ferric-oxide--saccharated and Inflammatory-Bowel-Diseases

Iron deficiency anemia (IDA) frequently occurs in patients suffering from inflammatory bowel disease (IBD) and negatively impacts their quality of life. Nevertheless, the condition appears to be both under-diagnosed and undertreated. Regular biochemical screening of patients with IBD for anemia by the gastroenterology community has to be advocated. Oral iron is a low cost treatment however its effectiveness is limited by low bioavailability and poor tolerability. Intravenous (IV) iron rapidly replenishes iron stores and has demonstrated its safe use in a number of studies in various therapeutic areas. A broad spectrum of new IV iron formulations is now becoming available offering improved tolerability and patient convenience by rapidly restoring the depleted iron status of patients with IBD. The following article aims to review the magnitude of the problem of IDA in IBD, suggest screening standards and highlight existing and future therapies.

Topics: Algorithms; Anemia, Iron-Deficiency; Clinical Trials as Topic; Diagnosis, Differential; Disaccharides; Dose-Response Relationship, Drug; Ferric Compounds; Ferric Oxide, Saccharated; Ferrosoferric Oxide; Glucaric Acid; Hematinics; Humans; Inflammatory Bowel Diseases; Infusions, Intravenous; Iron Deficiencies; Maltose; Prevalence; Thrombocytosis; Thromboembolism

The prevalence of anemia across studies on patients with inflammatory bowel disease (IBD) is high (30%). Both iron deficiency (ID) and anemia of chronic disease contribute most to the development of anemia in IBD. The prevalence of ID is even higher (45%). Anemia and ID negatively impact the patient's quality of life. Therefore, together with an adequate control of disease activity, iron replacement therapy should start as soon as anemia or ID is detected to attain a normal hemoglobin (Hb) and iron status. Many patients will respond to oral iron, but compliance may be poor, whereas intravenous (i.v.) compounds are safe, provide a faster Hb increase and iron store repletion, and presents a lower rate of treatment discontinuation. Absolute indications for i.v. iron treatment should include severe anemia, intolerance or inappropriate response to oral iron, severe intestinal disease activity, or use of an erythropoietic stimulating agent. Four different products are principally used in clinical practice, which differ in their pharmacokinetic properties and safety profiles: iron gluconate and iron sucrose (lower single doses), and iron dextran and ferric carboxymaltose (higher single doses). After the initial resolution of anemia and the repletion of iron stores, the patient's hematological and iron parameters should be carefully and periodically monitored, and maintenance iron treatment should be provided as required. New i.v. preparations that allow for giving 1000-1500 mg in a single session, thus facilitating patient management, provide an excellent tool to prevent or treat anemia and ID in this patient population, which in turn avoids allogeneic blood transfusion and improves their quality of life.

Topics: Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Gluconates; Humans; Inflammatory Bowel Diseases; Infusions, Intravenous; Injections, Intraventricular; Iron; Iron-Dextran Complex; Maltose; Treatment Outcome

Iron deficiency anemia (IDA) is common in chronic diseases and intravenous iron is an effective and recommended treatment. However, dose calculations and inconvenient administration may affect compliance and efficacy. We compared the efficacy and safety of a novel fixed-dose ferric carboxymaltose regimen (FCM) with individually calculated iron sucrose (IS) doses in patients with inflammatory bowel disease (IBD) and IDA.. This randomized, controlled, open-label, multicenter study included 485 patients with IDA (ferritin <100 μg/L, hemoglobin [Hb] 7-12 g/dL [female] or 7-13 g/dL [male]) and mild-to-moderate or quiescent IBD at 88 hospitals and clinics in 14 countries. Patients received either FCM in a maximum of 3 infusions of 1000 or 500 mg iron, or Ganzoni-calculated IS dosages in up to 11 infusions of 200 mg iron. Primary end point was Hb response (Hb increase ≥ 2 g/dL); secondary end points included anemia resolution and iron status normalization by week 12.. The results of 240 FCM-treated and 235 IS-treated patients were analyzed. More patients with FCM than IS achieved Hb response (150 [65.8%] vs 118 [53.6%]; 12.2% difference, P = .004) or Hb normalization (166 [72.8%] vs 136 [61.8%]; 11.0% difference, P = .015). Both treatments improved quality of life scores by week 12. Study drugs were well tolerated and drug-related adverse events were in line with drug-specific clinical experience. Deviations from scheduled total iron dosages were more frequent in the IS group.. The simpler FCM-based dosing regimen showed better efficacy and compliance, as well as a good safety profile, compared with the Ganzoni-calculated IS dose regimen.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Comorbidity; Dose-Response Relationship, Drug; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hemoglobins; Humans; Inflammatory Bowel Diseases; Infusions, Intravenous; Male; Maltose; Middle Aged; Outcome Assessment, Health Care; Treatment Outcome; Young Adult

