Study findings suggest that opioids are vastly overprescribed as a treatment for pain associated with AS, often in lieu of more effective treatments such as anti-TNFs and NSAIDs.
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| [06-November-2017] |
| BRUSSELS, Nov. 6, 2017 /PRNewswire/ -- Key data focus on inflammatory and osteoporosis in patient populations with unmet needs including women of childbearing age and others:
UCB, a global biopharmaceutical company focusing on immunology, neurology, and bone treatment and research, will present findings from 14 separate abstracts at the 2017 American College of Rheumatology/Association for Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in San Diego, CA (3 - 8 November 2017). These data will highlight some of the latest research on CIMZIA® (certolizumab pegol) and several investigational treatments, which collectively address serious unmet treatment needs among women of childbearing age and other populations with chronic inflammatory diseases such as rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), as well as osteoporosis. Data highlights include findings from CRIB, a first-of-its-kind prospective pharmacokinetic study, demonstrating minimal placental transfer from mother to infant of CIMZIA during pregnancy. A separate poster presentation on the pregnancy outcomes of over 530 women exposed to CIMZIA during pregnancy did not reveal an increased risk of major malformations or an increased risk of fetal death related to CIMZIA treatment for chronic inflammatory diseases, compared to the US general population. Data regarding the overuse of opioids in the treatment of AS when anti-TNFs may be indicated will also be presented. Study findings suggest that opioids are vastly overprescribed as a treatment for pain associated with AS, often in lieu of more effective treatments such as anti-TNFs and non-steroidal anti-inflammatory drugs (NSAIDs). As such, many patients are left with suboptimal disease management, and increased awareness of treatment options among prescribers and patients is indicated. “UCB’s 14 data presentations at ACR/ARHP 2017 illustrate both the breadth and depth of sustained, long-term research that is at the core of our commitment to patients with unique needs and undertreated serious diseases. Our work embraces a growing number of diagnoses and patients who do not fall within existing treatment practices, and we will go as far as necessary to improve these patients’ experience,” Emmanuel Caeymaex, Head of Immunology and Executive Vice President at UCB. “Ongoing evidence supporting CIMZIA’s use in women of childbearing age, many of whom often lack treatment options for their inflammatory diseases, and promising findings from our investigational programs for bimekizumab and romosozumab, give us great hope at UCB because they mean important potential new treatment options for patients.” Other CIMZIA findings include phase 3 data on rapid onset of response among RA patients who are not responsive to methotrexate and cost and utilization data for RA patients, as well as sustained improvement of enthesitis in axSpA patients over four years of treatment. Data on UCB’s pipeline demonstrate that, in addition to IL-17A, IL-17F also contributes to inflammation in disease-relevant models. Results also show that selective dual neutralization of both IL-17A and IL-17F with the monoclonal IgG1 antibody, bimekizumab, suppresses inflammation to a greater extent than IL-17A inhibition alone, supporting the potential of this novel approach for the management of immune mediated inflammatory diseases. Other studies on the investigational bone-forming monoclonal antibody, romosozumab, found a reduced risk of bone fracture in postmenopausal women with osteoporosis. Following is a guide to the UCB-sponsored data presentations: Presentations on CIMZIA® in Approved Indications: Rheumatoid Arthritis [1030]: Healthcare Service Utilization and Costs of Certolizumab Pegol Versus Infliximab Treatment in Patients with Rheumatoid Arthritis
[2451]: Rapid Onset of Response Observed with Certolizumab Pegol in Rheumatoid Arthritis Patients with Inadequate Response to Methotrexate: Efficacy and Safety Results of a Randomized, Double-Blind, Placebo-Controlled Phase 3 Study
Ankylosing Spondylitis (AS) [1527]: Do TNF Inhibitors Alter the Natural History of Ankylosing Spondylitis By Impacting the Incidence and Prevalence of Comorbidities and Extra-Articular Manifestations?
