McIntyre Roger S, Parikh Mousam, Ta Jamie, Waraich Simranpreet, Cohen-Stavi Chandra, Marci Carl, Nabulsi Nadia
Department of Psychiatry, University of Toronto, Toronto, Canada.
AbbVie, North Chicago, IL, USA.
J Med Econ. 2025 Dec;28(1):885-898. doi: 10.1080/13696998.2025.2513766. Epub 2025 Jun 10.
The efficacy of cariprazine for major depressive disorder (MDD) (adjunctive therapy) and bipolar I (BP-I) depression has been demonstrated in clinical trials. This study evaluated the real-world effectiveness of cariprazine in reducing depression severity among patients with moderate-to-severe MDD or BP-I depression.
Medical/pharmacy claims and electronic medical records (EMRs) from specialty providers in the OM1 Real-World Data Cloud were used to identify adults with MDD or BP-I who initiated cariprazine (adjunctively for MDD) (first dispensing = index) and had ≥1 EMR and ≥1 claim during 12-month baseline and ≤12-month follow-up periods. Included patients had a baseline Patient Health Questionnaire (PHQ)-9 total score ≥10, reflecting at least moderate depressive symptoms. Follow-up continued until cariprazine discontinuation, alternate diagnosis (e.g. BP-I [MDD cohort] or MDD [BP-I cohort]), or 12 months post-index. Depression severity was assessed using PHQ-9 total scores that were observed or estimated from clinical notes using a previously validated machine learning algorithm. Analyses included mean change in PHQ-9 score from baseline to 2, 6, and 12 months of follow-up. A sensitivity analysis using only observed PHQ-9 scores was conducted.
Of 754 patients at baseline, 396 had MDD (mean PHQ-9 = 16.4) and 358 had BP-I (mean PHQ-9 = 16.9). For patients with MDD, mean reductions in PHQ-9 scores from baseline to 2, 6, and 12 months of adjunctive cariprazine treatment were 3.5 (95% CI: 2.7, 4.4; = 127), 4.1 (2.9, 5.4; = 87), and 3.7 (1.6, 5.8; = 52), respectively. For patients with BP-I, mean reductions from baseline to 2, 6, and 12 months were 5.2 (95% CI: 4.2, 6.2; = 121), 6.5 (5.2, 7.8; = 90), and 6.9 (5.2, 8.5; = 54), respectively. Greater improvements were observed in the sensitivity analysis.
This real-world effectiveness study of cariprazine treatment for MDD (adjunctive use) or BP-I demonstrated clinically meaningful and sustained improvement in depression symptoms during short- and long-term follow-up.
卡立普嗪用于重度抑郁症（MDD）（辅助治疗）和双相I型（BP-I）抑郁症的疗效已在临床试验中得到证实。本研究评估了卡立普嗪在降低中度至重度MDD或BP-I抑郁症患者抑郁严重程度方面的实际效果。
使用OM1真实世界数据云中专科提供者的医疗/药房索赔和电子病历（EMR）来识别开始使用卡立普嗪（MDD辅助用药）（首次配药=索引）且在12个月基线期和≤12个月随访期内有≥1份EMR和≥1份索赔的MDD或BP-I成年患者。纳入患者的基线患者健康问卷（PHQ）-9总分≥10，反映至少中度抑郁症状。随访持续至卡立普嗪停药、替代诊断（如BP-I [MDD队列]或MDD [BP-I队列]）或索引后12个月。使用从临床记录中观察到的或使用先前验证的机器学习算法估计的PHQ-9总分评估抑郁严重程度。分析包括从基线到随访2、6和12个月时PHQ-9评分的平均变化。进行了仅使用观察到的PHQ-9评分的敏感性分析。
在基线时的754例患者中，396例患有MDD（平均PHQ-9 = 16.4），358例患有BP-I（平均PHQ-9 = 16.9）。对于MDD患者，辅助使用卡立普嗪治疗从基线到2、6和12个月时PHQ-9评分的平均降低分别为3.5（95%CI：2.7，4.4；n = 127）、4.1（2.9，5.4；n = 87）和3.7（1.6，5.8；n = 52）。对于BP-I患者，从基线到2、6和12个月的平均降低分别为5.2（95%CI：4.2，6.2；n = 121）、6.5（5.2，7.8；n = 90）和6.9（5.2，8.5；n = 54）。在敏感性分析中观察到更大的改善。
这项关于卡立普嗪治疗MDD（辅助使用）或BP-I的实际效果研究表明，在短期和长期随访期间，抑郁症状有临床意义且持续的改善。
