Efficacy and Safety of Ferric Derisomaltose/Iron Isomaltoside in Patients with Inflammatory Bowel Disease: A Systematic Review

Background Anemia in inflammatory bowel disease (IBD) presents as a common extraintestinal manifestation resulting in many complications. This condition is often missed or underrated, anemia is secondary to blood loss or defective absorption of iron which can result in a combination of iron deficiency anemia (IDA) or anemia of chronic disease (ACD). The management is iron replacement therapy which improves the quality of life in these patients. Due to the constraints in the use of oral iron, parenteral preparations are more used in IBD patients. Commonly used iron sucrose and ferric carboxymaltose are often associated with side effects leading to poor compliance. Our study explores data about ferric derisomaltose also known as iron isomaltoside (IIM), a recently approved IV iron preparation. The FDA approved this drug in 2020 for patients with poor compliance with other iron preparations. We explored the efficacy and safety data of ferric derisomaltose in adult patients with IBD. Material/Methods A literature search was performed using the following databases: PubMed, Cochrane, Embase, Clinical trials.gov, and Web of Science. The search was completed without using any filter and we used the MeSH Terms for “anemia”, “iron deficiency anemia”, “inflammatory bowel disease”, and “ferric compounds”. A total of 1590 articles were screened, and we finally selected 2 trials and 2 observational studies. We followed the PRISMA guidelines for literature search and selection of studies. Case reports, preclinical trials, meta-analyses, and review articles were excluded. Trial and observational studies related to IBD were included. Results In total, 294 patients with anemia in inflammatory bowel disease received ferric derisomaltose intravenously as a single dose between 500 mg to 2000 mg. All patients were >18 years of age. The mean pre-treatment hemoglobin (Hb) level varied from 10.0 g/dL to 12.3 g/dL. The mean serum ferritin ranged from 19.6 µg/L to 57 µg/L and the mean transferrin saturation (TSAT) ranged from 8.8% to 18.5%. J. Stein et al investigated the effectiveness and safety of IIM in routine practical care of IDA in IBD patients. Dahlerup et al (NCT01599702) compared single dose IIM with multiple dosages of IIM in IBD patients. The remaining two studies investigated the effectiveness and safety of high dose IIM in patients with IBD. Results are summarized in Table 1. Efficacy: The increase in hemoglobin ranged from 0.6 g/dl to 2.9 g/dl from baseline while the