BRUSSELS and ATLANTA, Nov. 14, 2014 /PRNewswire/ -- UCB, a global biopharmaceutical company, is sponsoring 27 data presentations at the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting, November 14 19, 2014 in Boston, MA. The multiple presentations will include the latest data evaluating the long-term efficacy and safety of certolizumab pegol (marketed as CIMZIA®) for the treatment of moderate to severe rheumatoid arthritis and psoriatic arthritis as well as for investigational use in axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis. Data will also be presented on epratuzumab, an investigational medicine in Phase 3 clinical development for systemic lupus erythematosus (SLE), and on romosozumab, an investigational medicine in Phase 3 clinical development for osteoporosis.
"UCB is pleased to sponsor multiple immunology presentations at ACR 2014 including oral and poster presentations on CIMZIA® as well as investigational data from our pipeline. The depth and breadth of presentations highlight our dedicated focus on delivering new and innovative treatment options and support our efforts to improve disease management for people with severe diseases," said Professor Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President, UCB. "Data presentations from our pipeline on epratuzumab and romosozumab reflect our valued partnerships with pharmaceutical companies and research institutions who share our goals."
In the US, CIMZIA® is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis, for the treatment of adults with active psoriatic arthritis (PsA) and for adults with active ankylosing spondylitis (AS).1 In addition, it is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.1 See important safety information including risk of serious infections and tuberculosis below.
In the EU, CIMZIA® in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying antirheumatic drugs (DMARDs) including MTX.2 CIMZIA® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. CIMZIA®, in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. CIMZIA® can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.2 CIMZIA® is also indicated in the EU for the treatment of adult patients with severe active axial spondyloarthritis (axSpA), comprising: 2
- Ankylosing spondylitis (AS) - adults with severe active AS who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs).
- Axial spondyloarthritis (axSpA) without radiographic evidence of AS - adults with severe active axSpA without radiographic evidence of AS but with objective signs of inflammation by elevated C-reactive protein (CRP) and/or Magnetic Resonance Imaging (MRI), who have had an inadequate response to, or are intolerant to NSAIDs. 2
Epratuzumab is licensed from Immunomedics Inc. and is not approved for the treatment of SLE by any regulatory authority worldwide.
Romosozumab is being co-developed by UCB and Amgen and is not approved for the treatment of osteoporosis by any regulatory authority worldwide.
Following is a guide to the UCB-sponsored data presentations:
Presentations on CIMZIA® in Rheumatoid Arthritis
1. [1844]:Identification of a Patient Phenotype which Impacts Response to Therapy in Rheumatoid Arthritis Clinical Trials: Certolizumab Pegol Phase 4 Trial Data
Curtis, J. et al.
- Date/Time: Monday, November 17th; 15:00 15:15
- Session Info: Oral Presentation, Exhibit Hall C
2. [464]:Analysis of Pooled Data from Two Randomized Controlled Trials and Their Open-Label Extensions: Long-Term Safety in Rheumatoid Arthritis Before and After Certolizumab Pegol Dose Increase/Decrease
Haraoui, B. et al.
- Date/Time: Sunday, November 16th; 8:30 16:00
- Session Info: Poster Session, Exhibit Hall B
3. [2475]:Multiple Approaches For Implementation of Long-Term Efficacy: Interpretation of Certolizumab Pegol Data in Rheumatoid Arthritis Case Study
Keystone, E. et al.
- Date/Time: Tuesday, November 18th; 8:30 16:00
- Session Info: Poster Session, Exhibit Hall B
4. [2472]:The First, Multicenter, Double-Blind, Randomized, Parallel-Group Study of Certolizumab Pegol in Early Rheumatoid Arthritis Demonstrates Inhibition of Joint Damage Progression
Atsumi, T. et al.
- Date/Time: Tuesday, November 18th; 8:30 16:00
- Session Info: Poster Session, Exhibit Hall B
5. [1180]:Dynamic Magnetic Resonance Imaging in the Assessment of the Response to Certolizumab Pegol in Rheumatoid Arthritis Patients: Results from a Phase IIIb Randomized Study
Ostergaard, M. et al.
