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    Atopic dermatitis pipeline

    Promising therapies under consideration, close to approval

    Leon Kircik, M.D.Dr. KircikWhen it comes to the sheer number of products in the pipeline for dermatology, targeting atopic dermatitis nearly tops the list.

    “For the first time, we now will have biologics to treat moderate-to-severe atopic dermatitis,” says Leon Kircik, M.D., a clinical associate professor of dermatology at Icahn School of Medicine at Mount Sinai in New York City and Indiana University Medical Center in Indianapolis.

    Dupilumab (Regeneron/Sanofi) is a monoclonal antibody that downregulates interleukin-4 (IL-4).

    “This will be the first FDA-approved biologic for atopic dermatitis. IL4 and IL 13 are major cytokines that play an important role in atopic dermatitis. Dupilumab inhibits the signaling of IL4 and IL13 by blocking the IL 4 receptor alpha,” says Dr. Kircik, with an indication of moderate-to-severe atopic dermatitis in adults age 18 and older.

    Dipilumab received FDA approval on March 28, 2017. (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm549078.htm)

    In an interview with Dermatology Times after his presentation on atopic dermatitis at February’s 2017 South Beach Symposium in Miami Beach, Fla., Dr. Kircik says the efficacy of dupilumab has been shown to be about 38% of patients in two Phase 3 trials achieving a score of 0 or 1 (clear or almost clear) on the 5-point Investigator’s Global Assessment (IGA).

    There were two different dosing regimens: every week and every other week. “However, there was no difference in efficacy between the two cohorts,” Dr. Kircik says.

    Two adverse events associated with dupilumab are injection site reactions and conjunctivitis.

    “But there is also concern about exacerbation of atopic dermatitis,” Dr. Kircik notes. “Studies demonstrate anywhere from 10% to 16% of patients experience exacerbation of their atopic dermatitis. This may be an issue that requires further investigation.”

    Next: Other biologics

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