UCB and Dermira are expecting to file anti-inflammatory Cimzia for psoriasis in the third quarter of this year, after the drug's strong performance in a late-stage trial involving patients with severe chronic plaque forms of the skin disease.
Data from the CIMPACT study, the last of three to assess Cimzia (certolizumab pegol) in this patient population, showed that the drug induced significant improvements in skin clearance compared to placebo.
At week 12, the response rate for patients who achieved a PASI 75 was 66.7 percent for those receiving Cimzia 400mg every two weeks and 61.3 percent for those getting Cimzia 200mg every two weeks, compared to just 5.0 percent for patients in the placebo group.
At week 16, response rates for patients who achieved a PASI 75 were 74.7 percent and 68.2 percent, respectively, versus 3.8 percent for those taking a placebo.
The firms noted that in all three CIMZIA Phase III clinical trials, the drug demonstrated statistically significant improvements for all primary or co-primary endpoints compared to placebo at both treatment doses.
"The results from CIMPACT support our belief that Cimzia may one day be an important treatment option for patients living with psoriasis," noted Emmanuel Caeymaex, head of Immunology and executive vice president, Immunology Patient Value Unit, UCB, who also said that additional data from the trials will be shared at an upcoming medical congress.
Cimzia is approved for use in rheumatoid arthritis, active psoriatic arthritis, ankylosing spondylitis and axial spondyloarthritis.