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Psoriasis Patients Improve With Infliximab (Remicade) Treatment: Presented at EADV

By Jill Stein

RHODES, GREECE -- October 11, 2006 -- The tumour necrosis factor alpha (TNF-a) antagonist infliximab (Remicade) is effective and safe for the management of plaque psoriasis, according to phase 3 results announced at the 15^th Congress of the European Academy of Dermatology and Venereology (EADV).

Alice Gottlieb, MD, dermatologist-in-chief, Tufts-New England Medical Center, Boston, Massachusetts, United States, and colleagues conducted a randomised study in 835 patients with moderate-to-severe psoriasis participating in the Evaluation of Infliximab for Psoriasis Efficacy and Safety (EXPRESS) II trial.

The study evaluated the safety and efficacy of induction doses of infliximab 3 mg/kg or 5 mg/kg, or placebo, at weeks 0, 2, and 6.

All participants had plaque-type psoriasis for at least 6 months, psoriasis area and severity index (PASI) of 12 or greater, body surface area of 10% or greater, and were candidates for phototherapy or systemic psoriasis treatment.

Patients who were on standard concomitant psoriasis therapies were not eligible for the trial.

Patients in the active induction treatment groups were randomised again at week 14 to receive either scheduled or "as-needed" maintenance treatment at the same dose administered during the induction phase.

At week 16, patients assigned to the placebo group crossed over to receive infliximab 5 mg/kg at weeks 16, 18, and 22, then every 8 weeks through week 46.

The treatment groups were well balanced in terms of demographic characteristics, baseline disease history, and psoriasis medication history.

Overall, 70% of patients treated with infliximab 3 mg/kg and 75% of patients treated with 5 mg/kg achieved at least 75% improvement in PASI score from baseline at week 10 compared with 2% of placebo-treated patients.

During the maintenance phase, a more sustained improvement was observed with regularly scheduled compared with as-needed maintenance therapy regimens within each dose. At week 50, patients receiving 5 mg/kg as regularly scheduled maintenance had the highest level of sustained improvement in PASI scores.

Results also showed that 62% of patients in the 3-mg/kg and 69% of patients in the 5-mg/kg treatment groups developed adverse effects during the placebo-controlled induction phase versus 55% of placebo-treated patients.

Infliximab was generally well tolerated, the researchers said.

The results show that infliximab 3 or 5 mg/kg administered at weeks 0, 2, and 6 significantly improved signs and symptoms of psoriasis compared with placebo at week 10 as measured by PASI response.

From week 14 through 50, the 5-mg/kg q8-week maintenance schedule was optimal for maintaining response and more patients in the q8-week maintenance groups compared with their respective PRN maintenance groups achieved PASI responses.

While infliximab was usually well tolerated, careful monitoring is appropriate, according to the researchers.

Psoriasis is a chronic inflammatory skin condition that affects approximately 1% to 3% of the population worldwide.


[Presentation title: One-Year Phase III Results of Infliximab for the Treatment of Moderate-to-Severe Psoriasis: EXPRESS II. Abstract P035.88]

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