P074 SUSTAINED IMPROVEMENTS IN FATIGUE AND QUALITY OF LIFE IN PATIENTS WITH IBD AND IRON DEFICIENCY ANEMIA FOLLOWING A SINGLE COURSE OF FERUMOXYTOL: RESULTS OF A 6-MONTH EXTENSION STUDY

Abstract

Iron deficiency anemia (IDA), common in patients with inflammatory bowel disease (IBD) due to blood loss, inflammation and malabsorption, negatively impacts patients’ health-related quality of life (HRQOL). Oral iron is often first-line treatment, but many patients do not tolerate it, or do not adequately respond; many live with chronic anemia and its related negative effects. A Phase 3 double-blind, placebo-controlled trial (NCT01114139) previously found that patients unsuccessfully treated with oral iron, including those with IBD, had very poor baseline HRQOL scores associated with fatigue, and that IV iron treatment resulted in significant, clinically meaningful improvement. To explore the durability of this treatment effect, this subgroup analysis reports on the impact on patient-reported outcomes (PRO) of a single course of IV ferumoxytol, received during the double-blind trial, over the subsequent 6-month extension study (NCT01114217) in patients with IBD. Patients with persistent or recurrent IDA (Hgb <11.0 g/dL and TSAT <20%) at any time during the extension study received ferumoxytol (1 course = 2x510 mg IV, 3 to 8 days apart). The same validated PRO instruments were administered as in the preceding double-blind trial: Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue), and Linear Analogue Scale Assessment (LASA) -Energy, -Activities of Daily Living (ADL) and -HRQOL. This analysis reports on the subgroup of patients who did not receive any additional ferumoxytol during the entire 6-month extension study. Most patients who had received a dose of ferumoxytol in the double-blind trial did not require any further doses during the extension study (285/471; 61% Overall) including 61% (23/30) of those with IBD. Among this cohort, the IBD patients’ mean Hgb had increased from 8.9 ± 0.7 g/dL at Baseline to 12.0 ± 0.8 at Week 5 of the double-blind trial and remained above 12.0 throughout the 6-month extension study visits (Month 7 Hgb 12.1 ± 1.0) despite receiving no further ferumoxytol. At Baseline of the double-blind trial, their FACIT-Fatigue scores were lower (Overall 24.3 ± 12.3; IBD 18.7 ± 12.6) than general (non-anemic) US population norms (40.1-43.6), and comparable to the scores of anemic cancer patients receiving chemotherapy (23.9, Cella 2002). By Week 5, FACIT-Fatigue scores increased significantly (Overall 36.1 ± 11.2; IBD 31.9 ± 13.4), and the improvement was sustained over 6 months (Month 7 score Overall 38.8 ± 11.5; IBD 37.0 ± 13.7). Significant improvements in the LASA domains that were observed in the double-blind study were also maintained. This study found that for the majority of patients, significant improvements in fatigue and quality of life domains, greater than the previously reported Minimal Clinically Important Differences (MID), were achieved and sustained for 6 months following a single treatment of ferumoxytol. Tabled 1Change from Baseline PRO Measures in IBD PatientsPRO InstrumentPretreatment BaselineMean (SD)Month 4 Change Mean (95% CI)Month 7 Change Mean (95% CI)MIDLASA-Energy36.2 (24.15)24.6 (12.8, 36.3)14.7 (4.5, 24.9)9.61LASA-Activity44.4 (23.7)15.9 (5.4, 26.3)13.3 (2.9, 23.8)8.74LASA-QOL46.9 (25.3)18.6 (8.2, 29.1)13.6 (4.5, 22.6)9.81FACIT-Fatigue18.7 (12.6)15.9 (9.3, 22.5)14.2 (8.1, 20.3)3.0PRO = Patient-reported outcomes; CI = confidence interval; MID = Minimum Important Difference (Patrick et al, Euro J Cancer 2003; Norman et al, Med Care 2003; Cella et al, J Pain Symptom Management 2002). Open table in a new tab PRO = Patient-reported outcomes; CI = confidence interval; MID = Minimum Important Difference (Patrick et al, Euro J Cancer 2003; Norman et al, Med Care 2003; Cella et al, J Pain Symptom Management 2002).