Table 3.

Randomized comparisons of dimethyl fumarate (DMF) vs. FAE combinations in clinical studies

Study	Design	Regimen	No. of patients	Diagnosis	Main outcome measures	Main efficacy findings	Main safety findings
Kolbach and Nieboer [19]	r	DMF (60–240 mg/day) × 24 mo	129	Nummular and plaque psoriasis (≥ 10% of BSA) n.b. Excluded: generalized pustular psoriasis	Simplified PSS	> 75% improvement in 18–32% of patients Yr 2 dropout rate = 84%	Frequent GI AEs during the first 6 mo Lymphopenia seen by 3 mo; frequent (85%) by 24 mo
		FAEs (containing DMF 120 mg, up to 4 × daily) × 24 mo	67			> 75% improvement in 46–51% of patients Yr 2 dropout rate = 45%
Mrowietz et al. [32]	r, db, mc, pc	DMF up to 720 mg tid	279	Moderate-to-severe chronic plaque psoriasis; ≥ 12 mo duration + PASI > 10 and > 10% BSA n.b. Excluded: guttate, erythrodermic or pustular psoriasis	PASI 75; PGA; BSA	PASI 75 wk 16 = 37.5%*† PGA ‘clear’ or ‘almost clear’ = 33%* BSA improvement wk 16 = 13.2 (p < 0.001 vs. placebo)	TEAEs = 83.9% Lymphopenia = 10.0% GI TEAEs = 62.7%
		FAEs (up to 720 mg of DMF tid)	283			PASI 75 wk 16 = 40.3%* PGA ‘clear’ or ‘almost clear’ = 37.4%* BSA improvement wk 16 = 11.3 (p < 0.001 vs. placebo)	TEAEs = 84.1% Lymphopenia = 10.6% GI TEAEs = 63.3%
		Placebo	137			PASI 75 wk 16 = 15% PGA ‘clear’ or ‘almost clear’ = 13% BSA improvement = 4.9	TEAEs = 59.9% Lymphopenia = 0%

BSA body surface area involvement, db double-blind, DMF dimethylfumarate, GI gastrointestinal, mc multicentre, mo month(s), PASI 75 Psoriasis Area and Severity Index 75% improvement, pc placebo controlled, PGA Physician’s Global Assessment, PSS Psoriasis Severity Score, r randomized, TEAE treatment-emergent adverse event, tid 3 times daily, yr year(s)

*p < 0.001 for superiority vs. placebo

^†p < 0.001 for noninferiority vs. FAEs