Treatment of Iron Deficiency Anemia With Oral Liposomal Iron in IBD: A Pilot Study Evaluating the Efficacy and Safety

BACKGROUND: Iron deficiency anemia (IDA) is one of the most common inflammatory bowel disease (IBD) complications. Importantly, anemia can contribute to patients’ poor quality of life, mainly because of its negative impact on the patients’ wellbeing, physical performance, mood, and cognitive function. In addition, anemia is a significant predictor of increased hospitalization risk, as well as of increased mortality in IBD patients. To the best of our knowledge, there are no published data concerning the use of oral liposomal iron to treat IDA in IBD patients. Therefore, the current study was a pilot study to assess the efficacy and safety of the oral liposomal iron in to treat mild IDA in patients with IBD, as well as to assess the impact of this treatment on psychometric scores. METHODS: Patients with inactive or mildly active IBD were screened for anemia in this interventional study conducted from November 2016 to March 2018. Patients with mild anemia were treated with oral liposomal iron for 8 weeks. The oral iron replenishment was provided to the patients on a compassionate use basis at the dose of two liposomal iron tablets per day (equivalent to 28 mg of liposomal iron). The primary endpoint of the study was the response rate to liposomal oral iron therapy. Treatment responders were defined as patients who achieved hemoglobin (Hb) increase of at least; 1 g/dL and/or Hb normalization by the 8th treatment week. The secondary endpoints included changes in ferritin concentration and transferrin saturation index (TSI) percentage from the baseline to the 8th week; impacts of the oral iron treatment on quality of life, and fatigue; changes in disease activity (assessed by HBI, Truelove and Witt’s criteria, and C-reactive protein - CRP); and treatment safety and tolerability. RESULTS: Of the 200 patients screened, 33 (16.5%) patients had anemia. Of the 21 patients who completed treatment, 13 (62%) responded to oral liposomal iron replacement therapy (mean increases of Hb 11.4 to 12.6 g/dL). The transferrin saturation index (TSI) increased by an average of 10.2 ( P = 0.006) and the quality of life 26.3 (P 0.0001), despite no significant difference in baseline ferritin values. There was also a mean reduction of 9.2 in the perception of fatigue (P 0.0001). There was a linear correlation between the increase in Hb levels and the improvement of quality of life as evaluated by IBDQ (r = 0.54; P = 0.01). Following oral liposomal iron therapy, no change was seen in clinical disease activity ( P = 0.10). In addition, CRP remains unchanged after treatment ( P = 0.98). CONCLUSION(S): Treatment of IBD patients with oral liposomal iron was effective in improving anemia and quality of life, as well as in decreasing fatigue. This pilot study provides actual data supporting the therapeutic use of liposomal iron for treating mild IDA in IBD and paves the way for future studies evolving larger IBD populations utilizing higher doses of this drug and longer follow-up, to confirm the role of oral liposomal iron in treating quiescent or mildly active IBD patients presenting mild IDA.*This study is partially supported by the FAPEMIG-Brazil.