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Efficacy and safety of ruxolitinib cream in patients with mild to moderate hidradenitis suppurativa: Results from a randomized, double-blind, vehicle-controlled phase 2 study

Dermatologia
Imagem de arquivo, ilustrativa — não é do estudo. Epiderme e derme humanas ao microscópio óptico, coloração HE. Kilbad · domínio público · Wikimedia Commons

Ensaio clínico randomizadoNível 2 · Nova evidênciaJournal of the American Academy of Dermatology15 nov 202514 citações

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Resumo original em inglês

O que aconteceu

There are no approved therapies for patients with milder hidradenitis suppurativa (HS), and available treatments are often inadequate.

To evaluate the efficacy and safety of ruxolitinib (Janus kinase 1 and Janus kinase 2 inhibitor) cream in adults with mild to moderate HS.

This phase 2 study enrolled adults with Hurley stage I/II HS and abscess and inflammatory nodule (AN) count 3-10 with no draining tunnels. Patients were randomized 1:1 to twice-daily 1.5% ruxolitinib cream or vehicle for 16 weeks, after which all patients applied ruxolitinib cream as needed through week 32. The primary endpoint was change from baseline in AN count at week 16.

O que encontraram

Sixty-nine patients were randomized. At week 16, change from baseline in AN count was significantly reduced with 1.5% ruxolitinib cream versus vehicle (least squares mean, -3.61 vs -2.42; P = .0215) with sustained improvement through week 32 with as-needed use. Patients applying ruxolitinib cream experienced fewer flares versus vehicle. Ruxolitinib cream was well tolerated, with no grade ≥3 treatment-emergent adverse events reported.

Por que isso importa

Ruxolitinib cream demonstrated greater clinical benefit versus vehicle in patients with milder HS and had a well-tolerated safety profile.

O que ainda não sabemos

Relatively small sample size; discontinuation rates and race were imbalanced between groups.

Resumo publicado sob licença CC BY. A tradução para o português ainda não chegou a este estudo.

O estudo original

Efficacy and safety of ruxolitinib cream in patients with mild to moderate hidradenitis suppurativa: Results from a randomized, double-blind, vehicle-controlled phase 2 study

Martina L Porter, M Celeste Ferreira-Cornwell, Mingyue Wang, Haq Nawaz, Melinda J Gooderham

Descritores MeSH

  • Pyrazoles
  • Hidradenitis Suppurativa
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Nitriles
  • Pyrimidines
  • Severity of Illness Index

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