Findings from an integrated analysis of data from three pivotal, randomised, placebo-controlled trials showed that at week 10 more than three-quarters of patients with severe psoriasis receiving Remicade 3 mg/kg or 5 mg/kg achieved a 75 per cent improvement in the chronic, inflammatory skin disease as measured by the Psoriasis Area Severity Index (PASI 75).
In addition, in a separate analysis, investigators presented findings from a phase 3 study, which showed that patients treated with Remicade experienced significant and progressive improvements in psoriasis affecting the nails. Nail disease occurs in up to 50 per cent of people with psoriasis1. These findings were presented today at the 65th Annual Meeting of the American Academy of Dermatology.
"The integrated data show the substantial efficacy of Remicade and present great hope for patients with severe psoriasis, particularly those patients burdened with this chronic disease who previously failed phototherapy or systemic therapy," said Alan Menter, MD, dermatologist, Baylor Research Institute, Dallas, and lead study investigator.
In the analysis of 1,462 randomised patients, 991 patients (68 percent) met criteria for severe disease as defined by a body surface area (BSA) of at least 20 percent. Out of the 991 patients, 73 per cent and 69 per cent of study patients had received previous phototherapy or systemic therapy, respectively.
At week 10, among patients with severe psoriasis treated with Remicade, 79 per cent of patients who had received prior phototherapy and 76 per cent who had been previously treated with one or more systemic agents achieved PASI 75, compared with three per cent and one per cent, respectively, of placebo patients.
"These data are promising because the results demonstrate the efficacy of Remicade in psoriasis patients whose disease is affecting the nails, a difficult-to-treat and chronic manifestation that can affect a large proportion of patients with psoriasis," said Phoebe Rich, MD, associate professor of dermatology, Oregon Health Sciences University. "Symptoms associated with nail disease may include deep holes in the nails or separation of the nails from the nail beds, which often result in pain and discomfort and may affect an individual's ability to perform daily activities. Given the nature of these symptoms, effectively treating both skin disease and nail disease, may greatly lessen the patients' overall burden of disease."