[1548]: Opioid Use in Patients with Ankylosing Spondylitis
Presentations on Investigational Studies of CIMZIA®: Women of Childbearing Age [1809]: Lack of Placental Transfer of Certolizumab Pegol during Pregnancy: Results from a Prospective, Postmarketing, Multicenter, Pharmacokinetic Study
[1309]: Characteristics and Outcomes of Prospectively Reported Pregnancies Exposed to Certolizumab Pegol from a Safety Database
Axial Spondyloarthritis (axSpA) [1515]: Improvements in Enthesitis Scores with Certolizumab Pegol Treatment in Males and Females with Active Axial Spondyloarthritis Are Maintained to Week 204
Presentations on UCB’s Investigational Pipeline: Romosozumab [1886]: Continued Fracture Risk Reduction after 12 Months of Romosozumab Followed By Denosumab through 36 Months in the Extension of the Phase 3 Fracture Study in Postmenopausal Women with Osteoporosis
[1213]: Prediction Model for the Two-Year Risk of Fracture Among Older US Women
[318]: A Randomized Alendronate-Controlled Trial of Romosozumab: Results of the Phase 3 Active-Controlled Fracture Study in Postmenopausal Women with Osteoporosis at High Risk
[319]: The Placebo-Controlled Fracture Study in Postmenopausal Women with Osteoporosis: The Foundation Effect of Rebuilding Bone with One Year of Romosozumab Leads to Continued Lower Fracture Risk after Transition to Denosumab
Bimekizumab [1571]: Bimekizumab Dual Inhibition of IL-17A and IL-17F Provides Evidence of IL-17F Contribution to Chronic Inflammation in Disease-Relevant Cells
[73]: Regulation of Th17 Cell Responses By IL-25
[1936]: Bimekizumab Blocks T Cell-Mediated Osteogenic Differentiation of Periosteal Stem Cells: Coupling Pathological Bone Formation to IL-17A and IL-17F Signaling
About Cimzia® In the US Cimzia® is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis, adults with active psoriatic arthritis (PsA), and adults with active ankylosing spondylitis (AS). 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. See important safety information including risk of serious bacterial, viral and fungal infections and tuberculosis below. Important Safety Information about Cimzia® in the US Risk of Serious Infections and Malignancy
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 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. Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-antagonists, including Cimzia®. Periodic skin examinations are recommended for all patients, particularly those with risk factors for skin cancer. Heart Failure Hypersensitivity Hepatitis B Reactivation Neurologic Reactions Hematologic Reactions Drug Interactions Autoimmunity Immunizations Adverse Reactions In controlled RA clinical trials, the most common adverse events that occurred in ≥3% of patients taking Cimzia® 200 mg every other week with concomitant methotrexate (n=640) and more frequently than with placebo with concomitant methotrexate (n=324) were upper respiratory tract infection (6% Cimzia®, 2% placebo), headache (5% Cimzia®, 4% placebo), hypertension (5% Cimzia®, 2% placebo), nasopharyngitis (5% Cimzia®, 1% placebo), back pain (4% Cimzia®, 1% placebo), pyrexia (3% Cimzia®, 2% placebo), pharyngitis (3% Cimzia®, 1% placebo), rash (3% Cimzia®, 1% placebo), acute bronchitis (3% Cimzia®, 1% placebo), fatigue (3% Cimzia®, 2% placebo). Hypertensive adverse reactions were observed more frequently in patients receiving Cimzia® than in controls. These adverse reactions occurred more frequently among patients with a baseline history of hypertension and among patients receiving concomitant corticosteroids and non-steroidal anti-inflammatory drugs. Patients receiving Cimzia® 400 mg as monotherapy every 4 weeks in RA controlled clinical trials had similar adverse reactions to those patients receiving Cimzia® 200 mg every other week. The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 5% for Cimzia® and 2.5% for placebo. The safety profile for patients with Psoriatic Arthritis (PsA) treated with CIMZIA® was similar to the safety profile seen in patients with RA and previous experience with Cimzia®. The safety profile for AS patients treated with Cimzia® was similar to the safety profile seen in patients with RA. For full prescribing information, please visit www.ucb.com CIMZIA® is a registered trademark of the UCB Group of Companies. About Bimekizumab About Romosozumab For further information, UCB: Corporate Communications Laurent Schots Investor Relations Isabelle Ghellynck Brand Communications About UCB UCB Forward-Looking Statements 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. 1 The trade name EVENITY™ is provisionally approved for use by the U.S. Food and Drug Administration and the European Medicines Agency View original content:http://www.prnewswire.com/news-releases/ucb-presents-new-findings-advancing-patient-care-for-chronic-inflammatory-diseases-and-osteoporosis-at-2017-acrarhp-annual-meeting-300549955.html SOURCE UCB | ||
Company Codes: EuronextBrussels:UCB, OTC-PINK:UCBJY |
