• linkedin
  • Increase Font
  • Sharebar

    Dupilumab demonstrates promising results

    The systemic therapy dupilumab met primary endpoints in two phase 3 studies on adults with inadequately controlled moderate-to-severe atopic dermatitis, according a recent release by Regeneron Pharmaceuticals and Sanofi.

    In the identically designed SOLO 1 and SOLO 2 trials, monotherapy with investigational dupilumab significantly improved disease severity, skin clearing, itching, quality of life and mental health.

    "These data provide strong evidence that the IL-4 and IL-13 signaling pathway is a fundamental driver of inflammation in atopic dermatitis. Dupilumab is the first in a new class of immunotherapies – in these 16 week trials, dupilumab blocked the aberrant activation of this pathway, resulting in significant efficacy without evidence of immune-suppressing side effects," George D. Yancopoulos, M.D., Ph.D., chief scientific officer of Regeneron and president of Regeneron Laboratories, says in the release.

    Researchers studied 1,379 subjects with moderate-to-severe disease who were inadequately controlled with topical medications or were not good candidates for topical treatment. They assessed subjects using the Investigator's Global Assessment (IGA) scale, ranging from 0 (clear) to 4 (severe). Study participants had IGA scores of 3 or 4 at baseline. They also assessed subjects with the Eczema Area and Severity Index (EASI).

    Subjects were randomized to receive dupilumab 300 mg subcutaneously once per week; dupilumab 300 mg subcutaneously every two weeks; or placebo for 16 weeks following an initial dupilumab loading dose of 600 mg subcutaneously, or placebo.

    In SOLO 1, 37% of patients who received 300 mg of dupilumab weekly and 38% who received the 300 mg of the investigational drug every two weeks achieved IGA 0 or 1, compared with 10% in the placebo group. In SOLO 2, 36% of those receiving the weekly and every-two-week regimens achieved IGA 0 or 1 compared to 8.5% of controls.

    EASI measures improved 72% from baseline in both the once-weekly and every-other-week treatment groups in SOLO 1, compared to 38% for placebo. In SOLO 2 EASI improved 69% in the weekly dose group and 67% among those who received dupilumab every two weeks, compared to 31% in placebo.

    A secondary endpoint for the United States studies was the percentage of patients who achieved EASI-75. In SOLO 1, 52.5% in the weekly dupilumab treatment group and 51% in the every two weeks treatment group achieved EASI-75, compared to 15% of those in the placebo group. In SOLO 2, researchers reported 48% of patients in the weekly group and 44% in the every two weeks treatment group achieved EASI-75, compared to 12% in the placebo group.

    NEXT: Adverse event rates

    Lisette Hilton
    Lisette Hilton is president of Words Come Alive, based in Boca Raton, Florida.


    You must be signed in to leave a comment. Registering is fast and free!

    All comments must follow the ModernMedicine Network community rules and terms of use, and will be moderated. ModernMedicine reserves the right to use the comments we receive, in whole or in part,in any medium. See also the Terms of Use, Privacy Policy and Community FAQ.

    • No comments available

    Latest Tweets Follow