- Date/Time: Monday, November 17th; 8:30 16:00
- Session Info: Poster Session, Exhibit Hall B
6. [468]:Identification of Baseline Risk Factors for Adverse Events in Certolizumab Pegol Treated Rheumatoid Arthritis Patients
Haraoui, B. et al.
- Date/Time: Sunday, November 16th; 8:30 16:00
- Session Info: Poster Session, Exhibit Hall B
7. [102]: Real-World Utilization, Patient Characteristics and Persistency of Certolizumab Pegol vs Other Anti-TNFs for the Treatment of Rheumatoid Arthritis in the United Kingdom
Humby, F. et al.
- Date/Time: Sunday, November 16th; 8:30 16:00
- Session Info: Poster Session, Exhibit Hall B
Presentations on CIMZIA® in Psoriatic Arthritis
8. [545]:Long-Term Safety and Efficacy of Certolizumab Pegol over 96 Weeks in Patients with Psoriatic Arthritis With and Without Prior Tumor Necrosis Factor Inhibitor Exposure
Mease, P. J. et al.
- Date/Time: Sunday, November 16th; 8:30 16:00
- Session Info: Poster Session, Exhibit Hall B
9. [1553]:Disease Activity And Clinical Response Early In The Course Of Treatment Predict Long-Term Outcomes In Psoriatic Arthritis Patients Treated With Certolizumab Pegol
Mease, P. J. et al.
- Date/Time: Monday, November 17th; 8:30 16:00
- Session Info: Poster Session, Exhibit Hall B
10. [1552]:Sustained Improvements in Workplace and Household Productivity and Social Participation with Certolizumab Pegol over 96 Weeks in Patients with Psoriatic Arthritis
Kavanaugh, A. et al.
- Date/Time: Monday, November 17th; 8:30 16:00
- Session Info: Poster Session, Exhibit Hall B
Presentations on Investigational Studies of Certolizumab Pegol in Axial Spondyloarthritis, including Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis
11. [852]:Safety and Efficacy of Certolizumab Pegol over 96 Weeks in Patients with Axial Spondyloarthritis, Including Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis
Sieper, J. et al.
- Date/Time: Sunday, November 16th; 14:30 16:00
- Session Info: Oral Presentation, Exhibit Hall B
12. [565]:Effect of Certolizumab Pegol over 96 Weeks of Treatment on Inflammation of Spine and Sacroiliac Joints Measured by Magnetic Resonance Imaging in Patients with Axial Spondyloarthritis
Braun, J. et al.
- Date/Time: Sunday, November 16th; 8:30 16:00
- Session Info: Poster Session, Exhibit Hall B
13. [566]:Structural Progression of the Spine Measured by X-Ray in Patients with Axial Spondyloarthritis Treated with Certolizumab Pegol over 96 Weeks, Including Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis
van der Heijde, D. et al.
- Date/Time: Sunday, November 16th; 8:30 16:00
- Session Info: Poster Session, Exhibit Hall B
14. [544]:Observed Incidence Rates of Uveitis Over 96 Weeks of Certolizumab Pegol Treatment in Patients with Axial Spondyloarthritis
Rosenbaum, J. et al.
- Date/Time: Sunday, November 16th; 8:30 16:00
- Session Info: Poster Session, Exhibit Hall B
15. [543]:Disease Activity And Clinical Response Early In The Course Of Treatment Predict Long-Term Outcomes In Axial Spondyloarthritis Patients Treated With Certolizumab Pegol
van der Heijde, D. et al.
- Date/Time: Sunday, November 16th; 8:30 16:00
- Session Info: Poster Session, Exhibit Hall B
16. [2560]:Sustained Improvements in Workplace and Household Productivity and Social Participation with Certolizumab Pegol over 96 Weeks in Patients with Axial Spondyloarthritis, Including Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis
van der Heijde, D. et al.
- Date/Time: Tuesday, November 18th; 8:30 16:00
- Session Info: Poster Session, Exhibit Hall B
Presentations on Systemic Lupus Erythematosus and Investigational Studies of Epratuzumab
17. [2834]:Correlation of Laboratory and Clinical Parameters with British Isles Lupus Assessment Group Response in an Open-Label Extension Study of Epratuzumab in Systemic Lupus Erythematosus
Furie, R. A. et al.
