Brodalumab in plaque psoriasis: Real‐world data on effectiveness, safety and clinical predictive factors of initial response and drug survival over a period of 104 weeks

Abstract

Background Brodalumab, a fully human IgG2k antibody blocking the receptor of IL17, is characterized by a rapid onset of action with high skin clearance rates in clinical trials. Since setting PASI90/100 or absolute PASI ≤ 3 as treatment goals have become attainable, evaluating the effectiveness and safety profile of biologic agents, such as brodalumab, in a real‐world setting is essential. Objective The aim of this study was to evaluate the effectiveness and safety profile of brodalumab over a period of 104 weeks in everyday practice. Clinical predictive factors of initial (week 12/16) response to treatment and long‐term drug survival were also investigated. Methods In this monocentric, retrospective study, PASI90/100 and absolute PASI ≤ 1/3 were assessed in 91 patients with moderate‐to‐severe skin psoriasis under brodalumab at weeks 12/16, 24, 52 and 104 of treatment. At week 12/16, patients with an absolute PASI ≤ 3 were defined as ‘initial responders’ and ≤1 as ‘super‐responders’. Clinical parameters, such as age, gender, BMI, comorbidities and previous systemic treatment, were assessed in order to predict ‘super‐responders’. Drug survival and its prognostic factors were also evaluated. Results PASI90/100 has reached 81.1/66.0% in week 12/16. This response rate increased at week 104, where 87.1/80.7% had PASI90/100 and 84.9% had absolute PASI ≤ 1. The presence of >3 comorbidities, prior treatment with >2 systemic agents and obesity tended to be negative predictive factors of ‘super‐response’. Previous exposure to IL17 inhibitors had no impact on both PASI < 1 and PASI < 3 initial response. One‐ and two‐year drug survival probability was 87.6% and 77.32%, respectively. ‘Initial responders’ and anti‐IL17 drug‐naïve patients had better drug survival. Drug discontinuation occurred in 24.2%, mostly due to secondary failure, and arthralgia was the most common adverse event that led to discontinuation. Conclusions Our study confirms the high effectiveness and good safety profile of brodalumab in the real‐world setting.

Real‐world drug survival of Brodalumab, in patients with psoriasis switched from Ixekizumab: Results of a single centre retrospective study (BroSwitch)

“…To our knowledge, this is the first description of a PsO patient group who switched from an originator biological to another originator from the same group, other than a biosimilar, not because of inefficacy but as a protocolled procedure, because of health economic reasons. Brodalumab has a 1‐year drug survival rate of 87.6%–89% at 1 year 18,22–24 …”

“…Brodalumab has a 1-year drug survival rate of 87.6%-89% at 1 year. 18,[22][23][24] Only a few studies had been performed where patients who failed on Ixekizumab were switched to Brodalumab and had favourable responses. 25,26 These two studies were limited to a duration of 16 weeks, and no drug survival was reported.…”

“…The CorEvitas Psoriasis Registry recently showed that switching after prior inefficacy of Secukinumab can lead to 20% failures in Ixekizumab users 16 . Only a few real world evidence studies have looked at the drug survival of Brodalumab after previous use of anti‐IL17 originators, and showed lowered but acceptable drug survival rates 17,18 . No drug survival data exists of deliberately switching patients from one anti‐IL17 originator to another due to nonmedical reasons.…”

Development of a Deep Eutectic Solvent-Assisted Kaempferol Hydrogel: A Promising Therapeutic Approach for Psoriasis-like Skin Inflammation

“…Psoriasis, an inflammatory skin disease caused by a disorder of the immune system, affects an estimated 1.25 million people. − It is characterized by red, itchy, and scaly patches that cause extreme discomfort. The exact cause is still not fully understood as it involves a complex interaction between genetic susceptibility, immune dysfunction, and environmental factors.…”

Predictors for the effectiveness of 75 mg risankizumab in treating psoriasis—A real‐word evidence from a 52‐week retrospective study

“…Previously, we had reported the treatment responses of 75 mg risankizumab for psoriatic patients with inadequate response to 150 mg secukinumab 5 . Multiple factors can contribute to the difference in the treatment response of biologics, including the presence of comorbidities, 6 the number of prior biologics used, 7,8 disease duration 9,10 and body weight. The presence of comorbidities, especially diabetes mellitus (DM), has been shown to affect drug survival of biologics in some studies, 11 but the result seemed to be inconsistent 12 .…”