https://multiplesclerosisnewstoday.com/ ... sclerosis/
The early findings, on gastrointestinal treatment-emergent adverse events (GI-TEAEs) in 696 participants, were published in the scientific journal Advances in Therapy. There were 215 GI TEAEs reported by the 696 patients (30.9%), of which 207 were mild or moderate in severity. Further, 191 out of 215 events (88.8%) were resolved within one to 87 days. Fewer than 1% of patients discontinued treatment because of GI-TEAEs.
EVOLVE-MS-2 was a head-to-head study that compared the gastrointestinal tolerability of 462 mg of Vumerity taken twice daily, and 240 mg of Tecfidera also taken twice daily. This five-week study was conducted in 506 patients with RRMS at 65 sites in the U.S. and Poland. The primary endpoint of the study was the number of days participants reported GI symptoms that were equal to or greater than a score of 2 on the individual gastrointestinal symptom and impact scale (IGSIS). The IGSIS scale rates symptoms from 0, or none, to 10, which indicates the most severe symptoms. Participants were evaluated twice daily to compare the intensity, frequency, and duration of common gastrointestinal symptoms, including nausea, vomiting, upper and lower abdominal pain, and diarrhea. The study was completed in June 2019.
The results showed that only 0.8% of patients treated with Vumerity discontinued treatment because of GI-related adverse events, compared with 4.8% of patients receiving Tecfidera. The most common symptom was flushing, reported by 32.8% of patients treated with Vumerity and 40.6% of those given Tecfidera. Other common symptoms were diarrhea, which affected 15.4% of those on Vumerity and 22.3% of those treated with Tecfidera, and nausea, reported by 14.6% of patients given Vumerity and 20.7% of those receiving Tecfidera.