International Journal of General Medicine (Aug 2023)
Patient-Reported Outcomes After Ferric Carboxymaltose Treatment for Iron Deficiency Anemia: A Prospective Observational Study
Abstract
Winghan J Kwong,1 Syed Numan,2 Tina D Hunter,3 Dalila Alves,3 Anish Patel,4 Satish Shanbhag5 1Daiichi Sankyo, Inc, Basking Ridge, NJ, USA; 2American Regent, Norristown, PA, USA; 3CTI Clinical Trial & Consulting Services, Covington, KY, USA; 4Brooke Army Medical Center, San Antonio, TX, USA; 5Cancer Specialists of North Florida, Jacksonville, FL, USACorrespondence: Tina D Hunter, CTI Clinical Trial & Consulting Services 100 E. Rivercenter Blvd, Covington, KY, 41011, USA, Tel +1 513-598-9290, Fax +1 859-261-3757, Email [email protected]: Iron deficiency anemia (IDA) is a common cause of fatigue and impaired quality of life. The present study aimed to evaluate the impact of intravenous iron supplementation with ferric carboxymaltose (FCM) on fatigue, physical function, and general health among patients with IDA attending routine clinical care.Methods: This was a prospective, single arm, observational study of adult patients prescribed with intravenous FCM for the treatment of IDA during routine clinical care. We used Patient-Reported Outcomes Measurement Information System (PROMIS) instruments to evaluate fatigue (PROMIS Short Form v1.0 13a [FACIT-Fatigue]), general health status (PROMIS Scale v1.2), and physical function (PROMIS Short Form v2.0 4a) before and at 3 and 6 months after FCM treatment.Results: A total of 152 patients were enrolled. Mean age was 47.4 ± 16.0 years and 82.2% were female. Mean serum hemoglobin was 10.2 ± 1.4 g/dL at baseline. All patients were treated with at least one FCM dose at baseline, with 77.6% receiving a two-dose treatment course. The mean baseline FACIT-Fatigue score was 61.0 ± 9.0, improving significantly to 50.2 ± 9.5 at 3 months after FCM treatment. A minimum 5-point improvement, pre-defined as clinically meaningful, was seen in the FACIT-Fatigue, PROMIS Global Physical Health, Global Mental Health and PROMIS Physical Function scores for 72.7%, 52.8%, 41.7% and 39.8% of patients at 3 months (p < 0.0001 for each change from baseline), with statistically significant improvement continuing at 6 months. Mean serum hemoglobin was significantly increased at both 3 and 6 months (12.8 g/dL [N = 44] and 12.4 g/dL [N = 54], respectively).Conclusion: IDA patients attending routine clinical practice reported substantial levels of fatigue and impairments in physical function and global health prior to intravenous iron treatment. Patients experienced significant improvements in fatigue symptoms, physical function, and global health at 3 months after treatment with FCM, which were sustained at 6 months.Keywords: iron deficiency anemia, quality of life, patient-reported outcomes, ferric carboxymaltose, intravenous iron
