Anemia, Iron Deficiency, Inflammatory Bowel Diseases
Conditions
Brief summary
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.
Detailed description
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
Interventions
None listed
Sponsors
Shield Therapeutics
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Transferrin Saturation at Week 4 | Baseline to Week 4 (permitting 3 to 5 weeks) | Change in transferrin saturation (TSAT) at Week 4 |
| 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. |
| 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. |
| 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 |
| 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 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® |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| Sex of Patient at Baseline | Baseline | Sex of patient at Baseline - Male or Female |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Number of Eligible Subjects Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data. | 59 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 12 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 10 |
| Overall Study | Missing Feraccru stop date | 3 |
| Overall Study | Physician Decision | 3 |
Baseline characteristics
| Characteristic | Number of Eligible Subjects | — |
|---|---|---|
| Age, Customized 18 < 25 | 8 Participants | — |
| Age, Customized 25 < 35 | 16 Participants | — |
| Age, Customized 35 < 45 | 12 Participants | — |
| Age, Customized 45 < 55 | 8 Participants | — |
| Age, Customized 55 < 65 | 5 Participants | — |
| Age, Customized >65 | 10 Participants | — |
| Baseline Haemoglobin | 11.1 g/dl STANDARD_DEVIATION 0.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 59 participants | — |
| Sex: Female, Male Female | 38 Participants | — |
| Sex: Female, Male Male | 21 Participants | — |
| Type of Inflammatory Bowel Disease Crohn's Disease (CD) | 28 Participants | — |
| Type of Inflammatory Bowel Disease Ulcerative Colitis (UC) | 28 Participants | — |
| Type of Inflammatory Bowel Disease Unspecified | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 59 |
| other Total, other adverse events | 9 / 59 |
| serious Total, serious adverse events | 1 / 59 |
Outcome results
Primary
The Percentage of Patients With Normalised Hb Levels at 12 Weeks After Initiation of Feraccru®.
Normalised haemoglobin is defined in this study as Hb ≥12.0 g/dL for females and and (≥13.0 g/dL for males.
Time frame: 12 weeks (permitting 10-16 weeks)
Population: Number of subjects with Hb measurement at 12 weeks (permitting 10-16 weeks) following initiation with Feraccru.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Normalised Hb at 12 Weeks | The Percentage of Patients With Normalised Hb Levels at 12 Weeks After Initiation of Feraccru®. | 19 Participants |
| Not Normalised Hb at 12 Weeks | The Percentage of Patients With Normalised Hb Levels at 12 Weeks After Initiation of Feraccru®. | 11 Participants |
Secondary
Adverse Events That Are Related to and Caused by Feraccru®
Type, severity and time of adverse events that are related to and caused by Feraccru®, from initiation of Feraccru®
Time frame: For the duration of study, average of 12 weeks.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Normalised Hb at 12 Weeks | Adverse Events That Are Related to and Caused by Feraccru® | definitely related | 1 Participants |
| Normalised Hb at 12 Weeks | Adverse Events That Are Related to and Caused by Feraccru® | probably related | 7 Participants |
| Normalised Hb at 12 Weeks | Adverse Events That Are Related to and Caused by Feraccru® | possibly related | 9 Participants |
Secondary
Change in Hb Levels at 12 Weeks
Change in Haemoglobin levels from baseline to Week 12
