Regeneron and Sanofi Announce Positive Results from Phase 2b Study of Dupilumab in Patients with Moderate-to-Severe Atopic Dermatitis
"These clinical data, coupled with our phase 2a results in asthma last year, support the growing scientific evidence that the IL-4/IL-13 pathway may be a fundamental driver in allergic diseases," said
In the Phase 2b trial, all five subcutaneous doses of dupilumab showed a dose-dependent improvement in the primary endpoint, the mean percent change in
The most common adverse event (AE) in the Phase 2b study was nasopharyngitis, which was balanced across dupilumab treatment groups (18.5 to 23 percent) compared to placebo (21 percent). Injection site reactions were more frequent in the dupilumab group (5 to 9.5 percent) compared to placebo (3 percent), as was headache (12 to 15 percent) compared to placebo (8 percent).
Dupilumab-treated patients showed highly statistically significant and dose-dependent improvements in additional key efficacy measures compared to placebo after 16 weeks of treatment:
- 12 percent to 33 percent of dupilumab-treated patients achieved clearing or near-clearing of skin lesions, as measured by an investigator's global assessment (IGA) score of 0 or 1, compared to 2 percent with placebo. (p=0.02 to p < 0.0001)
- Dupilumab-treated patients experienced a 16.5 percent to 47 percent mean reduction in itching, as measured by the pruritus numerical-rating scale (NRS) score, compared to an increase of 5 percent in the placebo group. (p=0.0005 to p < 0.0001)
"Atopic dermatitis is known to have a profoundly negative effect on quality of life and people with more severe forms of this disease have limited therapeutic choices," said
This Phase 2b double-blind, placebo-controlled, 16-week, dose-ranging study randomized 380 patients with moderate-to-severe atopic dermatitis, who could not be adequately controlled with topical medication or for whom topical treatment was not advisable. Patients were randomized to receive one of five doses of dupilumab (300 mg weekly, 300 mg every other week, 300 mg monthly, 200 mg every other week, 100 mg monthly) or placebo. Patients in the study had approximately 50 percent of their skin affected by atopic dermatitis at baseline. Within the past year, approximately 35 percent of patients received an oral corticosteroid and approximately 20 percent received a systemic non-steroid immunosuppressant for AD. Approximately 60 percent of patients had another allergic condition, including approximately 40 percent of patients who had a history of asthma. The follow-up period of the study is ongoing and patients will be followed for 16 weeks after treatment.
The NEJM Dupilumab Moderate-to-Severe Atopic Dermatitis Publication
About the IL-4/IL-13 Pathway and Atopic Dermatitis
Moderate-to-severe atopic dermatitis, a serious, chronic form of eczema, is a systemic inflammatory disease characterized by an allergic response driven by a subset of immune cells called Type 2 helper T cells, or Th2 cells. IL-4 and IL-13 are key cytokines that are required for the initiation and maintenance of this Th2 immune response. Moderate-to-severe forms of atopic dermatitis can be characterized by pronounced cutaneous dryness, and skin lesions marked by redness, infiltration/papulation, crusting/oozing, and lichenification (skin thickening), with periods of lesion exacerbation accompanied by intense itching, scratching, and skin damage that can lead to secondary infections. Moderate-to-severe atopic dermatitis can negatively impact patients' lives and is associated with a high burden to society in terms of direct costs of medical care and prescription drugs and loss of productivity.
Dupilumab, a fully-human monoclonal antibody, is directed against the shared IL-4R alpha subunit, which blocks signaling from both IL-4 and IL-13. Dupilumab was created using Regeneron's pioneering VelocImmune® technology and is being co-developed with
Regeneron is a leading science-based biopharmaceutical company based in
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