Dr Shawn Kwatra Discusses Study Results for Nemolizumab in Prurigo Nodularis

Shawn Kwatra, MD, dermatologist, John Hopkins University, recapped his study presented at the American Academy of Dermatology annual meeting that looked at the use of nemolizumab in patients with prurigo nodularis as well as the improved quality of life and itch relief patients could see.

Transcript

Were there any notable safety concerns or adverse events identified during the long-term treatment with nemolizumab in this study? How do these compare with the safety profile observed in earlier trials?

There's a very low incidence of adverse events related to the study drug; [it's] around 1%. So that was very low number. Some of the safety events that were noted: there's some small cases of eczematous dermatitis or headache, which were largely managed with topical or localized therapies. So safety results were very consistent with the results from the pivotal phase 3 trials.

How sustainable were the improvements in pruritus and other symptoms of prurigo nodularis over the 52-week period of the study?

Nemolizumab had a rapid improvement on itch. So within just four weeks of the placebo group being on nemolizumab, in this study for the switch from the lead and studies, they had just significant itch relief, and it continued to prove with around 90% of patients having that 4 point improvement inch so that was sustained itch relief.

In terms of the skin lesions and the nodule improve, it actually continued to improve. It did not plateau at the end of the study, that percentage of patients with clear almost clear skin at the IGA [Investigator's Global Assessment scale scores] zero to 1, so we'd actually expect that to continue to improve further. So there was no plateauing, so that was excellent.

Based on the interim analysis results, what are the implications for the potential long-term use of nemolizumab as a treatment option for patients with prurigo nodularis? Are there any considerations for further investigation or clinical practice?

This study is very significant, because we've never in the history of the world had a study on prurigo nodularis longer than 6 months. So this is the longest study that's ever been presented to a year. And now we know that living in an itch-free state. You know, having almost totally clear totally clear skin is achievable. And that's a huge metric. That's something that we can counsel patients on. That's something that we haven't had data for therapies before. These patients have suffered for so many years.

So this is a tremendous development to have improvements in the itch, the skin lesions, the sleep, the quality of life that is so robust—that sustained—and also with the long-term safety data, long-term efficacy data, so I think it will give physicians confidence once this drug becomes available, to be able to help patients with prurigo nodularis who have some of the most devastating itch and quality of life disruption among any patients in dermatology.