Background:Health systems’ guidelines and dermatology associations advise that the systemic drug treatment for moderate to severe psoriasis should be initiated with synthetic immunosuppressive or immunomodulatory drugs such as methotrexate, cyclosporine and acitretin. The Brazilian Ministry of Health recommends methotrexate as the first choice. Therefore, novel drugs for psoriasis should ideally be studied in a population that did not respond to this treatment alternative.
Objectives:To investigate the profile of patients enrolled in pivotal anti-TNF (infliximab, adalimumab and etanercept) phase III, randomised-controlled trials regarding the use of previous drugs, especially methotrexate.
Methods:Revision of all published data of three pivotal studies (1 with infliximab, 1 with adalimumab and 1 with etanercept) evaluating the treatment of plaque psoriasis in adults.
Results:Forty three per cent of patients included in the infliximab study had received methotrexate previously to study entry. This information is not available in the adalimumab study, in which a 'non-biological systemic treatment' group was created to include all synthetic immunosuppressive or immunomodulatory drugs used; and 22, 7% of all patients where in this category. In the etanercept study, the information is even less clear. Patients using systemic drugs or phototherapy were grouped in the same category, with 25% of patients entering the study without using any of these as previous therapy. Efficacy was not assessed according to previous use of systemic treatment.
Conclusions:Pivotal studies supporting the commercialisation approval of anti-TNFs (infliximab, adalimumab and etanercept) for psoriasis treatment included patients who did not use prior recommended systemic medications, which impairs the translation of efficacy results to real-life patients. The efficacy of anti-TNFs in these real life patients may be less relevant than demonstrated in the studies, since the results were influenced by data from patients who were naive of the usual systemic treatments.