genzyme, Hoffman-La Roche, Innate Immunotherapy, MedImmune, Mitsubishi, Novartis, Receptos, Acorda, Sanofi-Aventis, and Teva outside the submitted work, as well as grants from Biogen and Novartis.
Jang Yun, Matthias Meergans, and Maria L. Naylor are employees and stockholders of Biogen.