Late-Breaking Data: Long-Term Safety and Efficacy of Largest Prurigo Nodularis Study Ever Conducted

Live photo from Dr Kwatra's late-breaking presentation

Image courtesy of Dr Kwatra

“To give context to this study, we're here at the largest dermatology meeting in the history of the world, and I just presented the largest and longest prurigo nodularis study in the history of the world. We've never had a prurigo nodularis study going longer than 6 months,” said Shawn Kwatra, MD, in an interview after his late-breaking data presentation at the 2024 American Academy of Dermatology Annual Meeting in San Diego, California.¹

Kwatra, an associate professor of dermatology at Johns Hopkins University School of Medicine and director of the Johns Hopkins Itch Center, in Baltimore, Maryland, presented new data on nemolizumab demonstrating its long-term and increasing efficacy on skin lesions and improved itch in prurigo nodularis through week 52 in the OLYMPIA long-term extension (LITE) study.

The OLYMPIA open-label LTE study builds on the positive data from OLYMPIA 1 and OLYMPIA 2 and is an ongoing 184-week trial evaluating nemolizumab monotherapy in patients with moderate to severe prurigo nodularis. Patients in OLYMPIA LTE included those who had received nemolizumab in phase 2 and 3 lead-in trials as well as those who had previously received placebo.²

The findings from an interim analysis of OLYMPIA LTE up to week 52 include:

• 69% of patients who had received continuous nemolizumab treatment and 65% of nemolizumab-naïve patients had reached clearance or almost-clearance of skin lesions, as measured by an Investigator’s Global Assessment score
• 89% of patients who had received continuous nemolizumab treatment and 83% of nemolizumab-naïve patients achieved a significant response on itch intensity as measured by an at least 4-point improvement on the peak-pruritus numerical rating scale (PP-NRS)

“We now have evidence that prurigo nodularis can nearly, if not totally, be completely reversed over a one-year period,” concluded Kwatra.

Transcript

Hi, I'm Shawn Kwatra from Baltimore, Maryland. It was my pleasure today to present long-term data on nemolizumab for prurigo nodularis. So, to give context to this study, we're here at the largest dermatology meeting in the history of the world, and I just presented the largest and longest prurigo nodularis study in the history of the world. So, we've never had a prurigo nodularis study going longer than 6 months, and we don't even understand what might happen.

What we found was that nemolizumab had a rapid itch response similar to the pivotal phase 3 trials, which we published in the New England Journal of Medicine. And that itch response happens very quickly within the first 4 weeks and is very sustained. Around 90% of patients had a 4-point improvement in their itch. Sixty-five percent to 70% of patients had an IGA score of zero or one. This is an end point connotating no nodules or rare nodules, something we wouldn't even fathom could be possible.

We've never seen any nodule data or any itch data longer than 6 months. Also, two-thirds of patients entered a relative itch-free state, over 50% of patients had a DLQI of zero or one, which denotes no or minimal impact on their quality of life. So, we now have evidence that prurigo nodularis can nearly, if not totally, be completely reversed over a one-year period.

[Transcript lightly edited for space and clarity.]

References

1. Kwatra S. Nemolizumab long-term efficacy and safety up to 52 weeks in the OLYMPIA open- label extension study in patients with prurigo nodularis: An Interim analysis. Presented at: 2024 American Academy of Dermatology Annual Meeting; March 8-12, 2024; San Diego, CA.
2. Galderma @ AAD 2024: new data demonstrate the long-term efficacy of nemolizumab in prurigo nodularis and its durability in atopic dermatitis. News release. Galderma. March 10, 2024. Accessed March 10, 2024. https://www.galderma.com/news/galderma-aad-2024-new-data-demonstrate-long-term-efficacy-nemolizumab-prurigo-nodularis-and