Infliximab is a chimeric anti-TNF- monoclonal antibody that is given by intravenous infusion. It was the first anti-TNF therapy studied for the treatment of psoriasis, and is currently approved by the FDA for the treatment of moderate to highly active rheumatoid arthritis (in combination with methotrexate) and moderate to highly active Crohn's disease or for those patients who have rheumatoid arthritis or Crohn's disease and have failed previous conventional treatments, as well as psoriatic arthritis. A double-blind study by Chaudhari and colleagues showed that infliximab provides substantial clinical efficacy with high tolerability. Specifically, 82% and 73% of patients with psoriasis receiving 5 and 10 mg/kg of infliximab, respectively, achieved a PASI-75 at week 10. An open-label phase of the same study showed that at week 26, PASI response was maintained in 40 % and 73 % of patients receiving 5 and 10 mg/kg of infliximab, respectively. A double blind, placebo-controlled, phase 2 trial conducted by Gottlieb and colleagues found that at week 10 (intravenous infusions of placebo or infliximab at either 3 or 5 mg/kg given at weeks 0, 2, and 6), 72% of patients treated with infliximab (3 mg/kg) and 88 % of patients treated with infliximab, 5 mg/kg, achieved a PASI-75 or greater, compared to only 6 % of those receiving placebo. These improvements were seen as early as 2 weeks. More recently a phase 3, double-blind study examined the utility of infliximab as an induction and maintenance therapyto moderate to severe psoriasis. Patients were randomized to receive infliximab 5 mg/kg or placebo at weeks 0, 2, and 6, and then every 8 weeks until week 46. Those patients receiving placebo were crossed over to receive infliximab at week 24. At week 10, 80 % of patients treated with infliximab achieved a PASI-75 and 57 % achieved a PASI-90, compared to 3 % and 1 %, respectively, in the placebo group. PASI-75 scores were maintained at week 24 as well (82 % for infliximab compared to 4% for placebo). At week 50, 61 % of the infliximab treated patients achieved a PASI-75 and 45% achieved a PASI-90, showing a sustained effect.
Overall, infliximab has been well tolerated in clinical trials. The most common adverse events reported in 10% or more of infliximab treated patients include headache, nausea, and upper respiratory tract infection (Winterfield and Menter 2004). Similar safety issues are seen in patients receiving infliximab as are seen in eta-nercept treated patients including infections and reactivation of tuberculosis (with mandatory PPD testing), demyelinating conditions, congestive heart failure, malignancy, and autoimmunity.
Infliximab is approved by the EMEA and is filed at the FDA for treatment of moderate to severe psoriasis. Its use in the treatment of many other dermatological conditions has been reported and includes the following: Behcet's, graft versus host disease, hidradenitis suppurativa, panniculitis, pyoderma gangrenosum, SAPHO (synovitis, acne, hyperostosis, and osteitis), sarcoidosis, subcorneal pustular dermatosis, Sweet's syndrome, toxic epidermal necrolysis, and Wegener's syndrome.
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