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Late-breaking phase 3 data on nemolizumab monotherapy indicates substantial improvement in key primary and secondary endpoints for prurigo nodularis patients.
Nemolizumab monotherapy led to improvements in skin lesions, sleep disturbance, and itch for patients with moderate-to-severe prurigo nodularis (PN), according to recent phase 3 trial data.1
The study—a phase 3, multicenter, double-blind trial—was titled OLYMPIA 2 and aimed to examine the effects of nemolizumab on adult PN patients.
The research was authored by Shawn Kwatra, MD, an Associate Professor of Dermatology at Johns Hopkins University School of Medicine and director of the Johns Hopkins Itch Center.
The investigators note that nemolizumab is a first-in-class interleukin-31 receptor alpha antagonist that downregulates key PN pathways. PN is known for being a debilitating neuroimmune skin disorder characterized by itching and skin lesions.2
“If you look at all skin diseases, overall, prurigo nodularis, time after time, tends to have the greatest severity of itch,” Kwatra said in a prior HCPLive interview. “If you look at disease, comorbidities and associated conditions, it tends to have the highest even higher than psoriasis and atopic dermatitis, which we talk about a lot.”
In the OLYMPIA 2 trial, PN was characterized by the existence of at least 20 nodules, a peak pruritus numerical rating scale (PP-NRS) score of 7 or more, and an Investigator's Global Assessment (IGA) score of 3 or more.
The investigators randomly assigned participants to be treated with either nemolizumab monotherapy or a placebo. The nemolizumab arm were given an initial 60 mg subcutaneous dose which then was followed by 30 mg or 60 mg every 4 weeks for 16 total weeks.
The primary outcomes assessed by the investigators were improvement in PP-NRS score by a minimum of 4 points and by success in their IGA score. The latter was defined as a score of 0 or 1 and as a reduction of 2 grades minimum from baseline at 16 weeks.
Overall, the investigators found that all of their primary and key secondary endpoints ended up being met and showed statistical significance. The patients in the nemolizumab-treated arm showed a substantially higher proportion of achieving ≥4-point improvement from baseline in PP-NRS (56.3% versus 20.9%).
Additionally, the treatment arm reported better IGA success (37.7% versus 11.0%) at 16 weeks and a ≥4-point improvement in PP-NRS (41.0% versus 7.7%) at 4 weeks.
They also noted a a ≥4-point improvement in SD-NRS by the 4 week mark (37.2% versus 9.9%) and the 16 week mark (51.9% versus 20.9%) compared to the control group.
Lastly, the investigators reported that the incidence of treatment-emergent adverse events was found to be 61.2% in the nemolizumab-treated group and 52.7% for placebo.