Methotrexate or fumarates: which is the best oral treatment for psoriasis?

Abstract

Funding sources None. Conflicts of interest None declared. The advent of biologic therapy for moderate and severe psoriasis has highlighted the need for better randomized controlled trials of oral systemic therapies. These data are needed for many reasons which include the need to establish robust efficacy and safety data for them and to set a yardstick for the biological treatments. This latter point is all the more important in the EU (including the U.K.) where the licence for biologics demands prior consideration or usage of standard systemics. Furthermore, it is important that these drugs are assessed head to head in order for clinicians to determine the relative merits of one drug compared with another. Although only licensed in Germany, fumaric acid esters (FAE) are suggested by many to be a useful alternative to standard systemic therapy for psoriasis. Importantly, their mode of action is very different from that of the other available agents. The paper by Fallah Arani et al.1 in this issue examines FAE efficacy against methotrexate, often regarded as the gold standard for systemic therapy and so far the only oral agent used in active comparator studies of biologics. The authors report a 50% reduction in Psoriasis Area and Severity Index (PASI) at 12 weeks of 42% for FAE and 60% for methotrexate and a 75% PASI reduction of 19% for FAE and 24% for methotrexate. Two patients (8%) in the FAE group and four (16%) patients in the methotrexate group dropped out because of side‐effects. None of these differences was statistically significant. The authors concluded that compared with methotrexate with its inherent problems of long‐term toxicity, FAE performed well but with a favourable safety profile.