BRUSSELS, June 7, 2016 /PRNewswire/ --
For medical and trade media only.
New data highlight breadth of UCB's pioneering portfolio with four molecules across five indications:
- An oral presentation of data from the two year C-EARLY(TM) Phase 3 study of Cimzia
(R), exploring different dosing strategies
- Oral presentations from UCB's early pipeline include Phase 1b study results for
bimekizumab for psoriatic arthritis and Phase 1 results for dapirolizumab pegol for
systemic lupus erythematosus
- An oral presentation of Phase 3 data from the STRUCTURE study of romosozumab for
osteoporosis in post-menopausal women
- Long-term data from Phase 3 trials provide analyses of four-year efficacy and safety
of Cimzia(R) for the treatment of psoriatic arthritis and axial spondyloarthritis
(Logo: http://photos.prnewswire.com/prnh/201606... )
UCB, a global biopharmaceutical company focusing on immunology, neurology and bone treatment and research, is proud to present pivotal, long-term data on Cimzia(R) (certolizumab pegol), romosozumab, early phase molecules bimekizumab and dapirolizumab pegol, and patient-friendly injection devices in development at the Annual European Congress of Rheumatology (EULAR 2016) in London, England (8th - 11th June 2016). These data presentations offer new insights on the potential to improve patient experience and treatment outcomes across several diseases including rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (axSpA), systemic lupus erythematosus (SLE), and osteoporosis in post-menopausal women.
"The mission of UCB Immunology is to deliver value beyond expectations to our patients. We know that many people living with immunological diseases experience suboptimal response on existing therapies. This unmet need drives UCB's patient-centric approach towards scientific research and improving the patient experience," said Emmanuel Caeymaex, Head of Immunology and Executive Vice President at UCB, Immunology Patient Value Unit, UCB. "Cimzia(R) data at the Annual European Congress of Rheumatology (EULAR 2016) help to build increased understanding around the product's long-term safety and efficacy profile, while our pipeline data demonstrate momentum in bringing innovative new products to patients."
Data highlights will include four-year efficacy and safety data from both the RAPID-axSpA trial for the treatment of patients with axSpA, including ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA), and the RAPID-PsA trial for the treatment of patients with PsA. Period 2 data from the C-EARLY(TM) Phase 3 study will be presented, comparing different treatment strategies by continuing Cimzia(R) at the standard dose or reducing the dose frequency versus withdrawal, in disease-modifying antirheumatic drug (DMARD)-naïve early RA patients who achieved sustained low disease activity after one year of treatment with certolizumab pegol combined with optimized methotrexate.
Data being presented from UCB's pipeline include Phase 3 results from the STRUCTURE study of romosozumab for osteoporosis in post-menopausal women, Phase 1b results in PsA for bimekizumab (UCB4940), an investigational monoclonal antibody specifically designed to potently and selectively inhibit the biological function of both IL-17A and IL-17F cytokines, and Phase 1 results for dapirolizumab pegol (CDP7657), an anti-CD40L pegylated Fab' fragment being evaluated for SLE.
Following is a guide to the UCB-sponsored data presentations:
Presentations on Cimzia(R) in Rheumatoid Arthritis
1.[OP0227]: A Randomized Double-Blind Treatment Strategy Study Evaluating Continuation or Reduced-Frequency Dosing of Certolizumab Pegol versus Withdrawal to Maintain Low Disease Activity in Early RA Patients (C-EARLY Period 2) Emery, P. et al.
- Date/Time: Friday 10 June, 11:00
- Session Info: Developments in the treatment of RA; Hall D (oral presentation)
2. [THU0163]: Early Response as a Predictor of Long-Term Clinical Response in DMARD-Naïve Patients with Severe, Active and Progressive RA Treated with Certolizumab Pegol plus Optimized MTX versus Optimized MTX Alone Mariette, X. et al.
- Date/Time: Thursday 9 June, 11:45 - 13:30
- Session Info: Rheumatoid arthritis - anti-TNF therapy; Poster area (poster
presentation)
3. [THU0128]: Maintenance of Improvements in Workplace and Household Productivity and Physical Function at 2 Years in Early RA Patients with Severe Progressive Disease Who Achieved Sustained Low Disease Activity following 1 Year of Initial Therapy, with Two Dosing Frequencies of Certolizumab Pegol Bingham, C. et al.
- Date/Time: Thursday 9 June, 11:45 - 13:30
- Session Info: Rheumatoid arthritis - anti-TNF therapy; Poster area (poster
presentation)
4. [THU0157]: Clinical Outcomes at Week 104 and Analysis of Associated Baseline Factors after an Initial 1 Year of Certolizumab Pegol and MTX Treatment in MTX-Naïve Patients with Early RA: Results from the Second Year of the C-OPERA Study Atsumi, T. et al.
- Date/Time: Thursday 9 June, 11:45 - 13:30
- Session Info: Rheumatoid arthritis - anti-TNF therapy; Poster area (poster
presentation)
5. [THU0151]: Multicenter, Open-Label Study to Evaluate the Predictability of Disease Control at Week 52 Based on Early Response to Certolizumab Pegol (in Combination with Methotrexate) in Italian Patients with Moderate to Severe Rheumatoid Arthritis: The CZP-SPEED Study Sarzi-Puttini, P. et al.
- Date/Time: Thursday 9 June, 11:45 - 13:30
- Session Info: Rheumatoid arthritis - anti-TNF therapy; Poster area (poster
presentation)
Presentations on Cimzia(R) Devices
6. [SAT0631-HPR]: Chronic Disease and Self-Injection: An Ethnographic Investigation into the Patient Experience during Treatment Schiff, M.H. et al.
- Date/Time: Saturday 11 June, 10:15 - 12:00
- Session Info: Health Professionals in Rheumatology; Poster area (poster presentation)
7. [THU0639-HPR]: A New Electromechanical Platform for Subcutaneous Drug Delivery: Results from an EU Usability Study Domanska, B. et al.
- Date/Time: Thursday 9 June, 11:45 - 13:30
- Session Info: Health Professionals in Rheumatology; Poster area (poster presentation)
8. [AB0300]: Comparative Usability Study for a Certolizumab Pegol Auto-Injection Device in Patients with Rheumatoid Arthritis Domanska, B. et al.
- Session Info: Rheumatoid arthritis - anti-TNF therapy; Publication only
9. [AB0301]: Comparison of the Bioavailability of a Single Dose of Certolizumab Pegol Injected Either by a Pre-Filled Syringe or by an Auto-Injection Device Astruc, B. et al.
- Session Info: Rheumatoid arthritis - anti-TNF therapy; Publication only
Presentations on Cimzia(R) in Axial Spondyloarthritis, including Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis
10. [SAT0375]: Certolizumab Pegol for the Treatment of Axial Spondyloarthritis: 4-Year Outcomes from the RAPID-axSpA Trial van der Heijde, D. et al.
- Date/Time: Saturday 11 June, 10:20
- Session Info: Optimising treatment of axial SpA; Poster area (poster presentation and
poster tour)
(CONTINUA)