Table 2.

Comparative studies by Nieboer et al. [37] examining fumaric acid esters (FAEs) in patients with stable nummular or plaque psoriasis (≥ 10% of body surface area)

Study number (all published by Nieboer et al. [37])		Design and duration	Regimen	No. of patients	Outcome measures (all studies)	Main efficacy findings	Main safety findings
Study I		nb 1–32 months	FACT	36	PSS; haematological and biochemical parameters	64 and 44% of patients showed > 50 and > 90% improvement Itching and scaling improved after 1 month	One patient stopped due to serious GI AEs
Study II		db 4 months	Na-MEF 240 mg vs. Placebo	19 vs. 19		No difference between Na-MEF and placebo; greater itching score drop with Na-MEF	None reported
Study III		db 4 months	DMF 240 mg vs. Placebo	22 vs. 20		Significant differences between DMF and placebo (p < 0.01) within 6 wk: PSS ↓ to 60% for DMF vs. ↑ to 105% with placebo	27% of patients stopped due to serious GI AEs during the first 2 weeks
Study IV	Dose finding 3 months		Na-MEF 720 mg vs. 240 mg	10 vs. 10		Na-MEF doses equivalent for no. of improved patients; significant differences (p < 0.05) between final itching and scaling scores of scaling	None reported
Study V	nb 4–9 months (continuation study)		DMF 60–240 mg	56		22% moderate improvement; 33% > 50% improvement	20% of patients discontinued due to serious GI AEs

AE adverse event, db double-blind, DMF dimethylfumarate, FACT fumaric acid compound therapy (oral DMF + MEF), GI gastrointestinal, Na-MEF sodium monoethylfumarate, nb nonblind, PSS psoriasis severity score, wk week(s)