Treatment-free disease control after tralokinumab in patients with moderate-to-severe atopic dermatitis

Summary: Tralokinumab, a monoclonal antibody targeting IL-13, is approved for treatment of moderate-to-severe AD in individuals ≥12 years of age. Enduring treatment-free disease control was assessed post hoc using pooled data from phase 3 ECZTRA 1 & 2 (NCT03131648 & NCT03160885) patients re-randomized to placebo after achieving primary endpoints (IGA 0/1 or EASI-75) at Week 16 with tralokinumab Q2W (n=73). Treatment-free disease control was defined as no use of rescue therapy (ie, TCS), no transfer to open-label arm (tralokinumab Q2W + optional TCS), and no permanent trial discontinuation due to lack of efficacy. Patients maintained treatment-free disease control for a median of 22.3 weeks. At 26 weeks off treatment, 38.4% (28/73) of patients maintained treatment-free disease control, with 32.1% (9/28) and 17.9% (5/28) of those patients meeting IGA 0 and Itch NRS 0/1, respectively. Patients who maintained treatment-free disease control had lower baseline mean BSA (33.6% vs 52.6%) and EASI (25.3 vs 31.4) and more robust Week 16 response (eg, IGA 0: 25% [7/28] vs 0% [0/45]) than those who did not. Of patients who transferred to open-label tralokinumab after experiencing a pre-determined decline from their Week 16 response (n=31), 69% regained IGA 0/1 or EASI-75 by 24 weeks of open-label treatment, with a median recapture time of 12.1 weeks. Approximately 40% of Week 16 responders maintained treatment-free disease control for six months with no rescue therapy, indicating that some patients may experience a remittive effect following specific neutralization of IL-13 with tralokinumab. Andrew Blauvelt¹, Tina Bhutani², Ben Ehst³, Naiem Issa⁴, Matthew Zirwas⁵, Ulla Ivens⁶, Hannah Lo⁷, Shannon Schneider⁷, Raj Chovatiya⁸ 1. Blauvelt Consulting, LLC, Annapolis, MD, United States. 2. University of California San Francisco, San Francisco, CA, United States. 3. Oregon Medical Research Center, Portland, OR, United States. 4. Forefront Dermatology, Vienna, VA, United States. 5. Ohio University, Columbus, OH, United States. 6. LEO Pharma A/S, Ballerup, Capital Region of Denmark, Denmark. 7. LEO Pharma Inc., Madison, NJ, United States. 8. Rosalind Franklin University of Medicine and Science Chicago Medical School, North Chicago, IL, United States. Clinical Research: Interventional Research