Failure of low‐dose intravenous immunoglobulin therapy to suppress disease activity in patients with treatment‐refractory rheumatoid arthritis

Objective. Treatment with high‐dose (400 mg/kg/day) intravenous immunoglobulin (IVIg) shows benefit in many autoimmune diseases but is very expensive. Low‐dose IVIg has also been shown to be effective in inhibiting adjuvant arthritis in the rat. This pilot, randomized, double‐blind, placebo‐controlled trial was conducted to assess the use of low‐dose IVIg in patients with treatment‐refractory rheumatoid arthritis (RA). Methods. Twenty patients with active RA were recruited. Ten patients received IVIg and 10 received albumin. Study subjects were given 6 courses of either IVIg (5 mg/kg) or albumin (5 mg/kg), once every 3 weeks. Baseline medications were continued and not changed throughout the study. Results. There were no complications. Five patients dropped out before the 18‐week followup visit. No significant differences between treatment groups were noted during the 18‐week trial in terms of global activity indices (patient or physician assessment), joint swelling, joint pain or tenderness, erythrocyte sedimentation rate, C‐reactive protein level, or rheumatoid factor. The protocol was terminated prematurely because of reported contamination of IVIg by hepatitis C virus. None of the patients showed evidence of hepatitis C infection by serologic analysis or by polymerase chain reaction. Conclusion. Low‐dose IVIg, as administered in this trial, does not show a therapeutic effect in patients with refractory RA.