The FDA has approved extending the label for UCB’s Cimzia (certolizumab pegol) to include a new indication in adults with moderate-to-severe plaque psoriasis. Cimzia is indicated for the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.
The approval makes Cimzia the first Fc-free, PEGylated anti-TNF treatment option for this indication and marks the entry of UCB into immuno-dermatology, where significant unmet need currently exists. The approval also follows a recent FDA label update for Cimzia in pregnancy and breastfeeding that provides essential information to healthcare professionals and women.
“The Phase 3 clinical development program for Cimzia in plaque psoriasis demonstrated statistically significant improvements in efficacy endpoints at week 16. A clinically meaningful response was maintained up to week 48. This compelling body of evidence is especially significant for a disease like psoriasis, which often has significant emotional and social burdens in addition to the more widely recognized physical symptoms,” Alice Gottlieb, M.D., Ph.D., professor of dermatology at New York Medical College and lead investigator. “Today’s approval provides patients and their healthcare professionals with a robust new biologic option that provides durable disease control. The two dose regimens of Cimzia also allow for patient-tailored treatment. Cimzia also demonstrated similar efficacy in both biologic-naïve patients and those previously treated with other biologics.”
“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. 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,” said Emmanuel Caeymaex, head of immunology and executive vice president, Immunology Patient Value Unit, UCB. “The approval of Cimzia for psoriasis and the recent Cimzia label update regarding pregnancy and breastfeeding in women with chronic inflammatory diseases are important treatment advances.UCB is committed to improving care for psoriasis patients and is also investigating bimekizumab, a therapy with significant potential for psoriasis patients.”
This FDA approval is based on data from a Phase 3 clinical development program consisting of CIMPASI-1, CIMPASI-2 and CIMPACT. The trials enrolled over 1,000 patients, of whom nearly one third had prior biologic exposure, and confirmed the durable efficacy up to 48 weeks and safety of CIMZIA in the treatment of adults with moderate-to-severe plaque psoriasis.1
Each of the three studies included an assessment of the percentage of patients who achieved at least 75 percent and 90 percent or greater disease improvement from baseline, as measured by the Psoriasis Area and Severity Index (PASI 75 and PASI 90, respectively) compared to placebo; within 16 weeks in CIMPASI-1 and CIMPASI-2, and within 12 weeks in CIMPACT.
CIMPASI-1, CIMPASI-2, and CIMPACT also assessed the percentage of patients who achieved at least a two-point improvement on a five-point Physician’s Global Assessment (PGA) scale to a final score representing clear or almost clear skin, each compared with placebo, at week 16.
In all three trials, Cimzia demonstrated statistically significant improvements for all primary and co-primary endpoints compared to placebo at all tested doses, and the clinical benefit was maintained through to week 48.1 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 (PsA).2
According to the updated label, the recommended dose of Cimzia for adults with moderate-to-severe plaque psoriasis is 400 mg (given as two subcutaneous injections of 200 mg each) every other week. For some patients (with body weight ≤ 90 kg), Cimzia 400 mg (given as two subcutaneous injections of 200 mg each) initially and at Weeks two and four, 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, said Michael Siegel, Ph.D., senior vice president of Research and Clinical Affairs, National Psoriasis Foundation. “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.”
About the CIMPASI-1, CIMPASI-2 and CIMPACT Studies1
CIMPASI-1, CIMPASI-2 and CIMPACT Phase 3 trials each evaluated the efficacy and safety of CIMZIA (certolizumab pegol, CZP) in adults with moderate-to-severe plaque psoriasis. The three trials enrolled approximately 1,000 patients, including patients with and without prior treatment experience with biologic products
In CIMPASI-1 and CIMPASI-2, at week 16, the response rate for patients who achieved a PASI 75 response was 75 percent and 82 percent for patients receiving CZP 400 mg every two weeks (Q2W) and 65 percent and 81 percent for patients receiving CZP 200 mg every two weeks (Q2W), compared to seven percent and 13 percent for patients receiving placebo, respectively. The response rate for patients who achieved a PASI 90 response was 44 percent and 52 percent for patients receiving CZP 400 mg every Q2W and 36 percent and 50 percent for patients receiving CZP 200 mg Q2W, comparted to zero percent and five percent for patients receiving placebo, respectively.
In addition, the response rates for patients achieving at least a two-point improvement to a final score of clear or almost clear skin on the PGA scale (PGA 0/1) at week 16 was 55 percent and 65 percent for CZP 400 Q2W dose-treated subjects, and 45 percent and 61 percent for CZP 200 mg Q2W dose-treated patients, compared to four percent and three percent for subjects receiving placebo, respectively. Week 16 PASI 75 responders maintained a PASI 75 response to week 48 in 94 percent and 81 percent of patients receiving CZP 400mg Q2W, and 81 percent and 74 percent for patients receiving CZP 200 mg Q2W, respectively.
In CIMPACT, the response rate for patients who achieved a PASI 75 response at week 16 was 69 percent and 75 percent among patients receiving CZP 400 mg Q2W and CZP 200 mg Q2W, compared to four percent for patients receiving placebo, respectively. The response rate for patients who achieved a PASI 90 at week 16 was 49 percent and 40 percent among patients receiving CZP 400 mg Q2W and CZP 200 mg Q2W, compared to zero percent for patients receiving placebo. In patients who received CZP 400 mg Q2W and were PASI 75 responders at week 16, 98 percent maintained their response at week 48. In addition, 80 percent of patients who received CZP 200 mg Q2W from week 16 maintained their response at week 48.
In all three trials, Cimzia demonstrated statistically significant improvements for all primary or co-primary endpoints compared to placebo at all treatment doses, and the clinical benefit was maintained through to 48 weeks. The adverse event profile across all three trials appears consistent with the safety profile for Cimzia in other approved indications.
In the placebo-controlled portions of the clinical trials in psoriasis patients, elevated liver enzymes were reported more frequently in the Cimzia-treated patients than in placebo-treated patients, 4.3 percent in the 200mg group, 2.3 percent in the 400mg group, and 2.5 percent in placebo. Additionally, cases of other psoriasis subtypes were reported (including erythrodermic, pustular, and guttate) in <1 percent of Cimzia-treated patients.
REFERENCES
- UCB data on file.
- Oliveira Rocha B, et al. Psoriasis: classical and emerging comorbidities. An Bras Dermatol. 2015;90(1):9–20.
(Source: UBC)
Filed Under: Drug Discovery