- Date/Time: Tuesday, November 18th; 14:45 15:00
- Session Info: Oral Presentation, Boston Convention and Exhibition Center: 205 B
18. [2873]:Epratuzumab Induces Broad Inhibition of B Cell Receptor Proximal Signaling but Has Opposing Effects on Distal Signaling in B cell Subsets: A Profile of Effects on Functional Immune Signaling by Single Cell Network Profiling
Maloney, A. et al.
- Date/Time: Tuesday, November 18th; 17:30 17:45
- Session Info: Oral Presentation, Boston Convention and Exhibition Center: 109 A
19. [1077]:A 'Real-World' Characterization of US Patients with "Moderate-to-Severe" Systemic Lupus Erythematosus
Strand, V. et al.
- Date/Time: Monday, November 17th; 8:30 16:00
- Session Info: Poster Session, Exhibit Hall B
20. [1945]:Pharmacodynamic Effects of the CD22-Targeted Monoclonal Antibody Epratuzumab on B cells in Patients with Systemic Lupus Erythematosus
Shock, A. et al.
- Date/Time: Tuesday, November 18th; 8:30 16:00
- Session Info: Poster Session, Exhibit Hall B
21. [1942]:Regulation of the Responses of Human B Cell Subsets to Innate Immune Signals by Epratuzumab, a Humanized Monoclonal Antibody Targeting CD22
Giltiay, N. V. et al.
- Date/Time: Tuesday, November 18th; 8:30 16:00
- Session Info: Poster Session, Exhibit Hall B
22. [1944]:Targeting CD22 with Epratuzumab Impacts Cytokine Production by B Cells
Fleischer, V. et al.
- Date/Time: Tuesday, November 18th; 8:30 16:00
- Session Info: Poster Session, Exhibit Hall B
23. [1943]:In Vivo Effects of Epratuzumab, a Monoclonal Antibody Targeting Human CD22, on B Cell Function in Human CD22 Knock-In (Huki) Mice
Brandl, C. et al.
- Date/Time: Tuesday, November 18th; 8:30 16:00
- Session Info: Poster Session, Exhibit Hall B
Presentations numbered 21, 22 and 23 represent UCB collaborations with external research groups.
Presentations on Investigational Studies of Romosozumab in Osteoporosis
24. [916]:Effects of 2 Years of Treatment with Romosozumab Followed by 1 Year of Denosumab or Placebo in Postmenopausal Women with Low Bone Mineral Density
McClung, M. et al.
- Date/Time: Sunday, November 16th; 16:30 16:45
- Session Info: Oral Presentation, 153B
25. [2255]: Vertebral Cortical Bone Mass and Structure Significantly Improved with Romosozumab Compared with Teriparatide: HR-QCT Analyses of Postmenopausal Women with Low BMD from a Phase 2 Study
Damm, T. et al.
- Date/Time: Tuesday, November 18th; 8:30 16:00
- Session Info: Poster Session, Exhibit Hall B
Presentations on Pregnancy and Rheumatological Conditions
26. [1359]:Care of Women with Rheumatological Conditions during Family Planning and Pregnancy
Clowse, M. et al.
- Date/Time: Monday, November 17th; 8:30 16:00
- Session Info: Poster Session, Exhibit Hall B
27. [1409]:Pregnancy Outcomes after Exposure to Certolizumab Pegol: Updated Results from Safety Surveillance
Clowse, M. et al.
- Date/Time: Monday, November 17th; 8:30 16:00
- Session Info: Poster Session, Exhibit Hall B
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.
Important Safety Information about CIMZIA® in the US
Risk of Serious Infections and Malignancy
Patients treated with CIMZIA® are at an increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. CIMZIA® should be discontinued if a patient develops a serious infection or sepsis. Reported infections include:
- Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before CIMZIA® use and during therapy. Treatment for latent infection should be initiated prior to CIMZIA® use.
- Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
- Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.
The risks and benefits of treatment with CIMZIA® should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with CIMZIA®, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA® is a member. CIMZIA® is not indicated for use in pediatric patients.
Patients treated with CIMZIA® are at an increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis and tuberculosis have been reported with TNF blockers. Patients have frequently presented with disseminated rather than localized disease.
