OAKVILLE, ON, Jan. 15, 2020 /CNW/ - UCB Canada Inc. announced today that Health Canada has approved CIMZIA® (certolizumab pegol) for the treatment of adults with severe active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and / or magnetic resonance imaging (MRI) evidence who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).1
A chronic inflammatory condition, nr-axSpA mainly affects the spine and sacroiliac joints and is often undiagnosed and not appropriately treated. In nr-axSpA, definitive evidence of the disease is not evident on an x-ray. Disease onset typically begins in early adulthood and causes chronic and debilitating back pain, stiffness and fatigue, often having a profound impact on patients' lives.
"We're pleased to see this important advance for the spondyloarthritis community. Greater awareness, earlier diagnosis and more treatment options will help deliver better outcomes for Canadians living with this painful disease which often falls through the cracks, and carries with it a significant burden," said Gerald Major, President, Canadian Spondylitis Association.
The approval marks the fifth indication for CIMZIA, which is the only Fc-free, PEGylated anti-TNF option available for the treatment of the disease where significant unmet need currently exists.
A treatment that is Fc-free is an important consideration for patients with chronic inflammatory diseases who are pregnant or who are considering becoming pregnant due to concerns of placental transfer.2
Because it does not have an IgG Fc region, CIMZIA does not bind the neonatal Fc receptor, and therefore would not be anticipated to undergo neonatal Fc receptor-mediated transfer across the placenta.3
"The journey patients face from symptom onset to diagnosis and receiving appropriate treatment can be extremely lengthy – sometimes up to 10 years. So having a new and effective option for nr-axSpA is welcome news, both for those suffering and their physicians who are seeking a proven treatment to reduce the severe pain, stiffness, and other burdensome symptoms of the disease," said Dr. Walter Maksymowych, MD, FRCPC, FACP, Professor and Medical Scientist in the Department of Medicine, Division of Rheumatology at the University of Alberta.
"Non-Radiographic Axial Spondyloarthritis can often be misdiagnosed or there is a delay in diagnosis; but it's a severe, chronic, painful and progressive condition which can result in significant impairment. Given the tremendous burden to patients who are often struck at the prime of their lives, having a new treatment option can help prompt improved awareness, diagnosis and, ultimately, outcomes," said Dr. Louis Bessette, MD, MSc, FRCPC, Rheumatologist, CHU de Quebec, Assistant Professor, Laval University.
Spondyloarthritis (SpA) is a term used to describe a group of inflammatory arthritis diseases with common features, including inflammation of the spine, eyes, skin and gastrointestinal tract. Axial spondyloarthritis (AxSpA) affects the spine and sacroiliac joints (the joints between the pelvis and the sacrum or base of the spine).
About 90% of people who develop spondyloarthritis will carry the HLA-B27 gene. People who have a family member with spondyloarthritis are at higher risk of developing the disease, depending on whether they inherited the HLA-B27 gene. The frequency of ankylosing spondylitis is about 0.50% of the population (1 in every 200). The frequency of axial spondyloarthritis is about 1.4% of the population.
About Non-Radiographic Axial Spondyloarthritis (nr-axSpA) and Ankylosing Spondylitis (AS)
Non-radiographic-axSpA and AS share similar symptomatology and disease burden. In AS there is definitive structural damage in the sacroiliac joints detectable by x-ray. In nr-axSpA, there is no definitive radiographic sacroiliitis, though more sensitive magnetic resonance imaging (MRI) testing may detect evidence of active sacroiliitis, visible as inflammation in the sacroiliac joints. Historically, nr-axSpA has not been well-recognized due to a lack of understanding of the disease history, progression, and prognosis, resulting in substantial diagnostic delay.
Patients face a significant disease burden whether they have nr-axSpA (i.e., no definitive evidence of sacroiliitis on x-ray) or AS (i.e., definitive evidence of sacroiliitis on x-ray). They often experience substantial inflammatory back pain, prolonged and severe stiffness, fatigue, sleep disturbances, reduced physical function, decreased quality of life, impaired work and home productivity and social participation.
