Health Canada Approves CIMZIA (certolizumab pegol) for Moderate-to-Severe Psoriasis

UCB Canada Inc. announced today that Health Canada has approved a new indication for CIMZIA® (certolizumab pegol) for the treatment of adult patients with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy.ⁱ The approval makes CIMZIA the first Fc-free, PEGylated anti-TNF option available for the treatment of the disease where significant unmet need currently exists. UCB Canada Inc. also announced that Health Canada has approved label updates in pregnancy and breastfeeding based on two pivotal pharmacokinetic studies.^ii,iii This marks a major advance for Canadian women of all ages living with plaque psoriasis and other autoimmune diseases.

"The approval of a new and effective treatment option in plaque psoriasis with demonstrated durable and flexible disease control is welcome news for Canadian patients and physicians," said Dr. Wayne Gulliver, B.Sc., B.Med.Sc., M.D., FRCPC, dermatologist and Professor of Medicine (Dermatology) at Memorial University in St. John's, Newfoundland. "CIMZIA's similar efficacy in both biologic-naïve patients and those previously treated with other biologics also helps meet an unmet need in this area."

Psoriasis is a common chronic inflammatory skin condition that impacts more than one million Canadians^iv of all ages and about 125 million people worldwide.^v There is currently no cure for psoriasis and patients may experience recurrence of symptoms throughout their life. The disease affects both men and women, with about 75 per cent of psoriasis cases in women occurring before the age of 40.^vi Therefore, psoriasis may impact women during a critical time when many are planning for families.^vii

"For people living with plaque psoriasis, this is a welcome new treatment option to help them manage their disease," said Kathryn Andrews-Clay, Executive Director, Canadian Association of Psoriasis Patients. "Living with psoriasis can be isolating and, at times, stressful. Combine this with balancing treatment and planning for a family, or caring for a newborn, and it can be overwhelming. We are thrilled that with CIMZIA women now have an option to control their disease at any stage of their lives – including before, during and after pregnancy."

"The approval of CIMZIA for psoriasis, and label update regarding pregnancy and breastfeeding in women with autoimmune diseases, are important treatment advances which build on more than 10 years of market experience and proven efficacy and safety," said Lionel Houle, Head of Immunology, UCB Canada Inc."Today's announcement reflects our heritage of making a difference for specific patient populations with unmet needs. Many women living with autoimmune diseases would benefit from a clearer understanding of the impact treatment can have on their baby, flare management during pregnancy and breastfeeding, and whether to restart treatment after pregnancy."

Health Canada's approval for the treatment of adult patients with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy is based on data from a Phase 3 clinical development program consisting of CIMPASI-1, CIMPASI-2 and CIMPACT. The trials enrolled a total of 1,020 patients, ≥ 18 years of age 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.^viii Each of the three studies included an assessment of 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, 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 coprimary endpoints compared to placebo at all tested doses, and the clinical benefit was maintained through to week 48. 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).

According to the updated label, the recommended dose of CIMZIA for adults with moderate-to-severe plaque psoriasis is 400 mg every other week (given as two subcutaneous injections of 200 mg each). A dose of 400 mg initially (week 0) and at Weeks 2 and 4 followed by 200 mg every 2 weeks may be considered.

About Psoriasis
Psoriasis is a common chronic inflammatory skin condition. Psoriasis signs and symptoms can vary but may include red patches of skin covered with silvery scales, dry, cracked skin that may bleed and thickened, pitted or ridged nails.^ix

Psoriasis affects nearly three percent of the population, or approximately 125 million people worldwide.^x Symptoms vary from person to person, but for those who are more severely affected, psoriasis can have a major impact on their quality of life.^xi

As many as 42% of patients with psoriasis will develop psoriatic arthritis,^xii,xiii 33% will develop metabolic syndrome,[xiv] and approximately 46% are often or always depressed because of their psoriasis.^xv Despite drug development advances in the past decade, patient survey data suggest that moderate-to-severe psoriasis is being undertreated.^xvi

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