Patients with inflammatory bowel disease (IBD) often have low iron stores or anaemia. There is controversy about whether iron should be supplemented orally or intravenously (i.v.). The purpose of this study was to investigate whether treatment with intravenous iron is superior to treatment with oral iron. The primary end-points were response and remaining anaemia at the end of treatment (EOT).. Ninety-one patients with IBD and anaemia (B-Hb <115 g/L) were randomized to oral iron sulphate (n=46) or intravenous iron sucrose (n=45) treatment for 20 weeks.. Forty-three patients in the intravenous iron group completed the study compared to 35 patients in the oral iron group (p=0.0009). Only 22 patients (48%) tolerated the prescribed oral dose, and 52% reduced the dose or withdrew from treatment because of poor tolerance. At EOT, 47% patients in the oral iron group increased their B-Hb by > or =20 g/L, compared with 66% in the intravenous iron group (p=0.07). In the oral iron group, 41% still had anaemia versus 16% of the patients in the intravenous iron group (p=0.007), and 22% versus 42% reached their reference B-Hb level (p=0.04). Treatment with intravenous iron sucrose improved iron stores faster and more effectively than oral iron (p=0.002). Under treatment with intravenous iron, 74% of the patients had no anaemia and normal S-ferritin levels (>25 microg/L) at EOT compared with 48% of patients receiving oral iron (p=0.013).. Treatment with intravenous iron sucrose is effective, safe, well tolerated and superior to oral iron in correcting haemoglobin and iron stores in patients with IBD.

Topics: Administration, Oral; Adult; Anemia; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Glucaric Acid; Hematinics; Humans; Inflammatory Bowel Diseases; Injections, Intravenous; Male; Sweden; Treatment Outcome

Anemia is a common complication of inflammatory bowel disease (IBD) and iron deficiency (ID) is its predominant cause. Therefore, oral and intravenous iron replacements are widely used. This study was performed to evaluate the frequency and timing of anemia and ID recurrence after a successful treatment cycle.. Medical records of patients who had received iron sucrose with or without erythropoietin (EPO) in one of three prospective clinical trials that had been conducted at our center (Ann Intern Med 1997, Digestion 1999, and Am J Gastroenterol 2001) were analyzed for a 5-year follow-up period. The risk for recurrence of anemia (hemoglobin (Hb)<12/13 g per 100 ml) and ID (ferritin <30 microg/l) was evaluated by Kaplan-Meier analysis using the log-rank test.. Eighty-eight patients were available for analysis. Patients had received a mean iron dose of 2,500 mg (range 600-3,600 mg); 33 (37.1%) patients had also received EPO. Anemia recurred in a median of 10 months (95% confidence interval (CI) 8-12) and ID recurred within 19 months (95% CI 11-28). The iron dose had no influence on recurrence of ID or anemia. ID (but not anemia) recurred faster in patients with a post-treatment ferritin level <100 microg/l (median 4 months, 95% CI 1-7) than in patients with ferritin level between 100 and 400 microg/l (median 11 months, 95% CI 6-16) and >400 microg/l (median 49 months, 95% CI 32-66; P<0.001).. IBD-associated ID and anemia recur surprisingly fast, indicating that maintenance treatment may be needed in a portion of the patient population. Recurrence of ID (but not anemia) can be delayed by aiming for high post-treatment ferritin levels.

