OBJECTIVES To review the literature evaluating the clinical efficacy of Fumaderm (FAE) in patients suffering from psoriasis and psoriatic arthritis. METHODS Systematic literature search in electronic databases (MEDLINE, Cochrane and Embase) was performed (from inception to March 14, 2014). Results were presented by narrative synthesis including a quality assessment using Jadad scale. RESULTS Three randomized controlled trials were included (Fallah Arani 2011, Altmeyer 1994, Peeters 1992). Quality of studies ranged from 3 to 4 points. Observation period was 16 weeks for all studies. One open-label study comparing FAE with methotrexate (MTX) in moderate to severe chronic plaque psoriasis was identified. The primary efficacy endpoint was the difference in mean change from baseline in Psoriasis Area and Severity Index (PASI). After 12 weeks of treatment the mean PASI (± SD) decreased to 10.5 ± 6.7 compared with starting value of 18.1 ± 7.0 in patients treated with FAE and to 6.7 ± 4.5 compared to starting value of 14.5 ± 3.0 in patients treated with MTX. The absolute difference between groups (FAE vs. MTX) in the mean values was 1.4 (95%CI: 2.0; 4.7) and wasn’t statistically significant (p = 0.417). In the remaining two double-blind studies the efficacy and safety of Fumaderm was assessed against the placebo. One study shows that in psoriasis vulgaris population the mean PASI in FAE group decreased from 21.53 at baseline to 10.77, whereas in placebo group mean PASI has not changed (p<0.0001) after 16 weeks of treatment. Moreover, the results of study in psoriatic arthritis population revealed that FAE significantly (p<0.04) decrease joint pain compared to placebo. CONCLUSIONS The results revealed that FAE and MTX have similar clinical efficacy in the treatment of patients with moderate to severe psoriasis. Moreover, FAE is more effective than placebo in the treatment of psoriasis vulgaris and psoriatic arthritis.