UCB highlights new data from its immunology portfolio at EULAR 2013
Brussels (Belgium), June 10th 2013 – 0700 CEST – UCB, a global biopharmaceutical company with a focus on immunology treatment and research, is proud to sponsor new data for its immunology portfolio at the European League Against Rheumatism (EULAR) 2013 Congress in Madrid, Spain (12th-15th June 2013). The data will include oral, poster and abstract presentations across two compounds and four disease areas: Cimzia® (certolizumab pegol) in rheumatoid arthritis; investigational studies of certolizumab pegol in axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA); and investigational studies of epratuzumab in systemic lupus erythematosus (SLE).
"At UCB, we have established experience in rheumatoid arthritis with Cimzia® and are using our knowledge to develop further treatments to meet the unmet needs of patients with a broad range of immunological diseases,” said Professor Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President UCB. “The breadth of UCB sponsored presentations at EULAR this year demonstrates our commitment to developing innovative solutions for people living with severe diseases.”
In the European Union, certolizumab pegol in combination with methotrexate (MTX) is approved for the treatment of moderate to severe active rheumatoid arthritis in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs including MTX. Certolizumab pegol can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.1
In February 2013, UCB announced two new regulatory filings with the European Medicines Agency (EMA) to extend the marketing authorization for certolizumab pegol for the treatment of adult patients with active PsA and for adult patients with active axSpA. Certolizumab pegol is not currently licensed in these indications.
Epratuzumab, licensed from Immunomedics, Inc., is an investigational medicine in development for the treatment of SLE. It is the first monoclonal antibody targeting CD22, a B cell-specific protein that regulates B cell activity.2,3 Epratuzumab is not approved for the treatment of SLE.
Following is a guide to the UCB-sponsored data presentations being presented as oral presentations, posters or abstracts at EULAR.
Certolizumab pegol in rheumatoid arthritis
1. [THU0192]: 5-Year Results From The RAPID 1 Trial And Open-Label Extension: Long-Term Safety And Efficacy Of Certolizumab Pegol In Combination With Methotrexate In The Treatment Of Rheumatoid Arthritis
Keystone, E. et al.
o Date/Time: 13th June 2013; 1145-1330
o Session Info: Poster Session, Poster Area
2. [THU0204]: The Positive Effect of Stringent Criteria For Purified Protein Derivation (PPD) Skin Test On Patients Treated With Certolizumab Pegol
Vencovsky, J. et al.
o Date/Time: 13th June 2013; 1145-1330
o Session Info: Poster Session, Poster Area
3. [THU0199]: Week 12 Clinical Response To Certolizumab Pegol Predicts Long-Term Outcomes Regardless Of Concomitant Medications And Baseline Disease Characteristics In Japanese Patients With Active Rheumatoid Arthritis
Yamanaka, H. et al.
o Date/Time: 13th June 2013; 1145-1330
o Session Info: Poster Session, Poster Area
4. [FRI0186]: Long-Term Safety And Efficacy Of 4-Weekly Certolizumab Pegol Monotherapy And Combination Therapy In Rheumatoid Arthritis: 5-Year Results From An Open-Label Extension Study
Fleischmann, R. et al.
o Date/Time: 14th June 2013; 1145-1330
o Session Info: Poster Session, Poster Area
5. [FRI0176]: Outcomes Of Pregnancy In Subjects Exposed To Certolizumab Pegol
Clowse, M. et al.
o Date/Time: 14th June 2013; 1145-1330
o Session Info: Poster Session, Poster Area
6. [FRI0204]: Long-Term Benefits Of 4-Weekly Certolizumab Pegol Monotherapy And Combination Therapy On Household Productivity And Social Participation In Rheumatoid Arthritis: 5-Year Results From An Open-Label Extension Study
Strand, V. et al.
o Date/Time: 14th June 2013; 1145-1330
o Session Info: Poster Session, Poster Area
7. [FRI0162]: Investigation Into The Binding Affinity Of Certolizumab Pegol To FcRn And Functional Consequences For FcRn-Mediated Transcytosis: Comparison To Infliximab, Adalimumab And Etanercept
Baker, T. et al.
o Date/Time: 14th June 2013; 1145-1330
o Session Info: Poster Tour, Poster Area
8. [FRI0201]: Immunogenicity Of Certolizumab Pegol Without Concomitant Methotrexate And Clinical Response In Rheumatoid Arthritis Patients: Post-Hoc Analysis Of The HIKARI Study
Takeuchi, T. et al.
