FDA News

FDA expands approval of Cimzia for moderate-to-severe plaque psoriasis

Emmanuel Caeymaex

The FDA has approved a label extension for UCB’s TNF inhibitor Cimzia to include an indication for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, according to a company press release.

“Cimzia is the first Fc-free biologic of its kind approved by the FDA to treat this challenging skin condition, building on 10 years of market experience with demonstrated efficacy and established safety across multiple inflammatory diseases,” Emmanuel Caeymaex, head of immunology and executive vice president of the immunology patient value unit at UCB, said in the release. “This approval reflects our heritage of making a difference for specific patient populations with unmet needs, and we are especially gratified to welcome immuno-dermatology patients for the first time to our community of support.”

Caeymaex added that the approval of Cimzia (certolizumab pegol) for psoriasis, as well as its recent label update regarding pregnancy and breastfeeding in women with chronic inflammatory diseases, are important treatment advances.

The FDA has approved a label extension for UCB’s TNF inhibitor Cimzia to include an indication for adults with moderate-to-severe plaque psoriasis.
Source: Shutterstock

“UCB is committed to improving care for psoriasis patients and is also investigating bimekizumab, a therapy with significant potential for psoriasis patients,” he said in the release.

The FDA decision was based on data from a phase 3 clinical development program that included the CIMPASI-1, CIMPASI-2 and CIMPACT studies, according to the release. The trials enrolled more than 1,000 patients, of whom nearly one-third had prior biologic exposure. According to UCB, the studies confirmed certolizumab’s safety and 48-week durable efficacy in the treatment of adults with moderate-to-severe plaque psoriasis.

In addition, each of the studies assessed the percentage of patients who achieved at least 75% and 90% or greater disease improvement from baseline, as measured by the Psoriasis Area and Severity Index (PASI 75 and PASI 90), compared with placebo. These results were achieved within 16 weeks in the CIMPASI-1 and CIMPASI-2 trials, and within 12 weeks in the CIMPACT study. The studies also determined the percentage of patients who achieved at least a 2-point improvement on a 5-point Physician’s Global Assessment scale to a final score, representing clear or almost clear skin, each compared with placebo, at week 16.

In all three trials, certolizumab demonstrated statistically significant improvements for all primary and coprimary endpoints compared with placebo at all tested doses, with clinical benefits maintained through to week 48, according to the press release.

“This is especially relevant news given that the disease requires multiple treatment options,” Alice Gottlieb, MD, PhD, professor of dermatology at New York Medical College, and the studies’ lead investigator, told Healio Rheumatology. “These findings and the new approval in psoriasis that they support are significant because they build on four years of efficacy and safety data in psoriatic arthritis.”

The updated label recommends a 400-mg dose of certolizumab for adults with moderate-to-severe plaque psoriasis, administered through two subcutaneous injections measuring 200 mg each, every other week. For some patients with a body weight of 90 kg or less, certolizumab 400 mg, given as two subcutaneous injections of 200 mg each, initially and at weeks 2 and 4 followed by 200 mg every other week, can be considered.

“Due to the unique nature of psoriasis, it is critical for dermatologists to have as many options as possible to find the right treatment for each patient,” Michael Siegel, PhD, senior vice president of research and clinical affairs for the National Psoriasis Foundation, said in the release. “It’s a great day when new psoriasis treatments come to market, as both dermatologists and patients are given hope that this could be the treatment that will work for them.” – by Jason Laday

Emmanuel Caeymaex

The FDA has approved a label extension for UCB’s TNF inhibitor Cimzia to include an indication for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, according to a company press release.

“Cimzia is the first Fc-free biologic of its kind approved by the FDA to treat this challenging skin condition, building on 10 years of market experience with demonstrated efficacy and established safety across multiple inflammatory diseases,” Emmanuel Caeymaex, head of immunology and executive vice president of the immunology patient value unit at UCB, said in the release. “This approval reflects our heritage of making a difference for specific patient populations with unmet needs, and we are especially gratified to welcome immuno-dermatology patients for the first time to our community of support.”

Caeymaex added that the approval of Cimzia (certolizumab pegol) for psoriasis, as well as its recent label update regarding pregnancy and breastfeeding in women with chronic inflammatory diseases, are important treatment advances.

The FDA has approved a label extension for UCB’s TNF inhibitor Cimzia to include an indication for adults with moderate-to-severe plaque psoriasis.
Source: Shutterstock

“UCB is committed to improving care for psoriasis patients and is also investigating bimekizumab, a therapy with significant potential for psoriasis patients,” he said in the release.

The FDA decision was based on data from a phase 3 clinical development program that included the CIMPASI-1, CIMPASI-2 and CIMPACT studies, according to the release. The trials enrolled more than 1,000 patients, of whom nearly one-third had prior biologic exposure. According to UCB, the studies confirmed certolizumab’s safety and 48-week durable efficacy in the treatment of adults with moderate-to-severe plaque psoriasis.

In addition, each of the studies assessed the percentage of patients who achieved at least 75% and 90% or greater disease improvement from baseline, as measured by the Psoriasis Area and Severity Index (PASI 75 and PASI 90), compared with placebo. These results were achieved within 16 weeks in the CIMPASI-1 and CIMPASI-2 trials, and within 12 weeks in the CIMPACT study. The studies also determined the percentage of patients who achieved at least a 2-point improvement on a 5-point Physician’s Global Assessment scale to a final score, representing clear or almost clear skin, each compared with placebo, at week 16.

In all three trials, certolizumab demonstrated statistically significant improvements for all primary and coprimary endpoints compared with placebo at all tested doses, with clinical benefits maintained through to week 48, according to the press release.

“This is especially relevant news given that the disease requires multiple treatment options,” Alice Gottlieb, MD, PhD, professor of dermatology at New York Medical College, and the studies’ lead investigator, told Healio Rheumatology. “These findings and the new approval in psoriasis that they support are significant because they build on four years of efficacy and safety data in psoriatic arthritis.”

PAGE BREAK

The updated label recommends a 400-mg dose of certolizumab for adults with moderate-to-severe plaque psoriasis, administered through two subcutaneous injections measuring 200 mg each, every other week. For some patients with a body weight of 90 kg or less, certolizumab 400 mg, given as two subcutaneous injections of 200 mg each, initially and at weeks 2 and 4 followed by 200 mg every other week, can be considered.

“Due to the unique nature of psoriasis, it is critical for dermatologists to have as many options as possible to find the right treatment for each patient,” Michael Siegel, PhD, senior vice president of research and clinical affairs for the National Psoriasis Foundation, said in the release. “It’s a great day when new psoriasis treatments come to market, as both dermatologists and patients are given hope that this could be the treatment that will work for them.” – by Jason Laday