Dupixent Achieves Phase 3 Clinical Trial Endpoints in Adults with Prurigo Nodularis, Paving the Way for New Indication

On October 22, 2021, Regeneron and Sanofi announced that dupilumab injection (brand name Dupixent) met its primary and all key secondary endpoints in a pivotal Phase 3 clinical trial in adult patients with prurigo nodularis whose symptoms were inadequately controlled. The trial results demonstrated that, compared with placebo, dupilumab significantly reduced patients' itch symptoms and skin lesions.

Prurigo nodularis is a chronic type 2 inflammatory skin disease that causes intense chronic pruritus and skin lesions. The condition negatively impacts health-related quality of life, including mental health, activities of daily living, and social interactions. Currently, there are no approved therapies. Patients typically use high-potency topical corticosteroids to alleviate symptoms; however, long-term use poses safety risks.

Dupilumab is a fully human monoclonal antibody that inhibits the signaling pathways of interleukin-4 (IL-4) and interleukin-13 (IL-13). IL-4 and IL-13 are key drivers of type 2 chronic inflammation, including conditions such as atopic dermatitis, asthma, and chronic rhinosinusitis. Notably, in September this year, the drug received approval from China's National Medical Products Administration (NMPA) for a new indication: the treatment of moderate-to-severe atopic dermatitis in adolescents and adults aged 12 years and older.

The specific key results of this Phase 3 clinical trial are as follows:

The trial met the Week 12 primary endpoint, with 37% of patients in the dupilumab group achieving a clinically meaningful reduction in pruritus compared with 22% in the placebo group (p=0.0216).

At Week 24, the proportion of patients in the dupilumab group who achieved a clinically meaningful reduction in pruritus was nearly three times that in the placebo group (58% vs 20%, respectively; p < 0.0001).

At Week 24, compared with the placebo group (16%), nearly three times as many patients in the dupilumab group (45%) achieved clear or almost clear skin (p<0.0001).

Patients in the dupilumab group demonstrated significant improvements in health-related quality of life measures, skin pain, and anxiety and depressive symptoms.

The safety results of the trial were generally consistent with the known safety profile of dupilumab in its approved indications.

References:

[1] Dupixent® (Dupilumab) Is The First Biologic To Significantly Reduce Itch And Skin Lesions In Phase 3 Trial For Prurigo Nodularis, Demonstrating The Role Of Type 2 Inflammation In This Disease. Retrieved October 22, 2021, from https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-first-biologic-significantly-reduce-itch-and

(Original text abridged)

▽Follow 【WuXi AppTec`Virtue`】WeChat Official Account