RECOMBINANT ERYTHROPOIETIN FOR THE TREATMENT OF ANEMIA IN INFLAMMATORY BOWEL-DISEASE

Background. Some patients with inflammatory bowel disease have anemia that is refractory to treatment with iron and vitamins. We examined wh ether administering iron and recombinant erythropoietin could raise he moglobin levels in such patients. Methods. Thirty-four patients with i nflammatory bowel disease (15 with ulcerative colitis and 19 with Croh n's disease) and anemia refractory to iron therapy (hemoglobin concent rations below 10.0 g per deciliter [6.2 mmol per liter]) were randomly assigned in a prospective, double-blind, 12-week trial to receive eit her oral iron (100 mg per day) and subcutaneous erythropoietin (150 U per kilogram of body weight twice per week) (n=17) or oral iron and pl acebo (n=17). The primary measure of efficacy was an increase in hemog lobin levels of more than 1.0 g per deciliter (0.62 mmol per liter). A dditional analyses were performed with other patients with inflammator y bowel disease. Results. The severity of anemia was related to clinic al disease activity as well as to in vitro monocyte secretion of inter leukin-1 beta, a proinflammatory cytokine. Serum erythropoietin concen trations were increased in 52 randomly selected outpatients with infla mmatory bower disease and anemia, but the concentrations were inadequa te in relation to the degree of anemia. Twelve weeks of therapy with r ecombinant erythropoietin and oral iron increased mean (+/-SE) hemoglo bin concentrations from 8.81+/-0.27 g per deciliter (5.47+/-0.17 mmol per liter) to 10.52+/-0.41 g per deciliter (6.5+/-0.25 mmol per liter) ,whereas hemoglobin concentrations in the placebo group decreased from 8.69+/-0.11 g per deciliter (5.4+/-0.068 mmol per liter) to 7.84+/-0. 33 g per deciliter (4.9+/-0.2 mmol per liter) (P<0.001), After 12 week s, hemoglobin levels had increased by more than 1.0 g per deciliter in 82 percent of the patients in the erythropoietin group, as compared w ith 24 percent of those in the placebo group (P=0.002). There were fiv e treatment failures in the placebo group and two in the erythropoieti n group (P=0.18); treatment failure was defined as a decrease in hemog lobin levels of more than 2.0 g per deciliter (1.24 mmol per liter) to a value below 8.0 g per deciliter (4.96 mmol per liter) or any decrea se to less than 6.5 g per deciliter (4.03 mmol per liter). Conclusions . In patients with inflammatory bowel disease and anemia refractory to treatment with iron and vitamins, treatment with oral iron and recomb inant erythropoietin can raise hemoglobin levels. (C) 1996, Massachuse tts Medical Society.