-
-
Intravenous immunoglobulin therapy for
active, extensive, and medically refractory
idiopathic ulcerative or Crohn's colitis.
Levine DS, Fischer SH, Christie DL, Haggitt
RC, Ochs HD.
Department of Medicine, University of Washington
Medical Center, Seattle.
To determine whether intravenous immunoglobulin
produces demonstrable clinical improvement i
-
n patients with refractory idiopathic
inflammatory bowel disease, a pilot, open-label,
nonrandomized
-
, safety and therapeutic efficacy study was
carried out at a tertiary care referral medical
center.
-
Twelve consecutive patients with refractory
idiopathic colitis (nine ulcerative colitis,
three Crohn's colitis)
-
who were reluctant to receive
immunosuppressive therapy or have surgical
intervention were
-
referred by physicians not participating as
investigators in this study. Eleven patients
were symptomatic
-
for at least 6 months, with endoscopically
moderate or severe mucosal inflammation despite
-
medical therapy, including systemic
corticosteroids in all cases, and one patient
was
-
dependent on oral prednisone to remain in
clinical remission. Ten patients had extensive
colitis,
-
six of whom had pancolitis and four of whom had
colitis extending to the hepatic flexure or
transverse
-
colon. Nine patients required
hospitalization for treatment of colitis.
Intravenous immunoglobulin was
-
administered in one or two induction phases (2
g/kg over 2 or 5 days), followed by a
maintenance phase
-
(200-500 mg/kg every 2 wk for 12 or 24 wk).
Tapering of systemic corticosteroid therapy was
attempted,
-
whereas other medications for idiopathic
colitis were continued. Treatment response was
assessed
-
clinically and by colonoscopy with multiple
biopsies whenever possible. Immunoglobulin
therapy was
-
well-tolerated and did not produce any
biochemical abnormalities. In six patients who
completed
-
the treatment protocol, mean reductions +/- SE
were achieved in subjective symptoms as
quantified by
-
a colitis activity score, 13.3 +/- 1.2 to 4.7
+/- 0.9 (p less than 0.001), and daily mg dose
of prednisone,
-
41.7 +/- 8.0 to 1.9 +/- 1.2 (p less than
0.001). For all 12 patients, statistically
significant reductions were
-
achieved in the colitis activity score and daily
prednisone dose. Of five patients who completed
the
-
treatment protocol and improved clinically, four
underwent post-treatment colonoscopic and biopsy
-
evaluations and had unequivocal reductions in
the intensity of colonic mucosal inflammation.
Three
-
patients who had objective improvement with
intravenous immunoglobulin experienced relapses
of
-
colitis after discontinuation of this therapy.
Six patients did not complete the treatment
protocol,
-
two of whom required surgical intervention and
four of whom withdrew to undergo colectomy
electively.
-
Intravenous immunoglobulin may be beneficial in
subsets of patients with idiopathic colitis. The
results
-
of our pilot study justify the undertaking of a
prospective, randomized controlled trial to
determine the
-
efficacy of intravenous immunoglobulin in
carefully defined subsets of patients with
idiopathic inflammatory bowel disease.
