Feraccru® Real World Effectiveness Study in Hospital Practice ( FRESH )

The aim of the study is to understand the early experiences of Feraccru® in patients with inflammatory bowel disease (IBD) and iron deficiency anaemia (IDA) in the UK, including treatment effectiveness, patterns of use and tolerability. By describing the characteristics of patients treated with Feraccru® and their outcomes, this study will provide the medical community with important information to support treatment decisions for their patients. This will ultimately support improvements to patient care, including the long-term outcomes of patients with IBD and IDA

Primary outcomes

• The Percentage of Patients With Normalised Hb Levels at 12 Weeks After Initiation of Feraccru®. [12 weeks (permitting 10-16 weeks)]: Normalised haemoglobin is defined in this study as Hb ≥12.0 g/dL for females and and (≥13.0 g/dL for males.

Secondary outcomes

• Change in Hb Levels at Week 4 [Baseline to Week 4 (permitting 3 to 5 weeks)]: Change in Haemoglobin levels from baseline to Week 4
• Change in Hb Levels at 12 Weeks [Baseline to Week 12 (permitting 10-16 weeks)]: Change in Haemoglobin levels from baseline to Week 12
• Time to Normalisation of Hb Levels [Baseline to 12 weeks (permitting 10-16 weeks)]: Normalised haemoglobin is defined in this study as Hb ≥12.0 g/dL for females and ≥13.0 g/dL for males.
• Change in Serum Ferritin Levels at Week 4 [Baseline to Week 4 (permitting 3 to 5 weeks)]: Change in serum ferritin levels from baseline to week 4
• Change in Serum Ferritin Levels at Week 12 [Baseline to Week 12 (permitting 10-16 weeks)]: Change in serum ferritin levels from baseline to week 12
• Percentage of Patients With Normalised Ferritin Levels at 12 Weeks [Baseline to Week 12 (permitting 10-16 weeks)]: Normalised serum ferritin is defined in this study as serum ferritin concentration ≥30 microgram/L and ≤300 microgram/L.
• Time to Correction of Serum Ferritin Levels [Baseline to Week 12 (permitting 10 to 16 weeks)]: Normalised serum ferritin is defined in this study as serum ferritin concentration ≥30 microgram/L and ≤300 microgram/L.
• Change in Transferrin Saturation at Week 4 [Baseline to Week 4 (permitting 3 to 5 weeks)]: Change in transferrin saturation (TSAT) at Week 4
• Change in Transferrin Saturation at Week 12 [Baseline to Week 12]: Change in transferrin saturation (TSAT) at Week 12
• Percentage of Patients With Normalised Transferrin Saturation at 12 Weeks After Initiation of Feraccru® [Baseline to Week 12]: Normalised transferrin saturation is defined in this study as transferrin saturation between 20% and 50%.
• Time to Correction of Transferrin Saturation [Baseline to Week 12]: Normalised transferrin saturation is defined in this study as transferrin saturation between 20% and 50%.
• Time From Diagnosis of IBD to Initiation of Feraccru [Baseline]: Time from diagnosis of Inflammatory Bowel Disease to initiation of Feraccru.
• Time From Diagnosis of IDA to Initiation of Feraccru® [Baseline]: Time from diagnosis of Iron Deficiency Anaemia to initiation of Feraccru®
• Prior IV Treatment History [Baseline]: Prior intravenous iron treatment history
• Reason for Initiating Feraccru® [Baseline]: Reason(s) for initiation of Feraccru®
• Percentage of Patients Who Discontinue Feraccru® [Baseline to week 12]: Percentage of patients who discontinue Feraccru® during the 12 weeks period
• Reason for Discontinuing Feraccru® [Baseline to week 12]: Reasons for stopping will be collected as predefined common options and a free text field.
• Adverse Events That Are Related to and Caused by Feraccru® [For the duration of study, average of 12 weeks.]: Type, severity and time of adverse events that are related to and caused by Feraccru®, from initiation of Feraccru®
• Reason for Discontinuing Each Prior Oral Ferrous Product [Baseline]: Reason(s) for discontinuing each prior Oral Ferrous Product (OFP). Patients could have multiple reasons for discontinuation of previous OFP.

