FDA Approves Cimzia (certolizumab pegol) for the Treatment for Non-Radiographic Axial Spondyloarthritis
Brussels, Belgium – 29 March 2019 – UCB, a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved extending the label for Cimzia (certolizumab pegol) to include a new indication for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation. The approval makes Cimzia the first and only FDA-approved treatment for nr-axSpA.
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.
“This is such an important advancement for the spondyloarthritis community. More treatment options, earlier diagnosis, and awareness building will lead to better outcomes for people living with the disease,” said Cassie Shafer, Chief Executive Officer, Spondylitis Association of America.
“The FDA approval of Cimzia for adults with non-radiographic axial spondyloarthritis will be transformative for the many patients living with this disease,” said Emmanuel Caeymaex, Head of Immunology and Executive Vice President at UCB. “We are proud to be at the forefront of discovering and delivering valuable treatment options for patients with significant disease burden and high unmet need. We are committed to improving care and outcomes for patients across the axial spondyloarthritis spectrum of disease.”
“Non-radiographic axial spondyloarthritis requires early diagnosis, followed by appropriate treatment. Yet for some patients, the journey to diagnosis can take nearly a decade from symptom onset. This FDA indication will make it easier for patients to receive another avenue of treatment in reducing the severe pain, stiffness, and other burdensome symptoms associated with this disease, to help ultimately improve their quality of life,” said Dr. Atul Deodhar, MD, MRCP, FACP, FACR, Professor of Medicine, Oregon Health & Science University, and a lead author for the pivotal C-AXSPAND study.
This FDA approval is based on data from C-AXSPAND, 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.1 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.1 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.1 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.
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 RA and previous experience with Cimzia.
According to the updated label, 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. For full prescribing information, please visit www.ucb-usa.com.
Cimzia is also FDA-approved for ankylosing spondylitis (AS), as well as rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, and Crohn’s disease.
About Non-Radiographic Axial Spondyloarthritis (nr-axSpA) and Ankylosing Spondylitis (AS)
nr-axSpA and AS comprise the axial spondyloarthritis, or axSpA, spectrum of disease, which typically starts in patients under 45 years of age. nr-axSpA and AS share similar symptomology 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.
Limited evidence exists regarding the exact prevalence of axSpA, though it is thought to impact a substantial proportion of the population. Recent data suggest that 0.5% to 1.4% of the adult population have axSpA, similar to the prevalence of rheumatoid arthritis, which is 0.5% to 1.0%.2,3,4 Within the axSpA spectrum of disease, the prevalence is split roughly equally between nr-axSpA and AS.4
C-AXSPAND included adult patients with active axSpA without x-ray evidence of ankylosing spondylitis (AS). Patients needed to have objective evidence of inflammatory disease, defined as sacroiliitis on MRI and/or elevated C-reactive protein (CRP) levels. Patients must have had an inadequate response to, have a contraindication to, or have been intolerant to at least two non-steroidal anti-inflammatory drugs (NSAIDs). Inadequate response to an NSAID is defined as lack of response to at least 14 days of continuous NSAID therapy at the highest tolerated dose of the administered NSAID. Patients in both the treatment and placebo groups remained on their background therapy for the duration of the study, which could be adjusted at any point. Safety variables assessed in the study were adverse events, vital signs, physical examination, and measurements of laboratory parameters. The safety profile was consistent with previous clinical trials of Cimzia.
The primary objective of C-AXSPAND was to assess the safety and efficacy of Cimzia on the signs and symptoms of active axSpA in patients without x-ray evidence of AS. The primary endpoint assessed was ASDAS-MI response at Week 52. The secondary objectives of the study were to assess efficacy, safety, and tolerability, and to demonstrate the effect of Cimzia on health outcomes, disease activity, sacroiliac joints, inflammation through MRI, and changes in concomitant and background medications.
The first 52 weeks of the study have been completed and an additional two years of safety follow-up are ongoing.
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 TNF-alpha.
Cimzia is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (RA), adults with active psoriatic arthritis (PsA), and adults with active ankylosing spondylitis (AS). Cimzia is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.
Cimzia is also indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
In addition, it is indicated for reducing signs and symptoms of Crohn's disease (CD) and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. See important safety information including risk of serious bacterial, viral and fungal infections and tuberculosis below.
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases in immunology or neurology. With more than 7,500 people in approximately 40 countries, the company generated revenue of € 4.6 billion in 2018. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news
Forward looking statements – UCB
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. UCB is providing this information as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations.
There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.
- UCB Clinical Study Protocol. Protocol AS006 (C-AXSPAND) AMENDMENT. Data on File.
- Reveille JD (2012): Prevalence of axial spondylarthritis in the United States: estimates from a cross-sectional survey. Arthritis Care Res (Hoboken). 2012 Jun;64(6):905-10. doi: 10.1002/acr.21621. Epub 2012 Jan 24. Accessed at: https://www.ncbi.nlm.nih.gov/pubmed/22275150
- Reveille JD, Weisman MH. (2013): The epidemiology of back pain, axial spondyloarthritis and HLA-B27 in the United States. Am J Med Sci. 2013 Jun;345(6):431-6. Accesed at: https://www.ncbi.nlm.nih.gov/pubmed/23841117
- Strand et al paper (2013): Prevalence of axial spondyloarthritis in United States rheumatology practices: Assessment of SpondyloArthritis International Society criteria versus rheumatology expert clinical diagnosis. Arthritis Care Res (Hoboken). 2013 Aug;65(8):1299-306. Accessed at: https://www.ncbi.nlm.nih.gov/pubmed/23436774
Posted: March 2019
- UCB Announces the Approval of Cimzia (certolizumab pegol) for Moderate-to-Severe Plaque Psoriasis - May 28, 2018
- Cimzia Approved by FDA for Treatment of Adults with Active Ankylosing Spondylitis - October 18, 2013
- FDA Approves Cimzia for Treatment of Adult Patients with Active Psoriatic Arthritis - September 30, 2013
- U.S. FDA Arthritis Advisory Committee Votes On Cimzia (certolizumab pegol) For Treatment of Adults with Active Axial Spondyloarthritis, Including Patients with Ankylosing Spondylitis - July 24, 2013
- UCB's Cimzia (certolizumab pegol) Approved by the U.S. FDA for Adult Patients Suffering From Moderate to Severe Rheumatoid Arthritis - May 13, 2009
- UCB's meeting with U.S. FDA defines path forward for Cimzia in rheumatoid arthritis - February 6, 2009
- UCB Receives Complete Response Letter from U.S. FDA for Use of Cimzia in Rheumatoid Arthritis Patients - January 5, 2009
- Cimzia Approved in the US for the Treatment of Moderate to Severe Crohn's Disease - April 22, 2008
- FDA Agrees to Review Cimzia File for the Treatment of Rheumatoid Arthritis - February 6, 2008
- UCB Provides Update on Cimzia for Crohn's Disease and Rheumatoid Arthritis in the US - March 23, 2007
- UCB Submits Biologics License Application to FDA for New Treatment in Crohn's Disease - March 2, 2006
More News Resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
- Monthly Update Archive