PLEGRIDY® (peginterferon beta-1a) Priority Data for 2016 ECTRIMS

DRAFT – 9.8.2016

Indirect Rebif Comparison

Abstract Title: SC Peginterferon Beta-1a Every 2 Weeks Demonstrated Better Clinical Outcomes than SC Interferon Beta-1a TIW in Patients with RMS, Using a Matching-Adjusted Comparison of 7 Phase 3 Trials (EP1486, e-poster)

Lead Author: Patricia K. Coyle

Presentation Date: ePosters will be displayed on terminals during the congress, not presented at a specific session

Key Points:

  • PLEGRIDY (peginterferon beta-1a) and subcutaneous (SC) Rebif®(interferon beta-1a) have both demonstrated efficacy in treating relapsing forms of multiple sclerosis (MS), but comparative efficacy hasnot been studied in direct head-to-head trials.
  • A well-balanced matching-adjusted comparison can be used to indirectly compare therapies if there are no head-to-head studies available.[1]
  • Results from thisanalysis, a two-year follow up matching-adjusted indirect comparison,showed better clinical outcomes in patients treated with PLEGRIDY every two weeks when compared to those treated with Rebif three times per week. This suggests PLEGRIDY may have a similar or even more favorable efficacy profile than the high-dose, high-frequency interferon studied.
  • Following twoyears of treatment, the annualized relapse rate was numerically lower in patients receiving PLEGRIDY compared with patients receiving SC Rebif.
  • At twoyears, the percentage of patients with 24-week confirmed disability worsening was also significantly lower for PLEGRIDY patientscompared with patients receiving SC Rebif.
  • These findingscomplement previousmatching-adjusted indirect comparison analyses[2],[3] and reinforce the efficacy profile of PLEGRIDYas an appropriate choice for the early treatment of MS.

NEDA Status

Abstract Title: Peginterferon Beta-1a Every 2 Weeks Increased Achievement of NEDA Over 4 Years in the ADVANCE and ATTAIN Studies in Patients with RRMS (P1171)

Lead Author: Douglas Arnold

Presentation Date: Friday, 16 September, 15:30 p.m. to 17:00 p.m. BST

Key Points:

  • This post-hoc analysis assessed no evidence of disease activity (NEDA) status during the ADVANCE and ATTAIN studies and explored clinical outcomes in patients treated for three and four years with PLEGRIDY, after stratifying these patients by overall NEDA at year two.
  • ADVANCE was a two-year, Phase 3 study that compared PLEGRIDY to placebo in patients with relapsing-remitting MS (RRMS). ATTAIN was a two-year extension study of ADVANCE.
  • In the ADVANCE trial, a significantly higher proportion of patients receiving PLEGRIDY (dosed every two weeks) had clinical, MRI and overall NEDA compared to placebo at two years.
  • In this four-year analysis from the ATTAIN study, NEDA status was evaluated cross-sectionally, year by year.Overall NEDA was defined as no evidence of relapses, confirmed disability progression, gadolinium enhancing lesions, and new/newly-enlarging T2 lesions.
  • Findings of this analysis show PLEGRIDY (dosed every two weeks) achieved high rates of clinical, MRI, and overall NEDA outcomes at four years of treatment, consistent with those rates observed in the previous years.
  • While further evidence that NEDA is correlated with long term outcomes is still needed, results suggest that NEDA status after the first two years ofPLEGRIDYtreatment may help to identify those patients with better clinical outcomes in the long-term setting.
  • These data support results observed in the ADVANCE trial and provide further evidence of the benefits of PLEGRIDY treatment in the long-term setting, reinforcing the efficacy profile of PLEGRIDY as an appropriate option for the early treatment of MS.

1

[1]Signorovitch JE, et al. Pharmacoeconomics. 2010;28:935–945.

[2] You X et al. Poster presented at PACTRIMS 19–21 Nov 2015, Seoul, Korea. P33.

[3]Coyle P et al. Presented at EAN May 28-31, 2016. Copenhagen, Denmark.