FERACCRU® relieved patients’ IDA and maintained Hb levels during long-term treatment1,2
FERACCRU® relieved IDA in IBD patients who had previously failed on oral ferrous iron salts1
AEGIS-IBD 12-week randomised controlled trial design1
Phase 3, randomised, double-blind, placebo-controlled, multicentre study
Primary endpoint1
- Change in Hb concentration from baseline to Week 12
Secondary endpoints1
- Changes in Hb concentration from baseline to Weeks 4 and 8
- Serum ferritin concentration
- Percentage TSAT
Mean Hb concentration from baseline to Week 12 (mean ± SD)1
A clinically relevant increase in Hb was observed as quickly as Week 4 with FERACCRU®1
86% of patients had a normal Hb level after 64 weeks’ treatment with FERACCRU®2
AEGIS-IBD long-term extension study design1,2
Primary endpoint2
- Change in Hb from baseline to Week 64 (12 plus 52 weeks)
Secondary endpoints2
- Proportion of patients achieving normal Hb levels
- Serum ferritin concentration and percentrage TSAT
- Disease-specific QoL
Mean Hb concentration over 64 weeks’ treatment (mean ± SD)2
FERACCRU® was an effective long-term treatment for IBD patients who had previously failed on oral ferrous iron salts1
FERACCRU® Real-world Effectiveness Study in Hospital practice (FRESH)3
FRESH study design3
Design
- Observational, retrospective cohort study conducted in 7 secondary care gastroenterology centres in the UK
Objective
- To assess outcomes in patients with IBD and IDA treated with FERACCRU® in real-world practice
Primary endpoint
- The percentage of patients with normalised Hb levels at approximately 12 weeks after initiation of FERACCRU®
- normalised Hb was defined as ≥12 g/dL for women and ≥13 g/dL for men
Secondary endpoints
- Changes in Hb, ferritin and TSAT at Week 4 and 12
- Time to normalisation of serum ferritin
- normalised ferritin was defined as 30–300 μg/L
- Time to normalisation of TSAT
- normalised TSAT was defined as 20–50%
- Safety and tolerability
Inclusion criteria
- Aged ≥18 years
- UC, CD in remission or unspecified IBD
- Mild or moderate IDA:
- Hb 9.5–12 g/dL for women or 9.5–13.0 g/dL for men
and - Serum ferritin <30 μg/L or TSAT <20%
- Hb 9.5–12 g/dL for women or 9.5–13.0 g/dL for men
- Initiated on FERACCRU® since August 2017
Exclusion criteria
- Receiving FERACCRU® as part of an interventional clinical trial
- IBD flare at the time of study recruitment
- Requiring corticosteroids to treat flares at the time of FERACCRU® initiation
In an observational cohort study of patients with inactive IBD and mild to moderate IDA in routine clinical practice, FERACCRU® effectively increased Hb and ferritin, and was generally well tolerated (n=59)3
- 63% of patients had normalised Hb after 12 weeks (n=30)*3
- The median time to Hb normalisation was 46 days (n=30)3
- The most common AEs were abdominal pain or discomfort (15%),† constipation (5%) and diarrhoea (3%)3
- 20% of patients discontinued FERACCRU® due to AEs (n=59)3
*Normalised Hb was defined as ≥12 g/dL for women and ≥13 g/dL for men.
†Abdominal pain and discomfort included the combined categories of abdominal discomfort/distension, and abdominal pain and gastritis.
CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; CKD, chronic kidney disease; Hb, haemoglobin; IBD, inflammatory bowel disease; IDA, iron deficiency anaemia; QoL, quality of life; SCCAI, Simple Clinical Colitis Activity Index; SD, standard deviation; TSAT, transferrin saturation; UC, ulcerative colitis.
References:
- Gasche C, et al. Inflamm Bowel Dis 2015;21(3):579–588.
- Schmidt C, et al. Aliment Pharmacol Ther 2016;44(3):259–270.
- Cummings F, et al. BMJ Open Gastroenterol 2021;8(1):e000530.
