In the IMPACT ( Infliximab Multinational Psoriatic Arthritis Controlled Trial ) study, 104 patients with active psoriatic arthritis who had failed at least one DMARD ( disease-modifying antirheumatic drug ) were enrolled at nine centers in the United States, Canada and Europe.
Results demonstrated the safety and efficacy of Infliximab ( Remicade ) in treating this debilitating disorder.
The proportion of Infliximab-treated patients who achieved an ACR20 response at week 16 ( 65% ) was significantly higher than the proportion of placebo-treated patients who achieved this response ( 10% ).
In addition, 46% of Infliximab-treated patients achieved an ACR50 response, and 29% achieved an ACR70 response; no placebo-treated patient achieved these end points.
Among patients who had PASI scores of >/=2.5 at baseline, 68% of Infliximab-treated patients achieved improvement of >/=75% in the PASI score at week 16 compared with none of the placebo-treated patients.
Continued therapy with Infliximab resulted in sustained improvement in articular and dermatologic manifestations of psoriatic arthritis through week 50.
The incidence of adverse events was similar between the treatment groups.
Infliximab is a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha which has been shown to play a role in Crohn's disease, rheumatoid arthritis, ankylosing spondylitis and psoriasis, and may also be important in a wide range of other immune-mediated inflammatory disorders.
There are reports of serious infections, including tuberculosis and sepsis. Some of these infections have been fatal.
Remicade can lower the ability to fight infections.
In 2004, Centocor alerted U.S. healthcare professionals about hematologic and neurologic events that have occurred in patients being treated with Remicade.
The hematologic events, some of them fatal, have included leukopenia, neutropenia, thrombocytopenia and pancytopenia.
Although it's not clear that Remicade therapy causes these events and no high risk groups have been identified, Centocor advised practitioners to be cautious with patients who have significant hematologic abnormalities, or a history of these problems.
The company also informed that all patients on Remicade should be told to seek immediate medical attention if they develop signs suggestive of blood dyscrasias or infection, such as persistent fever, bruising or bleeding.
Practitioners should consider discontinuing Remicade therapy in patients who develop significant hematologic abnormalities.
The neurologic events have included rare cases of a central nervous system manifestation of systemic vasculitis.
Practitioners should consider discontinuing Remicade in patients who develop significant CNS reactions.
1) Arthritis & Rheumatism, 2005
2) FDA, 2004