AVAILABILITY OF IRON AND DEGREE OF INFLAMMATION MODIFIES THE RESPONSETO RECOMBINANT-HUMAN-ERYTHROPOIETIN WHEN TREATING ANEMIA OF CHRONIC DISEASE IN PATIENTS WITH RHEUMATOID-ARTHRITIS

Forty-six patients with rheumatoid arthritis (RA) and documented anemi a of chronic disease (Hb <100/1 10 g/l) were randomized to receive eit her human recombinant erythropoietin (r-HuEPO, n=36, 300 U/kg body wei ght) or placebo (n=10) for 12 weeks in a multicenter study. An adequat e response was defined as elevation of Hb greater than or equal to 120 g/l. Relevant clinical and laboratory assessments were made to evalua te efficacy and secure safety. A significant elevation in Hb from week 10 onwards was noted in twenty-six patients (five drop-outs) out of n ine patients receiving placebo (one drop-out) (12+/-1.2 g/l vs 4+/-0.5 g/l; Hb elevation from 95 g/l to 107 g/l vs 93 g/l to 97 g/l, P<0.05) . Only 14.6%, however, were considered responders according to preset criteria. In the responders a lower initial CRP, a significant reducti on in ESR but not in CRP was seen compared to the remaining r-HuEPO gr oup. A significant elevation of energy level was noted in the r-HuEPO group; otherwise, no differences in clinical variables were seen. No s erious adverse effects were noted. When analyzing patients receiving o ral iron in combination with r-HuEPO and adding five additional, openl y selected patients receiving both adequate iron supplementation and r -HuEPO, there was a significant weekly elevation of Hb from week 8 onw ards in favor of combination therapy over the ones only receiving r-Hu EPO (18+/-1.1 g/l vs 7+/-1.1 g/l, P<0.05). The initial six responders had now reached ten of whom seven belonged to the combination therapy group. Response to r-HuEPO in RA patients ap pears to be dependent on availability of iron and on the degree of inflammation. If r-HuEPO tre atment is considered, iron deficiency should always be corrected and s trenous efforts should have been made to control the disease itself.