Ustekinumab treatment for moderate to severe psoriasis. Eight-year real-world follow-up of 61 cases in a tertiary level hospital.

Background: Efficacy and safety profiles of ustekinumab have been proved in numerous clinical trials. However, relevant variations with daily practice have been shown and few studies value the long-term response maintenance.Objective: To evaluate the efficacy of long-term ustekinumab therapy in patients with moderate-to-severe plaque-type psoriasis in a real-world setting.Methods: Observational retrospective follow-up study including, patients receiving ustekinumab at least 3 months in our department. Efficacy was expressed as percentage of patients achieving Psoriasis area and severity index (PASI) 50, PASI75, and PASI90 and maintaining PASI ≤5, ≤3, and 0 every 3 months during the first year of treatment, and every 12 months to the end of follow-up or to withdrawal from the study.Results: Sixty-one patients. Fifty patients had previously been treated with other biologic therapies. The percentage of patients maintaining PASI90 was 72.1, 78.3, 70.0, 83.3, 96.2, 91.7, and 100.0%, and PASI value maintained 0 in 68.9, 73.9, 67.50, 80.6, 96.2, 91.7, and 100.0% at 3, 12, 24, 36, 60, 84, and 96 months. Ustekinumab was discontinued in 26.2% of patients. No patients were withdrawn because of adverse events.Conclusions: This real world-setting study shows maintenance of long-term efficacy and safety of ustekinumab treatment in moderate-severe plaque psoriasis in daily practice through 8 years.

Infliximab drug and antibody levels in patients with dermatological conditions.

BACKGROUND: In recent years, studies monitoring infliximab in rheumatoid arthritis and inflammatory bowel disease have confirmed the relationship between the clinical response and the infliximab and anti-infliximab antibodies serum levels. However, there is only limited evidence in the field of dermatology. OBJECTIVE: The aim of this study was to establish the correlation between plasma infliximab levels, the presence of anti-infliximab antibodies and the clinical response in dermatological conditions. SETTING: Retrospective observational study in a tertiary hospital (University Hospital of La Coruña, Spain). METHOD: Patients with dermatological conditions being treated with infliximab (5 mg/kg/8 weeks after the induction dose) were included in the study. The concentrations of infliximab and anti-infliximab antibodies were quantified by two sandwich-type ELISA immunoassays. The patients were classified into three groups based on the efficacy: good, partial or non-efficacy at the time of each blood assessment. The development of adverse reactions was also evaluated. MAIN OUTCOME MEASURES: Plasma levels of infliximab and anti-infliximab antibodies, clinical response and infusion reactions. RESULTS: 17 patients (45 assessments) were included. The good/partial efficacy rate was significantly higher in the case of >0.05 than <0.05 µg/mL infliximab concentration (93.3 vs. 40.0 %, p < 0.001). Anti-infliximab antibodies were only detected in five samples. Their presence was associated with a higher frequency of infusion reactions and a lower efficacy rate in comparison with the group without antiinfliximab antibodies (100.0 vs. 0.0 %, p < 0.001 and 0.0 vs. 85.0 %, p < 0.001 respectively). CONCLUSIONS: The results obtained show that the presence of infliximab concentrations higher than 0.05 µg/mL are correlated with a good clinical response and the absence of toxicity. The incidence of anti-infliximab antibodies is low, although a correlation was observed between the presence of antibodies, absence of infliximab concentration, loss of clinical response and the development of infusion reactions.