1. Use of Periodic Intravenous Iron Sucrose for Routine Iron Supplementation in Children with Inflammatory Bowel Disease
Istvan Danko, MD, PhD
Department of Pediatrics, Division of Gastroenterology Hepatology and Nutrition, University of Wisconsin, School of Medicine and Public Health, Madison, WI , USA

2. Background Anemia – Most Common Systemic Complication of IBD
Main Cause - Iron Deficiency
Up to 70% affected
Special implications in children d/t effect on cognition and brain development
Persistent problem
Oral Supplementation Remains the Mainstay of Routine Management
Problems with Oral Iron Supplementation
Poor adherence
Malabsorption in inflammatory states
Intravenous Iron - Last Resort
No efforts to incorporate IV iron into routine management of iron deficiency anemia
Minimal data on IV iron in pediatric IBD
Does Persistent Anemia Affect Health Related Quality of Life?
Subjective perception of the impact of illness
Key outcome measure in clinical research
Effects of GI symptoms on HRQL in children with IBD are well studied
Little is known about the impact of anemia
How does untreated anemia fit into the big picture of IBD management

3. Evaluation of HRQL as a Function of Anemia and Active Disease in a Cohort of Children with IBD
Pediatric QOL Inventory Generic Core Scales(Peds QL 4.0 )
Brief 23 item survey
Evaluates core dimensions of health and social functioning
Validated in pediatric IBD
Results reported as summary scores
Psychosocial: Emotional + Social + School Functioning (5 items each)
Physical Functioning (8 items)
Total (Composite)
Child Self and Parent-Proxy Report
Scale 0-100, higher is better
Scores below certain validated cut-off values (vary by domain) are consistent with poor HRQL

5. HRQL in Remission as a Function of Anemia
Mean (-SD) Scores in Relationship to Range Consistent with Poor HRQL
Proportion of Patients with Low Scores in Various Domains

6. Conclusions Anemia was Associated with Impaired HRQL
Association in Apparent Remission - Potential Opening for Quality Improvement
Correction of Anemia may Improve HRQL in this Group of Patients (?)
Further Studies Needed to Confirm

7. Study of the Feasibility of IV Iron For Routine Supplementation
IV Formulations
Iron Sucrose, Iron Dextran – approved for children
Ferumoxytol, Ferric carboxymaltose - not approved for children in the US
Iron Sucrose
Long Track Record of Safety
Chronic kidney disease in children
IBD in adults
Minimal risk of Anaphylaxis
Dose Limitations
Multiple infusions required to replace total iron deficit
Wide range of dosing schemes
Calculated iron deficit delivered with daily – weekly infusions
mg/kg (max. 100 – 300 mg single doses)
None designed for/studied in pediatric IBD
Ganzoni formula

8. Response to Mid-Range IS Doses in Children with IBD in Remission
2 x 3 mg/kg, max 200 mg week apart
Labs before and 2 weeks after IV IS
9 patients, 34 IS infusions
Results
Improvement in Individual patients (A)
Significant improvement of mean parameters (A, mean ± SD)
Normalization of ferritin in most, but Hemoglobin only in some pts (B, % of pts)
No side effects
Conclusions
Larger cumulative dose needed * * * *
Danko I. Journal of Pediatric Pharmacology and Therapeutics. 2016;21:

9. Protocol for Gradual Replacement and Maintenance of Iron Stores and Correction of Anemia with Periodic IV Iron Sucrose
Patients on Infliximab (~q8 wks) (IBD, ID, ≤18y)
H/H, Ferritin, TSAT, CRP, albumin
Disease Activity Indices (PCDAI, PUCAI)
IV IS if iron deficient (per IBD convention) until no iron deficiency x 2
(a) ferritin <30 ng/ml or TSAT <20% with normal CRP
(b) ferritin <100 ng/ml and TSAT <20% with elevated CRP.
Historic Controls
Compare Efficacy with Previous Routine
3 mg/kg, max. 200 mg

10. Results Historic Control Period vs. Study Period
Mean Hem/Iron Indices (left, mean ± SD)
Proportion of Patients with Normal Values (right, %)
No significant difference in inflammatory markers pre vs. post
No adverse reactions
Danko I, Weidkamp M.. J Pediatr Gastroenterol Nutr. 2016;63:e107-e111

11. Conclusions
Compared to our previous routine that relied primarily on oral iron there was significant improvement in hem and iron indices
Periodic IV iron sucrose is safe and effective for routine iron supplementation, easy to use and well accepted by patients on infliximab

12. Aknowledgements Department of Pediatrics Research Funds
Marcy Weidkamp, NP
Jens Eickhoff, PhD
Research Nurses
Stacey Moyer
Barb Bowman
Kirstin Carlson
Particia Filas-Mortensen