Mental Health Changes in Adolescents and Adults With Cystic Fibrosis After Initiation of Elexacaftor/Tezacaftor/Ivacaftor Therapy

CHEST pulmonary Pub Date : 2025-02-07 DOI:10.1016/j.chpulm.2025.100146

Els van der Heijden MA , Rutger M. van den Bor PhD , Marlou C. Bierlaagh MD , Danya Muilwijk MD, PhD , Jessica M. de Graaf MSc , Sanne L. Nijhof MD, PhD , Inez Bronsveld MD, PhD , Cornelis K. van der Ent MD, PhD , Sabine E.I. van der Laan MD, PhD

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Abstract

Background

Starting elexacaftor/tezacaftor/ivacaftor (ETI) is considered a positive life event for people with cystic fibrosis (pwCF). Nevertheless, some individuals report a decline in mental health after commencing ETI.

Research Question

How do various mental health indicators of pwCF ≥ 12 years of age change after starting ETI, and can potentially more vulnerable subgroups, in terms of their mental health, be identified?

Study Design and Methods

This was a prospective 60-week longitudinal cohort study with questionnaire-based measurements of mental health 12 weeks before (t0) and 12, 24, and 48 weeks after starting ETI (t1, t2, and t3, respectively). Subgroups were defined by age, sex, lung function at baseline, earlier use of any other modulator, and use of psychotropic medications. Data were analyzed using a covariance pattern model with a general variance covariance matrix.

Results

In total, 174 (98.31%), 146 (82.49%), 141 (79.66%), and 142 (80.23%) participants completed or partially completed the questionnaires at t0, t1, t2, and t3, respectively. The data showed an overall statistically significant and clinically relevant improvement in psychosocial health (P < .001; change in [Δ] estimated marginal means [EMM] t0-t3, 7.68), no change in anxiety symptoms (P = .46; ΔEMM t0-t3 = −0.42), a statistically significant but not clinically relevant improvement in depressive symptoms (P < .001; ΔEMM t0-t3 = −1.25), and a statistically significant and clinically relevant improvement in respiratory-related quality of life (P < .001; ΔEMM t0-t3 = 19.55) after the initiation of ETI. Female patients, those with lower lung function, and those using psychotropic medications at baseline seem to be more susceptible to lower mental health scores after starting ETI on several indicators, compared with their counterparts.

Interpretation

In this study, pwCF experienced an improvement in all mental health indicators, except in anxiety symptoms. Clinical physicians should be aware that female patients, people with lower lung function, and those using psychotropic medications might be more prone to less favorable mental health improvement.

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青少年和成人囊性纤维化患者接受elexaftor /Tezacaftor/Ivacaftor治疗后的心理健康变化

背景：对于囊性纤维化（pwCF）患者来说，启动elexacaftor/tezacaftor/ivacaftor （ETI）被认为是一件积极的生活事件。然而，一些人报告说，在开始ETI后，他们的心理健康状况有所下降。研究问题：≥12岁pwCF的各项心理健康指标在开始ETI后发生了怎样的变化，是否可以识别出更脆弱的心理健康亚群？研究设计和方法这是一项为期60周的前瞻性纵向队列研究，在开始ETI（分别为t1、t2和t3）前12周和开始ETI后12周、24周和48周进行基于问卷的心理健康测量。亚组根据年龄、性别、基线时肺功能、早期使用任何其他调节剂和使用精神药物来定义。数据分析使用协方差模式模型与一般方差协方差矩阵。结果共174人（98.31%）、146人（82.49%）、141人（79.66%）、142人（80.23%）在t0、t1、t2和t3完成或部分完成问卷。数据显示，在心理社会健康方面总体上有统计学意义和临床相关的改善(P <；措施;[Δ]估计边际均值[EMM] t0-t3, 7.68)变化，焦虑症状无变化(P = 0.46；ΔEMM t0-t3 = - 0.42)，抑郁症状的改善具有统计学意义，但与临床无关(P <；措施;ΔEMM t0-t3 =−1.25)，呼吸相关生活质量的改善具有统计学意义和临床相关性(P <；措施;ΔEMM t0-t3 = 19.55)。女性患者，肺功能较低的患者，以及在基线时使用精神药物的患者，在开始ETI后，与同行相比，似乎更容易在几个指标上出现较低的心理健康评分。在本研究中，除了焦虑症状外，pwCF在所有心理健康指标上都有改善。临床医生应该意识到，女性患者，肺功能低下的人，以及那些使用精神药物的人可能更容易出现不利的心理健康改善。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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CHEST pulmonary

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