P052 Nemolizumab elicits rapid itch-free state and sleep improvement in prurigo nodularis
Bibliographic record
Abstract
Abstract There is a need for rapid management of the debilitating symptoms of prurigo nodularis (PN), particularly the characteristically severe pruritus. Nemolizumab blocks interleukin (IL)-31, the first neuroimmune cytokine described to directly trigger pruritus. IL-31 also has an important role in inflammatory pathways, epidermal dysregulation and fibrotic responses. We analysed data from the pivotal phase III randomized controlled trials, OLYMPIA 1 and 2, to characterize the onset of action on additional pruritus metrics and sleep disturbances in patients with moderate-to-severe PN. In OLYMPIA 1 and 2 combined, 560 adult patients were randomized to receive an initial 60-mg dose of nemolizumab subcutaneously followed by nemolizumab 30 mg or 60 mg (depending on weight) (n = 373) or matching placebo (n = 187) every 4 weeks for 16 weeks (OLYMPIA 2) or 24 weeks (OLYMPIA 1). We analysed the daily response rates on itch-free or nearly itch-free status and a clinically meaningful improvement (≥ 4-point improvement from baseline) on daily Peak Pruritus Numerical Rating Scale (PP-NRS) and Sleep Disturbance Numerical Rating Scale (SD-NRS). Nearly itch free was defined as a mean daily PP-NRS < 2. By day 4, the proportion of itch-free or nearly itch-free patients was significantly greater with nemolizumab (5.5–6.8%) than with placebo (0–1.3%) in OLYMPIA 1 and 2 (P < 0.05). Further, in a pooled analysis of OLYMPIA 1 and 2, the proportion of patients with ≥ 4-point improvement from baseline in daily PP-NRS differed significantly between groups as early as day 1 (11.0% nemolizumab vs. 2.1% placebo, P = 0.001), similarly to previous results (Ständer S, Elmariah S, Kwatra SG et al. Nemolizumab elicits an early and rapid itch response in prurigo nodularis within 2 days: a post hoc analysis of OLYMPIA 1&2 data. Presented at the European Academy of Dermatology and Venereology Annual Meeting, Amsterdam, the Netherlands, 25–28 September 2024). Improvements in sleep also occurred rapidly. The proportion of patients with ≥ 4-point improvement from baseline in daily SD-NRS was significantly higher for nemolizumab compared with placebo by day 1 (pooled data: 8.8% vs. 3.7%, P = 0.03). As with pruritus, the differences between groups increased over time. With pruritus being the most burdensome symptom of PN, early control of itch provides an important benefit for patients. As consistently shown in both studies, rapid reduction in itch with nemolizumab translates to improved sleep. This work was sponsored by Galderma SA and Galderma UK.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".