Ustekinumab in Real-Life Practice: Experience in 116 Patients with Moderate-To-Severe Psoriasis

Abstract

Introduction: Ustekinumab is a monoclonal antibody directed against the p40 subunit common to both IL-12 and IL-23 cytokines. Although the evidence of ustekinumab efficacy and safety in clinical trials is extensively recognized, data on its use in clinical practice is limited. Our objective is to report on the real-life experience of two Portuguese dermatology departments with ustekinumab in patients with moderate to severe psoriasis, and to identify the clinical characteristics associated with a weaker clinical response.
Material and Methods: Clinical, demographic, and therapeutic response data was retrospectively collected in 116 patients with moderate to severe psoriasis treated with ustekinumab between November 2009 and December 2015.
Results: A PASI75 therapeutic response was observed in 67.2%, 85.3%, 89.6% and 88.7% of patients at weeks 4, 12, 24 and 52, respectively. Ustekinumab was discontinued in seven patients (three due to primary failure, three due to secondary treatment failure, and one due to adverse events). Neither cardiovascular events nor cases of reactivation of previous infections (tuberculosis, hepatitis B) were observed during follow-up. In nine patients methotrexate was used as adjuvant therapy, and fourteen patients required ustekinumab dosage optimization. No side effects were observed in the two latter groups. The therapeutic response was higher in patients naïve to biologic therapies as compared to non-naïve patients.
Discussion and Conclusion: A trend towards lower clinical response was observed in patients weighing between 90-100 kg, and dosage optimization in this group of patients may be of value prior to considering biologic switch.