Almirall and Eli Lilly's lebrikizumab, a monoclonal antibody targeting interleukin-13 (IL-13), has demonstrated promising results in a Phase 3 trial for the long-term management of moderate to severe atopic dermatitis (AD). The trial, which assessed the drug's efficacy over 52 weeks, showed sustained symptom control compared to the 16-week maintenance observed in earlier studies. These findings, presented at the European Academy of Dermatology and Venerology (EADVC) conference, suggest that lebrikizumab could offer a durable treatment option for patients with AD, a chronic dermatological condition characterized by itching, dry skin, pain, and inflammation.
Sustained Efficacy and Dosage Tailoring
Dr. Jacob Thyssen, a professor at the University of Copenhagen and a leading expert on AD, highlighted the significance of the 52-week data. "The week 52 data confirms the maintenance of response of lebrikizumab until week 52 with both doses: lebrikizumab administered only once a month (Q4W) and two times a month (Q2W)," he stated. This suggests that IL-13 is a key cytokine in the pathogenesis of AD, making it a promising target for therapeutic intervention. The potential for less frequent dosing could also improve patient convenience and adherence.
Safety Profile and Side Effects
The Phase 3 trial also evaluated the safety profile of lebrikizumab. The most frequently reported adverse events were conjunctivitis, common cold, and headaches. According to Dr. Thyssen, these side effects were generally mild and did not lead to treatment discontinuation. "Conjunctivitis is a known adverse event of IL-4/IL-13 inhibitors... Regarding both common cold and headache, they are as well among the side effects reported for similar drugs. Their incidence was low, less than 10%, and they are manageable for both clinicians and patients."
Trial Design and Patient Population
The Phase 3 program included five global studies involving over 2,000 adult and adolescent patients (12 years and older, weighing at least 40kg). These studies included two 52-week monotherapy trials (ADvocate 1 and 2), a 16-week combination study with topical corticosteroids (ADhere), a 52-week adolescent open-label study (ADore), and a 52-week long-term extension study (ADjoin). The trials aimed to assess the efficacy and safety of lebrikizumab as both a monotherapy and in combination with topical corticosteroids.
Future Outlook and Regulatory Submissions
Almirall and Lilly are preparing to submit regulatory applications to the European Union and the United States, respectively, based on the Phase 3 results. The FDA granted lebrikizumab Fast Track designation in December 2019. Karl Ziegelbauer, Almirall’s chief scientific officer, expressed optimism about the potential launch of lebrikizumab after its anticipated approval in 2023, stating it would be "a promising first-line advanced systemic treatment for moderate to severe AD that offers robust and durable efficacy with less frequent dosing."
Dr. Thyssen noted that despite recent advancements in AD treatment, unmet needs remain, particularly in achieving robust efficacy over time without safety trade-offs and with more convenient regimens. Lebrikizumab aims to address these needs by providing a durable and effective treatment option with less frequent dosing, potentially improving patient outcomes and quality of life.
