Eficácia dos medicamentos biológicos e gastos no tratamento de Psoríase e Artrite Psoriásica no Sistema Único de Saúde em Minas Gerais: 2010 - 2013

Abstract

Psoriasis is a disease with predominantly cutaneous manifestations, being the most prevalent immune-mediated skin disease in adults. Its systemic treatment consists of phototherapy and the use of synthetic and biological medicines. Psoriatic arthritis (PsA) is a seronegative spondyloarthropathy associated with psoriasis. Its treatment comprises the use of synthetic and biological diseasemodifying antirheumatic drugs (DMARDs). Both diseases are associated with a significant decrease in quality of life. Since 2002 acitretin and cyclosporin are provided by the Unified Health System (SUS Sistema Único de Saúde) through the Specialized Medicines Component of Pharmaceutical Assistance(from now on referred as Component). In 2010 methotrexate was included and PsA was covered, with the provision of synthetic and biological (adalimumab, etanercept and infliximab) DMARDs. Considering that the expenditures with the Components medicines is increasing, it is timely to conduct studies to evaluate the effects of biological DMARDs and to chraracterize the profile of patients andthe spending of the Component with psoriasis and PsA. To evaluate efficacy, effectiveness and safety of adalimumab, etanercept, golimumab e infliximab for the treatment of active adult PsA, we conducted a systematic review of randomized controlled clinical trials (RCT) and observational studies (registries and cohort studies). We assessed clinical outcomes, radiographic progression, quality of life, adverse events and persistence. Nine RCT and six observational studies were included. Two observational ongoing studies on golimumab werealso included. ACR20, ACR50, PsARC and PASI75 responses were achieved by more anti-TNF users than control after up to 24 weeks of treatment. More participants who used etanercept and infliximab achieved ACR70. After all patients originally randomized to placebo had used anti-TNF for at least 24 weeks, we observed difference only with regard to ACR70 response. Radiographic end points were achieved by more patients in anti-TNF group, and they seem to be time dependent the longer patients use the medicine the better the results. Etanercept and infliximab presented the worse results on application site reactions, but in general anti-TNF drugs, in the regimens studied, were as safe as control/placebo. There seems to be no difference in efficacy and effectiveness among anti-TNFs, but superiority head-to-headstudies are still needed. To characterize the patients profile and the expeditures of Minas Gerais State with psoriasis and PsA we developed a cohort of patients attended by the Component from March 2010 to February 2013, using deterministic-probabilistic linkage of the Outpatient Information System (Sistema de Informação Ambulatorial do SUS) databases. 1,623 psoriasis patients and 218 patients with AP were attended by the Component. The total expenditure was R$3.438.798,00 and R$7.013,663,00, respectively. Sex distribution was approximately 1:1 for both diseases. Psoriasis patients were older than expected. Guidelines of both diseases recommend the use of methotrexate as first-line therapy. In our study the most used synthetic medicines were acitretin for psoriasis ans leflunomide for PsA. Unlike what wasobserved by the Brazilian Registry of Bilogicals, the most widely used biological was etanercept. The average per capita expenditure increased over time and was higher for patients with PsA who started treatment with synthetic drugs than for patients with psoriasis. The average expenditure for adalimumab and etanercept groups decreased over time. Considering the results of the two works, we can conclude that adalimumab, etanercept and infliximab are effective both in RCTs and in the real world studies. Golimumab presented favourable results of efficacy and safety, but these results need to be confirmed by the results of the included ongoing observational studies. The differences between the cohorts population and the literature with respect to the use of medicines seem to have to do with the low cost of methotrexate whencompared to acitretin and leflunomide, so that it could have been payed by the patients themselves, and with the likelihood of patients with PsA having required infliximab as patients with rheumatoid arthritis. This and the increasing expenditure with biologicals indicate that stricter mechanisms should be adopted for the provision of medicines of the Component. To broaden access to treatment and contain costs, measures can be adopted by SUS, among them the periodis revision of investiment and disinvestment decisions, egotiation wiith the pharmaceutical industry, the establishment of stricter criteria for theprovision of medicines, the monitoring of prescriptions and dissemination of evidence through academic detailing.