Topics: Adult; Anemia, Iron-Deficiency; Dose-Response Relationship, Drug; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Follow-Up Studies; Glucaric Acid; Hemoglobins; Humans; Inflammatory Bowel Diseases; Injections, Intravenous; Iron; Male; Prognosis; Prospective Studies; Recurrence; Treatment Outcome

Anemia is a frequent complication in patients with inflammatory bowel disease (IBD). The optimal route for iron supplementation to replenish iron stores has not been determined so far. We therefore evaluated the efficacy and safety of intravenous iron sucrose as compared with oral iron sulfate for the treatment of iron deficiency anemia (IDA) in patients with IBD.. A randomized, prospective, open-label, multicenter study was performed in 46 patients with anemia and transferrin saturation

Topics: Abdominal Pain; Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Follow-Up Studies; Glucaric Acid; Hematinics; Hemoglobins; Humans; Inflammatory Bowel Diseases; Infusions, Intravenous; Male; Middle Aged; Nausea; Prospective Studies; Transferrin; Treatment Outcome

Inflammatory bowel disease (IBD)-associated anemia responds to i.v. iron therapy. However, because of concurrent chronic inflammation, some patients do not respond adequately. Erythropoietin therapy has been shown to be effective in the latter cohort. Our goal was to find parameters that can predict the effectiveness of iron sucrose in IBD-associated anemia.. One hundred three patients with severe IBD-associated anemia (Hb < or = 10.5 g/dl) were treated prospectively for 4 wk with iron sucrose (total iron dose = 1.2 g) in an open label, multicenter trial. Treatment response was defined as an increase in Hb of > or =2.0 g/dl. A logistic regression analysis was performed with treatment response as the dependent variable and the following independent variables: serum erythropoietin, mean corpuscular Hb, transferrin, ferritin, soluble transferrin receptor (sTfR), C-reactive protein, interleukin 6 (IL-6), and disease activity.. Sixty-seven of 103 patients (65%) responded to iron sucrose. From the variables under investigation, erythropoietin, sTfR, transferrin, and IL-6 were significantly associated with treatment response. The R2 values showed that erythropoietin (8.0%), sTfR (11.4%), and transferrin (10.4%), but not IL-6 (1.3%), contribute a relevant amount of information to the model. An estimated 80% probability of treatment response was found at erythropoietin levels of >166 U/L, sTfR levels of >75 nmol/L, or transferrin levels of >3.83 g/L.. Serum erythropoietin, sTfR, and transferrin concentrations have the potential to predict the response to iron sucrose therapy in IBD-associated anemia. These parameters may help to identify individuals who benefit the most from additional erythropoietin treatment.

Topics: Anemia, Iron-Deficiency; Enzyme-Linked Immunosorbent Assay; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Inflammatory Bowel Diseases; Interleukin-6; Logistic Models; Male; Prospective Studies; Receptors, Transferrin; ROC Curve; Sensitivity and Specificity; Transferrin; Treatment Outcome

