Abstract Details

Title Sustained improvement in clinical and MRI outcomes in Newly Diagnosed relapsing-remitting multiple sclerosis (RRMS) patients treated for up to 4 years with peginterferon beta-1a: subgroup analysis of ADVANCE/ATTAIN

Topic Multiple Sclerosis

Presentation(s) P3 - Poster Session 3 (5:30 PM-6:30 PM)

Poster/Presentation
Number 15-082

Objective Assess clinical and MRI outcomes of peginterferon beta-1a treatment up to 4 years in Newly Diagnosed (ND; diagnosis ≤1 year before study enrollment and disease-modifying therapy naive) and Non–Newly Diagnosed (NND) RRMS patients in the 2-year phase 3 ADVANCE trial and the 2-year ATTAIN extension study.

Background In ADVANCE year (Y) 1, patients (N=1512) were randomized 1:1:1 to placebo or peginterferon beta-1a every 2 or 4 weeks; for Y2, placebo patients were re-randomized to peginterferon beta-1a every 2 or 4 weeks. ADVANCE completers entering ATTAIN (beyond Y2) maintained their ADVANCE Y2 dosing regimen.

Design/Methods Adjusted annualized relapse rates (ARRs) and adjusted mean numbers of MRI lesions (new/newly enlarging T2 [NET2], gadolinium-enhancing [Gd+], and T1-hypointense) were assessed in placebo (ADVANCE intent-to-treat [ITT]; ND, n=229; NND, n=271) and peginterferon beta-1a every-2-weeks continuous-treatment (ATTAIN ITT; ND, n=180; NND, n=196) patients in Y1. No evidence of disease activity (NEDA; no relapses, 24-week–confirmed disability worsening, Gd+ or NET2 lesions) was evaluated in ATTAIN ITT patients (ND, n=343; NND, n=379). ARR, MRI, and NEDA outcomes were evaluated at Y4 in ATTAIN peginterferon beta-1a patients.

Results ND and NND peginterferon beta-1a patients had lower ARRs and fewer MRI lesions than placebo in Y1; patients continuing in ATTAIN maintained low ARRs and lesion numbers in Y4. Peginterferon beta-1a patients were significantly more likely to achieve NEDA in Y1 than placebo (ND, 28.3% vs 13.5%, P=0.001; NND, 40.8% vs 15.8%, P<0.0001); patients continuing in ATTAIN had yearly NEDA rates of 53.0%–54.4% in Y4. Patients who achieved NEDA in Y1–Y2 had significantly lower ARRs beyond Y2 than patients without NEDA (P<0.001).

Conclusions ND and NND patients treated with continuous peginterferon beta-1a exhibited sustained effects on ARR, MRI lesions, and NEDA up to 4 years. NEDA achievement in Y1-Y2 predicted positive long-term clinical and MRI outcomes.

Authors/Disclosures
Scott D. Newsome, DO, FAAN (Johns Hopkins Hospital) PRESENTER	Dr. Newsome has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Newsome has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Newsome has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. The institution of Dr. Newsome has received research support from Biogen. The institution of Dr. Newsome has received research support from Genentech/Roche. The institution of Dr. Newsome has received research support from Department of Defense. The institution of Dr. Newsome has received research support from Patient Centered Outcomes Research Institute. The institution of Dr. Newsome has received research support from National MS Society. The institution of Dr. Newsome has received research support from Lundbeck. The institution of Dr. Newsome has received research support from Sanofi. The institution of Dr. Newsome has received research support from Kyverna Therapeutics. Dr. Newsome has received personal compensation in the range of $10,000-$49,999 for serving as a Lead PI for Clinical Trial with Roche.
Thomas F. Scott, MD (AHN Neurology)	Dr. Scott has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genzyme-Sanofi. Dr. Scott has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Serono. Dr. Scott has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Scott has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Genentech. Dr. Scott has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genzyme.
Douglas L. Arnold, MD, FAAN (Montreal Neurological Institute, McGill Univ)	Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BMS. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Frequency Therapeutics. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Arnold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Arnold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shionogi. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Xfacto communications. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Find therapeutics. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GSK. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Idorsia. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kiniksa. Dr. Arnold has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Clario.
	No disclosure on file
Matthias Meergans	No disclosure on file
Maria Naylor, PhD	Dr. Naylor has received personal compensation for serving as an employee of Dyne Therapeutics. Dr. Naylor has stock in Biogen. Dr. Naylor has stock in Dyne Therapeutics.

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