An integrated analysis of data from three pivotal trials shows that patients with severe psoriasis experienced significant improvements with Remicade therapy//.
Three pivotal, randomized, placebo-controlled trials showed that more than three-quarters of patients with severe psoriasis receiving REMICADE? (infliximab) 3 mg/kg or 5 mg/kg achieved a 75 percent 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 percent of people with psoriasis. 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 1462 randomized 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 percent and 69 percent of study patients had received previous phototherapy or systemic therapy, respectively. At week 10, among patients with severe psoriasis treated with REMICADE (combined 3 mg/kg and 5 mg/kg groups), 79 percent of patients who had received prior phototherapy and 76 percent who had been previously treated with one or more systemic agents achieved PASI 75, compared with three percent and one percent, respectively, of placebo patients (P < 0.001, for both).
In a separate analysis from the Evaluation of Inflix
imab for Psoriasis in a [REMICADE] Efficacy and Safety Study (EXPRESS II), among patients with severe psoriasis who were either dissatisfied with or were intolerant to phototherapy, 73 percent of those treated with REMICADE achieved PASI 75 at week 10, compared with two percent of patients receiving placebo (P < 0.001). Sixty-nine percent of patients who were dissatisfied with or were intolerant to one or more systemic therapies prior to starting REMICADE achieved PASI 75 at week 10, compared with zero patients in the placebo group (P < 0.001).
A separate analysis from the European Infliximab for Psoriasis [REMICADE] Efficacy and Safety Study (EXPRESS) trial showed that among study patients with psoriasis affecting the nails at baseline who were treated with REMICADE 5 mg/kg, seven percent, 26 percent and 45 percent had clearance of nail psoriasis at weeks 10, 24 and 50, respectively, compared with 5 percent of patients in the placebo group at week 24 (P = 0.0002). In addition, at weeks 10 and 24, the mean percent improvements in the Nail Psoriasis Severity Index (NAPSI) scores were 27 percent and 57 percent, respectively, among patients in the REMICADE 5 mg/kg group compared with disease worsening observed among patients receiving placebo with increases in NAPSI scores of eight percent and four percent, respectively (P < 0.001, for both).
"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."
The progressive improvements in nail psoriasis observed in patients receiving REMICADE 5 mg/kg were consistent with normal nail growth rates, and the improvement was sustained over time. Treatment also resulted in significant improvements in nail matrix and nail bed signs of the disease, as measured by the NAPSI scoring system, including lunular red spots and splinter hemorrhages (small areas of bleeding under the nails), which completely resolved in two-thirds of REMICADE-treated patients at 10 weeks. The NAPSI scoring system evaluates nail bed psoriasis and nail matrix psoriasis by area of involvement in the nail unit and assesses eight characteristic features of psoriatic nail involvement, including pitting, leukonychia (discoloration), nail plate crumbling, red spots in the lunula (crescent-shaped area at bottom of nail), onycholysis (separation of nail from nail bed), nail bed hyperkeratosis (thickening of skin), splinter hemorrhages and oil drop discoloration.
In September 2006, REMICADE was approved in the U.S. for the treatment of adult patients with chronic severe (i.e. extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. The recommended dose is an infusion of 5 mg/kg followed by additional doses at two and six weeks after the first infusion and then every eight weeks thereafter.
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