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Efficacy and Safety of Abrocitinib in Prurigo Nodularis and Chronic Pruritus of Unknown Origin: A Nonrandomized Controlled Trial.
Kwatra, Shawn G; Bordeaux, Zachary A; Parthasarathy, Varsha; Kollhoff, Alexander L; Alajmi, Ali; Pritchard, Thomas; Cornman, Hannah L; Kambala, Anusha; Lee, Kevin K; Manjunath, Jaya; Ma, Emily Z; Dillen, Carly; Kwatra, Madan M.
Afiliação
  • Kwatra SG; Department of Dermatology, University of Maryland School of Medicine, Baltimore.
  • Bordeaux ZA; Maryland Itch Center, University of Maryland School of Medicine, Baltimore.
  • Parthasarathy V; Department of Anesthesiology, Duke University School of Medicine, Durham, North Carolina.
  • Kollhoff AL; Department of Dermatology, George Washington University School of Medicine and Health Sciences, Washington, DC.
  • Alajmi A; Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
  • Pritchard T; Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
  • Cornman HL; Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
  • Kambala A; Department of Dermatology, University of Maryland School of Medicine, Baltimore.
  • Lee KK; Maryland Itch Center, University of Maryland School of Medicine, Baltimore.
  • Manjunath J; Department of Dermatology, George Washington University School of Medicine and Health Sciences, Washington, DC.
  • Ma EZ; Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
  • Dillen C; Department of Dermatology, George Washington University School of Medicine and Health Sciences, Washington, DC.
  • Kwatra MM; Department of Dermatology, University of Maryland School of Medicine, Baltimore.
JAMA Dermatol ; 160(7): 717-724, 2024 Jul 01.
Article em En | MEDLINE | ID: mdl-38837144
ABSTRACT
Importance Prurigo nodularis (PN) and chronic pruritus of unknown origin (CPUO) are chronic pruritic diseases that dramatically impair quality of life, but therapeutic options are limited. Abrocitinib, a Janus kinase 1 inhibitor, represents a promising therapy for both conditions.

Objective:

To assess the efficacy and safety of 200-mg oral abrocitinib administered once daily in adults with moderate to severe PN or CPUO. Design, Setting, and

Participants:

This phase 2, open-label, nonrandomized controlled trial conducted between September 2021 and July 2022 took place at a single center in the US. A total of 25 adult patients with moderate to severe PN or CPUO were screened. Ten patients with PN and 10 patients with CPUO were enrolled. All 20 patients completed the 12-week treatment period, 18 of whom completed the 4-week follow-up period. Intervention Abrocitinib, 200 mg, by mouth once daily for 12 weeks. Main Outcomes and

Measures:

The primary efficacy end point was the percent change in weekly Peak Pruritus Numerical Rating Scale (PP-NRS) scores from baseline to week 12. Key secondary end points included the percentage of patients achieving at least a 4-point reduction in weekly PP-NRS score from baseline to week 12 and the percent change in Dermatology Life Quality Index (DLQI) scores.

Results:

A total of 10 patients with PN (mean [SD] age, 58.6 [13.1] years; all were female) and 10 patients with CPUO (mean [SD] age, 70.7 [5.6] years; 2 were female) enrolled in the study. The mean (SD) baseline PP-NRS score was 9.2 (1.0) for PN and 8.2 (1.2) for CPUO. PP-NRS scores decreased by 78.3% in PN (95% CI, -118.5 to -38.1; P < .001) and 53.7% in CPUO (95% CI, -98.8 to -8.6; P = .01) by week 12. From baseline to week 12, 8 of 10 patients with PN and 6 of 10 patients with CPUO achieved at least a 4-point improvement on the PP-NRS. Both groups experienced significant improvement in quality of life as demonstrated by percent change in DLQI scores (PN -53.2% [95% CI, -75.3% to -31.1%]; P = .002; CPUO -49.0% [95% CI, -89.6% to -8.0%]; P = .02). The most common adverse event among patients was acneiform eruption in 2 of 20 patients (10%). No serious adverse events occurred. Conclusions and Relevance The results of this nonrandomized controlled trial suggest that abrocitinib monotherapy may be effective and tolerated well in adults with PN or CPUO. Randomized, double-blind, placebo-controlled trials are warranted to validate these findings. Trial Registration ClinicalTrials.gov Identifier NCT05038982.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Prurigo / Prurido / Pirimidinas / Qualidade de Vida / Índice de Gravidade de Doença Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: JAMA Dermatol Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Prurigo / Prurido / Pirimidinas / Qualidade de Vida / Índice de Gravidade de Doença Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: JAMA Dermatol Ano de publicação: 2024 Tipo de documento: Article