Dpt. of Rheumatology, Goethe University and Fraunhofer ITMP and CIMD, 60590, Frankfurt am Main, Germany.
Eli Lilly and Company, Indianapolis, USA.
Clin Rheumatol. 2021 Dec;40(12):4943-4954. doi: 10.1007/s10067-021-05891-5. Epub 2021 Sep 13.
Improvements in both musculoskeletal and non-musculoskeletal manifestations are important treatment goals in psoriatic arthritis (PsA).
These post hoc analyses determined whether additional benefits related to various PsA domains are observed in patients simultaneously achieving 50% improvement in American College of Rheumatology criteria (ACR50) and 100% improvement in Psoriasis Area Severity Index (PASI100), the primary endpoint of the SPIRIT-H2H study.
Patients with active PsA and psoriasis in SPIRIT-H2H (N = 566) were categorised into two sets of four response groups irrespective of treatment allocation (approved dosages of ixekizumab or adalimumab): patients who simultaneously achieved ACR50 and PASI100 response, achieved ACR50 response only, achieved PASI100 response only, or did not achieve ACR50 or PASI100 response after 24 and 52 weeks of treatment. Patients achieving simultaneous ACR50 and PASI100 response were compared with the other patient response groups at the corresponding time point for efficacy and health-related quality of life (HRQoL) outcomes.
Patients simultaneously achieving ACR50 and PASI100 responses at week 24 or 52 showed higher rates of ACR70 response, minimal disease activity, Disease Activity in Psoriatic Arthritis ≤ 4, resolution of enthesitis and dactylitis, and HRQoL improvement at weeks 24 and 52, respectively, than the other corresponding response groups at both time points.
High levels of disease control, such as those obtained with simultaneous achievement of ACR50 and PASI100 response, were linked to better outcomes across a wide range of endpoints that are important for patients with PsA. Patients meeting this combined endpoint showed more comprehensive and thus greater control of disease activity. Trial registration NCT03151551 Key Points • Treatment goals for patients with psoriatic arthritis emphasise the importance of improving both musculoskeletal and non-musculoskeletal manifestations of the disease. • A combined endpoint considering both these manifestations, achievement of at least 50% improvement in American College of Rheumatology criteria and 100% improvement in Psoriasis Area Severity Index, was linked with achievement of a number of other endpoints relevant to psoriatic arthritis, including health-related quality of life that are important to patients with psoriatic arthritis. • Patients meeting the combined endpoint were more likely to achieve a disease state of remission, which is the stated aim of treatment for psoriasis.
改善肌肉骨骼和非肌肉骨骼表现是银屑病关节炎（PsA）的重要治疗目标。
这些事后分析旨在确定在 SPIRIT-H2H 研究中，同时达到美国风湿病学会标准（ACR50）改善 50%和银屑病面积严重程度指数（PASI100）改善 100%的患者（主要终点）是否会观察到与各种 PsA 领域相关的额外获益。
SPIRIT-H2H 中的活动性 PsA 和银屑病患者（N=566）被分为两组，每组分为四个反应组，无论治疗分配情况如何（依西美坦或阿达木单抗的批准剂量）：同时达到 ACR50 和 PASI100 反应的患者、仅达到 ACR50 反应的患者、仅达到 PASI100 反应的患者或在 24 周和 52 周治疗后未达到 ACR50 或 PASI100 反应的患者。在相应的时间点，比较达到同时 ACR50 和 PASI100 反应的患者与其他患者反应组在疗效和健康相关生活质量（HRQoL）结果方面的差异。
在第 24 周或第 52 周同时达到 ACR50 和 PASI100 反应的患者，在第 24 周和第 52 周时，与其他相应反应组相比，其 ACR70 反应率、最小疾病活动度、疾病活动度在银屑病关节炎中 ≤ 4、附着点炎和指（趾）炎缓解以及 HRQoL 改善的发生率更高。
高水平的疾病控制，如同时达到 ACR50 和 PASI100 反应所获得的控制，与患者的广泛终点相关，这些终点对 PsA 患者很重要。达到联合终点的患者表现出更全面的疾病活动控制，因此控制效果更好。
试验注册 NCT03151551
银屑病关节炎患者的治疗目标强调改善疾病的肌肉骨骼和非肌肉骨骼表现的重要性。
同时考虑到这两种表现的联合终点，即美国风湿病学会标准至少改善 50%和银屑病面积严重程度指数改善 100%，与其他一些与银屑病关节炎相关的终点相关联，包括对银屑病关节炎患者很重要的健康相关生活质量。
达到联合终点的患者更有可能达到疾病缓解状态，这是治疗银屑病的既定目标。
