The drug also demonstrated efficacy in improving sleep quality and reducing sleep disruption.
In adults with prurigo nodularis, dupilumab proved to be efficacious in reducing nodule pruritus and skin pain, leading to a reduction in sleep disturbances and an improvement in overall sleep quality, according to a poster1 presented at the Society of Dermatology Physician Assistants (SDPA) Annual Summer Dermatology Conference in Boston, Massachusetts.
In a series of 2 randomized trials, LIBERTY PN-PRIME (NCT04183335) and PRIME2 (NCT, researchers sought to determine the drug’s efficacy in reducing itch, citing its characteristic nature in prurigo nodularis, noting that this characteristic itch can also be accompanied by persistent skin pain and sleep disturbances/poor sleep quality. The trials were phase 3, double-blind, placebo-controlled, and randomized.
Study participants included adult patients (n=311) with prurigo nodularis and a history of inadequate disease improvement or control despite the use of prescribed topical therapies. Patients who had a history of non-advisable therapeutic use were also included in the study.
In order to determine the rate of patients achieving clinically and statistically meaningful improvement, researchers utilized the PN: Worst Itch Numerical Rating Scale (WI-NRS), Skin Pain-NRS, and Sleep-NRS, looking for improvements in itch and skin pain, which would ultimately lead to improvements in sleep quality.
Upon inclusion in the study, patients were randomly assigned to 1 of 2 treatment groups: either a group receiving 300 mg of dupilumab (n=153) or a placebo (n=158) on a biweekly basis for a total of 24 weeks. At baseline, WI-NRS, Skin Pain-NRS, and Sleep-NRS were similar among patients in both treatment groups.
However, as a result of the study, researchers found that a statistically significant and larger number of patients in the dupilumab treatment group achieved clinically meaningful improvements when compared to members of the placebo group.
“Adults with PN [prurigo nodularis] uncontrolled on topical therapies treated with dupilumab achieved statistically significant and clinically meaningful improvement in itch, skin pain, and sleep quality,” wrote Kwatra et al. “The safety profile of dupilumab was consistent with the known safety profile in its approved indications.”