069 Peginterferon beta-1a improves clinical and radiological disease outcomes in patients who are newly diagnosed with relapsing-remitting multiple sclerosis (RRMS): subgroup analysis of advance. Issue 6 (24th May 2018)

• Record Type: Journal Article
• Authors: Newsome, Scott D; Arnold, Douglas L; Yun, Jang; Meergans, Matthias; Naylor, Maria L
• Is Part Of: Journal of neurology, neurosurgery and psychiatry. Volume 89:Issue 6(2018)
• Page Start: A28
• Page End: A28
• Publication Date: 2018-05-24
• Subjects: Neurology -- Periodicals; Nervous system -- Surgery -- Periodicals; Psychiatry -- Periodicals; 616.8
• DOI: 10.1136/jnnp-2018-ANZAN.68
• Languages: English
• ISSNs: 0022-3050

Abstract

Abstract : Introduction: The pivotal phase 3 ADVANCE study evaluated the efficacy of subcutaneous peginterferon beta-1a 125 mcg every 2 weeks in RRMS patients, approximately 45% of whom were newly diagnosed and had no prior disease-modifying therapy (DMT) use. We evaluated peginterferon beta-1a's effect on clinical and radiological disease activity in newly diagnosed, treatment-naive patients from ADVANCE. Methods: ADVANCE was a 2 year double-blinded study. In year 1, patients were randomised to receive peginterferon beta-1a every 2 or 4 weeks or placebo. In year 2, placebo patients were re-randomised to receive peginterferon beta-1a every 2 or 4 weeks (delayed-treatment group). Here, the subgroup of patients diagnosed ≤1 year prior to enrolment who had no prior DMT use was analysed. Annualised relapse rate (ARR), time to first relapse, 24 week confirmed disability worsening (CDW), MRI endpoints, and safety were compared between the every-2-weeks group and the delayed-treatment group. Results: Over 2 years, the adjusted ARR in newly diagnosed patients was 32.3% lower for the peginterferon beta-1a every-2-weeks group (n=231) than for the delayed-treatment group (n=229; p=0.0352). Time to first relapse was longer in the every-2-weeks group than in the delayed-treatment group (p=0.0101), and the rate of 24 week CDW was numerically lower in the every-2-weeks group than in the delayed-treatment group. At year 2, the number of new/newly-enhancing T2 lesions was lower in the every-2-weeks than in the delayed-treatment group (p<0.0001), although no difference in the number of gadolinium-enhancing lesions was observed. The safety profile in newly diagnosed patients was similar to that of the overall patient population. Conclusion: Newly diagnosed, treatment-naive patients had significantly reduced disease activity when administered peginterferon beta-1a every 2 weeks compared with delayed-treatment patients. These results are generally consistent with results from the ADVANCE overall population and highlight the benefits of initiating therapy early in the RRMS disease course. Study support: Biogen