Caracterização multidimensional da eficácia de xeligekimab em psoríase em placas moderada a grave: respostas regionais, alvos de tratamento e resultados notificados pelos pacientes de um ensaio controlado randomizado

Resumo original em inglês

O que aconteceu

Xeligekimab, a monoclonal antibody targeting interleukin-17A ( IL-17A ), has demonstrated high efficacy in treating moderate-to-severe plaque psoriasis. However, the detailed response patterns across anatomical regions, treatment targets, and patient-reported outcomes remain incompletely elucidated

This post hoc analysis of a phase 3, randomized, double-blind, placebo-controlled trial (CHICTR2100043223) included 420 Chinese patients randomized 2:1 to receive subcutaneous xeligekimab 200 mg every 2 weeks or placebo for 12 weeks, followed by open-label xeligekimab through week 52. Regional Psoriasis Area and Severity Index (PASI) responses across four anatomical sites, treatment targets [ideal target: PASI 90 or absolute PASI ≤3 or body surface area (BSA) ≤1% or Physician’s Global Assessment (PGA) 0/1; acceptable target: PASI 75 or absolute PASI ≤5 or BSA ≤3% or PGA 0/1/2; sustained remission: BSA = 0% or PGA = 0 for ≥6 months], and Dermatology Life Quality Index (DLQI) domain-specific improvements were comprehensively analyzed

https://www.chictr.org.cn , identifier CHICTR2100043223

O que encontraram

Xeligekimab produced rapid improvements across all PASI dimensions by week 4, with induration (−60.1%), scaling (−61.9%), and erythema (−50.3%) versus −5.3% to −7.7% for placebo (all P < 0.001). By week 12, reductions reached −91.1%, −90.9%, and −82.3%, respectively. Regional analysis showed that head lesions responded most rapidly (PASI 90: 84.2% at week 12), with week 52 regional PASI 90 rates ranging from 81.2% to 92.1%. Ideal and acceptable target achievement rates reached 86.6% and 94.9% at week 12 versus 4.6% and 9.9% for placebo (both P < 0.001), increasing to 91.0% and 98.0% by week 52. The median time to sustained remission was 48 weeks for xeligekimab. By weeks 52 and 60, sustained remission rates reached 50.1% and 54.1%, respectively. Patient-reported outcomes demonstrated rapid and comprehensive improvement across all DLQI functional dimensions by week 4, with low-impact rates exceeding 90% by week 12 for physical symptoms (97.0% for symptoms, 92.0% for pruritus), psychological burden (98.0%), daily activities (97.1%–98.2%), social functioning (98.0%), work/study (97.0%), and treatment burden (99.0%), all significantly superior to placebo (all P < 0.001)

Por que isso importa

Xeligekimab provides rapid symptom resolution across all clinical dimensions, high and sustained achievement of treatment targets, and comprehensive restoration of quality of life

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