25 Jun Atopic Dermatitis: Study Finds Monoclonal Antibody Tralokinumab + Topical Steroids Effective for Moderate to Severe Disease
MedicalResearch.com Interview with:
Dr. Jonathan L. Silverberg MD PhD MPH
Assistant Professor in Dermatology
Medical Social Sciences and Preventive Medicine
Northwestern, Chicago, Illinois
MedicalResearch.com: What is the background for this study?
Response: Topical anti-inflammatory therapy is often inadequate to achieve disease control in patients with moderate-to-severe atopic dermatitis (AD), and systemic therapy is often warranted. Tralokinumab is a fully human immunoglobulin G4 monoclonal antibody that specifically binds to the IL-13 cytokine with high affinity and inhibits downstream IL-13 pro-inflammatory signaling.
Tralokinumab was previously studied as a monotherapy in moderate-severe AD in the ECZTRA1 and ECZTRA2 studies. In this Phase 3 randomized controlled study, ECZTRA3, tralokinumab was studies in combination with topical corticosteroids compared to placebo with topical corticosteroids. The use of topical anti-inflammatory therapy is more akin to the way in which systemic and biologic therapies are typically used in the real-world.
MedicalResearch.com: What are the main findings?
Response: At week 16, significantly more patients treated with tralokinumab + TCS verses placebo + TCS achieved IGA-0/1 (38.9% vs 26.2%), EASI-50 (79.4% vs. 59.7%), EASI-75 (56.0% vs 35.7%), EASI-90 (32.9% vs. 21.4%), and ≥4-point improvement of NRS-itch (45.4% vs. 34.1%). Tralokinumab + TCS also resulted in significantly lower mean SCORAD and DLQI scores than placebo + TCS. Patients treated with tralokinumab +TCS received less rescue treatment (2.8% vs. 10.2%), and used less cumulative TCS compared to placebo + TCS.
Approximately 90% of patients who were tralokinumab responders at week 16 maintained IGA-0/1 and/or EASI-75 response at week 32 with tralokinumab every other week. 77.6% of and 90.8% of patients treated with tralokinumab every 4 weeks also maintained IGA-0/1 and/or EASI-75. Among patients who did not achieve IGA-0/1 and/or EASI-75 with tralokinumab every other week at week 16, 30.5% and 55.8% achieved IGA-0/1 and EASI-75 at week 32. The overall incidence of adverse events was similar across treatment groups and the adverse event profile over 32 weeks was comparable to the initial 16 weeks.
MedicalResearch.com: What should readers take away from your report?
Response: The results show that tralokinumab 300 mg plus TCS every other week was effective and well tolerated in patients with moderate-to-severe stopic dermatitis. Tralokinumab is currently an investigational agent for moderate-severe AD, but may soon be an important addition to our therapeutic armamentarium. Tralokinumab + TCS showed better efficacy in ECZTRA3 than tralokinumab monotherapy as observed in the ECZTRA1 and ECZTRA2 studies.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: One big question that remains is how well tralokinumab will work in patients who previously failed treatment with dupilumab, cyclosporine and oral immunosuppressants.
Disclosures: Dr Silverberg has been a consultant, advisory board member, and investigator for Leo Pharma.
Citation: AAD VMS 2020 presentation:
Efficacy and safety of tralokinumab with concomitant topical corticosteroid in adult patients with moderate-to-severe atopic dermatitis: Results from the 32-week Phase 3 ECZTRA 3 trial
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