Iron deficiency and iron deficiency anemia are common in pediatric inflammatory bowel disease and often require supplementation with iron. There is a paucity of literature regarding optimal iron formulation. The aim of this study is to compare outcomes in pediatric patients with inflammatory bowel disease receiving either iron sucrose or ferric carboxymaltose during inpatient hospitalizations.. This was a single-center retrospective study of pediatric patients with inflammatory bowel disease admitted for newly diagnosed disease or flare who received either iron sucrose or ferric carboxymaltose. Linear regression was used to assess differences in iron repletion. Longitudinal linear mixed-effects models and generalized estimating equations compared hematologic and iron outcomes 6 months post-iron repletion.. Thirty patients received ferric carboxymaltose. Sixty-nine patients received iron sucrose. Baseline hemoglobin and iron deficits were similar in both groups. A larger percentage of iron deficit was repleted in the ferric carboxymaltose group (81.4%) compared with iron sucrose (25.9%) (P < 0.001) with fewer infusions. Cumulative doses of ferric carboxymaltose administered (18.7 mg/kg) were higher than iron sucrose (6.1 mg/kg) (P < 0.001). Hemoglobin increased more quickly with ferric carboxymaltose compared with iron sucrose (P = 0.04 and P = 0.02, respectively). Total iron binding capacity and red cell distribution width levels decreased more over time with ferric carboxymaltose vs iron sucrose (P < 0.01 and P = 0.01, respectively). No adverse effects were seen.. Hematologic and iron parameters responded more quickly with fewer infusions in patients who received ferric carboxymaltose vs iron sucrose. Patients who received ferric carboxymaltose achieved a higher percentage of iron deficit repleted.

Topics: Child; Ferric Compounds; Ferric Oxide, Saccharated; Hemoglobins; Humans; Inflammatory Bowel Diseases; Iron; Retrospective Studies

Iron deficiency anemia (IDA) is a common complication of pediatric inflammatory bowel disease (IBD), yet the effectiveness of oral iron supplementation is limited. Intravenous iron sucrose is an effective and safe alternative treatment for IDA in adults with IBD, but its role in the treatment of IDA in pediatric IBD is unclear. The primary aim of this study was to evaluate the use of iron sucrose in pediatric IBD subjects with IDA and determine the clinical response as measured by improvement in hemoglobin concentration. The secondary aim was to describe adverse events associated with iron sucrose use in this cohort.. A retrospective chart review was performed of all pediatric patients with IBD receiving iron sucrose infusions for IDA at a single tertiary care center between 2011 and 2015.. Seventy-two subjects (53 with Crohn disease, 11 with ulcerative colitis, and 8 with IBD-unclassified) received a total of 273 iron sucrose infusions. Forty-three subjects qualified for the efficacy analysis. There was a significant increase in hemoglobin over the treatment course, with mean (±SD) hemoglobin increasing from 9.6 ± 1.2 g/dL at baseline to 12.1 ± 1.3 g/dL after iron sucrose treatment (P < 0.001). Eighteen adverse events were reported in 13 subjects (18.1% of subjects and 6.6% of infusions). No anaphylaxis reactions occurred and none of the adverse events were, however, life-threatening or required hospitalization.. Intravenous iron sucrose is a safe and potentially efficacious treatment choice for IDA in pediatric IBD.

Topics: Administration, Intravenous; Adolescent; Anemia, Iron-Deficiency; Child; Child, Preschool; Female; Ferric Oxide, Saccharated; Hemoglobins; Humans; Inflammatory Bowel Diseases; Iron; Male; Philadelphia; Retrospective Studies; Treatment Outcome; Young Adult

Iron deficiency is the leading cause of anemia in patients with inflammatory bowel disease (IBD). Intravenous iron is the first-line treatment for clinically active IBD or previous oral iron intolerance. The aim of the present study was to develop a comparative model of iron deficiency and delivery for iron isomaltoside (IIM), ferric carboxymaltose (FCM), low molecular weight iron dextran (LMWID), and iron sucrose (IS) in the treatment of iron deficiency anemia associated with IBD. Areas covered: A model was developed to evaluate iron delivery characteristics, resource use and costs associated with IIM, FCM, LMWID and IS. Iron deficiency was modeled using dosing tables and retreatments were modeled based on a pooled retrospective analysis. The analyses were conducted over 5 years in patients with IBD with mean bodyweight of 75.4 kg and hemoglobin levels of 10.77 g/dL based on observational data. Expert opinion: The modeling analysis showed that using IIM required 1.2 infusions (per treatment) to correct the mean iron deficit, compared with 1.6, 1.2, and 7.1 with FCM, LMWID and IS, respectively. Costs were estimated to be 2,518 pounds sterling (GBP) per patient with IIM or LMWID, relative to GBP 3,309 with FCM or GBP 14,382 with IS.