o Date/Time: 14th June 2013; 1145-1330
o Session Info: Poster Session, Poster Area
9. [FRI0184]: Cost-Effectiveness And Budget Impact Of Certolizumab Pegol Against The Current Mix Of Anti-TNF Treatments In An Outcomes-Based Risk-Sharing Scheme In Finland
Assesburg, C. et al.
o Date/Time: 14th June 2013; 1145-1330
o Session Info: Poster Session, Poster Area
10. [SAT0545]: Comparing Health-Related Quality Of Life Across Rheumatoid Arthritis, Psoriatic Arthritis And Axial Spondyloarthritis: Analyses From Certolizumab Pegol Clinical Trial Baseline Data
Mease, P. et al.
o Date/Time: 15th June 2013; 1015-1200
o Session Info: Poster Session, Poster Area
11. [AB0288]: Safety, Effectiveness, Work And Household Productivity Of Anti-TNF Alpha Therapy With Certolizumab Pegol Observed In Adult Rheumatoid Arthritis Patients In Daily Practice In Canada: First Interim Analysis Of The Non-Interventional FAST Can Study
Shaikh, SA et al.
o Abstract Book
12. [AB0294]: Long-Term Comprehensive Disease Control With Certolizumab Pegol Regardless Of Concomitant DMARDs: Results From The Japanese Cohort
Tanaka, Y. et al.
o Abstract Book
Rheumatoid Arthritis
13. [THU0512]: Rheumatoid Arthritis (RA), Comorbidities And Biological Agents Uptake In France: Analysis Of A National Claims Database
Fautrel, B. et al.
o Date/Time: 13th June 2013; 1145-1330
o Session Info: Poster Session, Poster Area
Investigational studies of certolizumab pegol in psoriatic arthritis
14. [SAT0298]: Effect Of Certolizumab Pegol On Signs And Symptoms In Patients With Psoriatic Arthritis From The RAPID-PsA Study: Impact Of Baseline Skin Involvement And Prior Anti-TNF Therapy
Mease, P.J. et al.
o Date/Time: 15th June 2013; 1015-1200
o Session Info: Poster Session, Poster Area
15. [SAT0281]: Impact Of Imputation Methodology On Radiographic Progression Outcomes In The RAPID-PsA Study Of Certolizumab Pegol In Patients With Psoriatic Arthritis
van der Heijde, D. et al.
o Date/Time: 15th June 2013; 1015-1200
o Session Info: Poster Session, Poster Area
16. [SAT0275]: High Economic Burden Of Moderate To Severe Psoriatic Arthritis On Paid Work And Household Productivity: Baseline Results From The RAPID-PsA Study
Kavanaugh, A. et al.
o Date/Time: 15th June 2013; 1015-1200
o Session Info: Poster Session, Poster Area
17. [SAT0260]: Effect Of Certolizumab Pegol On The Multiple Facets Of Psoriatic Arthritis As Reported By Patients With And Without Prior Anti-TNF Exposure: 24-Week Patient-Reported Outcome Results Of RAPID-PsA Study
Gladman, D. et al.
o Date/Time: 15th June 2013; 1015-1200
o Session Info: Poster Tour, Poster Area
18. [SAT0276]: Improvements In Productivity At Paid Work And Within Household, And Increased Participation In Daily Activities After 24 Weeks Of Certolizumab Pegol In Patients With Psoriatic Arthritis: Results Of RAPID-PsA Study
Kavanaugh, A. et al.
o Date/Time: 15th June 2013; 1015-1200
o Session Info: Poster Session, Poster Area
Psoriatic Arthritis
19. [AB0772]: Validity, Responsiveness And Reliability Of The Arthritis-Specific Work Productivity Survey Assessing Work Productivity Within And Outside The Home In Subjects With Psoriatic Arthritis
Osterhaus, J.T. et al.
o Abstract Book
Investigational studies of certolizumab pegol in axial spondyloarthritis
20. [OP0106]: Effect Of Certolizumab Pegol On Signs And Symptoms Of Axial Spondyloarthritis, Including Ankylosing Spondylitis And Non-Radiographic Axial Spondyloarthritis: 24-Week Results Of RAPID-AxSpA Study
Landewé, R. et al.
o Date/Time: 13th June 2013; 1050; Room N117
o Session Info: Oral. Scientific Session
21. [OP0107]: Improvements In Work And Household Productivity After 24 Weeks Of Certolizumab Pegol In Treatment Of Axial Spondyloarthritis Patients, Including Patients With Ankylosing Spondylitis: Results Of RAPID-AxSpA Study
van der Heijde, D. et al.