Time frame: Baseline to Week 12 (permitting 10-16 weeks)
Population: Subjects with available Hb at Week 12 (permitting 10-16 weeks).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normalised Hb at 12 Weeks | Change in Hb Levels at 12 Weeks | 1.4 g/dl | Standard Deviation 1.7 |
Secondary
Change in Hb Levels at Week 4
Change in Haemoglobin levels from baseline to Week 4
Time frame: Baseline to Week 4 (permitting 3 to 5 weeks)
Population: Subjects with available Hb at Week 4 (permitting 3 to 5 weeks).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normalised Hb at 12 Weeks | Change in Hb Levels at Week 4 | 0.8 g/dl | Standard Deviation 0.8 |
Secondary
Change in Serum Ferritin Levels at Week 12
Change in serum ferritin levels from baseline to week 12
Time frame: Baseline to Week 12 (permitting 10-16 weeks)
Population: Subjects with available ferritin measurement at Week 12 (permitting 10-16 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normalised Hb at 12 Weeks | Change in Serum Ferritin Levels at Week 12 | 19.1 ug/ml | Standard Deviation 36 |
Secondary
Change in Serum Ferritin Levels at Week 4
Change in serum ferritin levels from baseline to week 4
Time frame: Baseline to Week 4 (permitting 3 to 5 weeks)
Population: Subjects with available ferritin measurements at Week 4 (permitting 3 to 5 weeks).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normalised Hb at 12 Weeks | Change in Serum Ferritin Levels at Week 4 | 11.9 ug/ml | Standard Deviation 12.5 |
Secondary
Change in Transferrin Saturation at Week 12
Change in transferrin saturation (TSAT) at Week 12
Time frame: Baseline to Week 12
Population: Due to insufficient data, this outcome could not be measured.
Secondary
Change in Transferrin Saturation at Week 4
Change in transferrin saturation (TSAT) at Week 4
Time frame: Baseline to Week 4 (permitting 3 to 5 weeks)
Population: Due to insufficient data, this outcome could not be measured.
Secondary
Percentage of Patients Who Discontinue Feraccru®
Percentage of patients who discontinue Feraccru® during the 12 weeks period
Time frame: Baseline to week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Normalised Hb at 12 Weeks | Percentage of Patients Who Discontinue Feraccru® | 49 percentage of participants |
Secondary
Percentage of Patients With Normalised Ferritin Levels at 12 Weeks
Normalised serum ferritin is defined in this study as serum ferritin concentration ≥30 microgram/L and ≤300 microgram/L.
Time frame: Baseline to Week 12 (permitting 10-16 weeks)
Population: Subjects with available ferritin measurements at Week 12 (permitting 10-16 weeks).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Normalised Hb at 12 Weeks | Percentage of Patients With Normalised Ferritin Levels at 12 Weeks | 9 Participants |
Secondary
Percentage of Patients With Normalised Transferrin Saturation at 12 Weeks After Initiation of Feraccru®
Normalised transferrin saturation is defined in this study as transferrin saturation between 20% and 50%.
Time frame: Baseline to Week 12
Population: Due to insufficient data, this outcome could not be measured.
Secondary
Prior IV Treatment History
Prior intravenous iron treatment history
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Normalised Hb at 12 Weeks | Prior IV Treatment History | ≥1 course of intravenous iron | 24 Participants |
| Normalised Hb at 12 Weeks | Prior IV Treatment History | not received previous IV | 22 Participants |
| Normalised Hb at 12 Weeks | Prior IV Treatment History | unkown | 13 Participants |
Secondary
Reason for Discontinuing Each Prior Oral Ferrous Product
Reason(s) for discontinuing each prior Oral Ferrous Product (OFP). Patients could have multiple reasons for discontinuation of previous OFP.
