Monoclonal Antibodies Be Used to Treat Psoriasis?
Efficacy and Safety of Infliximab Monotherapy for Plaque-Type
Psoriasis: A Randomised Trial
Chaudhari U, Romano P, Mulcahy L, Dooley L and others
Lancet 2001; 357: 1842-47 (June 9)
treatments available for severe psoriasis are associated with
serious toxic effects (e.g. methotrexate and ciclosporin). Tumor
necrosis factor appears to have a significant role in the
pathogenesis of psoriasis. This randomized US study examines
whether infliximab, a monoclonal antibody against tumor necrosis
factor, can have a role in the safe treatment of severe
were adult patients with moderate-to-severe plaque psoriasis
involving at least 5% of body surface area. They were recruited
at a dermatology department and by advertisement; all had a
history of topical corticosteroid failure. The subjects were
randomly assigned into three groups that received placebo,
infliximab 5 mg/kg or infliximab 10 mg/kg by intravenous
infusion at weeks zero, two, and six. Treatments were given
double-blind. The patients were not allowed to use any other
treatments for their psoriasis during the study except for
non-medicated emollients and non-prescription shampoos.
Follow-up continued for ten weeks after the start of study
primary outcome measure were the physician's global assessment
(PGA) at week ten. The PGA is an overall assessment of the
psoriasis relative to baseline. A positive response was defined
as attaining good clearing (50-74%), excellent clearing (75-99%)
or clear (100 %). The Psoriasis Area Severity Index (PASI) was a
secondary outcome measure. The PASI is based on the level of
erythema, scaling, and thickness of plaques in four anatomical
areas (head, trunk, arms, legs). The maximum PASI score is 72.
Patients were also carefully monitored for all adverse events.
patients were enrolled; 11 were assigned to each treatment
group. One dropped out from each group and 10 completed their
planned treatments. Mean age was 44 years. The mean baseline
PASI was 20.3 in the placebo group, 22.1 in the infliximab 5
mg/kg group, and 26.6 in the 10 mg/kg group.
responses to treatment occurred in nine subjects in the
infliximab 5 mg/kg group, ten subjects in the 10 mg/kg group,
and only two subjects in the placebo group. Nine and seven,
respectively, of the positive responders in the two infliximab
groups achieved either an excellent or clear rating on the PGA.
The PASI score improved by at least 75% in nine, eight, and two
subjects in the three groups, respectively. The mean percentage
improvement in PASI score was significantly higher in the
infliximab-treated patients as early as week two of therapy.
were no serious adverse events. Headache occurred in seven of
the eleven patients who received 10 mg per kg infliximab
compared with two of eleven patients in the placebo group.
results suggest that infliximab is an effective treatment for
severe psoriasis with no serious adverse events identified in
this small cohort of patients in the short-term. Infliximab
treatment is not without risk; studies in patients with
rheumatoid arthritis and Crohn's disease have shown its
potential to reactivate tuberculosis and there is a question as
to whether there is an associated increased risk of lymphoma.
Further studies are needed to determine whether these impressive
short-term results for both safety and efficacy in the treatment
of psoriasis persist in the longer term.
Words: Infliximab, Psoriasis, Monoclonal antibodies, Treatment.
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