New CIMZIA® Findings Presented at European Academy of Dermatology and Venereology (EADV) Congress
Brussels, Belgium and Menlo Park, California, Sept. 14, 2017 — UCB (Euronext: UCB) and Dermira, Inc. (NASDAQ: DERM) today announced new 48-week data from three Phase 3 trials evaluating the efficacy and safety of CIMZIA® (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis, which were presented in poster presentations during the 26th European Academy of Dermatology and Venereology (EADV) Congress, taking place in Geneva, Switzerland, September 13-17.
New 48-week safety and efficacy data from the CIMPASI-1, CIMPASI-2 and CIMPACT trials were presented, as well as patient-reported outcomes including quality of life as defined by the Dermatology Quality of Life (DLQI) and work productivity and activity impairment (WPAI) measures. CIMPASI-1 and CIMPASI-2 are randomized, blinded, parallel group, placebo-controlled, multi-center trials that have previously reported statistically and clinically significant improvements at week 16 in adult patients with moderate-to-severe chronic plaque psoriasis treated with CIMZIA compared to placebo. CIMPACT is a randomized, blinded, parallel group, placebo- and active-controlled, multi-center trial that demonstrated clinically significant improvements in skin severity at 12 weeks in patients receiving CIMZIA versus placebo. Data from all three studies demonstrated that the clinical benefit was maintained through 48 weeks in patients who responded at week 16.
Additionally, improvements in DLQI and WPAI patient-reported outcomes were demonstrated in all three trials at week 16 and maintained through week 48 in patients who responded at week 16. DLQI is a widely used and recognized quality of life measurement instrument used across several dermatological diseases. 7 The WPAI looks at the effect of dermatological conditions on factors affecting work productivity and activity impairment, which include absenteeism and work productivity loss, among others.
Based on these data, in July 2017, UCB and Dermira announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA), and a separate submission to the European Medicines Agency (EMA), to expand the approved indications for CIMZIA to include treatment of adult patients with moderate-to-severe chronic plaque psoriasis. CIMZIA is not currently approved for the treatment of psoriasis by any regulatory authority worldwide.
“Data from the CIMZIA Phase 3 clinical program present a compelling picture of CIMZIA’s potential clinical benefit to patients living with chronic plaque psoriasis, a common and often debilitating immune-mediated inflammatory disorder affecting the skin,” said Luis Peña, chief development officer of Dermira. “These positive findings support our belief that, if approved, CIMZIA could represent an important new treatment option for psoriasis patients.”
Results from the UCB-sponsored CRIB study, a prospective pharmacokinetic study showing minimal to no placental transfer of CIMZIA from mother to fetus during pregnancy, and from CRADLE, a prospective
pharmacokinetic study, which found minimal to no transfer of CIMZIA into breast milk, were presented in an oral presentation. Both studies included a safety evaluation.
The CRIB and CRADLE studies included women with rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (axSpA)/ankylosing spondylitis (AS), and Crohn’s disease (CD) – chronic inflammatory diseases (CID) that often affect women of child bearing age. Adequate disease control in these diseases is crucial to ensure optimal infant and maternal health, yet many women with CID face inadequate disease control before pregnancy and experience disease flares during and after pregnancy.8 These women often have limited options when making treatment decisions during pregnancy and lactation due to the potential associated health risks for fetuses and infants. These women often face uncertainty regarding the use of biologics during pregnancy and breastfeeding.9 The potential role of CIMZIA in these women will be evaluated for moderate-to-severe chronic plaque psoriasis.
“UCB is executing on its Patient Value Strategy to connect the unmet needs of patients with innovative science. Psoriasis has a significant emotional and physical impact on patients, and there is still a need for new therapies to more effectively control skin symptoms. Additionally, women of childbearing age with immune disease are often in the difficult position of navigating treatment for their condition and pregnancy. Developing CIMZIA in psoriasis and conducting the CRIB and CRADLE studies, which provide critical information for physicians and women as they plan for pregnancy and appropriate disease management, are important advancements in addressing these unmet needs for patients,” said Emmanuel Caeymaex, Head of Immunology and Executive Vice President at UCB.