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Montreal,
QC—Infliximab (Remicade®) clears
psoriasis very rapidly. The monoclonal antibody is safe, well-tolerated,
and may be superior to other biologics, said Ian Landells, MD, at
Dermatology Update.
“My colleague had a patient whose psoriatic arthritis confined
her to a wheelchair. After two doses of this drug, her skin was
clear, she was out of the chair shoveling her driveway, and she
was not showing any side effects,” said Dr. Landells, clinical
assistant professor of dermatology, Memorial University of Newfoundland,
St. John’s. “It was a very, very impressive response.”
Efficacy and safety was demonstrated in the SPIRIT trial. The multicentre,
randomised, double-blind, placebo-controlled trial enrolled 249
patients with moderate-to-severe psoriasis.
Inclusion criteria were: age greater than 18 years, psoriasis affecting
at least 10 per cent of the body surface, a PASI score of at least
12, and previous unsuccessful treatment with an anti-psoriatic agent.
Any history of chronic infectious disease, any opportunistic infection,
and any serious infection were grounds for exclusion, Dr. Landells
said. “There is a concern that if somebody has TB it can be
reactivated with tumour necrosis factor-alpha inhibitors. It is
important to point out to physicians and the public that TNF alpha
inhibitors do not cause TB, they reactivate it.”
Patients were randomised to either placebo (n=51), infliximab 3
mg/kg (n=99), or infliximab 5 mg/kg (n=99). They were assessed at
Weeks two, four, six, eight, and 10, using the PASI.
By Week 10, one person in the placebo arm, 72 per cent of the 3
mg/kg arm, and 88 per cent of the 5 mg/kg arm had improved by at
least 75 per cent. About 60 per cent of the 5 mg/kg arm achieved
PASI-90 (a 90 per cent improvement), which is clear or almost clear.
The therapy was not associated with any significant adverse events.
Headache, itching, fatigue, and backache were reported; more side
effects were reported at Week 30 than at Week 10.
“If you follow a group of people long enough they’re going
to have more coughs, aches, and pains, etc.” One serious adverse
event, cholecystitis, was reported in the 3 mg/kg arm. “You
never know if these things are related to the drug or not, but they
have to be reported.”
Although there is concern that infliximab may cause infusion reactions
in some individuals, only six per cent of the people who received
the therapy reported reactions. All the reactions were mild to moderate
(the one patient who was initially thought to have had a severe
infusion reaction was found to have back pain). Most of the patients
who had had reactions were premedicated (eg, acetaminophen and diphenhydramine)
before successive infusions, so that those infusions were well tolerated.
The results of other trials have shown that infliximab is more effective
than some of the other biologics. At 10 weeks, infliximab was associated
with a 75 per cent improvement in psoriasis in 80 per cent of patients;
etanercept, 49 per cent; and alefacept, 33 per cent.
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