From the FDA Drug Label
The WI-NRS is comprised of a single item, rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Proportion of subjects with improvement (reduction) in WI-NRS by ≥4 points from baseline at Week 24*18.4%60.0%42.7%(27.8,57.7)19.5%57.7%42.6%(29.1,56. 1)
The expected Numerical Rating Scale (NRS) improvement with dupilumab treatment for prurigo nodularis is a reduction of ≥4 points from baseline in WI-NRS at Week 24, with 42.7% and 42.6% of subjects achieving this improvement in the PRIME and PRIME2 trials, respectively 1.
- Key points:
- WI-NRS reduction: ≥4 points
- Timeframe: Week 24
- Percentage of subjects: 42.7% (PRIME), 42.6% (PRIME2)
From the Research
Dupilumab treatment for prurigo nodularis typically results in a significant improvement on the Numerical Rating Scale (NRS) for itch intensity, with a reduction of approximately 6.8 points on the 0-10 NRS scale, as reported in the most recent and highest quality study 2. Patients can expect this level of improvement within 12-24 weeks of starting treatment. The standard dosing regimen for adults is 300 mg administered subcutaneously every two weeks following an initial loading dose of 600 mg. This improvement is clinically significant as a reduction of at least 4 points on the 0-10 NRS scale represents meaningful relief for patients suffering from the intense, chronic itch associated with prurigo nodularis. The mechanism behind this improvement involves dupilumab's action as a monoclonal antibody that blocks interleukin-4 and interleukin-13 signaling, which are key inflammatory pathways involved in pruritus. Some key points to consider include:
- The improvement in NRS scores is statistically significant, with 60.0% of patients achieving a ≥4-point reduction in Worst Itch Numeric Rating Scale (WI-NRS) from baseline at week 24, compared to 18.4% of patients in the placebo arm 2.
- Dupilumab has been shown to be effective in reducing itch and improving skin lesions in patients with prurigo nodularis, with a consistent proportion of patients achieving at least a 2-grade reduction in Investigator Global Assessment score 3.
- The safety profile of dupilumab is consistent with its known safety profile, with no new safety concerns identified in patients with prurigo nodularis 2.
- Regular follow-up appointments are important to monitor response and adjust treatment as needed, as some patients may require longer treatment durations to achieve optimal benefit 4, 5.