Dr. Jonathan L. Silverberg MD PhD MPH Assistant Professor in Dermatology Medical Social Sciences and Preventive Medicine Northwestern University, Chicago, Illinois

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 University, Chicago, Illinois

Dr. Jonathan Silverberg

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

https://www.aad.org/member/meetings-education/aadvmx

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Last Modified: Jun 25, 2020 @ 10:31 am 

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