VUMERITY Offers the Efficacy Demonstrated by dimethyl fumarate Across 2 Pivotal Trials1

The efficacy of VUMERITY is based upon bioavailability studies in patients with relapsing forms of multiple sclerosis and healthy subjects comparing oral dimethyl fumarate delayed-release capsules to VUMERITY delayed-release capsules. The clinical studies described below were conducted using dimethyl fumarate.

Study 1: A 2-year, randomized, double-blind, placebo-controlled study of 1234 patients with RRMS. The primary endpoint was proportion of patients relapsed.

Study 2: A 2-year, multicenter, randomized, double-blind, placebo-controlled study that also included an open-label comparator arm in 1417 patients with RRMS. The primary endpoint was annualized relapse rate.

Dimethyl fumarate reduced the risk and frequency of relapse and disability progression

Study 1
Study 2
Placebo n=408; DMF 240 mg BID n=410
Placebo n=363; DMF 240 mg BID n=359
PPR at 2 Years
Primary endpoint
49

Relative risk reduction

Placebo: 46%; DMF: 27%
(P<0.0001)

34

Relative risk reduction

Placebo: 41%; DMF: 29%
(P=0.0020)

ARR at 2 Years
53

Relative reduction

Placebo: 0.364; DMF: 0.172
(P<0.0001)

Primary endpoint
44

Relative reduction

Placebo: 0.401; DMF: 0.224
(P<0.0001)

Disability Progression*
38

Relative risk reduction

Placebo: 27%; DMF: 16%
(P=0.0050)

21

Relative risk reduction

Placebo: 17%; DMF: 13%
Not statistically significant (P=0.25)

*Disability progression was defined as at least a 1-point increase from baseline EDSS of ≥1.0, OR at least a 1.5-point increase for patients with baseline EDSS of 0 sustained for 12 weeks.

Dimethyl fumarate significantly reduced all studied measures of MRI activity1-4

MRI table
MRI table