Scholarlink

Introduction <p>Mental health status potentially influences treatment responses. The effect of probable anxiety and/or depressive disorder (pADD) on tofacitinib efficacy, patient-reported outcomes (PROs), and safety in psoriatic arthritis (PsA) was assessed.</p> Methods <p>This was a post hoc analysis of two phase 3 trials in patients with PsA receiving tofacitinib, adalimumab, or placebo, and an open-label extension study. Outcomes were stratified by presence/absence of baseline pADD (Short Form-36 Health Survey [SF-36] Mental Component Summary score ≤ 38/ &gt; 38). American College of Rheumatology ≥ 20%, ≥ 50%, and ≥ 70% (ACR20/50/70) responses, remission and/or low disease activity based on Psoriatic Arthritis Disease Activity Score and Disease Activity Index for Psoriatic Arthritis score, minimal disease activity, and PROs (pain/Health Assessment Questionnaire-Disability Index/fatigue) were assessed through month 36. Safety was assessed through month 12.</p> Results <p>Overall, 323/706 (45.8%) patients had baseline pADD; of these, a higher proportion were female versus male (61.9% vs. 38.1%). Numerically higher proportions achieved efficacy/PRO responses with tofacitinib versus placebo, regardless of baseline pADD (month 3). Responses with tofacitinib were generally similar in patients with versus without baseline pADD (e.g., month 3 ACR20 responses: 54.0% vs. 58.5%); some differences were observed at later time points (e.g., month 9 minimal disease activity: 25.0% vs. 43.8%; <i>p</i> &lt; 0.05). Baseline pADD did not appear to affect the incidence of treatment-emergent adverse events.</p> Conclusions <p>Baseline pADD was frequent in patients with PsA initiating tofacitinib and was higher&#xa0;in female patients. Tofacitinib-treated patients had generally similar efficacy/safety outcomes,&#xa0;regardless&#xa0;of baseline pADD. Some differences in efficacy outcomes were noted in the longer term (9–12&#xa0;months). Limitations&#xa0;of this study&#xa0;include small numbers in some analyses&#xa0;and use of SF-36 as pADD&#xa0;proxy.</p> <p><b>Trial registration:</b> ClinicalTrials.gov: NCT01877668; NCT01882439; NCT01976364.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Response to Tofacitinib in Patients with Psoriatic Arthritis and Probable Anxiety/Depressive Disorder: A Post Hoc Analysis of Phase 3 Trials

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年10月28日

查看全文
  • Laure Gossec,
  • Agustí Sellas,
  • David C. Gruben,
  • Mónica Valderrama,
  • Susana Gómez,
  • Cassandra Kinch,
  • Gustavo Citera

摘要

Introduction

Mental health status potentially influences treatment responses. The effect of probable anxiety and/or depressive disorder (pADD) on tofacitinib efficacy, patient-reported outcomes (PROs), and safety in psoriatic arthritis (PsA) was assessed.

Methods

This was a post hoc analysis of two phase 3 trials in patients with PsA receiving tofacitinib, adalimumab, or placebo, and an open-label extension study. Outcomes were stratified by presence/absence of baseline pADD (Short Form-36 Health Survey [SF-36] Mental Component Summary score ≤ 38/ > 38). American College of Rheumatology ≥ 20%, ≥ 50%, and ≥ 70% (ACR20/50/70) responses, remission and/or low disease activity based on Psoriatic Arthritis Disease Activity Score and Disease Activity Index for Psoriatic Arthritis score, minimal disease activity, and PROs (pain/Health Assessment Questionnaire-Disability Index/fatigue) were assessed through month 36. Safety was assessed through month 12.

Results

Overall, 323/706 (45.8%) patients had baseline pADD; of these, a higher proportion were female versus male (61.9% vs. 38.1%). Numerically higher proportions achieved efficacy/PRO responses with tofacitinib versus placebo, regardless of baseline pADD (month 3). Responses with tofacitinib were generally similar in patients with versus without baseline pADD (e.g., month 3 ACR20 responses: 54.0% vs. 58.5%); some differences were observed at later time points (e.g., month 9 minimal disease activity: 25.0% vs. 43.8%; p < 0.05). Baseline pADD did not appear to affect the incidence of treatment-emergent adverse events.

Conclusions

Baseline pADD was frequent in patients with PsA initiating tofacitinib and was higher in female patients. Tofacitinib-treated patients had generally similar efficacy/safety outcomes, regardless of baseline pADD. Some differences in efficacy outcomes were noted in the longer term (9–12 months). Limitations of this study include small numbers in some analyses and use of SF-36 as pADD proxy.

Trial registration: ClinicalTrials.gov: NCT01877668; NCT01882439; NCT01976364.