Topics: Anemia, Iron-Deficiency; Budgets; Disaccharides; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Inflammatory Bowel Diseases; Infusions, Intravenous; Iron-Dextran Complex; Maltose; Retrospective Studies; United Kingdom

The optimal route for iron administration in anemic patients with inflammatory bowel disease (IBD) has not been determined. The aim of this study was to compare the efficacies of parenteral and oral iron therapy in IBD patients in Korea.. A retrospective multicenter study was performed. Patients who had been administered parenteral iron were matched to the controls with oral iron at a 1:1 ratio according to age, sex, and type of IBD.. Patients that received parenteral iron exhibited increases in hemoglobin levels of ≥20% from the baseline at lower doses and in shorter durations (p=0.034 and p=0.046, respectively). In the multivariate analysis, parenteral iron therapy appeared to be more efficient than oral iron therapy, but this difference was not statistically significant (hazard ratio [HR], 1.552; 95% confidence interval [CI], 0.844 to 2.851; p=0.157). Patients with ulcerative colitis responded better to iron therapy than those with Crohn's disease (HR, 3.415; 95% CI, 1.808 to 6.450; p<0.001). Patients with an initial hemoglobin level of 10 g/dL or higher responded poorly to iron therapy (HR, 0.345; 95% CI, 0.177 to 0.671; p=0.002).. Parenteral iron therapy appears to be more efficient than oral iron therapy. Physicians should focus on the iron deficiency of IBD patients and consider parenteral iron supplements in appropriate patient groups.

Topics: Administration, Oral; Adolescent; Adult; Anemia, Iron-Deficiency; Dietary Supplements; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Glucaric Acid; Hematinics; Humans; Inflammatory Bowel Diseases; Infusions, Parenteral; Male; Republic of Korea; Retrospective Studies; Treatment Outcome; Young Adult

Iron deficiency anemia (IDA) is common in children with inflammatory bowel disease (IBD) affecting their cognitive development and school performance. Oral iron supplementation has serious limitations including poor adherence and iron malabsorption related to chronic inflammation. Our objective was to evaluate the feasibility of periodic intravenous (IV) iron treatments for correction of IDA in children with IBD.. This prospective study was conducted in 24 children with IBD treated with infliximab (IFX). Participants received 3 mg/kg (maximum 200 mg) IV iron sucrose (IS) after IFX treatments if they were iron deficient according to criteria: ferritin <30 ng/mL or transferrin saturation (TSAT) <20% with normal C-reactive protein (CRP), or ferritin <100 ng/mL and TSAT <20% with elevated CRP. They continued to receive IV IS with each IFX treatment until 2 consecutive laboratories showed no evidence of iron deficiency. Hematology and iron indices obtained during the study were compared with historic controls from the same patients.. Mean ferritin, TSAT, and hemoglobin (Hb) (±SE) rose from 21.9 (±3.2) to 48.8 (±6.3) ng/mL (P = 0.0004), 13.2 (±1.8) to 23.6 (±2.6)%, (P = 0.0009) and 11.4 (±0.3) to 12.7 (±0.3) g/dL, (P = 0.006) respectively. The proportion of patients with normal mean ferritin, TSAT, and Hb rose from 33% to 75% (P = 0.002), 21% to 63% (P = 0.006), and 25% to 79% (P = 0.0002), respectively. There were no adverse reactions.. Periodic IV IS is safe and effective for routine management of IDA in children with IBD.