"The approval of CIMZIA for nr-axSpA is an important treatment advance which builds on more than a decade 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."
Health Canada's approval is based on data from C-AXSPAND5, a Phase 3, multi-center, double-blind, placebo-controlled 52-week study that randomized 317 adult patients to receive either CIMZIA or placebo plus common background medications, which included NSAIDs, corticosteroids, analgesics and slow-acting anti-rheumatic drugs. The study met its primary endpoint, with 47.2% of patients treated with CIMZIA demonstrating major improvement response in Ankylosing Spondylitis Disease Activity Score (ASDAS-MI) at week 52, compared to 7.0% of patients treated with placebo. ASDAS-MI is a validated, rigorous response threshold, defined as an ASDAS decrease of at least two points from baseline or reaching the lowest possible value. C-AXSPAND is the first study to adopt this stringent threshold as a primary outcome measure. Detailed findings from the study were published online in Arthritis & Rheumatology on March 8, 2019.6
The study also met ASAS40, an important secondary endpoint, with 47.8% of CIMZIA-treated patients achieving a 40% improvement in Ankylosing Spondylitis Assessment Score (ASAS40) compared to 11.4% of placebo-treated patients at week 12.
The safety profile for patients with nr-axSpA treated with CIMZIA was similar to the safety profile seen in patients with rheumatoid arthritis and previous experience with CIMZIA.
The recommended dose of CIMZIA for adult patients with nr-axSpA is 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at weeks 2 and 4, followed by 200 mg every 2 weeks or 400 mg every 4 weeks.
About CIMZIA in Canada1
CIMZIA is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Factor). CIMZIA has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNFalpha.
CIMZIA in combination methotrexate (MTX) is indicated for reducing signs and symptoms, inducing major clinical response, and reducing the progression of joint damage as assessed by X-ray, in adult patients with moderately-to-severely active rheumatoid arthritis (RA). CIMZIA may be used alone for reducing signs and symptoms in adult patients with moderately- to -severely active rheumatoid arthritis (RA) who do not tolerate MTX.
CIMZIA alone or in combination with MTX is indicated for reducing signs and symptoms and inhibiting the progression of structural damage as assessed by X-ray, in adult patients with moderately-to-severely active psoriatic arthritis (PsA) who have failed one or more disease-modifying anti-rheumatic drugs (DMARDs).
CIMZIA is also indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy.
CIMZIA is approved for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.
CIMZIA is approved for the treatment of adults with severe active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and / or magnetic resonance imaging (MRI) evidence who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
Important and complete prescribing and safety information about CIMZIA can be found by accessing the product monograph at https://ucb-canada.ca/_up/ucbpharma_ca_en/documents/2019-11-13%20cimzia-pm-en.pdf.
About UCB Canada Inc.
Inspired by patients and driven by science, UCB Canada Inc. is a biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe autoimmune and central nervous system diseases. For more information, please consult https://www.ucb-canada.ca/.
1CIMZIA Product Monograph. November 13, 2019
2Mariette X, et al. Ann Rheum Dis 2018;77:228–233. doi:10.1136/annrheumdis-2017-212196
3Kimball A, et al. Characteristics and outcomes of pregnancies exposed to certolizumab pegol prospectively reported to a safety database JAAD, 2018 79, Issue 3, Supplement 1, Page AB68
4Canadian Spondylitis Association http://www.spondylitis.ca/spondyloarthritis/what-is-spondyloarthritis/ accessed November 26, 2019
5 UCB Clinical Study Protocol. Protocol AS006 (C-AXSPAND) AMENDMENT. Data on File.
6Deodhar Z, et al. A Fifty-Two-Week, Randomized, Placebo-Controlled Trial of Certolizumab Pegol in Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol 2019 Jul;71(7):1101-1111. First published March 2018.
SOURCE UCB Canada Inc.
For further information: Ben Faienza, UCB Canada Inc., Tel: (905) 287-5115, [email protected]