Infliximab Treatment for Psoriasis in 120 Patients on Therapy for a Minimum of One Year: A Review

May 2011 | Volume 10 | Issue 5 | Original Article | 539 | Copyright © May 2011


Abstract

Infliximab is a chimeric monoclonal antibody, which acts by binding to both the soluble and membrane-bound tumor necrosis factor-a. In clinical practice, it is used as either monotherapy or in combination with other systemic therapies, particularly methotrexate. This study reviews clinical response and adverse events in 120 psoriasis patients with moderate-to-severe psoriasis who have received infliximab for a minimum of one year. The medical records of 120 infliximab-treated psoriasis patients at our referral psoriasis clinic in Dallas between 2002-2008 were reviewed for response rates, side effects and concomitant therapies. Of 120 charts reviewed, 112 (93%) patients had plaque type psoriasis, six (5%) had recalcitrant palmoplantar disease and two (1.6%) had severe acropustulosis of Hallopeau. Eighty-four (70%) patients had symptomatic psoriatic arthritis. The mean follow-up time was 2.2±1.1 years. One hundred and nine (91%) of the 120 patients had clearance of their psoriasis (response of more than 90% of initial BSA) at a median time of 12 weeks. Concomitant systemic treatments, primarily methotrexate, were given to 62 (52%) patients. Nineteen patients (16%) discontinued infliximab in the post-one-year treatment period for a variety of reasons, primarily failure to maintain adequate response. One hundred and four (87%) of patients required more than the standard dose of 5 mg/kg every eight weeks to maintain clearance. Infliximab either as monotherapy or in combination with traditional antipsoriatic agents is an effective and well-tolerated treatment option for patients with moderate to severe psoriasis and psoriatic arthritis on therapy for over one year and continuing for the long term.

J Drugs Dermatol. 2011;10(5):539-544.

INTRODUCTION

Psoriasis is a chronic, genetic, immune-mediated, inflammatory skin disorder affecting approximately two percent of the Caucasian population.1 Tumor necrosis factor-α (TNF-α) has been postulated to be a key regulator of T cell proliferation and the development of psoriasis.2 Infliximab is a chimeric human/murine monoclonal antibody specific for TNF-α. It acts by binding to both the soluble and membrane-bound TNF-α leading to reduced emigration of leukocytes by decreasing the levels of cellular adhesion molecules. It is administered for psoriasis intravenously at a traditional dose of 5 mg/kg over 2-3 hours at weeks 0, 2, 6 and then every eight weeks pending therapeutic response.3 Randomized controlled trials have shown that infliximab produces a rapid improvement in patients with moderate-to-severe psoriasis and psoriatic arthritis.4,5 It was approved for use in psoriasis by the European Medicines Agency in August 2005 and by the Food and Drug Administration in September 2006.
Concern about its long-term safety profile includes the risk of cancer and lymphomas, opportunistic infection, infusion-related side effects6 and triggering effects on demyelinating disorders.7 Although infliximab has been widely used in clinical practice for the treatment of psoriasis and psoriatic arthritis, there is limited data regarding its long-term efficacy, toxicity, and use in combination regimens for psoriasis. Phase III clinical studies of the use of infliximab in psoriasis were limited to monotherapy for one year.4,5
Since its approval in 2006, we have initiated infliximab therapy at our infusion clinic for severe psoriasis and psoriatic arthritis in over 300 patients. We conducted a retrospective review of 120 patients who had been maintained on infliximab for a minimum of one year.

METHODS

Approval from the Institutional Review Board of Baylor University Medical Center at Dallas was obtained. A review of charts of patients with psoriasis treated with infliximab for a minimum of one year, alone or in combination with other systemic drugs, was performed.