Other outcomes

• Sex of Patient at Baseline [Baseline]: Sex of patient at Baseline - Male or Female
• Type of IBD at Baseline (Crohn's Disease or Ulcerative Colitis) [Baseline]: Type of Inflammatory Bowel Disease at baseline (Crohn's Disease or Ulcerative Colitis)
• Platelets Count at Baseline [Baseline]: Mean platelets count at baseline
• Vitamin B12 Value at Baseline [Baseline]: Vitamin B12 mean value at baseline
• Mean Corpuscular Volume at Baseline [Baseline]: Mean value of C-reactive protein (CRP) at Baseline
• Mean Corpuscular Hb at Baseline [Baseline]: Mean corpuscular haemoglobin (MCH) at Baseline

Sex: All, ages: 18 Years to 99 Years

Inclusion Criteria:

* Male and female patients aged ≥ 18 years at the time of initiation .
* Patient presenting with mild to moderate IDA that is secondary to either Crohn's disease (CD) or ulcerative colitis (UC) defined as Hb ≥9.5 g/dL and <13.0 g/dL in males, or Hb ≥9.5 g/dL and <12.0 g/dL in females
* Serum ferritin concentration <30 microgram/L or transferrin saturation of <20% .
* Patient receiving Feraccru® since the time of UK launch in June 2016.

Exclusion Criteria:

* Patient receiving Feraccru® as part of an interventional clinical trial.
* Patients with severely active IBD or requiring corticosteroids at the time of initiation on Feraccru®.
* Patient with an IBD flare, as determined by the clinician.
* Patient with medical records that are not available for review.
* Patient not willing or unable to consent to study participation, or patient is deceased at the start of data collection period

Participant flow

Outcome results

• The Percentage of Patients With Normalised Hb Levels at 12 Weeks After Initiation of Feraccru®. (Primary), Count of participants, Participants: Normalised Hb at 12 Weeks 19; Not Normalised Hb at 12 Weeks 11
• Change in Hb Levels at Week 4 (Secondary), Mean, g/dl: Number of Eligible Subjects 0.8 +/- 0.8
• Change in Hb Levels at 12 Weeks (Secondary), Mean, g/dl: Number of Eligible Subjects 1.4 +/- 1.7
• Time to Normalisation of Hb Levels (Secondary), Mean, days: Number of Eligible Subjects 49.5 +/- 25.6
• Change in Serum Ferritin Levels at Week 4 (Secondary), Mean, ug/ml: Number of Eligible Subjects 11.9 +/- 12.5
• Change in Serum Ferritin Levels at Week 12 (Secondary), Mean, ug/ml: Number of Eligible Subjects 19.1 +/- 36.0
• Percentage of Patients With Normalised Ferritin Levels at 12 Weeks (Secondary), Count of participants, Participants: Number of Eligible Subjects 9
• Time to Correction of Serum Ferritin Levels (Secondary), Mean, days: Number of Eligible Subjects 68.0 +/- 25.1
• Change in Transferrin Saturation at Week 4 (Secondary)
• Change in Transferrin Saturation at Week 12 (Secondary)
• Percentage of Patients With Normalised Transferrin Saturation at 12 Weeks After Initiation of Feraccru® (Secondary)
• Time to Correction of Transferrin Saturation (Secondary)
• Time From Diagnosis of IBD to Initiation of Feraccru (Secondary), Mean, years: Number of Eligible Subjects 9.4 +/- 9.7
• Time From Diagnosis of IDA to Initiation of Feraccru® (Secondary), Mean, days: Number of Eligible Subjects 53.8 +/- 110.4
• Prior IV Treatment History (Secondary), Count of participants, Participants: Number of Eligible Subjects 24
• Reason for Initiating Feraccru® (Secondary), Count of units, initiation reasons: Number of Eligible Subjects 22
• Percentage of Patients Who Discontinue Feraccru® (Secondary), Number, percentage of participants: Number of Eligible Subjects 49
• Reason for Discontinuing Feraccru® (Secondary), Number, percentage of participants: Number of Eligible Subjects 12
• Adverse Events That Are Related to and Caused by Feraccru® (Secondary), Count of participants, Participants: Number of Eligible Subjects 1
• Reason for Discontinuing Each Prior Oral Ferrous Product (Secondary), Number, individual reasons: Number of Eligible Subjects 4
• 6 more outcome measures not shown.

Adverse events

Time frame: Baseline to approximately 12 weeks (permitting 10-16 weeks)

Serious adverse events by term

Other adverse events by term

Limitations and caveats: Multiple patients lacked Hb (and other clinical parameters) at the 3-5- and 10-16-week time points, limiting the analysis that could be performed; due to this, overestimation or underestimation of the true normalisation rates may have been observed.

• Study Protocol and Statistical Analysis Plan (PDF, 2017-03-02)