Patients who completed
EVOLVE-MS-2 could roll over
into a 96-week open-label study
*In study week 1, the titrated dose for VUMERITY was one 231 mg delayed-release capsule taken orally, twice daily. The titrated dose for dimethyl fumarate was one 120 mg delayed-release capsule taken orally, twice daily. From study weeks 2–5, the full dose for VUMERITY was two 231 mg delayed-release capsules taken orally, twice daily, and the full dose for dimethyl fumarate was one 240 mg delayed-release capsule taken orally, twice daily.
Secondary endpoints were assessed in this study, but results are not presented here.
Over a 5-week treatment period, VUMERITY showed a 46% reduction (P=0.0003) in the number of days (adjusted rate ratio, 0.54 [95% CI, 0.39-0.75]) patients experienced a GI symptom intensity score rated ≥2 on an Individual GI Symptom and Impact Scale (a 0- to 10-point scale)
Overall, 19.3% (17/88) of patients in the VUMERITY group and 30.6% (37/121) of patients in the DMF group used concomitant medications to treat GI-related AEs during the treatment period
†Intensity of nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea reported twice per day.
‡Patients completed ≥1 postbaseline tolerability eDiary assessment and were included in the analysis of patient-assessed GI tolerability.
§VUMERITY, n=253; DMF, n=249.