o Date/Time: 13th June 2013; 1100; Room N117
o Session Info: Oral. Scientific Session
22. [THU0360]: Rapid Improvements In Patient-Reported Outcomes With Certolizumab Pegol In Patients With Axial Spondyloarthritis, Including Ankylosing Spondylitis: 24-Week Results Of RAPID-AxSpA Study
Sieper, J. et al.
o Date/Time: 13th June 2013; 1145-1330
o Session Info: Poster Session, Poster Area
23. [FRI0419]: Effect Of Certolizumab Pegol On Inflammation Of Spine And Sacroiliac Joints In Patients With Axial Spondyloarthritis: 12-Week Magnetic Resonance Imaging Results Of RAPID-AxSpA Study
van der Heijde, D. et al.
o Date/Time: 14th June 2013; 1145-1330
o Session Info: Poster Tour, Poster Area
24. [FRI0439]: High Economic Burden Of Axial Spondyloarthritis Related To Paid Work And Household Productivity At Baseline In The RAPID-axSpA Study: Differences And Similarities Between Ankylosing Spondylitis And Non-Radiographic Axial Spondyloarthritis
van der Heijde, D. et al.
o Date/Time: 14th June 2013; 1145-1330
o Session Info: Poster Session, Poster Area
Axial Spondyloarthritis
25. [FRI0523]: Validity Of Ankylosing Spondylitis Patient-Reported Outcome Instruments In The Broad Axial Spondyloarthritis Population
van Tubergen, A. et al.
o Date/Time: 14th June 2013; 1145-1330
o Session Info: Poster Tour, Poster Area
Investigational studies of epratuzumab for SLE
26. [THU0045]: Epratuzumab, An Antibody Targeting CD22 On B Cells, Induces Phosphoprotein Changes Following B-Cell Receptor Activation In Vitro
Lumb, S. et al.
o Date/Time: 13th June 2013; 1145-1330
o Session Info: Poster Tour, Poster Area
27. [THU0277]: Epratuzumab: Sustained Safety Profile And Effect On Corticosteroid Use On Long-Term Treatment In Patients With Moderate-To-Severe Systemic Lupus Erythematosus: Results From An Open-Label Long-Term Extension Study (SL0008)
Wallace, D. et al.
o Date/Time:13th June 2013; 1145-1330
o Session Info: Poster Session, Poster Area
28. [THU0272]: Epratuzumab Maintains Improvements In Disease Activity For Over 2 Years In Patients With Moderate-To-Severe Systemic Lupus Erythematosus: Results From An Open-Label Long-Term Extension Study (SL0008)
Gordon, C. et al.
o Date/Time: 13th June 2013; 1145-1330
o Session Info: Poster Session, Poster Area
29. [THU0286]: Immunologic Response To Long-Term Epratuzumab Treatment In SL0008, An Open-Label Longterm Extension Study In Patients With Moderate-To-Severe Systemic Lupus Erythematosus
Strand, V. et al.
o Date/Time: 13th June 2013; 1145-1330
o Session Info: Poster Session, Poster Area
30. [THU0029]: Epratuzumab Influences BCR Signalling On TLR9 Pre-Activated B Cells By Targeting CD22
Sieger, N. et al.
o Date/Time: 13th June 2013; 1145-1330
o Session Info: Poster Session, Poster Area
Notes to Editors
About CIMZIA®
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. Over the past decade, TNF-alpha has emerged as a major target of basic research and clinical investigation. This cytokine plays a key role in mediating pathological inflammation, and excess TNF-alpha production has been directly implicated in a wide variety of diseases. Cimzia® in combination with MTX is approved in the EU for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying antirheumatic drugs (DMARDs) including MTX. Cimzia® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. UCB is also developing Cimzia® in other autoimmune disease indications. Cimzia® is a registered trademark of UCB PHARMA S.A.
