. 2015 Jan 5;5:9–23. doi: 10.2147/PTT.S51490

Table 1.

Overview of efficacy results of RCTs of fumaric acid esters in psoriasis treatment

Study (year)	Study design	Study population	Treatment arms	No of patients	Treatment duration in weeks	Efficacy results
Balak et al (2014)³⁶	Single center double-blind RCT	Moderate-to- severe psoriasis PASI <10	FAE + cetirizine	25	12	Mean change in PASI – 65% PASI-75 response 20%
Balak et al (2014)³⁶	Single center double-blind RCT	Moderate-to- severe psoriasis PASI <10	FAE + placebo	25	12	Mean change in PASI – 66% PASI-75 response 20%
Fallah Arani et al (2011)³⁴	Multicenter RCT	Moderate-to- severe psoriasis PASI <10	FAE (Dutch formulation)	30	12	Mean change in PASI from 18.1 to 10.5 (−42.0%) PASI-75 response 19%
Fallah Arani et al (2011)³⁴	Multicenter RCT	Moderate-to- severe psoriasis PASI <10	MTX	30	12	Mean change in PASI from 14.5 to 6.7 (−53.8%) PASI-75 response 24%
Gollnick et al (2002)³⁵	Multicenter double-blind RCT	Severe psoriasis	FAE (Fumaderm) + calcipotriol ointment	68	13	Mean change in PASI – 76.1%
Gollnick et al (2002)³⁵	Multicenter double-blind RCT	Severe psoriasis	FAE (Fumaderm) + placebo ointment	66	13	Mean change in PASI – 51.9%
Altmeyer et al (1994)¹³	Multicenter double-blind RCT	BSA <10%	FAE (Fumaderm)	50	16	Mean decrease in PASI from 21.6 to 10.8 (−50.0%)
Altmeyer et al (1994)¹³	Multicenter double-blind RCT	BSA <10%	Placebo	50	16	Not reported
Nieboer et al (1990)³³	Single-center RCT	BSA <10%	FAE (Fumaderm)	23	12	More than 50% improvement in 52%
Nieboer et al (1990)³³	Single-center RCT	BSA <10%	DMF (Dutch formulation)	11	12	More than 50% improvement in 45%
Nugteren-Huying et al (1990)¹⁴	Single-center RCT	BSA <10%	FAE (Fumaderm)	13	16	Mean decrease BSA from 21.0% to 6.7%
			Octyl FAE	13	16	Not reported
			Placebo	13	16	Not reported

Abbreviations: BSA, body surface area affected; DMF, dimethyl fumarate; FAE, fumaric acid esters; MTX, methotrexate; PASI, psoriasis area and severity index; RCT, randomized controlled trial.