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 alon e and in combination with erythropoietin for the treatment of anemia a ssociated with Crohn disease. Design: Double-blind, randomized, placeb o-controlled trial with a subsequent open-label phase. Setting: Univer sity-based gastroenterology outpatient clinic. Patients: 40 patients w ith Crohn disease and a hemoglobin concentration of 10.5 g/dL or less. Intervention: All patients received intravenous iron saccharate for 1 6 weeks. During the blinded phase of the trial, they received either e rythropoietin or placebo. During the open phase, the erythropoietin do se was increased in nonresponders who had received erythropoietin and erythropoietin therapy was initiated in nonresponders who had received placebo. Measurements: Response was defined as an increase in hemoglo bin 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 res ponse rate (P = 0.036) and a more pronounced mean increase in hemoglob in 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 t o 2.5 g/dL]; P = 0.004). in the open phase, all 6 previous nonresponde rs had a response. Hematologic response was associated with improved q uality of life (P = 0.03). Conclusions: Most patients who have anemia associated with Crohn disease respond to intravenous iron alone. Eryth ropoietin has additional effects on hemoglobin concentrations.