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These findings, presented at the Fall Clinical Dermatology conference, resulted from the ADjoin long-term extension study.
Individuals with moderate-to-severe atopic dermatitis (AD) that maintain monthly dosing of lebrikizumab therapy for up to 2 years may sustain pruritus relief, clearance of skin, and AD severity, according to new findings presented at the Fall Clinical Dermatology Conference in Las Vegas.1
These new results on the use of lebrikizumab were revealed in the ADjoin long-term extension study by Eli Lilly and Company, with ADjoin participants having been drawn from the ADvocate 1 and 2 trials and the ADhere trial.
"Long-term data is critical for healthcare providers making treatment decisions with patients,” Emma Guttman-Yassky, MD, PhD, Health System Chair of the department of dermatology at the Icahn School of Medicine of Mount Sinai and senior author of ADjoin, said in a statement. “These impressive two-year data underscore the lasting impact this potential first-line biologic treatment option may provide for people living with this disruptive disease."2
The drug itself is a monoclonal antibody that is currently in the investigational stage, operating by binding to interleukin (IL)-13 and preventing the formation of the IL-13Rα1/IL-4Rα heterodimer complex and resulting signaling. This inhibition leads to a hampering of IL-13, a crucial cytokine in eczema which triggers the type-2 inflammatory cascade.
The ADjoin study, taking place over 2 years, was conducted to look at the efficacy and the safety of treatment with lebrikizumab. Subjects from the ADvocate 1 and ADvocate 2 trials, as well as the ADhere study, had previously achieved IGA 0,1 or EASI-75 at the 16 week mark.
The individuals featured in the new long-term extension phase were given lebrikizumab either every 2 weeks or on a monthly basis with a 250-mg dosing regimen. The new phase 3 program with 5 global studies ended up involving over 1,300 subjects.
ADvocate 1 and 2 had been monotherapy studies, and ADhere was a combination study with topical corticosteroids.
By ADjoin’s conclusion, the safety findings for lebrikizumab remained in line with what had been observed in previous research involving subjects with moderate-to-severe AD. Over the course of up to 2 years of therapy, investigators found no indications of any new safety concerns.
Among subjects in the ADjoin research, 62 percent of themreported experiencing adverse events (AEs), with the majority of the AEs being mild or moderate intensity. The most commonly-reported side effects associated with the drug included conjunctivitis, reactions at the site of injection, and instances of shingles.
Notably, the investigators found that fewer than 3 percent of the subjects had reported that their AEs had led to discontinuation of the treatment.
“The two-year data from the ADjoin study further validate the promising efficacy and safety profile of lebrikizumab in people with moderate-to-severe atopic dermatitis,” Karl Ziegelbauer, PhD, Chief Scientific Officer at Almirall SA, said in a statement. “These results demonstrated that monthly maintenance dosing of lebrikizumab provided long-lasting relief from the distressing symptoms of this chronic disease, bringing us one step closer to offering a first-line biologic treatment option.”
The new findings from ADjoin’s long-term extension study represent the longest efficacy data known to be available currently for this particular drug. Despite the encouraging new findings, the drug has faced setbacks recently.
In early October, the US Food and Drug Administration (FDA) had issued a complete response letter (CRL) to lebrikizumab for the treatment of moderate-to-severe AD as a result of reported manufacturing problems. The FDA officials did note that the newly-issued CRL did not relate to any concerns related to the safety, the clinical data package, or the labeling of the AD treatment.3
In response to the FDA’s CRL, president of Lilly Immunology and Lilly USA Patrik Jonsson reiterated the company’s confidence in the drug’s potential to help those with eczema and in the clinical data.