UCB and Dermira have reported positive results from its Phase III CIMPACT trial of Cimzia (certolizumab pegol) to treat adult patients with moderate-to-severe chronic plaque psoriasis.
Cimzia is an Fc-free, PEGylated anti-tumour Necrosis Factor(TNF) with high affinity for human TNF-alpha and specifically neutralises its pathophysiological effects.
It is currently indicated to treat adults with moderate-to-severe active rheumatoid arthritis, active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS).
Additionally, it can also be used to treat symptoms of Crohn's disease and maintain a clinical response in adult patients who are not responsive to conventional therapy.
The Phase III CIMPACT study was conducted as a multi-centre, placebo-controlled and active-controlled clinical trial intended to determine the safety and efficacy of Cimzia while examining 559 patients with psoriasis.
The trial was held as a part of a Phase III clinical development programme carried out by Dermira and UCB, which enrolled 1,000 patients with moderate-to-severe chronic plaque psoriasis, including patients who were either treated or not treated with biologic products.
During the trial, the patients were randomised into one of four dosing arms of CIMZIA at 400mg every two weeks, CIMZIA at 400mg at weeks 0, 2, and 4, 200mg of CIMZIA every two weeks and ENBREL at 50mg on a twice-weekly basis or placebo every two weeks.
Results suggested that the study achieved its primary endpoint as patients experienced 75% or greater disease improvement determined on the basis of psoriasis area and severity index (PASI 75) compared with placebo.
It had also met its secondary efficacy endpoint, which was indicated when a safety parameter was compared between CIMZIA and placebo on the basis of PASI scores.
Dermira CEO Tom Wiggans said: “We are pleased that the CIMPACT results are consistent with the efficacy and safety findings observed in two earlier trials evaluating CIMZIA in patients with moderate-to-severe plaque psoriasis.
“Both companies look forward to submitting the data to regulatory authorities to support a potential approval of CIMZIA as a treatment option for moderate-to-severe chronic plaque psoriasis.”
Image: Psoriasis of the palms. Photo: courtesy of US Military / Wikipedia.
