QualityMetric Incorporated LLC, Johnston, RI, USA.
Department of Gastroenterology, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.
Qual Life Res. 2024 Aug;33(8):2285-2294. doi: 10.1007/s11136-024-03642-y. Epub 2024 Jun 14.
Iron deficiency anemia is common in people with inflammatory bowel disease (IBD), causing deterioration in quality of life, which can be reversed by treatment that increases iron stores and hemoglobin levels. The present post hoc analyses estimate health state utility values for patients with IBD after treatment with ferric derisomaltose or ferric carboxymaltose and evaluate the health domains driving the changes.
SF-36v2 responses were recorded at baseline and day 14, 35, 49, and 70 from 97 patients enrolled in the randomized, double-blind, PHOSPHARE-IBD trial (ClinicalTrials.gov ID: NCT03466983), in which patients with IBD across five European countries were randomly allocated to either ferric derisomaltose or ferric carboxymaltose. Changes in SF-36v2 scale scores and SF-6Dv2 health utility values were analyzed by mixed models.
In both treatment arms, SF-6Dv2 utility values and all SF-36v2 scale scores, except Bodily Pain, improved significantly (p = < 0.0001). The improvement in SF-6Dv2 utility values showed no significant treatment group difference. The improvement in utility values was completely explained by improvement in Vitality scores. Vitality scores showed significantly larger improvement with ferric derisomaltose versus ferric carboxymaltose (p = 0.026). Patients with the smallest decrease in phosphate had significantly larger improvements in Vitality scores at each time point (p = < 0.05 for all comparisons) and overall (p = 0.0006).
Utility values improved significantly with intravenous iron treatment. Improvement in utility values was primarily driven by Vitality scores, which showed significantly greater improvement in the ferric derisomaltose arm. Smaller decreases in phosphate were associated with significantly higher Vitality scores, suggesting that quality of life improvement is attenuated by hypophosphatemia. The utility values can inform future cost-utility analysis.
缺铁性贫血在炎症性肠病(IBD)患者中很常见,导致生活质量下降,但通过增加铁储存和血红蛋白水平的治疗可以逆转这种情况。本事后分析旨在评估铁源性麦芽糖铁或羧基麦芽糖铁治疗后 IBD 患者的健康状况效用值,并评估驱动这些变化的健康领域。
来自五个欧洲国家的 IBD 患者参加了这项随机、双盲、PHOSPHARE-IBD 试验(ClinicalTrials.gov ID:NCT03466983),患者在基线和第 14、35、49 和 70 天记录了 SF-36v2 反应。患者被随机分配至铁源性麦芽糖铁或羧基麦芽糖铁治疗组。采用混合模型分析 SF-36v2 量表评分和 SF-6Dv2 健康效用值的变化。
在两个治疗组中,SF-6Dv2 效用值和除身体疼痛外的所有 SF-36v2 量表评分均显著改善(p < 0.0001)。SF-6Dv2 效用值的改善无显著治疗组间差异。效用值的改善完全由活力评分的改善解释。与羧基麦芽糖铁相比,铁源性麦芽糖铁组的活力评分改善显著更大(p = 0.026)。磷酸盐下降最小的患者在每个时间点的活力评分均有显著改善(所有比较均 p < 0.05),总体改善也显著(p = 0.0006)。
静脉用铁治疗可显著提高效用值。效用值的改善主要由活力评分驱动,铁源性麦芽糖铁组的活力评分改善显著更大。磷酸盐下降越小,活力评分越高,提示低磷血症会减弱生活质量的改善。效用值可用于未来的成本效用分析。