Novel Therapy for Iron Deficiency Effective in IBD

A novel, fixed-dose intravenous ferric carboxymaltose regimen was more effective than was Ganzoni-calculated iron sucrose at treating iron-deficiency anemia, according to a report by Dr. Rayko Evstatiev and colleagues in the September issue of Gastroenterology.

The regimen, which included a maximum of three infusions, was well tolerated, "and the lower number of infusions increases the convenience and cost-effectiveness of intravenous iron repletion in patients with iron deficiency," wrote the authors (Gastroenterology 2011 September [doi: 10.1053/j.gastro.2011.06.005].

Dr. Evstatiev, of the Medical University of Vienna, and colleagues studied 485 patients with iron-deficiency anemia, defined as hemoglobin of 7-12 g/dL for females and 7-13 g/dL for males, along with ferritin values of less than 100 mcg/L.

All patients also had mild to moderate inflammatory bowel disease – either Crohn’s disease with a Crohn’s Disease Activity Index of less than 220 or ulcerative colitis with a Colitis Activity Index less than or equal to 7.

Exclusion criteria were administration of intravenous or oral iron treatment or blood transfusion within 4 weeks of screening, or a history of erythropoietin treatment, chronic alcohol abuse, or chronic liver disease.

Patients were randomized in a 1:1 ratio to receive either ferric carboxymaltose or the standard, individually calculated iron sucrose.

The intravenous ferric carboxymaltose, marketed as Ferinject by Vifor Pharma, the study’s sponsor, was administered in once-weekly infusions over at least 15 minutes.

In the ferric carboxymaltose group, for patients with an initial hemoglobin of greater than or equal to 10 g/dL, weighing less than 70 kg, a cumulative total dose of 1,000 mg of the drug was given; for patients weighing 70 kg or more, a total of 1,500 mg was administered.

Likewise, for patients with an initial hemoglobin of 7-10 g/dL weighing less than 70 kg, a total dose of 1,500 mg was infused. This was raised to 2,000 mg in patients weighing 70 kg or more.

Patients weighing less than 67 kg received a maximum of 500 mg per infusion, such that low-hemoglobin, low-weight patients could receive up to three total infusions, on days 1, 8, and 15. All other patients received 1,000 mg per infusion.

The iron sucrose regimen (Venofer, also from Vifor Pharma) was calculated for each patient individually by using the standard Ganzoni formula with a target hemoglobin of 15 g/dL, and included up to 11 infusions of 200 mg over at least 30 minutes, given up to twice weekly.

By week 12, an increase of hemoglobin concentration of greater than or equal to 2 g/dL was achieved in 66% of patients in the ferric carboxymaltose group, versus 54% receiving calculated iron sucrose (P = .004).

Moreover, normal hemoglobin values, defined as greater or equal to 12 g/dL in women and 13 g/dL in men, were seen in 73% of ferric carboxymaltose patients, versus 62% of iron sucrose recipients (P = .015).

Finally, the researchers also noted that normal transferrin saturation (20%-50%), normal ferritin concentration (greater than or equal to 100 mcg/L), and normal hemoglobin combined with normal ferritin were achieved significantly more often by patients in the ferric carboxymaltose group.

In a cost-effectiveness analysis, Dr. Evstatiev found that while treatment costs for the ferric carboxymaltose infusions were nearly double the price of iron sucrose per infusion, since more infusions were required among the latter group, "total treatment costs for [ferric carboxymaltose] over the whole study period were lower than those for [iron sucrose] (US$ 653 vs. US$ 891, respectively)."

Both treatment regimens were well tolerated, with the most common adverse events being nasopharyngitis and worsening of ulcerative colitis, reported the authors. No true hypersensitivity reactions were noted.

One of the authors was employed by Vifor Pharma, and others received speaker and consultancy fees from the company.

A novel, fixed-dose intravenous ferric carboxymaltose regimen was more effective than was Ganzoni-calculated iron sucrose at treating iron-deficiency anemia, according to a report by Dr. Rayko Evstatiev and colleagues in the September issue of Gastroenterology.

The regimen, which included a maximum of three infusions, was well tolerated, "and the lower number of infusions increases the convenience and cost-effectiveness of intravenous iron repletion in patients with iron deficiency," wrote the authors (Gastroenterology 2011 September [doi: 10.1053/j.gastro.2011.06.005].

Dr. Evstatiev, of the Medical University of Vienna, and colleagues studied 485 patients with iron-deficiency anemia, defined as hemoglobin of 7-12 g/dL for females and 7-13 g/dL for males, along with ferritin values of less than 100 mcg/L.

All patients also had mild to moderate inflammatory bowel disease – either Crohn’s disease with a Crohn’s Disease Activity Index of less than 220 or ulcerative colitis with a Colitis Activity Index less than or equal to 7.

Exclusion criteria were administration of intravenous or oral iron treatment or blood transfusion within 4 weeks of screening, or a history of erythropoietin treatment, chronic alcohol abuse, or chronic liver disease.

Patients were randomized in a 1:1 ratio to receive either ferric carboxymaltose or the standard, individually calculated iron sucrose.

The intravenous ferric carboxymaltose, marketed as Ferinject by Vifor Pharma, the study’s sponsor, was administered in once-weekly infusions over at least 15 minutes.

In the ferric carboxymaltose group, for patients with an initial hemoglobin of greater than or equal to 10 g/dL, weighing less than 70 kg, a cumulative total dose of 1,000 mg of the drug was given; for patients weighing 70 kg or more, a total of 1,500 mg was administered.

