Lilly's EBGLYSS™ Shows Significant Skin and Itch Improvement in Atopic Dermatitis Patients After Stopping Dupilumab

Eli Lilly and Company's EBGLYSS has demonstrated significant improvements in skin condition and itch relief among patients with moderate-to-severe atopic dermatitis, formerly treated with dupilumab. These findings are part of the Phase 3b ADapt study, which will be discussed at the Fall Clinical Dermatology Conference.

EBGLYSS operates as a selective interleukin-13 (IL-13) inhibitor, disrupting IL-13 signaling, which is crucial in atopic dermatitis. IL-13 perpetuates a type-2 inflammatory cycle in the skin, causing barrier dysfunction, itching, thickening, and infection.

Linda Stein Gold, M.D., a principal investigator of the ADapt study and head of dermatology at Henry Ford Health System, emphasized the need for diverse treatment options for patients, especially for challenging areas like the face and hands. According to Dr. Gold, the data indicate that EBGLYSS significantly alleviates skin symptoms and itch for most patients who had ceased dupilumab treatment, underscoring its potential for a broader patient population.

The ADapt study assessed both the efficacy and safety of EBGLYSS in patients who discontinued dupilumab due to inadequate response, intolerance, adverse events, or other reasons. The primary endpoint was a 75% improvement in the Eczema Area and Severity Index (EASI-75) at 16 weeks, while secondary endpoints included an Investigator Global Assessment (IGA) score of clear or almost clear skin, and at least a four-point improvement in the Pruritus NRS score.

Results from the ADapt study showed that 57% of patients reached the EASI-75 threshold at Week 16, increasing to 60% at Week 24. These outcomes aligned with data from previous EBGLYSS monotherapy trials (ADvocate 1 and 2), showing the drug's consistency in treating patients regardless of prior dupilumab exposure. Additionally, 46% of patients who had an inadequate response to dupilumab achieved EASI-75 with EBGLYSS at Week 16.

Notably, 53% and 62% of patients who switched from dupilumab to EBGLYSS reported at least a four-point reduction in itch severity at Weeks 16 and 24, respectively. Furthermore, over half of the patients saw improvements in facial dermatitis, with 52% achieving clear or nearly clear skin by Week 24. Those with moderate-to-severe hand dermatitis experienced a significant 75% reduction in their modified total lesion symptom score (mTLSS).

Adverse events led to treatment discontinuation in less than 6% of patients, with the safety profile of EBGLYSS being consistent with previous studies. Common side effects included conjunctivitis and injection site reactions. Notably, none of the patients who discontinued dupilumab due to eye-related events, facial dermatitis, or inflammatory arthritis reported similar issues with EBGLYSS.

Mark Genovese, M.D., senior vice president of Lilly Immunology development, highlighted the trial's contribution to evidence supporting the use of EBGLYSS as a first-line treatment for moderate-to-severe atopic dermatitis. He noted the drug's effectiveness, even among patients who had previously tried other biologic treatments like dupilumab.

Additionally, Lilly plans to present further data at the Fall Clinical Dermatology conference, including long-term extension study results from the ADjoin study, which includes data up to three years. EBGLYSS received FDA approval last month for adults and children aged 12 and older with moderate-to-severe atopic dermatitis that is poorly controlled with topical therapies. The drug, administered as a 250 mg/2 mL injection, follows an initial dosage phase and then a monthly maintenance injection.

EBGLYSS has also been approved in the European Union and Japan, with more markets anticipated to follow. Lilly holds exclusive global development and commercialization rights for EBGLYSS, except in Europe where Almirall S.A. manages dermatology indications.

The ADapt study's success reinforces the value of EBGLYSS for patients with atopic dermatitis, especially those who have not found relief with dupilumab, offering a promising new option for managing this challenging condition.