Topics: Adolescent; Anemia, Iron-Deficiency; C-Reactive Protein; Child; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Gastrointestinal Agents; Glucaric Acid; Hemoglobins; Humans; Inflammatory Bowel Diseases; Infliximab; Injections, Intravenous; Iron; Male; Prospective Studies

Topics: Anemia, Iron-Deficiency; Cost-Benefit Analysis; Dose-Response Relationship, Drug; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Inflammatory Bowel Diseases; Injections, Intravenous; Maltose; Quality of Life; Treatment Outcome

Anemia is common in IBD patients and intravenous iron treatment is preferred. The drug cost of intravenous iron carboxymaltose is approximately twice the cost of intravenous iron sucrose. The aim was to evaluate the health care costs of intravenous iron sucrose (Venofer®, Vifor) and intravenous iron carboxymaltose (Ferinject®, Vifor) treatment to IBD patients in an outpatient setting.. Based on data from 111 IBD patients treated with intravenous iron in an outpatient setting health care costs were evaluated by means of Budget Impact Analysis, Cost Effective Analysis and Cost Benefit Analysis.. The Cost Effective Analysis showed that iron carboxymaltose was more cost-effective than iron sucrose, due to fewer outpatient setting visits. Even a sensitivity analysis using a reduced patient income (50%) in the Cost Effective Analysis showed iron carboxymaltose to be the most cost effective treatment. The Budget Impact Analysis from a hospital perspective showed that iron carboxymaltose was more expensive than iron sucrose regardless of the dose given. In contrast the Cost Benefit Analysis showed that the average patients' 'willingness to pay' for a total of iron dose of 1400 mg was €233 in order to reduce the number of infusions from 7 to 2 by using iron carboxymaltose rather than iron sucrose.. Both the Cost Effective Analysis and the Cost Benefit Analysis showed clearly that iron carboxymaltose is a more cost effective way of giving intravenous iron than iron sucrose in IBD patients. Only the Budget Impact Analysis showed that intravenous iron sucrose was the cheapest choice if only direct cost was included in the analysis.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Ambulatory Care; Anemia, Iron-Deficiency; Cost-Benefit Analysis; Drug Costs; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Health Care Costs; Humans; Inflammatory Bowel Diseases; Infusions, Intravenous; Male; Maltose; Middle Aged; Young Adult

The combination of intravenous iron and recombinant human erythropoietin has been proved to be effective in the treatment of refractory anaemia in patients with inflammatory bowel disease (IBD). Darbepoetin-alpha (DPO) has a three-fold longer terminal half-life than erythropoietin. The purpose of this pilot study was to determine whether darbepoetin-alpha is also effective for the treatment of refractory anaemia in IBD.. Twenty IBD patients (nine ulcerative colitis and 11 Crohn's disease) and refractory anaemia received intravenous iron sucrose (total iron dose 1.3+/-0.5 g, range 0.7-1.9) and darbepoetin-alfa at the single, weekly dose of 0.9 microg/kg subcutaneously for 4 weeks. Serum erythropoietin, ferritin, transferrin, soluble transferrin receptor, C-reactive protein and interleukin-6 were measured at baseline and after treatment.. Haematopoietic response (increase of haemoglobin > or = 2.0 g/dl) was observed in 15 out of the 20 patients (75%). The mean haemoglobin concentrations increased from 9.48+/-0.82 g/dl at baseline to 12.71+/-1.12 g/dl after treatment (P<0.0001). Mean corpuscular volume and serum ferritin levels were also significantly increased whereas mean C-reactive protein levels and endogenous erythropoietin levels significantly decreased after treatment.. In IBD patients with refractory anaemia the administration of darbepoetin in combination with intravenous iron sucrose can raise haemoglobin levels.

Topics: Anemia, Refractory; C-Reactive Protein; Darbepoetin alfa; Drug Therapy, Combination; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hematinics; Hemoglobins; Humans; Inflammatory Bowel Diseases; Injections, Intravenous; Interleukin-6; Male; Pilot Projects; Receptors, Transferrin; Transferrin; Treatment Outcome

Topics: Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Inflammatory Bowel Diseases; Infusions, Intravenous; Pregnancy; Pregnancy Complications; Pregnancy Complications, Hematologic; Pregnancy Outcome