Time frame: Baseline
Population: Each discontinuation reason is exclusive per patient. Some patients had multiple reason for discontinuation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Normalised Hb at 12 Weeks | Reason for Discontinuing Each Prior Oral Ferrous Product | Diarrhoea | 4 individual reasons |
| Normalised Hb at 12 Weeks | Reason for Discontinuing Each Prior Oral Ferrous Product | Nausea | 3 individual reasons |
| Normalised Hb at 12 Weeks | Reason for Discontinuing Each Prior Oral Ferrous Product | Not known | 6 individual reasons |
| Normalised Hb at 12 Weeks | Reason for Discontinuing Each Prior Oral Ferrous Product | Lack of efficacy | 8 individual reasons |
| Normalised Hb at 12 Weeks | Reason for Discontinuing Each Prior Oral Ferrous Product | Treatment completion | 4 individual reasons |
| Normalised Hb at 12 Weeks | Reason for Discontinuing Each Prior Oral Ferrous Product | Constipation | 1 individual reasons |
| Normalised Hb at 12 Weeks | Reason for Discontinuing Each Prior Oral Ferrous Product | Flatulence | 1 individual reasons |
| Normalised Hb at 12 Weeks | Reason for Discontinuing Each Prior Oral Ferrous Product | Abdominal pain | 3 individual reasons |
| Normalised Hb at 12 Weeks | Reason for Discontinuing Each Prior Oral Ferrous Product | Unable to tolerate | 3 individual reasons |
| Normalised Hb at 12 Weeks | Reason for Discontinuing Each Prior Oral Ferrous Product | Dramatically worsened GI symptoms | 1 individual reasons |
Secondary
Reason for Discontinuing Feraccru®
Reasons for stopping will be collected as predefined common options and a free text field.
Time frame: Baseline to week 12
Population: The categories are not mutually exclusive so a single subject could have multiple reasons listed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Normalised Hb at 12 Weeks | Reason for Discontinuing Feraccru® | Abdominal pain | 12 percentage of participants |
| Normalised Hb at 12 Weeks | Reason for Discontinuing Feraccru® | Clinician decision | 5 percentage of participants |
| Normalised Hb at 12 Weeks | Reason for Discontinuing Feraccru® | Diarrhoea | 3 percentage of participants |
| Normalised Hb at 12 Weeks | Reason for Discontinuing Feraccru® | Constipation | 3 percentage of participants |
| Normalised Hb at 12 Weeks | Reason for Discontinuing Feraccru® | Treatment complete | 3 percentage of participants |
| Normalised Hb at 12 Weeks | Reason for Discontinuing Feraccru® | Lack of efficacy | 2 percentage of participants |
| Normalised Hb at 12 Weeks | Reason for Discontinuing Feraccru® | Nausea | 2 percentage of participants |
| Normalised Hb at 12 Weeks | Reason for Discontinuing Feraccru® | Not known | 17 percentage of participants |
| Normalised Hb at 12 Weeks | Reason for Discontinuing Feraccru® | Other | 5 percentage of participants |
Secondary
Reason for Initiating Feraccru®
Reason(s) for initiation of Feraccru®
Time frame: Baseline
Population: The initiation reasons are not exclusive per patient. Some subjects had multiple reasons for initiating Feraccru®.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Normalised Hb at 12 Weeks | Reason for Initiating Feraccru® | Intolerance to ferrous sulphate | 22 initiation reasons |
| Normalised Hb at 12 Weeks | Reason for Initiating Feraccru® | Intolerance to ferrous fumarate | 15 initiation reasons |
| Normalised Hb at 12 Weeks | Reason for Initiating Feraccru® | Intolerance to ferrous gluconate | 18 initiation reasons |
| Normalised Hb at 12 Weeks | Reason for Initiating Feraccru® | Intolerance to oral iron | 7 initiation reasons |
| Normalised Hb at 12 Weeks | Reason for Initiating Feraccru® | Clinician decision | 6 initiation reasons |
| Normalised Hb at 12 Weeks | Reason for Initiating Feraccru® | Not recorded | 11 initiation reasons |
| Normalised Hb at 12 Weeks | Reason for Initiating Feraccru® | Other | 13 initiation reasons |
Secondary
Time From Diagnosis of IBD to Initiation of Feraccru
Time from diagnosis of Inflammatory Bowel Disease to initiation of Feraccru.
