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<font size="4.5">FERACCRU<sup>®</sup> Clinical Data - Inflammatory Bowel Disease (IBD)</font>

FERACCRU® Clinical Data - Inflammatory Bowel Disease (IBD)

In 2018, the licensed indication for FERACCRU® was expanded to ‘adults for the treatment of iron deficiency’ by the European Medicines Agency (EMA). This was based on several studies pre-dating the clinical development programme, which complemented the findings of the pivotal trials conducted with FERACCRU®

For more information please review the European Public Assessment Report (EPAR) documentation here

AEGIS Clinical Trial in IBD1

  • Randomised phase 3 clinical trial programme
  • Assessed efficacy and tolerability of FERACCRU®
  • Patients with mild-to-moderate inflammatory bowel disease (IBD) or in remission, with IDA (Hb ≥9.5g/dl)
  • Previously failed to response to, or intolerant to, oral ferrous salts

FERACCRU® was shown to be effective in relieving IDA and well-tolerated at both 12 weeks (vs placebo) and 64 weeks1,2


 

A statistically significant increase in Hb concentration (2.25 g/dL) was observed in the FERACCRU® group versus placebo over 12 weeks (p<0.0001)1

 

 

Median time to Hb normalisation was <8 weeks1

At Week 12:

  • Hb concentrations increased by 2.25 g/dL from baseline in
    the FERACCRU® group vs. placebo1
  • 66% of the FERACCRU® group had normal Hb levels
    (percentage based on a responder analysis)1
  • Efficacy of FERACCRU® was not affected by IBD type, severity or time since flare1

 

 

 

Long-term FERACCRU® treatment maintained normal haemoglobin levels in 89% of patients2

Mean Hb concentration over 64 weeks’ treatment2

 

 

All analyses based on the long term extension are descriptive - no statistical analysis was conducted

 RCT - Randomised Controlled Trial                         OLE - Open Label Extension

 

  •  Mean Hb concentrations increased from 11.00 g/dL at baseline to 13.95 g/dL at Week 64 in continued patients (n=35), and from 11.10 g/dL to 13.33 g/dL at Week 64 in switched patients (n=36)2
  • Among all patients, 71% had Hb normalisation after 12 weeks of FERACCRU® treatment, and 86% had normalisation at Week 642
  • Mean absolute serum ferritin concentration increased from 8.4 μg/L at baseline to 25.5 μg/L at Week 16, and 57.4 μg/L at Week 64. TSAT increased from 10% at baseline to 26% at Week 16, and 29% at Week 642

 

 

FERACCRU® was well-tolerated vs placebo1,2

Incidence of AEs at Week 12 (pre-planned safety set)1

 

  • No negative impact on disease-specific quality of life scores or disease severity1
  • No treatment-related serious adverse events attributed to FERACCRU® at 12 weeks1
  • 74% of patients completed 64 weeks of treatment

The most common treatment-related AEs in FERACCRU®  in treated patients were abdominal pain, constipation, and flatulence3

No statistical comparison of treatment-emergent AEs was valid due to low numbers in both arms.

 

AEGIS IBD 1 & 2 and AEGIS IBD long-term extension study design1,2

AEGIS IBD 1 & 21

Primary endpoint
• Change in Hb concentration from baseline to Week 12
Secondary endpoints
• Changes in Hb concentration from baseline to Weeks 4 and 8
• Serum ferritin concentration
• Percentage transferrin saturation (TSAT)

 

 

 

AEGIS IBD long-term extension2

Main efficacy endpoint
• Absolute change in Hb from baseline to Week 64
(12 plus 52 weeks)
Secondary endpoints
• Proportion of patients achieving normal haemoglobin levels
• Absolute serum ferritin concentration and transferrin
saturation at 4- and 12-weekly intervals
• Disease specific quality of life at randomisation,
Week 12 and 12-weekly intervals thereafter