Biogen Inc. (Nasdaq: BIIB) today announced detailed results from the Phase 3 EVOLVE-MS-2 study demonstrating the improved patient-assessed gastrointestinal (GI) tolerability of VUMERITY™ (diroximel fumarate), a new FDA-approved treatment for relapsing forms of multiple sclerosis (MS), compared to TECFIDERA® (dimethyl fumarate). These EVOLVE-MS-2 results are being presented at the 27th Annual Meeting of the European Charcot Foundation in Italy (Nov. 21-23).

“We know that each patient’s journey can vary greatly in MS, so Biogen aims to meet individual treatment goals through our broad MS portfolio,” said Alfred Sandrock, Jr., M.D., Ph.D., Executive Vice President, Research and Development, and Chief Medical Officer at Biogen. “TECFIDERA is a clinically meaningful treatment for patients, and we believe VUMERITY now builds upon our franchise as another compelling option for relapsing MS.”

EVOLVE-MS-2 is the first study to directly compare the GI tolerability of two relapsing MS treatments. In this study involving relapsing-remitting MS (RRMS) patients, VUMERITY was associated with significantly shorter duration, severity and daily impact of five key GI symptoms, compared to TECFIDERA. Results for the primary endpoint show patients treated with VUMERITY self-reported 46 percent fewer days with intensity scores of ≥2 on the Individual Gastrointestinal Symptom and Impact Scale (IGISIS), compared to TECFIDERA (adjusted rate ratio [95% confidence interval]: 0.54 [0.39−0.75], p = 0.0003). IGISIS is a novel and exploratory scale used by patients in the study to self-assess the intensity and duration of key GI symptoms, including nausea, vomiting, upper and lower abdominal pain and diarrhea. Results observed with TECFIDERA in EVOLVE-MS-2 are consistent with its well-characterized safety profile.

The EVOLVE-MS-2 results also indicate that compared to TECFIDERA, VUMERITY-treated patients had:

• Lower discontinuations due to GI adverse events (AEs) (0.8 percent vs. 4.8 percent).
• Fewer days with IGISIS intensity scores of ≥1 and ≥3 (29 percent relative reduction and 44 percent relative reduction, respectively).
• Fewer days with a self-reported intensity score of ≥1 (30 percent reduction, on the Global Gastrointestinal Symptom and Impact Scale (GGISIS), which assessed the overall intensity of GI symptoms, their impact on daily activities and how bothersome they were. Fewer days with GGISIS intensity scores of ≥2 and ≥3 were also observed.
• A gradual decline in worst IGISIS intensity scores over the five-week treatment period.

These findings using the patient-assessed symptom intensity scales were supported by lower investigator-reported incidences of GI AEs with VUMERITY (34.8 percent) compared to TECFIDERA (49.0 percent). Overall AEs occurred in 78.3 percent of patients with VUMERITY and 83.7 percent with TECFIDERA. Most AEs were mild or moderate in severity. The overall proportion of patients with AEs leading to study discontinuation were 1.6 percent for VUMERITY and 5.6 percent for TECFIDERA.

EVOLVE-MS-2 was a multi-center, double-blind, active-controlled, five-week Phase 3 study designed to evaluate the GI tolerability, including duration and severity, of VUMERITY compared to TECFIDERA in 506 patients with RRMS. The study’s primary endpoint assessed the number of days patients reported GI symptoms with a symptom intensity score ≥2 on the IGISIS rating scale. Secondary endpoints evaluated the number of days (relative to exposure) that patients reported GI symptoms with an IGISIS intensity scores of ≥1 or ≥3 in the overall population; IGISIS intensity score of ≥2 in patients from Part B only; GGISIS intensity scores of ≥1, ≥2, or ≥3 in the overall population; and worst (i.e., highest) IGISIS individual symptom score by study week. Patients who completed the five-week treatment period were eligible to enroll in EVOLVE-MS-1, a 96-week, open-label, safety study for VUMERITY.

VUMERITY is now available in the U.S. for relapsing forms of MS.