Treatment with CIMZIA® should not be initiated in patients with an active infection, including clinically important localized infections. CIMZIA® should be discontinued if a patient develops a serious infection or sepsis. Patients greater than 65 years of age, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants (e.g., corticosteroids or methotrexate) may be at a greater risk of infection. Patients who develop a new infection during treatment with CIMZIA® should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for immunocompromised patients, and appropriate antimicrobial therapy should be initiated. Appropriate empiric antifungal therapy should also be considered while a diagnostic workup is performed for patients who develop a serious systemic illness and reside or travel in regions where mycoses are endemic.
Malignancies
During controlled and open-labeled portions of CIMZIA® studies of Crohn's disease and other diseases, malignancies (excluding non-melanoma skin cancer) were observed at a rate of 0.5 per 100 patient-years among 4,650 CIMZIA®-treated patients versus a rate of 0.6 per 100 patient-years among 1,319 placebo-treated patients. In studies of CIMZIA® for Crohn's disease and other investigational uses, there was one case of lymphoma among 2,657 CIMZIA®-treated patients and one case of Hodgkin lymphoma among 1,319 placebo-treated patients. In CIMZIA® RA clinical trials (placebo-controlled and open label), a total of three cases of lymphoma were observed among 2,367 patients. This is approximately 2-fold higher than expected in the general population. Patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of TNF blocker therapy in the development of malignancies is not known.
Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy 18 years of age), of which CIMZIA® is a member. Approximately half of the cases were lymphoma (including Hodgkin's and non-Hodgkin's lymphoma), while the other cases represented a variety of different malignancies and included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents. Most of the patients were receiving concomitant immunosuppressants.
Cases of acute and chronic leukemia have been reported with TNF-blocker use. Even in the absence of TNF-blocker therapy, patients with RA may be at a higher risk (approximately 2-fold) than the general population for developing leukemia.
Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma that has a very aggressive disease course and is usually fatal, have been reported in patients treated with TNF blockers, including CIMZIA®. The majority of reported TNF blocker cases occurred in adolescent and young adult males with Crohn's disease or ulcerative colitis. Almost all of these patients had received treatment with the immunosuppressants azathioprine and/or 6-mercaptopurine (6-MP) concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treatment with CIMZIA®, especially in these patient types.
Periodic skin examinations are recommended for all patients, particularly those with risk factors for skin cancer.
Heart Failure
Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. CIMZIA® has not been formally studied in patients with CHF. Exercise caution when using CIMZIA® in patients who have heart failure and monitor them carefully.
Hypersensitivity
Symptoms compatible with hypersensitivity reactions, including angioedema, dyspnea, hypotension, rash, serum sickness, and urticaria, have been reported rarely following CIMZIA® administration. Some of these reactions occurred after the first administration of CIMZIA®. If such reactions occur, discontinue further administration of CIMZIA® and institute appropriate therapy.
Hepatitis B Reactivation
Use of TNF blockers, including CIMZIA®, has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. Some cases have been fatal. Test patients for HBV infection before initiating treatment with CIMZIA®. Exercise caution in prescribing CIMZIA® for patients identified as carriers of HBV, with careful evaluation and monitoring prior to and during treatment. In patients who develop HBV reactivation, discontinue CIMZIA® and initiate effective anti-viral therapy with appropriate supportive treatment.
Neurologic Reactions
Use of TNF blockers, including CIMZIA®, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis, and with peripheral demyelinating disease, including Guillain-Barre syndrome. Rare cases of neurological disorders, including seizure disorder, optic neuritis, and peripheral neuropathy have been reported in patients treated with CIMZIA®. Exercise caution in considering the use of CIMZIA® in patients with these disorders.
Hematologic Reactions
Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia (e.g., leukopenia, pancytopenia, thrombocytopenia) has 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 hematologic abnormalities.
Drug Interactions
An increased risk of serious infections has been seen in clinical trials of other TNF blocking agents used in combination with anakinra or abatacept. Formal drug interaction studies have not been performed with rituximab or natalizumab; however, because of the nature of the adverse events seen with these combinations with TNF blocker therapy, similar toxicities may also result from the use of CIMZIA® in these combinations. Therefore, the combination of CIMZIA® with anakinra, abatacept, rituximab, or natalizumab is not recommended. Interference with certain coagulation assays has been detected in patients treated with CIMZIA®. There is no evidence that CIMZIA® therapy has an effect on in vivo coagulation.
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