A trial to compare the biologic drug ixekizumab with two other treatments for psoraisis, fumaric acid esters and methotrexate

摘要

Summary Plaque psoriasis is a skin disease which causes red, scaly patches of skin. It is a chronic disease, which means that it generally persists for a long time. Medications used to treat plaque psoriasis include a drug called methotrexate and, in some European countries, a medicine called fumaric acid esters (FAE). In more recent years, new, powerful drugs called biologics have been used to treat psoriasis. Ixekizumab is one such biologic treatment for moderate‐to‐severe plaque psoriasis. It is an antibody, which means a type of protein that the body's immune system uses to fight off disease. Ixekizumab binds to and neutralises interleukin‐17A, a protein involved in inflammatory responses in the skin that cause psoriasis symptoms. Blocking interleukin‐17A activity in this way is a useful treatment for diseases such as psoriasis. The aim of this study was to compare the efficacy of ixekizumab to methotrexate and FAE in a randomised, controlled trial (RCT) in patients with chronic moderate‐to‐severe plaque psoriasis. A RCT trial means that patients are randomly assigned to a treatment group for one of the drugs being studied, and there is also a control group who do not receive any of the treatments being compared. Efficacy (treatment success) was evaluated using the Psoriasis Area and Severity Index (PASI), a measure of the redness, thickening, scaling, and extent of the psoriatic lesions (affected patches of skin). PASI 75 indicates that a patient experienced at least a 75% improvement in their PASI score since the start of the study. 162 adult patients in Germany were randomly assigned to one of the three treatments. After 24 weeks, 90.7% of patients treated with ixekizumab had achieved PASI 75, compared to 70.4% treated with methotrexate and 22.2% treated with FAE, indicating higher treatment success with ixekizumab. In addition, significantly more patients treated with ixekizumab achieved PASI 90 and PASI 100 (indicating a 90% and 100% improvement in their PASI score, respectively), and had significantly improved Dermatology Life Quality Index (which was measured at multiple time‐points during the trial and measures the patient's quality of life), compared to patients treated with methotrexate or FAE. The percentage of patients who terminated treatment due to adverse health events (unwanted side effects) was lower with ixekizumab compared to FAE (3.7% versus 38.5%), and was similar between ixekizumab and methotrexate (3.7% versus 0.0%). These results confirm the benefit of ixekizumab over methotrexate and FAE as a first‐line treatment for patients with moderate‐to‐severe plaque psoriasis, and may be useful in refining future treatment guidelines. This is a summary of the study: A 24‐week multicentre, randomized, open‐label, parallel‐group study comparing the efficacy and safety of ixekizumab vs. fumaric acid esters and methotrexate in patients with moderate‐to‐severe plaque psoriasis naive to systemic treatment