Augustin Matthias, Napolitano Maddalena, Izu-Belloso Rosa, Kleyn C Elise, Grond Susanne, Otero-Asman Joaquin R, Liu Chunyuan, Reguiai Ziad, Nomura Toshifumi
Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.
University of Naples Federico II, Naples, Italy.
Dermatol Ther (Heidelb). 2025 Feb;15(2):437-444. doi: 10.1007/s13555-024-01330-w. Epub 2025 Jan 29.
Patients with moderate-to-severe atopic dermatitis (AD), a body surface area (BSA) of ≤ 40%, and an itch numerical rating scale (NRS) score of ≥ 7 ("BARI itch dominant") have been characterized as an important group to consider for the oral janus kinase (JAK) 1/2 inhibitor baricitinib (BARI). Herein we aim to evaluate quality of life (QoL) and functioning outcomes in adult patients with BSA ≤ 40% and itch NRS ≥ 7 at baseline (BL) who received BARI 4 mg in the topical corticosteroid (TCS) combination trial BREEZE-AD7.
BREEZE-AD7 was a randomized, double-blind, placebo-controlled, parallel-group outpatient study involving adult patients with moderate-to-severe AD who received once-daily placebo or 2-mg or 4-mg BARI in combination with TCS for 16 weeks. Patients eligible for enrollment had to have BSA ≥ 10%. This post-hoc analysis focused on placebo and BARI 4 mg for patients with BSA ≤ 40% and itch NRS ≥ 7. QoL impairment was measured using a Dermatology Life Quality Index (DLQI) of ≤ 5, and functioning outcomes were assessed using the Work Productivity and Activity Impairment (WPAI) questionnaire. Data were reported descriptively. Last observation carried forward (LOCF) data were reported, excluding data collected after the first rescue therapy date or permanent study drug discontinuation. Non-responder imputation was used to account for missing data.
At BL, patients with BSA ≤ 40% and itch NRS ≥ 7 had high QoL impairment. The mean DLQI score at BL for patients who received BARI 4 mg and placebo indicates a very large effect of AD on patients' QoL. Patients who received BARI and placebo experienced a significant itch burden and reported a similar itch NRS. At week 16, 61.5% of patients treated with BARI 4 mg indicated that it had no to only a small effect on their QoL (DLQI ≤ 5), versus 24.1% for patients receiving placebo (p < 0.01). A decrease in WPAI work impairment score of - 41.6 for BARI patients and - 7.0 for placebo patients was observed at week 16 (p < 0.01). Patients receiving BARI also observed a noticeable improvement in WPAI daily activity impairment of - 30.4 from baseline at week 16 compared to patients on placebo, who achieved - 12.2 (p < 0.01).
Despite having high QoL impairment at baseline, patients with itch-dominant AD treated with BARI 4 mg showed marked benefits in QoL, daily life activity, and work function compared to placebo after 16 weeks of treatment. Limitations include the small sample size analyzed.
中度至重度特应性皮炎（AD）患者，体表面积（BSA）≤40%，瘙痒数字评定量表（NRS）评分≥7（“BARI瘙痒为主型”）被视为口服Janus激酶（JAK）1/2抑制剂巴瑞替尼（BARI）的重要考虑治疗群体。在此，我们旨在评估在局部糖皮质激素（TCS）联合试验BREEZE - AD7中，基线（BL）时BSA≤40%且瘙痒NRS≥7的成年患者接受4mg BARI后的生活质量（QoL）和功能结局。
BREEZE - AD7是一项随机、双盲、安慰剂对照、平行组门诊研究，纳入中度至重度AD成年患者，他们每日接受一次安慰剂或2mg或4mg BARI联合TCS治疗，为期16周。符合入组条件的患者BSA须≥10%。这项事后分析聚焦于BSA≤40%且瘙痒NRS≥7的患者使用安慰剂和4mg BARI的情况。使用皮肤病生活质量指数（DLQI）≤5来衡量QoL损害，使用工作效率和活动障碍（WPAI）问卷评估功能结局。数据以描述性方式报告。报告末次观察向前结转（LOCF）数据，排除首次抢救治疗日期或永久停用研究药物后收集的数据。采用非应答者插补法处理缺失数据。
在基线时，BSA≤40%且瘙痒NRS≥7的患者有较高的QoL损害。接受4mg BARI和安慰剂的患者在基线时的平均DLQI评分表明AD对患者QoL有非常大的影响。接受BARI和安慰剂的患者都有显著的瘙痒负担，且报告的瘙痒NRS相似。在第16周时，61.5%接受4mg BARI治疗的患者表示其对QoL没有影响至仅有轻微影响（DLQI≤5），而接受安慰剂的患者这一比例为24.1%（p<0.01）。在第16周时，观察到接受BARI治疗的患者WPAI工作障碍评分下降了 - 41.6，接受安慰剂的患者下降了 - 7.0（p<0.01）。与安慰剂组患者相比，接受BARI治疗的患者在第16周时WPAI日常活动障碍从基线下降了 - 30.4，而安慰剂组患者下降了 - 12.2（p<0.01）。
尽管基线时QoL损害较高，但与安慰剂相比，接受4mg BARI治疗的以瘙痒为主型AD患者在治疗16周后，在QoL、日常生活活动和工作功能方面显示出显著益处。局限性包括分析的样本量较小。
