Table 1.
Table summarizing clinical trial data on delayed-release dimethyl fumarate.
| Patient numbers/randomization | Outcome measures |
|||
|---|---|---|---|---|
| MRI (T2-, T1- and Gd-enhancing lesions) | Clinical (ARR, disease progression, freedom of disease) | Adverse events | ||
|
DMF 480 mg, 720 mg
(BG-12®, BiogenIdec, Cambridge, MS, USA) |
1237 RRMS BG-12 480 mg versus 720 mg daily versus placebo 1 : 1 : 1 (DEFINE study) |
90% (480 mg) and 73% (720 mg) fewer Gd-lesions under BG-12 versus placebo (p < 0.0001); 85% (480 mg) and 74% (720 mg) fewer new or enlarged T2-lesions under BG-12 versus placebo (p < 0.0001) | 53% ARR reduction under BG-12 (480 mg) and 48% (720 mg) versus placebo (p < 0.0001); ~40% less cumulative risk of disability progression under BG-12 doses versus placebo (p < 0.0001) | GI side effects, such as mild and moderate diarrhea, flushing, lymphopenia |
| 1430 RRMS BG-12 480 mg versus 720 mg daily versus GLAT s.c. 20 mg daily versus placebo 1 : 1 : 1 : 1 (CONFIRM study) |
71% (480 mg) and 73% (720 mg) fewer new or enlarged T2-lesions under BG-12 (p < 0.0001) and 54% by GLAT versus placebo (p < 0.0001); 57% (480 mg) and 65% (720 mg) fewer T1-hypointense lesions under BG-12 (p < 0.0001) and 41% by GLAT versus placebo (p < 0.003) | 44% ARR reduction under BG-12 (480 mg) and 51% (720 mg) (p < 0.0001) and 29% GLAT (p = 0.02) versus placebo; reduced risk of disability progression by 21% (480 mg) and 24% (720 mg) under BG-12 (not significant) and 7% by GLAT (not significant) versus placebo |
As for DEFINE study | |
ARR, annualized relapse rate; DMF, dimethylfumarate; Gd, gadolinium; GI, gastrointestinal; GLAT, galtiramer acetate; MRI, magnetic resonance imaging; RRMS, relapsing-remitting multiple sclerosis; s.c., subcutaneously.