Article Text

PDF
CP-060 Effectiveness and safety of ferric carboxymaltose treatment in patients with inflammatory bowel diseases
  1. P Lopez Sanchez1,
  2. JM Martinez-Sesmero2,
  3. FJ Manzano Lista2,
  4. T Sanchez Casanueva1,
  5. JJ Marquez Nieves1,
  6. P Moya Gomez2
  1. 1Gerencia de Área Integrada de Tomelloso, Hospital Pharmacy, Tomelloso, Spain
  2. 2Complejo Hospitalario de Toledo, Hospital Pharmacy, Toledo, Spain

Abstract

Background Patients with inflammatory bowel disease (IBD) are at risk for iron deficiency. Absorption of orally given iron may be impaired by intestinal inflammation, and treatment with oral iron may aggravate intestinal inflammation. The treatment of iron deficiency anaemia with IBD is a particular challenge and often insufficient.

Purpose To describe the effectiveness and safety of intravenous ferric carboxymaltose (FCM) in IBD adult patients.

Material and methods Observational, retrospective study in two general hospitals. IBD adult patients who had received at least one dose of FCM from August 2013 to August 2015 for up to 3 months were analysed. Data collection from clinical records: age, gender, IBD (Crohn’s disease (CD) or ulcerative colitis (UC)), FCM dosage, biological drug treatment, haemoglobin (g/dL), haematocrit (%), mean corpuscular Hb concentration (MCHC g/dL), serum ferritine level (SFL ng/mL), all pre-FCM and post-FCM infusion. The safety profile was evaluated on the basis of the proportion of patients who experienced any adverse drug reaction (ADR). Statistical analysis was powered by SPSS 15.0 (paired t test).

Results In total, 46 IBD patients were treated for concomitant iron deficiency anaemia: mean age 49.3 ± 6.6 years, 22 (47.8%) women, 28 with CD (60.9%) and 18 with UC (39.1%). The mean cumulative dose was 978 ± 103.2 mg of iron; without concomitant biological drug 27 (58.7%) patients, 14 (30.4%) with infliximab, 4 (8.7%) with adalimumab and 1 (2.2%) with golimumab. Correction of iron deficiency anaemia was observed with improved mean Hb levels from 11.7 ± 1.4 g/dL at baseline to 13.6 ± 0.9 g/dL within 12 weeks (p < 0.001), mean haematocrit 36.1 ± 4.7% vs 41.0 ± 3.1% (p < 0.001), mean MCHC 27.9 ± 3.2 g/dL vs 30.2 ± 2.4 g/dL (p < 0.001), mean SFL 49.9 ± 84.5 ng/mL vs 205.2 ± 194.4 ng/mL (p < 0.001), respectively. Six (13.1%) subjects reported mild ADRs related to FCM; 4 (8.7%) of these were considered to be potentially related to long duration of administration and to a high volume of saline solution for dilution.

Conclusion Overall FCM was well tolerated in this population and appeared to be effective in correcting iron deficiency anaemia. We cannot exclude the fact that correction of iron deficiency anaemia is in some part due to the treatment of the underlying disease and not related to the iron supplementation alone.

No conflict of interest.

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.