New analyses reinforce efficacy of Remicade in treatment of severe psoriasis

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.