Intravenous iron and erythropoietin for anemia associated with Crohn disease. A randomized, controlled trial.
BACKGROUND
Anemia often complicates Crohn disease and affects quality of life.


OBJECTIVE
To evaluate the efficacy of intravenous iron alone and in combination with erythropoietin for the treatment of anemia associated with Crohn disease.


METHODS
Double-blind, randomized, placebo-controlled trial with a subsequent open-label phase.


METHODS
University-based gastroenterology outpatient clinic.


METHODS
40 patients with Crohn disease and a hemoglobin concentration of 10.5 g/dL or less.


METHODS
All patients received intravenous iron saccharate for 16 weeks. During the blinded phase of the trial, they received either erythropoietin or placebo. During the open phase, the erythropoietin dose was increased in non-responders who had received erythropoietin and erythropoietin therapy was initiated in nonresponders who had received placebo.


METHODS
Response was defined as an increase in hemoglobin concentration of 2 g/dL or more.


RESULTS
15 of 20 patients in the placebo group (75% [95% CI, 51% to 91%]) and 18 of 19 patients in the erythropoietin group (95% [CI, 74% to 100%]) responded to intravenous iron (P = 0.20). The erythropoietin group had a higher cumulative response rate (P = 0.036) and a more pronounced mean increase in hemoglobin concentration (4.9 g/dL in the erythropoietin group compared with 3.3 g/dL in the placebo group, a difference of 1.6 g/dL [CI, 0.6 g/dL to 2.5 g/dL]; P = 0.004). In the open phase, all 6 previous nonresponders had a response. Hematologic response was associated with improved quality of life (P = 0.03).


CONCLUSIONS
Most patients who have anemia associated with Crohn disease respond to intravenous iron alone. Erythropoietin has additional effects on hemoglobin concentrations.
Gasché
C
C
University of Vienna, Austria.
Dejaco
C
C
Waldhoer
T
T
Tillinger
W
W
Reinisch
W
W
Fueger
G F
GF
Gangl
A
A
Lochs
H
H
D000293:Adolescent; D000328:Adult; D000368:Aged; D000740:Anemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology / Q000523:psychology; D003424:Crohn Disease / Q000150:complications* / Q000523:psychology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004921:Erythropoietin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007262:Infusions, Intravenous; D007501:Iron / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects
D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin; D007501:Iron