Tralokinumab Safe, Effective for Long-Term Treatment of Atopic Dermatitis

May 3, 2021
Linda Stocum, Assistant Editor

Interim analysis of data from the ECZTEND study evaluating the long-term safety, efficacy, and tolerability of tralokinumab for treatment of atopic dermatitis was presented at AAD VMX 2021.

New safety and efficacy data on tralokinumab (LEO Pharma) for the treatment of atopic dermatitis (AD) from the ECZTEND (NCT03587805) study was presented by Andrew Blauvelt, MD, MBA, president of Oregon Medical Research Center, Portland, Oregon, at the American Academy of Dermatology Virtual Meeting Experience 2021 (AAD VMX 2021).1

Tralokinumab is a fully human monoclonal antibody that binds to and inhibits interleukin (IL)-13, a key driver of the underlying inflammation in AD. The purpose of this phase 3 trial was to investigate the long-term safety and efficacy of tralokinumab in patients with AD who participated in previous trials. 

When patients enrolled in the study, they received a 600 mg dose of tralokinumab at Week 0. After, they received 300 mg every 2 weeks with optional topical corticosteroid (TCS) for a 5-year period.

The study’s primary endpoint was the number of adverse events from baseline up to Week 268. The secondary endpoints were an Investigator Global Assessment (IGA)score of 0/1 and Eczema Area and Severity Index (EASI) 75 from Week 16 to Week 248. 

The data presented only included patients from the ECZTRA 1 (NCT03131648), ECZTRA 2 (NCT03160885), ECZTRA 3 (NCT03363854), and ECZTRA 5 (NCT03562377) trials. This totaled to 1,174 patients. 

Patients were broken up into 2 cohorts. The Week 56 cohort is defined as all patients who reached the 1-year mark or would have reached the 1-year mark if they did not discontinue early. The other is the 2-year cohort, defined as patients who have been previously treated with tralokinumab monotherapy for 52 weeks in ECZTRA 1 and 2, and 56 weeks of treatment in ECZTEND.

The baseline characteristics in the parent trials included a median EASI score of 26.6 and a median IGA score of 3. When beginning the ECZTEND study, the median EASI score was 1.7 and IGA score of 2.

“So really what we are looking at with ECZTEND, to me, is maintenance or durability of response in patients who have done well with 1 year of therapy,” said Blauvelt.

About 12% of patients withdrew from the ECZTEND trial. Roughly 2% due to adverse events (AEs) and 4.3% for lack of efficacy, according to investigator or patient opinion. IGA 0/1 scores were sustained with tralokinumab at Week 56. A high percentage of patients achieved EASI 50 at 95.1%, EASI 75 at 82.8%, and EASI 90 at 61% according to the observed standard. These numbers all pertain to the Week 56 cohorts.

The study also tracked two most mentioned side effects itch and lack of sleep. A scale was made from 0-10, 10 being the most affected and 0 being unaffected. The mean baseline scores were 5 for itchiness and 3 for sleep. By the conclusion of the study, patients achieved scores equivalent to mild to moderate itch and mild sleep interference at Week 56.

For the 2-year cohorts, 93.8% achieved EASI 50, 82.8% achieved EASI 75, and 59.8% achieved EASI 90 according to the observed standard.

Serious adverse events (SAEs) in the first 4 trails were 7.4% tralokinumab and 11.9% placebo. In the ECZTEND data, SAEs were at 4.8%. 

There were also lower incident rates (IRs) with conjunctivitis. Out of 100 patient years, there was a 29% rate in the 4 starter studies in the tralokinumab arm, which was higher than the 12.3% for the placebo arm, but in ECZTEND this rate dropped to 6.9%.

“To me this is very encouraging results I am showing you today,” concluded Blauvelt. 

Disclosure:

Andrew Blauvelt has served as a scientific advisor and/or clinical study investigator for AbbVie, Abcentra, Aligos, Almirall, Amgen, Arcutis, Arena, Athenex, Boehringer Ingelheim, Bristol-Meyers Squibb, Dermavant, Eli Lilly, Evommune, Forte, Galderma, Incyte, Janssen, Landos, LEO Pharma, Novartis, Pfizer, Rapt, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB Pharma.

Reference:

1. Blauvelt A, et al. Long-term Improvements Observed in Tralokinumab-treated Patients with Moderate-to-severe Atopic Dermatitis: An ECZTEND Interim Analysis. American Academy of Dermatology Association Virtual Meeting Experience (AAD VMX); April 23-25, 2021. On-demand video oral presentation 29393.