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, OPTIMUM1-9

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, all patients, including those who had received PONVORY®, underwent this procedure.1,10

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 ENDPOINTS1,8

  • 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 groups8

DMT = disease modifying therapy.

*Without double counting of lesions.1

OPTIMUM study: patient population8†

OPTIMUM study: patient population

MS = multiple sclerosis; 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.1,10

OPTIMUM study: baseline characteristics8

Baseline characteristics

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

OPTIMUM study: Key inclusion and exclusion criteria11

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.11

§An accelerated elimination procedure was needed to accelerate the reduction of teriflunomide plasma concentrations. To maintain blinding, all patients, including those who had received PONVORY®, underwent this procedure.1,10

Including cardiovascular, infection, pulmonary, metabolic, hematological, hepatic, immunological, ophthalmological, ocular, renal, and malignancy.11