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A pair of phase 3 clinical trials presented at EADV 2022 indicate dupilumab significantly improves PN symptoms over 24 weeks.
Phase 3 trial data presented at the European Academy of Dermatology and Venerology (EADV) 2022 Congress this week demonstrated dupilumab’s improvement in skin lesions and itching among treated patients with prurigo nodularis (PN).
Led by Gil Yosipovitch, MD, professor of dermatology at the Miller School of Medicine at University of Miami, the trial investigators found that the new results from the second phase 3 assessment of the interleukin-4 and -13 (IL-4; IL-13) inhibitor for PN confirm that dupilumab can “significantly reduce the unrelenting itch and extensive severe skin lesions that often impair patient quality of life.”
Dupilumab was investigated for the treatment of symptoms associated with PN, which are driven by the same type 2 inflammatory pathways associated with other dupilumab treatment-indicated diseases including atopic dermatitis.
The data analyzed by Yosipovitch and colleagues come from the phase 3 PRIME and PRIME2 trials that assessed the efficacy of dupilumab in treating PN. Yosipovitch and colleagues assessed 151 adult patients with uncontrolled PN from the double-blind PRIME study comparing dupilumab with a placebo over the course of 24 weeks. This included patients who were using topical prescription therapies such as corticosteroids.
The investigators had the PRIME study participants receive either dupilumab or the placebo every 2 weeks, with patients’ respective topic therapies continued if they were using the treatments at randomization. Their primary endpoint evaluated those participants with clinically significant itch improvement after 24 weeks, with a reduction of ≥4 points on a 0-10 Worst-Itch Numeric Rating Scale, versus placebo.
The PRIME researchers found that 60% of patients treated with dupilumab reported a clinically significant PN itch reduction from baseline, as opposed to only 18% of patients given the placebo (P <.0001). They also found that 48% of those treated for PN with dupilumab achieved clear or almost clear skin as a result, compared to 18% of placebo patients (P = .0004).
The investigators found that dupilumab toxicities maintained consistent with its safety profile when used as treatment for related conditions in which the treatment had been approved prior to the 2 studies.
The PRIME study results demonstrated that although adverse events (AEs) occurred with 71% of participants treated with dupilumab, the AEs were not significantly reported any more than with those receiving the placebo.
"In my practice, relieving itch and clearing skin are often the top priorities for my patients across a range of chronic skin diseases,” Yosipovitch said in a statement. “These data demonstrate dupilumab has the potential to address and manage these debilitating symptoms in another chronic skin disease with underlying type 2 inflammation.”