Cimzia® (certolizumab pegol) EU/EEA* Important Safety Information
Cimzia® was studied in 4,049 patients with RA in controlled and open label trials for up to 92 months. The commonly reported adverse reactions (1-10%) in clinical trials with Cimzia® and post-marketing were viral infections (includes herpes, papillomavirus, influenza), bacterial infections (including abscess), rash, headache (including migraine), asthaenia, leukopaenia (including lymphopaenia, neutropaenia), eosinophilic disorder, pain (any sites), pyrexia, sensory abnormalities, hypertension, pruritus (any sites), hepatitis (including hepatic enzyme increase), injection site reactions, and nausea. Serious adverse reactions include sepsis, opportunistic infections, tuberculosis, herpes zoster, lymphoma, leukaemia, solid organ tumours, angioneurotic oedema, cardiomyopathies (includes heart failure), ischemic coronary artery disorders, pancytopaenia, hypercoagulation (including thrombophlebitis, pulmonary embolism), cerebrovascular accident, vasculitis, hepatitis/hepatopathy (includes cirrhosis), and renal impairment/nephropathy (includes nephritis). In RA controlled clinical trials, 4.4% of patients discontinued taking Cimzia® due to adverse events vs. 2.7% for placebo.
Cimzia® is contraindicated in patients with hypersensitivity to the active substance or any of the excipients, active tuberculosis or other severe infections such as sepsis or opportunistic infections or moderate to severe heart failure.
Serious infections including sepsis, tuberculosis and opportunistic infections have been reported in patients receiving Cimzia®. Some of these events have been fatal. Monitor patients closely for signs and symptoms of infections including tuberculosis before, during and after treatment with Cimzia®. Treatment with Cimzia® must not be initiated in patients with a clinically important active infection. If an infection develops, monitor carefully and stop Cimzia® if infection becomes serious. Before initiation of therapy with Cimzia®, all patients must be evaluated for both active and inactive (latent) tuberculosis infection. If active tuberculosis is diagnosed prior to or during treatment, Cimzia® therapy must not be initiated and must be discontinued. If latent tuberculosis is diagnosed, appropriate anti-tuberculosis therapy must be started before initiating treatment with Cimzia®. Patients should be instructed to seek medical advice if signs/symptoms (e.g. persistent cough, wasting/weight loss, low grade fever, listlessness) suggestive of tuberculosis occur during or after therapy with Cimzia®.
Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including Cimzia® who are chronic carriers of the virus (i.e. surface antigen positive). Some cases have had a fatal outcome. Patients should be tested for HBV infection before initiating treatment with Cimzia®. Carriers of HBV who require treatment with Cimzia® should be closely monitored and in the case of HBV reactivation Cimzia® should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
TNF antagonists including Cimzia® may increase the risk of new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease; of formation of autoantibodies and uncommonly of the development of a lupus-like syndrome; of severe hypersensitivity reactions. If a patient develops any of these adverse reactions, Cimzia® should be discontinued and appropriate therapy instituted.
With the current knowledge, a possible risk for the development of lymphomas, leukaemia or other malignancies in patients treated with a TNF antagonist cannot be excluded. Rare cases of neurological disorders, including seizure disorder, neuritis and peripheral neuropathy, have been reported in patients treated with Cimzia®.
Adverse reactions of the hematologic system, including medically significant cytopaenia, have been infrequently reported with Cimzia®. Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on Cimzia®. Consider discontinuation of Cimzia® therapy in patients with confirmed significant haematological abnormalities.
The use of Cimzia® in combination with anakinra or abatacept is not recommended due to a potential increased risk of serious infections. As no data are available, Cimzia® should not be administered concurrently with live vaccines. The 14-day half-life of Cimzia® should be taken into consideration if a surgical procedure is planned. A patient who requires surgery while on Cimzia® should be closely monitored for infections.
Please consult the full prescribing information in relation to other side effects, full safety and prescribing information. European SmPC date of revision 25th April 2013.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001037/WC500069763.pdf
References
1. Cimzia® EU Summary of Product Characteristics. Accessed May 2013 from http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001037/WC500069763.pdf
2. Sanz I. & Lee F. Eun-Hyung B cells as therapeutic targets in SLE. Nat. Rev. Rheumatology; Vol. 6. 2010; Pp 326-337
3. Walker J. & Smith K. CD22: an inhibitory enigma. Immunology; Vol. 123. 2008; Pp 314-325
For further information
Eimear O Brien, Director, Brand Communications
T +32.2.559.9271, eimear.obrien@ucb.com
Antje Witte, Investor Relations UCB
T +32.2.559.9414, antje.witte@ucb.com
France Nivelle, Global Communications, UCB
T +32.2.559.9178, france.nivelle@ucb.com
Laurent Schots, Media Relations, UCB
T +32.2.559.9264, laurent.schots@ucb.com
About UCB
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 of the immune system or of the central nervous system. With more than 8 500 people in about 40 countries, the company generated revenue of EUR 3.4 billion in 2012. UCB is listed on Euronext Brussels (symbol: UCB).
Forward looking statements
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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.
IMNL-PRR-022193-052013
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