ORLANDO – Results from two phase III trials indicated the tumor necrosis factor alpha inhibitor certolizumab pegol led to significant improvements in moderate to severe chronic plaque psoriasis, compared with placebo, according to an oral presentation at this year’s annual Academy of Dermatology Meeting.
Across the CIMPASI-1 and CIMPASI-2 trials, at 16 weeks, both certolizumab pegol (Cimzia) 400 mg and 200 mg, administered subcutaneously every 2 weeks in groups of patients with moderate to severe chronic plaque psoriasis, demonstrated statistically significant, clinically meaningful improvements in Psoriasis Area and Severity Index (PASI) scores, and on the Physician Global Assessment (PGA) scores, when compared with placebo. The data were presented by Alice B. Gottlieb, MD, PhD, professor of dermatology at New York Medical College, Valhalla. Certolizumab pegol currently is approved in the United States for use in psoriatic arthritis, but not for psoriasis.
In CIMPASI-1, 234 mostly white male patients in their mid-40s who had moderate to severe chronic plaque psoriasis were randomly assigned to one of three groups. There were 88 participants in the arm given 400 mg every 2 weeks at weeks 0, 2, and 4; 95 given 200 mg at weeks 0, 2, and 4; and 51 given placebo. At week 16, the percentage of patients who achieved a PASI 75 was 75.8% in the first group, 66.5% in the second, and 6.5% for placebo. A PGA scale improvement of at least two points over baseline toward a final score of clear or almost clear skin at week 16 was 57.9% for group 1, 47.0% for the second group, and 4.2% for placebo.
Also at week 16, the percentage of patients who achieved a PASI 90 was 43.6% in the 400 mg dose group, 35.8% in the 200 mg dose group, and 0.4% in the placebo group.
In CIMPASI-2, 227 mostly white patients with moderate to severe chronic plaque psoriasis, most of whom were in their mid-40s, evenly distributed across the sexes, were randomly assigned to one of three groups. There were 87 participants in the 400 mg every 2 weeks at weeks 0, 2, and 4 group; 91 in the 200 mg every 2 weeks at weeks 0, 2, and 4 arm, and 49 in the placebo group. At week 16, 82.6% of patients in the first group and 81.4% in the second group had a PASI 75, compared with 11.6% of the placebo group. Also at 16 weeks, a PGA scale improvement of at least two points over baseline toward a final score of clear or almost clear skin at week 16 was 71.6% for group 1, 66.8% for the second group, and 2.0% for placebo. At week 16, 55.4% of patients receiving the 400 mg dose had a PASI 90, as did 52.6% of patients receiving the 200 mg dose every 2 weeks, compared with only 4.5% of the placebo group.
Additionally, Dr. Gottlieb said that at week 16, patients in the 400-mg and 200-mg groups showed significant improvements over baseline Dermatology Life Quality Index (DLQI) average scores, compared with placebo: a 10.2 decrease in the 400-mg group and a 9.3 decrease in the 200-mg group, compared with a 3.3 decrease in the placebo arm (P less than .001) in the CIMPASI-1 study. In the CIMPASI-2 study at week 16, there was a drop of 10.0 DLQI in average scores in the 400-mg group, 10.4 in the 200-mg group, and an average drop of only 3.8 in controls (P less than .001).
Dr. Gottlieb, who disclosed that her mother suffers from severe plaque psoriasis, told the audience that the patient improvements were on par with those seen with infliximab, which she said was “the best anti–TNF alpha in the pack to date, and that’s an intravenous drug. These are impressive drops in the DLQI.”
Adverse events were, said Dr. Gottlieb, “a whole lot of nothing. There’s nothing that stands out.” She said there were no cases of tuberculosis, one case of vulvovaginal candidiasis, and equal distribution of herpes zoster across the study.
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