Efficacy an safety of biologics in patients with moderate to severe psoriasis

E Blanco1, JM Segura2, T Martín2, I Bellido1. 1University of Málaga, Pharmacology, School of Medicine, Spain, 2Carlos Haya Universitary Hospital, Dermatology Service, Spain

Psoriasis is a chronic, relapsing disease, now considered a systemic disease with predominantly skin manifestations. In moderate and severe forms there is a large impact on patient´s quality of life. In these cases it is necessary to use systemic therapy with either conventional or new biologic agents. The European Medicines Agency (EMEA) has approved the biologic agents infliximab, etanercept, adalimumab and ustekinumab for the treatment of moderate to severe plaque psoriasis in adults who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including cyclosporine, methotrexate, or PUVA. Biologics are of great interest because of its high cost and safety precautions.

Objectives: Assessment of prescription profile of biologic therapy in psoriasis, with evaluations of efficacy, safety and adherence to clinical guidelines.

Patients and methods: Patients with moderate to severe psoriasis treated in the Dermatology Service at a University Hospital during 2008-2010. Cross-sectional study collecting information through interviews and review of medical records. Patients monitoring during treatment. Variables: sociodemographic, comorbidity, clinical management of psoriasis, Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA), and pharmacological treatments.

Results: Average age of patients was 45.96 (± 15.6) years, with slight predominance of males (56.5%). The most frequent comorbidities were hypertension (28%), dyslipidemia (25%), diabetes mellitus (12%) and COPD (9%). The prevalence of psoriatic arthritis among patients with psoriasis was 14 %. The average time of psoriasis was 14.7 (± 11) years (range: 6 months-50 years). Plaque psoriasis was the most common form of psoriasis. Treatment of patients at baseline visit was predominantly topical corticosteroids being present in more than half of patients, either alone or in combination with vitamin D derivatives. The mean baseline PASI score was 11.31. At visit 1 systemic treatment was started, being the most commonly used drug methotrexate (22.5%), followed by acitretin (21.1%) and etanercept (15.5%). With this treatment the average PASI decreased more than 50% and 21% of patients achieved remission. At visit 2 the most commonly used drug was etanercept (21%), and incorporated a new biologic ustekinumab (3%). At visit 3 cyclosporine was the most prescribed therapy (28%) and at visit 4, the eight patients who still needed treatment received ustekinumab and etanercept. Over successive visits patients were significantly improving, which is demonstrated by the progressive decrease in average PASI score (initial 11.3 to 3.8 final). There were no serious adverse events. In a minority of patients (25%) occurred hyperlipidemia, gastrointestinal disturbances and transient hypertransaminasemia.

Conclusions: The most appealing improvement in patients with moderate to severe psoriasis occurs after the first addition of systemic treatment, with the drugs methotrexate and acitretin largely responsible. In resistant cases, biologic therapy is efficient and safe, with minimal adverse reactions. Its inclusion in our patients attaches to current guideline recommendations for clinical practice.

References: Sivamani RK, Goodarzi H, García MS, et al. Biologic therapies in the treatment of psoriasis: a comprehensive evidence-based science and clinical review and a practical guide to tuberculosis monitoring. Clin Rev Allergy Immunol.