Real-World Evidence Demonstrating Tralokinumab Onset of Action and Efficacy in Two Skin of Color Patients with Moderate-to-Severe Atopic Dermatitis

Abstract

Introduction: Atopic dermatitis (AD) is a chronic, inflammatory skin disease that has higher prevalence, persistence, and severity, as well as different response to treatment, in skin of color (SOC) patients. This underscores the importance of clinical trial diversity and real-world case reports to help reduce health inequity, improve clinical understanding, and enhance treatment access for all patient populations. Tralokinumab specifically targets interleukin-13, and the onset, efficacy, and safety outcomes from the initial clinical trials revealed striking therapeutic potential. 
 Objective: To provide examples of rapid tralokinumab onset of action in SOC patients, including improvement of the difficult-to-treat head and neck subtype and of hyperpigmentation on the hands.
 Methods: The authors describe the clinical outcomes of two SOC patients: an 18-year-old Asian male [patient 1] and a 37-year-old African-American male [patient 2]. Data related to tralokinumab treatment were collected during routine clinical practice.
 Results: Both patients were diagnosed with AD in infancy and continued to suffer from AD. At baseline, each had clearly perceptible erythema, induration, and lichenification and were assigned IGA scores of 3. Patient 1 had a BSA of 22%, managed with clobetasol 0.05% ointment for the body and ruxolitonib 1.5% cream for the face. He had never received systemic treatment. Patient 2 had previous medical history of mild asthma and BSA of 29%. His AD was managed with clobetasol 0.05% ointment. Over the prior two decades, he had been managed with myriad topical corticosteroids, prednisone tapers, as well as methotrexate. Due to insurance barriers, there were challenges obtaining tralokinumab immediately for both patients. The lapse in time was less than 6 weeks in each case. Not surprisingly, IGA 3 was assigned at both time of initial presentation and at time of tralokinumab initiation. Both patients were prescribed an initial dose of 600 mg (four 150 mg subcutaneous injections) followed by 300 mg (two 150 mg subcutaneous injections) administered every other week. After 10 weeks, patient 1 experienced a decrease in IGA from 3 to 1; his BSA decreased from 22% to 7%. After only 6 weeks, patient 2 also exhibited a decrease in IGA from 3 to 1; his BSA decreased from 29% to 6%. The improvement was sustained throughout a 6-month follow-up period in both patients. The authors observed significant improvement in the quality of life for both patients, subjectively and objectively. To date, no patient-reported or investigator-recognized adverse outcomes have occurred.
 Conclusions: Treatment with tralokinumab 300 mg, every other week, showed a rapid onset of action, with superior efficacy to the original clinical trials in two SOC patients with moderate-to-severe AD, one of which had involvement of the difficult-to-treat area of the head and neck. With no patient- or physician- adverse events reported to date, this observational study underscores the importance of future real-world reports to potentially corroborate our findings.