Long-term tralokinumab maintains safety, efficacy in atopic dermatitis
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BOSTON — Long-term use of tralokinumab showed sustained atopic dermatitis improvement with no new safety signals, according to a poster presented at the American Academy of Dermatology Annual Meeting.
“These results represent the longest treatment period reported to date for any selective [interleukin (IL)]-13 inhibitor,” Andrew Blauvelt, MD, president of Oregon Medical Research Center and the study’s lead author, told Healio. “The drug does not appear to cause any adverse events that newly develop with chronic treatment, nor does the response to tralokinumab go down over time.”
Blauvelt presented 3.5-year interim safety analysis of the long-term, open-label extension ECZTEND trial, which included 1,442 moderate to severe atopic dermatitis patients.
In 616 patients who received tralokinumab 300 mg (Adbry, LEO Pharma) subcutaneously every other week for at least 3 years, 85.1% achieved at least a 75% improvement in the Eczema Area and Severity Index score and 50.5% achieved an Investigator Global Assessment score of 0 or 1 (clear or almost clear).
Adverse events were reported in 1,127 patients, with 102 reporting serious adverse events and 34 withdrawing from the study.
Viral upper respiratory tract infections were the most common adverse event, followed by atopic dermatitis, upper respiratory tract infection, headache and conjunctivitis.
“Many of the patients entering this long-term treatment period had previously responded to therapy in the original parent studies, so in essence, the data show how responders continue to safely respond over time,” Blauvelt said. “Dermatologists can continue to keep their patients with moderate to severe AD on tralokinumab and continue to expect that these patients will do very well over time.”