The IPSS-R more accurately captures fatigue severity of newly diagnosed patients with myelodysplastic syndromes compared with the IPSS index

Abstract

We aimed to compare fatigue of newly diagnosed patients with myelodysplastic syndromes (MDS) with that of the general population (GP). We also investigated the ability of the IPSS and IPSS-R to capture severity of patient-reported fatigue at diagnostic workup. A sample of 927 newly diagnosed patients with MDS was consecutively enrolled in a large international observational study and all patients completed the FACIT-Fatigue questionnaire at baseline. Fatigue was compared with that of the GP (N = 1075) and a 3-point difference in mean scores was considered as clinically meaningful. Fatigue of MDS patients was on average 4.6 points below the mean of the GP (95% CI, -5.9 to -3.2, p < 0.001), reflecting clinically meaningful worse fatigue. Unlike the IPSS, the IPSS-R identified clearly distinct subgroups with regard to burden of fatigue. Mean scores differences compared with GP ranged from nonclinically relevant for very low risk (Δ = -1.8, 95% CI, -4.0 to 0.5, p = 0.119) to large clinically meaningful differences for very high-risk IPSS-R patients (Δ = -8.2, 95% CI, -10.3 to -6.2, p < 0.001). At diagnostic workup, fatigue of MDS is clinically meaningful worse than that reported by the GP. Compared with the IPSS classification, the IPSS-R provides a better stratification of patients with regard to fatigue severity.

Conflict of interest statement

Conflict of interest FE: Consultancy: Bristol-Myers Squibb, Amgen, Orsenix, Incyte, Takeda; Research funding to his insitution: Amgen. DC: President, FACIT.org. AP: Advisory board: Sanofi, Amgen, Novartis. GAP: Honoraria: Jannsen, Novartis, Celgene. ML: Consultancy: Abbvie, Gilead Sci, Novartis, Daiichi Sankyo, MSD, Sanofi; Honoraria for speaking: Gilead Sci, Novartis. MB: Honoraria: Novartis, Pfizer, Incyte, Celgene. RS: Honoraria, Membership on an entity’s Board of Directors or advisory committees: Novartis, Celgene; Research funding: Teva. UP: Research funding and Honoraria: Celgene, Amgen, Janssen, Novartis. MV: personal fees: Pfizer, Amgen, Novartis. DP: received support for active participation on congresses from Roche and Sanofi Genzyme.

Figures

Fig. 1. The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire.

This is the questionnaire that was used to assess patient-reported fatigue in the current study.

Fig. 2. Cumulative distribution of FACIT-Fatigue scores in patients with MDS and the general adult population.

Starting from the left side of the figure, the height of each curve represents the overall proportion of individuals reporting an equal or higher fatigue burden than that represented by the corresponding FACIT-fatigue score. The vertical line represents the mean FACIT-Fatigue score in the general population.

Fig. 3. Cumulative distribution of FACIT-Fatigue scores in patients with MDS by transfusion dependency and the general adult population.

Transfusion dependency was defined as having received at least one red blood cell transfusion every 8 weeks over a period of 4 months. Starting from the left side of the figure, the height of each curve represents the overall proportion of individuals reporting an equal or higher fatigue burden than that represented by the corresponding FACIT-fatigue score. The vertical line represents the mean FACIT-Fatigue score in the general population.

Fig. 4. Mean differences in FACIT-Fatigue scores between MDS patients and the GP by IPSS-R risk classification.

Mean differences were adjusted for age, sex, and presence of comorbidity. Connecting lines among adjusted mean differences of different MDS risk groups were plotted only for descriptive purposes. The gray shaded area indicates that the difference lies below the threshold for a clinically meaningful difference (3 points).