Importance: There is poor accuracy and reproducibility for the histopathologic diagnosis of melanocytic skin lesions, and the provision of clinical information may improve this.
Objective: To examine the impact of clinical information on the histopathologic diagnosis of melanocytic skin lesions.
Evidence review: PubMed, Embase, and Cochrane Library were searched for new records published from January 2018 to January 2024. References included in the 2018 Cancer Council Australia evidence review were also screened, and forward and backward citation searches were conducted.
Findings: From 2224 records screened, 162 full-text studies were assessed, and 7 studies were included. Studies included pathologists from Austria, Germany, the US, Italy, the UK, and Australia. Patient populations had a mean age of 43 to 55 years and a proportion of female participants of 23% to 63%. The risk of bias assessment demonstrated that all studies had domains at unclear or high risk of bias. Clinical images increased diagnostic certainty (3 studies) and agreement between pathologists (2 studies) led to diagnostic upgrades in 7.6% to 16.7% of interpretations. Clinical diagnosis on the pathology requisition form reduced the odds of missing a melanoma with progression (1 study), while more clinical elements on the form correlated with higher re-excision rates (1 study). Among patients with distant metastases on long-term follow-up, a prior consensus diagnosis of melanoma was established on histopathology alone.
Conclusions and relevance: Providing clinical information to pathologists may improve diagnostic confidence and interobserver agreement and result in upgrading of the histopathologic diagnosis. While providing the clinical diagnosis may prevent missing a progressive melanoma, more research is needed to determine the appropriateness of histopathology upgrading when clinical images are provided and the impacts on patient outcomes.
Importance: Prurigo nodularis (PN) is a chronic and debilitating skin condition, characterized by intense itch with multiple nodular lesions. Nemolizumab demonstrated significant improvements in itch and skin nodules in adults with moderate to severe PN in a previous 16-week phase 3 study (OLYMPIA 2).
Objective: To assess the efficacy and occurrence of adverse events in adults with moderate to severe PN treated with nemolizumab vs those receiving placebo.
Design, setting, and participants: OLYMPIA 1 was a multicenter, placebo-controlled, phase 3 randomized clinical trial, conducted from August 2020 to March 2023 at 77 centers across 10 countries in adults with moderate to severe PN (at least 20 nodules and an Investigator's Global Assessment [IGA] score ≥3) and Peak Pruritus Numerical Rating Scale (PP-NRS) score of at least 7.0; consisted of screening (up to 4 weeks), 24-week treatment, and 8-week follow-up periods.
Interventions: Patients were randomized (2:1) to nemolizumab monotherapy, 30 mg or 60 mg (depending on baseline weight of less than 90 kg vs 90 kg or greater, respectively), or matching placebo administered every 4 weeks for 24 weeks.
Main outcomes and measures: The primary end points were the proportion of patients with itch response (≥4-point improvement from baseline in weekly average PP-NRS) and IGA success (score of 0/1 [clear/almost clear] and 2-grade or more improvement from baseline) at week 16.
Results: Of 286 patients (mean [SD] age, 57.5 [13.0] years; mean [SD] body weight, 85.0 [20.7] kg; 166 [58.0%] female), 190 were randomized to receive nemolizumab, and 96 were randomized to placebo. A significantly greater proportion of patients assigned to nemolizumab vs placebo achieved itch response (111/190 [58.4%] vs 16/96 [16.7%]; Δ, 40.1% [95% CI, 29.4%-50.8%]; P < .001) and IGA success (50/190 [26.3%] vs 7/96 [7.3%]; Δ, 14.6% [95% CI, 6.7%-22.6%]; P = .003) at week 16. At week 24, the proportion of patients with itch response was 58.3% vs 20.4% (Δ, 38.7% [95% CI, 27.5%-49.9%]) in the ad hoc analysis, and IGA success was 58/190 (30.5%) vs 9/96 (9.4%) (Δ, 19.2% [95% CI, 10.3%-28.1%]) in the nemolizumab-treated vs placebo group. During the treatment period, 134 patients (71.7%) receiving nemolizumab vs 62 patients (65.3%) receiving placebo had at least 1 adverse event; most events were of mild to moderate severity.
Conclusions and relevance: In this randomized clinical trial, nemolizumab monotherapy led to clinically meaningful and statistically significant improvements in core signs and symptoms of PN.
Trial registration: ClinicalTrials.gov Identifier: NCT04501666.
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