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These findings highlight dupilumab’s use as a potential treatment option for individuals with prurigo nodularis.
Dupilumab treatment of prurigo nodularis can effectively improve patients’ pruritus, quality of life, and nodular lesions in real-world settings, according to recent findings.1
These findings were the result of new research authored by a team led by Zuotao Zhao, from Tianjin Institute of Integrative Dermatology at Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital in China. Zhao et al. noted that there had been a general dearth of multicenter data on the topic of dupilumab’s real-world efficacy and safety.
“Dupilumab, a monoclonal antibody targeting interleukin-4Rα, has shown good efficacy and safety in clinical trials, becoming the first drug approved for [prurigo nodularis],” Zhao and colleagues wrote. “However, in the phase 3 clinical study of dupilumab for [prurigo nodularis], only small number of Asian patients were included…Therefore, we aimed to address this gap by using real-world multicenter data to evaluate its effectiveness and safety in Chinese patients with moderate-to-severe [prurigo nodularis].”1,2
The investigators of this analysis looked at a total of 73 individuals who reported having prurigo nodularis (PN), with the prospective research being carried out across 14 hospitals between July 2023 - January 2024. Only 10 sites ultimately contributed data to the study.
Those who became involved as study participants were required to have met specific criteria for inclusion, with examples including a prurigo nodularis diagnosis based on chronic pruritus lasting more than 6 weeks and evidence of lesions and repeated scratching. Those functioning as trial subjects were required to have a mean peak pruritus numeric rating scale (PP-NRS) score of ≥7 within the week prior to treatment.
The subjects were also required to have an Investigator Global Assessment (IGA) score of ≥3 and to be resistant or intolerant to conventional methods of disease management such as corticosteroids. These participants had accessible records spanning at least 5 visits over the course of the 16-week period of treatment.
In terms of data collected by the research team at baseline, examples included gender, body mass index (BMI), age, duration of disease, lesion distribution, and previous therapies. Additionally, the team looked at such factors as comorbidities, participants’ family histories, and scores of prurigo nodularis severity.
The regimen of dupilumab treatment utilized by the investigators followed the dosing schedule that is applied for patients with atopic dermatitis. They highlighted that adult and pediatric subjects who were shown to weigh ≥60 kg were provided with an initial 600 mg subcutaneous injection and this was then followed by 300 mg administered every 2 weeks.
On an every-4-week basis, pediatric patients who were under 60 kg were provided with injections. Due to lack of availability, the researchers did not use the 200 mg preparation during their analysis. Additionally, participants were given concomitant medications, such as topical calcineurin inhibitors (TCI) or corticosteroids (TCS).
The research team utilized several measures, such as the IGA for prurigo nodularis, PP-NRS, the Dermatology Life Quality Index (DLQI), and the Children’s Dermatology Life Quality Index (CDLQI) for the purposes of assessing life quality and disease control. Additionally, they monitored subjects for adverse events.
Among the 73 individuals the team assessed, there was a mean age 45.9 ± 21.5 years, with 33 being reported as female and 40 as male. The investigators noted that a clinically significant disease improvement was achieved by 84.9%, with ≥4 points noted in the PP-NRS by the 12-week mark (PP-NRS4).
In terms of those succeeding in IGA score achievements of 0 or 1, percentages rose from 0% at the point of baseline to 37.0% at the 12-week mark and then 46.6% at the 16-week mark (P < .05). In their evaluation of participants’ quality of life, which they assessed using DLQI/CDLQI, improvements among subjects were shown to have risen substantially.
Specifically, participants’ mean scores dipped from 16.6 ± 6.8 at the point of baseline to 7.2 ± 4.9 and 6.4 ± 4.5 at the 12-week and 16-week mark, respectively (P < .001). The investigators also highlighted the favorable safety profile of dupilumab, noting that there had only been 1 subject who reported dry eyes as an adverse event.
“In conclusion, our real-world study suggested that dupilumab was effective in improving the signs and symptoms of Chinese [prurigo nodularis] patients and revealed a well-tolerated safety profile,” they wrote. “Effectiveness of dupilumab in [prurigo nodularis] was consistent regardless of the atopic status and age. Ongoing studies hold the potential to address unmet needs and reshape the therapeutic landscape in [prurigo nodularis].”1
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