Likewise, for patients with an initial hemoglobin of 7-10 g/dL weighing less than 70 kg, a total dose of 1,500 mg was infused. This was raised to 2,000 mg in patients weighing 70 kg or more.

Patients weighing less than 67 kg received a maximum of 500 mg per infusion, such that low-hemoglobin, low-weight patients could receive up to three total infusions, on days 1, 8, and 15. All other patients received 1,000 mg per infusion.

The iron sucrose regimen (Venofer, also from Vifor Pharma) was calculated for each patient individually by using the standard Ganzoni formula with a target hemoglobin of 15 g/dL, and included up to 11 infusions of 200 mg over at least 30 minutes, given up to twice weekly.

By week 12, an increase of hemoglobin concentration of greater than or equal to 2 g/dL was achieved in 66% of patients in the ferric carboxymaltose group, versus 54% receiving calculated iron sucrose (P = .004).

Moreover, normal hemoglobin values, defined as greater or equal to 12 g/dL in women and 13 g/dL in men, were seen in 73% of ferric carboxymaltose patients, versus 62% of iron sucrose recipients (P = .015).

Finally, the researchers also noted that normal transferrin saturation (20%-50%), normal ferritin concentration (greater than or equal to 100 mcg/L), and normal hemoglobin combined with normal ferritin were achieved significantly more often by patients in the ferric carboxymaltose group.

In a cost-effectiveness analysis, Dr. Evstatiev found that while treatment costs for the ferric carboxymaltose infusions were nearly double the price of iron sucrose per infusion, since more infusions were required among the latter group, "total treatment costs for [ferric carboxymaltose] over the whole study period were lower than those for [iron sucrose] (US$ 653 vs. US$ 891, respectively)."

Both treatment regimens were well tolerated, with the most common adverse events being nasopharyngitis and worsening of ulcerative colitis, reported the authors. No true hypersensitivity reactions were noted.

One of the authors was employed by Vifor Pharma, and others received speaker and consultancy fees from the company.

A novel, fixed-dose intravenous ferric carboxymaltose regimen was more effective than was Ganzoni-calculated iron sucrose at treating iron-deficiency anemia, according to a report by Dr. Rayko Evstatiev and colleagues in the September issue of Gastroenterology.

The regimen, which included a maximum of three infusions, was well tolerated, "and the lower number of infusions increases the convenience and cost-effectiveness of intravenous iron repletion in patients with iron deficiency," wrote the authors (Gastroenterology 2011 September [doi: 10.1053/j.gastro.2011.06.005].

Dr. Evstatiev, of the Medical University of Vienna, and colleagues studied 485 patients with iron-deficiency anemia, defined as hemoglobin of 7-12 g/dL for females and 7-13 g/dL for males, along with ferritin values of less than 100 mcg/L.

All patients also had mild to moderate inflammatory bowel disease – either Crohn’s disease with a Crohn’s Disease Activity Index of less than 220 or ulcerative colitis with a Colitis Activity Index less than or equal to 7.

Exclusion criteria were administration of intravenous or oral iron treatment or blood transfusion within 4 weeks of screening, or a history of erythropoietin treatment, chronic alcohol abuse, or chronic liver disease.

Patients were randomized in a 1:1 ratio to receive either ferric carboxymaltose or the standard, individually calculated iron sucrose.

The intravenous ferric carboxymaltose, marketed as Ferinject by Vifor Pharma, the study’s sponsor, was administered in once-weekly infusions over at least 15 minutes.

In the ferric carboxymaltose group, for patients with an initial hemoglobin of greater than or equal to 10 g/dL, weighing less than 70 kg, a cumulative total dose of 1,000 mg of the drug was given; for patients weighing 70 kg or more, a total of 1,500 mg was administered.

Likewise, for patients with an initial hemoglobin of 7-10 g/dL weighing less than 70 kg, a total dose of 1,500 mg was infused. This was raised to 2,000 mg in patients weighing 70 kg or more.

Patients weighing less than 67 kg received a maximum of 500 mg per infusion, such that low-hemoglobin, low-weight patients could receive up to three total infusions, on days 1, 8, and 15. All other patients received 1,000 mg per infusion.

The iron sucrose regimen (Venofer, also from Vifor Pharma) was calculated for each patient individually by using the standard Ganzoni formula with a target hemoglobin of 15 g/dL, and included up to 11 infusions of 200 mg over at least 30 minutes, given up to twice weekly.

By week 12, an increase of hemoglobin concentration of greater than or equal to 2 g/dL was achieved in 66% of patients in the ferric carboxymaltose group, versus 54% receiving calculated iron sucrose (P = .004).

Moreover, normal hemoglobin values, defined as greater or equal to 12 g/dL in women and 13 g/dL in men, were seen in 73% of ferric carboxymaltose patients, versus 62% of iron sucrose recipients (P = .015).

Finally, the researchers also noted that normal transferrin saturation (20%-50%), normal ferritin concentration (greater than or equal to 100 mcg/L), and normal hemoglobin combined with normal ferritin were achieved significantly more often by patients in the ferric carboxymaltose group.

In a cost-effectiveness analysis, Dr. Evstatiev found that while treatment costs for the ferric carboxymaltose infusions were nearly double the price of iron sucrose per infusion, since more infusions were required among the latter group, "total treatment costs for [ferric carboxymaltose] over the whole study period were lower than those for [iron sucrose] (US$ 653 vs. US$ 891, respectively)."

Both treatment regimens were well tolerated, with the most common adverse events being nasopharyngitis and worsening of ulcerative colitis, reported the authors. No true hypersensitivity reactions were noted.

One of the authors was employed by Vifor Pharma, and others received speaker and consultancy fees from the company.