Ixekizumab With Tirzepatide Achieved Greater Disease Control Than Ixekizumab Alone in Adults With Psoriatic Arthritis and Overweight or Obesity: Results From a Randomized Clinical Trial.

We assessed the efficacy and safety of ixekizumab (IXE) concomitantly administered with tirzepatide (TZP) compared with IXE alone in adult participants with active PsA and overweight with at least one weight-related comorbidity or obesity.

我们评估了依克珠单抗（IXE）与曲美替尼（TZP）联合使用与IXE单独使用在活跃的PsA和超重成人参与者中的疗效和安全性，这些参与者至少有一种与体重相关的合并症或肥胖。

Methods

TOGETHER-PsA (ClinicalTrials.gov identifier: NCT06588296) is a phase 3b, randomized, 52-week trial in adults with active PsA and overweight (body mass index [BMI] ≥27 to <30) with at least one weight-related comorbidity or obesity (BMI ≥30) using US-approved doses for IXE and TZP.

TOGETHER-PsA（ClinicalTrials.gov注册号：NCT06588296）是一项3b期、随机、52周的试验，针对活跃的PsA和超重（体重指数[BMI]≥27至<30）的成人参与者，这些参与者至少有一种与体重相关的合并症或肥胖（BMI≥30），使用美国批准的IXE和TZP剂量。

The primary end point was simultaneous achievement of 50% improvement in American College of Rheumatology response criteria (ACR50) and ≥10% weight reduction at 36 weeks.

主要终点是在36周时同时达到美国风湿病学会反应标准（ACR50）的50%改善和≥10%的体重减轻。

Key secondary outcomes included ACR50.

关键次要结果包括ACR50。

Additional secondary outcomes and patient-reported outcomes (PROs) were assessed.

还评估了其他次要结果和患者报告的结果（PROs）。

Safety was assessed as adverse events (AEs), treatment-emergent AEs, and serious AEs.

安全性评估包括不良事件（AEs）、治疗后出现的不良事件和严重不良事件。

Results

A total of 271 participants were randomized (IXE + TZP, n = 138; IXE, n = 133).

共有271名参与者被随机分配（IXE + TZP，n = 138；IXE，n = 133）。

The primary end point was achieved with significant improvements in the IXE + TZP arm (31.7%) compared to IXE alone (0.8%) (P < 0.001).

主要终点得到了实现，IXE + TZP组（31.7%）与IXE单独组（0.8%）相比有显著改善（P < 0.001）。

Greater improvements in ACR50 were demonstrated in IXE + TZP (33.5%) versus IXE alone (20.4%) (P = 0.02), with significant early separation at week 4 (nominal P < 0.05).

在IXE + TZP组中，ACR50的改善更为显著（33.5%）与IXE单独组（20.4%）相比（P = 0.02），并且在第4周就出现了显著的早期分离（名义P < 0.05）。

IXE + TZP demonstrated nominally significant improvements in ACR20 (P < 0.001), minimal disease activity (P < 0.05), and absolute Psoriasis Area and Severity Index score (P < 0.01) compared to IXE alone.

与IXE单独组相比，IXE + TZP在ACR20（P < 0.001）、最小疾病活动度（P < 0.05）和绝对银屑病面积和严重性指数评分（P < 0.01）方面显示出名义上的显著改善。

IXE + TZP demonstrated significant improvements in PROs, including Health Assessment Questionnaire-Disability Index (∆ -0.2; nominal P < 0.001) and Functional Assessment of Chronic Illness Therapy-Fatigue (improvement of 3.8; nominal P < 0.01) compared to IXE alone.

与IXE单独组相比，IXE + TZP在患者报告的结果（PROs）方面显示出显著改善，包括健康评估问卷-残疾指数（∆ -0.2；名义P < 0.001）和慢性疾病治疗功能评估-疲劳（改善3.8；名义P < 0.01）。

Safety profiles were consistent with previous studies for each drug.

每种药物的安全性特征与以往的研究一致。

Conclusions

Participants with active PsA and complex inflammatory-metabolic disease achieved clinically meaningful improvement of PsA, physical function, weight reduction, and quality of life when treated with IXE + TZP compared to IXE alone, with no new safety concerns.

与IXE单独治疗相比，接受IXE + TZP治疗的活动性银屑病关节炎（PsA）患者和复杂的炎症-代谢性疾病患者在PsA、身体功能、减重和生活质量方面实现了临床意义上的改善，且没有出现新的安全问题。