OPTIMUM Study Jump to

PONVORY™ is the first and only oral DMT approved by the FDA that was studied against an established oral comparator, Aubagio® (teriflunomide), in a phase 3 study, OPTIMUM1-8

The OPTIMUM Study:

A phase 3, multicenter, randomized, double-blind, parallel-group, active-controlled superiority study of 1133 adult patients randomized to either once-daily PONVORY™ or Aubagio®.1,8

OPTIMUM study design_PONVORY™ 20 mg (567) patients compared to teriflunomide, (566) patients

In the study, patients underwent a 14-day titration or mock titration at the start of treatment, followed by a once-daily maintenance dose up to end of treatment (EOT). An accelerated elimination procedure was needed to accelerate the reduction of teriflunomide plasma concentrations. To maintain blinding, nearly all patients (~93%), including those who had received PONVORY™, underwent this procedure.1,9

PRIMARY ENDPOINT1

  • Annualized relapse rate (ARR) over the study period

SECONDARY ENDPOINTS1

  • Number of new gadolinium-enhancing (GdE) T1 lesions and the number of new or enlarging T2 hyperintense lesions from baseline to Week 108*
  • Time to 3-month confirmed disability progression (CDP)

EXPLORATORY ENDPOINTS1,10

  • Patients without relapse
  • Mean percentage change in brain volume from baseline to Week 108
  • A 14-day up-titration schedule was used when initiating PONVORY™ to help reduce cardiac effects1
  • Patient baseline characteristics were similar in the 2 treatment groups11

DMT = disease modifying therapy; MS = multiple sclerosis.

*Without double counting of lesions.1

OPTIMUM study: patient population8†

OPTIMUM study: patient population

SD = standard deviation.

The study included patients diagnosed with relapsing courses of MS from onset (relapsing-remitting MS or secondary progressive MS with superimposed relapses) using the revised 2010 McDonald Diagnostic Criteria for MS and an Expanded Disability Status Scale (EDSS) score of 0 to 5.5, having experienced 1 or more documented MS attacks with onset within the period of 12 to 1 months prior to baseline EDSS assessment, or 2 or more documented MS attacks with onset within the period of 24 to 1 months prior to baseline EDSS assessment, or having at least 1 GdE T1 lesion on a brain MRI within the prior 6 months or at baseline.1,9

OPTIMUM study: baseline characteristics8

OPTIMUM study: baseline characteristics

DMT = disease-modifying therapy; EDSS = Expanded Disability Status Scale; GdE = gadolinium-enhancing; SD = standard deviation.

OPTIMUM study: Key inclusion and exclusion criteria9

OPTIMUM study: inclusion and exclusion criteria

DMT = disease-modifying therapy; EDSS = Expanded Disability Status Scale; GdE = gadolinium-enhancing; MS = multiple sclerosis.

Interferon (IFN) beta-1a, IFN beta-1b, glatiramer acetate, natalizumab, or dimethyl fumarate.9

§An accelerated elimination procedure was needed to accelerate the reduction of teriflunomide plasma concentrations. To maintain blinding, nearly all patients (~93%), including those who had received PONVORY™, underwent this procedure.1,9