Despite the approval of dupilumab (Dupixent) in September 2022, there is an ongoing dearth of clinically effective treatments for prurigo nodularis, prompting the present investigation of the monoclonal antibody for the chronic inflammatory skin condition.
For adult patients living with prurigo nodularis, dupilumab (Dupixent) was shown to significantly improve their skin lesions, quality of life (QOL), and itching, reports a new study in Anais Brasileiros de Dermatologia.1
Dupilumab was approved by the FDA2 on September 29, 2022, as the first treatment for prurigo nodularis, a rare chronic inflammatory skin disease characterized by hard itchy lumps.
“Patients with prurigo nodularis often experience severe itch and thereafter, develop anxiousness about their conditions,” the study authors wrote. “This study consecutively enrolled patients who have been diagnosed with [prurigo nodularis] for at least 6 months and have failed to respond to traditional therapies.”
The treatment regimen for this study consisted of a 600-mg induction dose of dupilumab, followed by 300 mg administered every other week for at least 16 weeks. Concomitant use of topical glucocorticoids, oral antihistamines, topical antibiotics, and traditional Chinese medicine was permitted. Blood tests performed at weeks 0 and 16 evaluated while blood cell (WBC) count, serum absolute eosinophil count (AEC), and total serum IgE) levels. All patients included in this analysis failed all previous treatments, and their mean (SD) duration of prurigo nodularis was 5.525 (6.6) years; 20 years was the longest duration.
When the study kicked off, every patient had widespread erythematous nodules, with plaques distributed symmetrically on the extremities, hands, and trunk. Most notably, skin lesions abated in 87.5% of the patients by week 16.
Further, by week 16, a complete response (a 3-grade decrease in Investigator’s Global Assessment [IGA] score) was seen in 25.0% of the study participants, 50.0% of patients reported a partial response (less than a 2-grade IGA score drop) to dupilumab treatment, and just 1 patient had a poor treatment response, with rashes significantly reduced only on the extensor side of his lower limbs.
In addition, there was an overall reduction in mean IGA scale ratings between weeks 0 and 16 (P < .0001). At week 0, the mean overall IGA score was 3.75 compared with 1.50 by week 16, with 5 patients having an IGA score of 1 at week 16. Subjective improvements were also seen at week 16 for pruritus symptoms, QOL, anxiety, and IgE levels:
No significant differences were seen in either WBCs (P = .4137) or AEC (P = .2438), and there were no adverse events reported for the entire study.
Among the patients, the most common comorbid allergic disorders were allergic rhinitis, chronic urticaria, and asthma; 3 patients also had a family history of allergic disorders. In addition, 62.5% of the study participants (mean [SD] age, 64 [10.3] years) had a comorbidity, with the most common being hypertension in 50.0%.
With the risk of severe adverse effects (AEs) being common among patients being treated for prurigo nodularis, there is a long-lasting, unsatisfied need for a safe and effective treatment for the condition, the study authors noted.
“In this real-life observational study, 16 weeks of dupilumab treatment resulted in statistically significant and clinically meaningful improvements in signs, symptoms, pruritus intensity, anxiety levels, depression levels, and QOL,” the authors concluded, “with no cases of AEs reported.”
They further highlighted the clinical significance of their findings by noting that their findings echo several previous studies of dupilumab that also reported no AEs.
1. Zhang Z, Li S, Wang Y, Zhao J. A real-world observational study of dupilumab treatment in adult patients with prurigo nodularis. An Bras Dermatol. Published online March 23, 2023. doi:10.1016/j.abd.2022.09.008
2. FDA approves first treatment for prurigo nodularis. News release. FDA. September 29, 2022. Accessed March 30, 2023. https://bit.ly/3TSWfwY