Remicade Effective in Treating Psoriasis
October 19, 2005
Remicade (infliximab), an established treatment for a variety of conditions, has been shown effective in treating moderate to severe psoriasis involving the skin, according to researchers in Germany. Infliximab is already approved for rheumatoid arthritis, Crohn's disease, psoriatic arthritis, ulcerative colitis and ankylosing spondylitis, according to MedPage Today.
Results of a study by Kristian Reich, MD, and colleagues on Remicade's efficacy in treating psoriasis were published in the 15 October 2005 edition of The Lancet and reported by MedPage Today on 14 October 2005.
The researchers chose to study infliximab because the drug inhibits the activity of tumour necrosis factor alpha, which is believed to be involved in the development of psoriasis:
"Tumour necrosis factor α (TNFα) is thought to play a part in the pathogenesis of psoriasis," the investigators wrote in The Lancet. "We assessed the efficacy and safety of continuous treatment with infliximab, a monoclonal antibody that binds to and neutralises the activity of TNFα, in patients with psoriasis."
Study Method
A total of 378 patients were randomized to receive Remicade (5 mg/kg) or placebo in a 4:1 ratio at weeks 0, 2 and 5, and then every 8 weeks to week 46. At week 24, the 77 patients originally assigned to placebo began to receive Remicade.
Eligible patients had moderate to severe plaque-type psoriasis for at least 6 months prior to the start of the study, with a PASI score of 12 or more, and at least 10% of total body surface area affected.
The primary endpoint was the percentage of patients who achieved at least a 75% improvement in PASI from baseline to week 10.
At week 24, 82% of Remicade patients and 4% of placebo patients maintained PASI 75, and while 58% of Remicade patients and 1% of placebo patients maintained PASI 90. These improvements were sustained through 50 weeks, when 61% of Remicade patients achieved PASI 75 and 45% achieved PASI 90.
Results
In the multi-center, double-blind study, at week 10, 80% of patients who received Remicade in an induction-and-maintenance regimen showed a 75% improvement in their psoriasis area and severity index (PASI 75), compared with baseline. Additionally, 57% of patients receiving Remicade achieved at least a 90% improvement in PASI (PASI 90) at 10 weeks, compared with 1% of patients on placebo.
In contrast, patients receiving placebo showed only a 3% improvement at 10 weeks, according to the investigators.
During the study, Remicade demonstrated "high efficacy, rapid onset, and long-term maintenance of therapeutic response for skin as well as nail lesions," said Reich and colleagues.
Accompanying Editorial
Also published in the same edition of The Lancet, an editorial by Michael P. Schon, MD, of the University of Wurzburg in Germany, stated Remicade and other biologicals' main advantage is their "low risk for end-organ toxicity and drug-drug interactions."
However, Schon noted that Remicade and other biologicals have not been extensively studied in comparison with established drugs used to treat psoriasis. Additionally, because Remicade suppresses the immune system by blocking tumor necrosis factor alpha, it may increase the risk of opportunistic infections, said Schon.
Sources:
Remicade
Shows Efficacy for Moderate to Severe Psoriasis, MedPage Today,
14 October 2005.
Infliximab induction and maintenance therapy for moderate-to-severe
psoriasis: a phase III, multicentre, double-blind trial, Reich
K, et al, The Lancet, volume 366, pages 1367-1374, 2005.
Pharma Industry News Archive
2007: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2006: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2005: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2004: Jan | Feb | Mar | Apr | May | Jul | Aug | Sep | Oct | Nov | Dec
2003: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2002: Jan | Apr | May | Jun | Aug | Sep | Oct | Nov | Dec
