26 Mar NEJM: Two Phase 3 Trials Find Lebrikizumab Safe and Highly Effective for Atopic Dermatitis
MedicalResearch.com Interview with:
Jonathan Silverberg, MD, PHD, MPH
Director of Clinical Research
Director of Patch Testing
George Washington University School of Medicine and Health Sciences
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Lebrikizumab was previously shown to be safe and effective as a treatment for moderate-severe atopic dermatitis in a phase 2 study. These Phase 3 randomized placebo-controlled trials are the largest studies to date of lebrikizumab in AD. They showed that lebrikizumab was safe and highly effective for the treatment of moderate-severe atopic dermatitis. These studies will hopefully support the approval of lebrikizumab in the United States later this year.
MedicalResearch.com: What should readers take away from your report?
Response: Since Atopic Dermatitis tends to wax and wane or even resolve spontaneously over time, how would you know when to stop therapy? Is it worth the (small) risk of immunosuppression?
Response: This manuscript reported the trial results at the primary efficacy time-point of 16 weeks. Future publications will examine the long-term efficacy of lebrikizumab out to 52 weeks and the maintenance of clinical response after treatment discontinuation.
Based on the data from the trials, it is fair to conclude that lebrikizumab is not an immunosuppressant. There were no increases in infections overall, no opportunistic infections, and decreased skin infections observed with lebrikizumab compared to placebo. One of the major strengths of lebrikizumab is the clean long-term safety profile, which allows for it to be used safely long-term in those who need it.
Disclosures: I have been a consultant and investigator for Eli Lilly and Company.
Silverberg JI, Guttman-Yassky E, Thaçi D, Irvine AD, Stein Gold L, Blauvelt A, Simpson EL, Chu CY, Liu Z, Gontijo Lima R, Pillai SG, Seneschal J; ADvocate1 and ADvocate2 Investigators. Two Phase 3 Trials of Lebrikizumab for Moderate-to-Severe Atopic Dermatitis. N Engl J Med. 2023 Mar 23;388(12):1080-1091. doi: 10.1056/NEJMoa2206714. Epub 2023 Mar 15. PMID: 36920778.
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