Time frame: Baseline
Population: Subjects with available medical history on IBD prior to Feraccru.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normalised Hb at 12 Weeks | Time From Diagnosis of IBD to Initiation of Feraccru | 9.4 years | Standard Deviation 9.7 |
Secondary
Time From Diagnosis of IDA to Initiation of Feraccru®
Time from diagnosis of Iron Deficiency Anaemia to initiation of Feraccru®
Time frame: Baseline
Population: Subjects with available medical history on IDA prior to Feraccru.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normalised Hb at 12 Weeks | Time From Diagnosis of IDA to Initiation of Feraccru® | 53.8 days | Standard Deviation 110.4 |
Secondary
Time to Correction of Serum Ferritin Levels
Normalised serum ferritin is defined in this study as serum ferritin concentration ≥30 microgram/L and ≤300 microgram/L.
Time frame: Baseline to Week 12 (permitting 10 to 16 weeks)
Population: Subjects with available ferritin measurement at Week 12 (permitting 10 to 16 weeks).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normalised Hb at 12 Weeks | Time to Correction of Serum Ferritin Levels | 68.0 days | Standard Deviation 25.1 |
Secondary
Time to Correction of Transferrin Saturation
Normalised transferrin saturation is defined in this study as transferrin saturation between 20% and 50%.
Time frame: Baseline to Week 12
Population: Due to insufficient data, this outcome could not be measured.
Secondary
Time to Normalisation of Hb Levels
Normalised haemoglobin is defined in this study as Hb ≥12.0 g/dL for females and ≥13.0 g/dL for males.
Time frame: Baseline to 12 weeks (permitting 10-16 weeks)
Population: Subjects with available Hb at Week 12 (permitting 10-16 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normalised Hb at 12 Weeks | Time to Normalisation of Hb Levels | 49.5 days | Standard Deviation 25.6 |
Other Pre-specified
Mean Corpuscular Hb at Baseline
Mean corpuscular haemoglobin (MCH) at Baseline
Time frame: Baseline
Population: 53 patients had MCH measured at Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normalised Hb at 12 Weeks | Mean Corpuscular Hb at Baseline | 27.0 pg/cell | Standard Deviation 8.3 |
Other Pre-specified
Mean Corpuscular Volume at Baseline
Mean value of C-reactive protein (CRP) at Baseline
Time frame: Baseline
Population: Subjects with available CRP value at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normalised Hb at 12 Weeks | Mean Corpuscular Volume at Baseline | 11.9 mg/L | Standard Deviation 18 |
Other Pre-specified
Platelets Count at Baseline
Mean platelets count at baseline
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normalised Hb at 12 Weeks | Platelets Count at Baseline | 370.7 cells*10^9/L | Standard Deviation 131.4 |
Other Pre-specified
Sex of Patient at Baseline
Sex of patient at Baseline - Male or Female
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Normalised Hb at 12 Weeks | Sex of Patient at Baseline | Male | 21 Participants |
| Normalised Hb at 12 Weeks | Sex of Patient at Baseline | Female | 38 Participants |
Other Pre-specified
Type of IBD at Baseline (Crohn's Disease or Ulcerative Colitis)
Type of Inflammatory Bowel Disease at baseline (Crohn's Disease or Ulcerative Colitis)
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Normalised Hb at 12 Weeks | Type of IBD at Baseline (Crohn's Disease or Ulcerative Colitis) | Ulcerative Colitis (UC) | 28 Participants |
| Normalised Hb at 12 Weeks | Type of IBD at Baseline (Crohn's Disease or Ulcerative Colitis) | Unspecified IBD | 3 Participants |
| Normalised Hb at 12 Weeks | Type of IBD at Baseline (Crohn's Disease or Ulcerative Colitis) | Chron's Disease | 28 Participants |
Other Pre-specified
Vitamin B12 Value at Baseline
Vitamin B12 mean value at baseline
Time frame: Baseline
Population: Subjects with available B12 measurement at Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normalised Hb at 12 Weeks | Vitamin B12 Value at Baseline | 354.6 pmol/L | Standard Deviation 266.7 |