LEO Pharma presented long-term data from an interim analysis of its ECZTEND 5-year extension trial, showing no new safety signals.
LEO Pharma announced data up to 3.5 years in the making that supports the long-term safety and efficacy of tralokinumab-ldrm (Adbry; LEO Pharma) in adult patients with moderate to severe atopic dermatitis (AD), according to a press release. Interim results were shared as a poster presentation at the American Academy of Dermatology (AAD) 2022 Annual Meeting.
Tralokinumab-ldrm was approved to treat moderate to severe AD in patients 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The treatment is the first FDA approved biologic that specifically binds to and inhibits the interleukin (IL)-13 cytokine, according to the release.
The safety analysis, which included data with in the last 3 and a half years, had 1,442 patients in total from the ECZTEND long-term, open-label extension trial (NCT03587805). This data was used to capture the overall safety profile of tralokinumab-ldrm 300-mg every other week (Q2W) plus optional topical corticosteroids (TCS). It was found the profule was consistent with those in the parent trials of tralokinumab-ldrm and no new safety signals emerged. To be included in the analysis, the patients had to be treated with at least 1 dose of tralokinumab-ldrm and enrolled in one of the following studies: ECZTRA 1 and 2, ECZTRA 3, ECZTRA 4, ECZTRA 5, and ECZTRA 7.
The efficacy analysis saw that tralokinumab-ldrm 300-mg Q2W plus optional TCS maintained improvement AD, itch severity, and quality of life in adult patients treated with tralokinumab-ldrm for up to 3 years. Patients who had enrolled in the parent trials and continued into ECZTEND were on treatment for up to 3.5 years, including up to 2.5 years in ECZTEND and up to 1 year in the parent trials, according to the release.
“It is reassuring to see such consistent results as the ECZTEND trial continues to unfold,” said Andrew Blauvelt, MD, MBA, President of the Oregon Medical Research Center in Portland, Oregon, and lead investigator of ECZTEND, in the press release. “The latest interim safety and efficacy findings are similar to earlier reports and continue to reinforce the rationale for treatment specifically targeting IL-13 in adult patients with moderate to severe [AD].”
From ECZTEND baseline to data cut-off (up to 2.5 years in ECZTEND), 22.9% of patients withdrew from the study, and 2.4% due to adverse events (AEs). The most common AEs (occurring in at least 5% of participants) included viral upper respiratory tract infection (mainly reported as common cold), AD, upper respiratory infection, headache, and conjunctivitis—none of which were considered serious, according to the press release.
In the cohort of 616 patients who received tralokinumab-ldrm for up to 3 years, 85.1% achieved an Eczema Area and Severity Index score (EASI)-75. Half of the patients (50.5%) achieved an Investigator Global Assessment score of 0/1 meaning clear or almost clear (IGA 0/1). Also, patients achieved improvements in itch and quality of life as measured by 60.6% of patients achieving a Worst Weekly Pruritus Numerical Rating Scale (NRS) score of less than or equal to 3 and 76.4% achieving a Dermatology Life Quality Index (DLQI) score of less than or equal to 5. Data reported as observed, the press release stated.
LEO Pharma presents new interim long-term safety and efficacy data for Adbry (Tralokinumab-ldrm) in moderate-to-severe atopic dermatitis at the 2022 AAD annual meeting. BusinessWire. Press release. Published March 25, 2022. Accessed March 29, 2022. https://www.businesswire.com/news/home/20220324005846/en/LEO-Pharma-Presents-New-Interim-Long-Term-Safety-and-Efficacy-Data-for-Adbry%E2%84%A2-tralokinumab-ldrm-in-Moderate-to-Severe-Atopic-Dermatitis-at-the-2022-AAD-Annual-Meeting