在加拿大真实世界APPRAISE研究中，使用阿普米司特实现银屑病关节炎治疗目标及1年时的满意度
Use of Apremilast to Achieve Psoriatic Arthritis Treatment Goals and Satisfaction at 1 Year in the Canadian Real-World APPRAISE Study.
作者信息
Chandran Vinod, Bessette Louis, Thorne Carter, Sheriff Maqbool, Rahman Proton, Gladman Dafna D, Anwar Sabeen, Jelley Jennifer, Gaudreau Anne-Julie, Chohan Manprit, Sampalis John S
机构信息
Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, 399 Bathurst St., 1E 416, Toronto, ON, M5T 2S8, Canada.
Laval University, 2325 Rue de l'Université, Québec, QC, G1V 0A6, Canada.
出版信息
Rheumatol Ther. 2024 Apr;11(2):443-455. doi: 10.1007/s40744-024-00641-w. Epub 2024 Feb 28.
INTRODUCTION
The APPRAISE study was conducted to better understand the 12-month effectiveness, tolerability, and patient satisfaction with apremilast treatment for patients with psoriatic arthritis (PsA) in real-world settings.
METHODS
APPRAISE (NCT03608657), a prospective, multicenter, observational study, enrolled adults with active PsA prescribed apremilast per routine care between July 2018 and March 2020. Patients were followed for 12 months with visits suggested every 4 months. The primary outcome measure was achievement of remission (REM) or low disease activity (LDA), defined as a Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) score ≤ 13.
RESULTS
Of the 102 patients who enrolled, 45 (44.1%) discontinued the study by 12 months. Most patients (75.5%) had moderate or high disease activity, and 24.5% were in REM/LDA at baseline based on cDAPSA score. Achievement of cDAPSA REM/LDA was 63.7%, 67.2%, and 53.8% at months 4, 8, and 12, respectively. In those continuing in the study, significant improvements were seen in swollen and tender joint counts, pain visual analog scale, psoriasis body surface area, and complete dactylitis resolution. Enthesitis reduction was also observed. Improvements in treatment satisfaction and patient-reported outcomes, including Health Assessment Questionnaire-Disability Index and the 36-item Short Form physical and mental component scores, were observed over 12 months. The proportion of patients achieving a Patient-Acceptable Symptom State (PASS) increased significantly from baseline at months 4, 8, and 12 (P < 0.001). Apremilast was well tolerated; the most frequent adverse events (AEs) leading to discontinuation were diarrhea (9/102 [8.8%]), nausea (4/102 [3.9%]), and migraine (4/102 [3.9%]).
CONCLUSION
In this real-world study conducted in Canadian rheumatology clinics, apremilast demonstrated clinical effectiveness in patients with active PsA, along with patient satisfaction with treatment. Safety findings were consistent with previously reported clinical data.
TRIAL REGISTRATION
ClinicalTrials.gov identifier, NCT03608657.
引言
开展APPRAISE研究是为了更好地了解在现实环境中，阿普米拉斯治疗银屑病关节炎（PsA）患者12个月的有效性、耐受性及患者满意度。
方法
APPRAISE（NCT03608657）是一项前瞻性、多中心观察性研究，纳入了2018年7月至2020年3月期间按常规护理处方服用阿普米拉斯的活动性PsA成年患者。对患者进行12个月的随访，建议每4个月就诊一次。主要结局指标为达到缓解（REM）或低疾病活动度（LDA），定义为银屑病关节炎临床疾病活动指数（cDAPSA）评分≤13。
结果
102例入组患者中，45例（44.1%）在12个月时停止研究。大多数患者（75.5%）疾病活动度为中度或高度，根据cDAPSA评分，24.5%的患者基线时处于REM/LDA。cDAPSA达到REM/LDA的比例在第4、8和12个月时分别为63.7%、67.2%和53.8%。在继续参与研究的患者中，肿胀和压痛关节计数、疼痛视觉模拟量表、银屑病体表面积及完全指（趾）炎消退情况均有显著改善。附着点炎也有所减轻。在12个月期间，治疗满意度及患者报告结局有所改善，包括健康评估问卷-残疾指数以及36项简明健康调查问卷的身体和精神成分评分。达到患者可接受症状状态（PASS）的患者比例在第4、8和12个月时较基线显著增加（P<0.001）。阿普米拉斯耐受性良好；导致停药的最常见不良事件（AE）为腹泻（9/102[8.8%]）、恶心（4/102[3.9%]）和偏头痛（4/102[3.9%]）。
结论
在加拿大风湿病诊所进行的这项现实研究中，阿普米拉斯在活动性PsA患者中显示出临床有效性，患者对治疗也感到满意。安全性结果与先前报告的临床数据一致。
试验注册
ClinicalTrials.gov标识符，NCT03608657。
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