IMMUNOGLOBULIN THERAPY IN INFLAMMATORY BOWEL-DISEASE

A pilot, open-label study was carried out to determine if intravenous immunoglobulin (Ig) produces clinical improvement in patients with inflammatory bowel disease (IBD). Twelve consecutive patients with idiopathic ulcerative colitis (n=9) or Crohn's colitis (n=3) were enrolled. Eleven patients were refractory to medical treatment, including adrenocorticosteroids in all cases, and were symptomatic for at least six months with endoscopically moderate or severe mucosal inflammation; one patient had relapsed repeatedly during withdrawal of steroid therapy. Six patients had pancolitis and four patients had colitis to the right flexure or transverse colon. Nine patients required hospitalization for treatment of colitis. Intravenous Ig was administered in one or two induction phases (2 g/kg over two or five days) followed by a maintenance phase (200 to 500 mg/kg every two weeks for 12 or 24 weeks). Tapering of adrenocorticosteroid therapy was attempted, but oral aminosalicylates and retention enema medications for idiopathic colitis were continued. Treatment response was assessed clinically, as well as endoscopically and histologically whenever possible. Intravenous Ig therapy was well tolerated and biochemical abnormalities were not detected. For all 12 patients, statistically significant reductions were achieved in subjective symptoms, as quantified by a colitis activity score, and in daily doses of prednisone. Five of six patients who completed the treatment protocol improved clinically. Four of five who underwent post treatment colonoscopic and biopsy evaluations had unequivocal reductions in the intensity of colonic mucosal inflammation. Three patients who had objective improvement with intravenous Ig experienced relapses of colitis after discontinuation of this therapy. Of six patients who did not complete the treatment protocol, two required surgical intervention and four withdrew to undergo elective colectomy. Intravenous Ig may be beneficial in some patients with idiopathic colitis. The results of this pilot study justify the undertaking of prospective, randomized controlled trials to investigate the therapeutic efficacy and mode of action of intravenous Ig in different subsets of patients with idiopathic IBD.