Dupilumab + TCS superior to TCS alone in treating atopic dermatitis
Posted: 6 June 2016 | | 1 comment
Sanofi and Regeneron have announced that a Phase III study evaluating dupilumab in atopic dermatitis met its primary and key secondary endpoints…
In the study, dupilumab with topical corticosteroids (TCS) was compared to TCS alone in moderate-to-severe atopic dermatitis (AD) adult patients. Patients enrolled in the study were inadequately controlled by topical corticosteroids (TCS) with or without topical calcineurin inhibitor (TCI). Dupilumab with TCS significantly improved measures of overall disease severity at 16 and 52 weeks, when compared to placebo with TCS.
Commenting on the data, George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories, said: “These are the first long-term Phase III data that demonstrated dupilumab with topical corticosteroids was superior to topical corticosteroids alone, and provided sustained efficacy, significantly improving measures of overall disease severity, skin clearing, itching, and quality of life through one year of treatment. Although topical corticosteroids are standard therapies for atopic dermatitis, they are non-specific anti-inflammatory agents, while dupilumab is a targeted therapy that specifically blocks the IL-4/IL-13 signaling pathway. Our collective clinical data demonstrate that this pathway is a root cause in atopic dermatitis, asthma and nasal polyposis and we continue to evaluate the potential of this pathway in these atopic and allergic diseases.”
Elias Zerhouni, M.D., President, Global R&D, Sanofi, said: “These one-year data strengthen the earlier 16-week results, suggesting that dupilumab impacts the aberrant activation of the IL-4/IL-13 pathway which resulted in significant efficacy without the side effects associated with immune-suppressing therapies. We will continue to advance dupilumab for patients worldwide suffering from inadequately controlled moderate-to-severe atopic dermatitis, with the first regulatory submission planned in the US for the third quarter of this year.”
Clearing skin lesions
A primary endpoint of the study at week 16, 39% of patients who received either dupilumab 300 mg weekly or dupilumab 300 mg every two weeks with TCS achieved clearing or near-clearing of skin lesions (IGA 0 or 1), compared to 12% of patients receiving placebo with TCS. Also, 64% of patients who received dupilumab 300 mg weekly with TCS, and 69 percent of patients who received dupilumab 300 mg every two weeks with TCS achieved EASI-75, compared to 23% of patients receiving placebo with TCS. These were the primary endpoints of the study.
The secondary endpoint 52-week results were the following: 40% of patients who received dupilumab 300 mg weekly with TCS, and 36% of patients who received dupilumab 300 mg every two weeks with TCS achieved clearing or near-clearing of skin lesions (IGA 0 or 1), compared to 12.5% of patients receiving placebo with TCS; 64% of patients who received 300 mg weekly with TCS, and 65% of patients who received 300 mg every two weeks with TCS achieved EASI-75, compared to 22 percent with placebo with TCS.
The overall rate of adverse events was comparable between the dupilumab with TCS groups and the placebo with TCS group.