Real-world use of ustekinumab therapeutic drug monitoring in moderate to severe psoriasis.

Introduction: There is growing evidence that therapeutic drug monitoring of biologic therapy is beneficial in psoriatic patients. With respect to ustekinumab, the available evidence has not shown any relationship yet. The objective of this study is to identify correlations among ustekinumab trough concentrations, anti-ustekinumab antibodies and clinical response in moderate-to-severe plaque psoriasis patients, in a real-world setting. Methods: Observational prospective follow-up study in psoriatic patients treated with ustekinumab. Patients were classified in optimal (PASI ≤ 3) and suboptimal responders (PASI > 3). Mann-Whitney U test and Spearman's rank correlation coefficient were used. Receiver-operator characteristic curve analysis was performed to identify ustekinumab concentration cut-off to achieve optimal response. A p-value < 0.05 was considered statistically significant. Results: A total of 59 patients were included. Forty-eight patients (81.4%) corresponded to optimal responders and 11 (18.6%) to suboptimal responders. There was significant difference to ustekinumab concentrations: 0.7 µg/mL (range <0.1-1.8) vs. 0.4 µg/mL (range <0.1-0.8) respectively (p = 0.007). Positive correlation between ustekinumab concentration and psoriasis area and severity index (PASI) value was detected (p = 0.009). A cut-off value of 0.6 µg/mL ustekinumab concentration was found to achieve clinical response. Anti-ustekinumab antibodies were detected in 2 (3.4%) samples, both suboptimal responders. Conclusion: A positive correlation exits between ustekinumab concentration and clinical response (optimal response PASI values ≤ 3) in blood draws performed before drug administration. The measurement of anti-ustekinumab antibodies could be considered in treatment failure.

Biologic Therapy for Moderate to Severe Psoriasis. Real-World Follow-up of Patients Who Initiated Biologic Therapy at Least 10 Years Ago.

INTRODUCTION: The aim of this study was to evaluate response and drug survival of biologic therapy in patients with moderate to severe plaque-type psoriasis who initiated biologic therapy at least 10 years ago, in a real-world setting. METHODS: This was an observational retrospective follow-up study that included patients with moderate to severe plaque-type psoriasis who initiated biologic therapy between October 2006 and December 2009. Efficacy was expressed as the percentage of patients achieving a 50, 75 and 90% reduction from baseline in the Psoriasis Area and Severity Index (PASI 50, PASI 75, PASI 90, respectively) every 3 months during the first year of therapy and then every 12 months up to the end of follow-up or withdrawal from the study. RESULTS: A total of 56 patients were included in the study, representing 140 treatment lines (median 2, range 1-8); of these patients, 53 were still receiving biologic therapy at the end of the study. The mean duration of biologic therapy was 140.4 (range 47.6-175.4) months. Etanercept was used in 98.2% of patients, followed by efalizumab (42.9%), adalimumab (41.1%), ustekinumab (33.9%) and infliximab (16.1%). Treatment lines were switched in 62.1% of treatments: 24.3% due to secondary failure, 20.7% due to primary failure and 3.6% due to side effects. No patient treated with anti-interleukins had to discontinue treatment due to side effects. Ustekinumab had the highest drug survival. CONCLUSIONS: This study in the real-world-setting shows maintenance of long-term efficacy and safety of biologic therapy in patients with moderate to severe plaque psoriasis in daily practice who initiated biologic therapy 10 years ago.

Efficacy and safety of adalimumab in psoriatic patients previously treated with etanercept in a real-world setting.

INTRODUCTION: Knowledge on the efficacy and safety of adalimumab in psoriasis patients switching from etanercept is scarce, especially on the influence that causes of etanercept discontinuation may have on adalimumab response. OBJECTIVES: To evaluate the response, adverse effects and factors that may influence the efficacy and safety of adalimumab in psoriasis patients who failed on etanercept therapy in a real-world setting. METHODS: Data from all moderate to severe plaque psoriasis patients who switched from etanercept to adalimumab were extracted from a registry of biological therapies of our department. Primary endpoint was the percentage of patients achieving PASI 50 at weeks 12, 24, and 52. Secondary endpoints were the percentages of patients achieving PASI 75 and PASI 90, patients who maintained PASI values <5 and <3, and the safety of adalimumab. RESULTS: Of 35 patients who fulfilled the study criteria, 82.9% achieved PASI 50 at week 12, 74.3% at week 24, and 74.3% at week 52 on adalimumab treatment. Eleven of 16 primary and 11 of 17 secondary nonresponders to etanercept responded to adalimumab. There were no treatment discontinuations due to side effects. CONCLUSIONS: Previous etanercept failure seems not influence the success and safety of adalimumab treatment in moderate to severe plaque psoriasis.