Nemolizumab relieves itch, clears skin in patients with prurigo nodularis

Treatment with nemolizumab significantly improves itch and skin clearance in patients with prurigo nodularis compared with placebo, according to the phase III OLYMPIA 2 trial presented at WCD 2023.

The researchers conducted a phase III, multicentre, double-blind trial involving 274 adults (mean age 52.7 years, 61.3 percent female) with moderate-to-severe prurigo nodularis who had a PP-NRS* score of ≥7 and an IGA** score of ≥3 at baseline. Participants were randomly assigned to receive nemolizumab (n=183) subcutaneously based on their body weight (<90 kg: 60 mg loading dose at baseline, followed by 30 mg; and ≥90 kg: 60 mg), or placebo (n=91) Q4W for a 16-week treatment period. [WCD 2023, abstract LB01]

As early as week 4, a significantly higher proportion of patients treated with nemolizumab achieved an itch-free state, as indicated by a weekly average PP-NRS score of <2, than those treated with placebo (19.7 percent vs 2.2 percent; p<0.0001), which was sustained through week 16 (35.0 percent vs 7.7 percent; p<0.0001).

Significantly more nemolizumab-treated patients also achieved a ≥4-point improvement in PP-NRS score from baseline to week 4 (41.0 percent vs 7.7 percent; p<0.0001) and week 6 (56.3 percent vs 20.9 percent p<0.0001) than the placebo-treated patients.

The proportion of patients who achieved an IGA status of clear or almost clear skin (score of 0 or 1) with ≥2-grade improvement was significantly greater with nemolizumab than with placebo at week 16 (37.7 percent vs 11.0 percent; p<0.0001).

More than half of the patients in the nemolizumab arm also achieved a significant improvement in sleep intensity, as shown by a ≥4-point improvement in Sleep Disturbance-NRS (SD-NRS), at week 16 (51.9 percent vs 20.9 percent; p<0.0001) than those in the placebo arm.

“Overall, all primary and key secondary endpoints were met (p<0.0001),” the researchers noted.

“Nemolizumab monotherapy Q4W (without TCS*** or TCI⁺) significantly improved the signs and symptoms of prurigo nodularis at week 16 ... with [early] improvements in itch, lesions, and sleep disturbance observed as early as week 4,” said Professor Sonja Ständer from the University Hospital Münster, Germany, who presented the study.

In terms of safety, the overall incidence of treatment-emergent adverse events was similar between the nemolizumab and placebo arms (61.2 percent vs 52.7 percent), with no deaths reported in either treatment arm, she noted.