Infliximab is a chimaeric monoclonal antibody which binds to and inhib
its the activity of tumour necrosis factor-alpha (TNF alpha), a cytoki
ne which is involved in the development of both Crohn's disease and rh
eumatoid arthritis. In patients with treatment-resistant Crohn's disea
se, infliximab was significantly more effective than placebo in the re
lief of symptoms. 50 to 89% of patients responded to infliximab and mo
st of them also achieved remission. Patients showed signs of relapse 8
to 12 weeks after a single infusion but responded to additional infus
ions of the drug. Infliximab was also effective in closing the fistula
e in 68% of patients with fistulising Crohn's disease; the response ra
te with placebo was 26%. Infliximab achieved a clinical response in 44
to 81% of patients with refractory rheumatoid arthritis. Following a
single infusion, symptom recurrence was evident after 6 to 12 weeks, b
ut subsequent infusions re-established a clinical response. Concurrent
methotrexate appeared to prolong the effects of infliximab in this pa
tient group. Anti-infliximab and anti-double-stranded DNA antibodies d
eveloped in some patients, particularly those who received multiple in
fusions of infliximab. Acute adverse events consistent with hypersensi
tivity occurred in some patients who received multiple infusions of in
fliximab. Infection occurred slightly more frequently with infliximab
than with placebo. Conclusions: Infliximab appears to be an effective
therapy for patients with treatment-resistant or fistulising Crohn's d
isease or refractory rheumatoid arthritis. The tolerability, long term
efficacy and optimal dosage regimen need to be further defined in com
parative trials before the full potential of infliximab is realised in
these patients.