Long-term CimziaÂ® (certolizumab pegol) Data Demonstrated Rapid Sustained Improvements in Clinical Outcomes and Quality of Life in Moderate to Severe Rheumatoid Arthritis (RA) Patients
ATLANTA, June 16 /PRNewswire-FirstCall/ — UCB today announced new CimziaÃ‚® (certolizumab pegol) data demonstrating rapid and sustained improvements in managing moderate to severe rheumatoid arthritis (RA) symptoms and pain for patients, as well as results of a survey showing the impact of RA pain on the daily lives of women, focusing on productivity and relationships, during the 2010 European League Against Rheumatism (EULAR) annual congress in Rome, Italy, June 16-19.
“Insights from these data help us better understand the true impact of living with RA,” said Vibeke Strand, M.D., Adjunct Clinical Professor, Division of Immunology and Rheumatology, at Stanford University, California, and lead author of the Good Days and FAST4WARD studies. “Observations, such as those made in these studies with certolizumab pegol, also suggest that effective treatments can significantly improve productivity and quality of life for those living with RA.”
Following is a guide to UCB-sponsored oral and poster presentations (featuring US-based investigators, patients and study sites) that will be presented during EULAR.
PARE: The Impact of Rheumatoid Arthritis on Women: Focus on -- Pain, Productivity and Relationships Oral Presentation 0002, Wednesday, June 16, 2010, 3:00 pm, Room 7B PARE: People with Arthritis/Rheumatism in Europe
The analysis of the Good Days Study explores the impact of RA on the daily lives and relationships of women 25-65 years of age who have been living with RA for at least 6 months. RA patients from five countries participated in the study, including 300 RA patients from the US. Specifically, the impact of RA on pain, productivity and interpersonal and intimate relationships is highlighted. Results show that the pain associated with the disease drives nearly 70 percent of patients to seek different treatment options. In all countries evaluated, respondents indicated that RA had a negative impact on productivity at work, as well as interpersonal and intimate relationships. For full study information, please see: https://b-com.mci-group.com/AbstractList/EULAR10.aspx
Efficacy and Safety of Certolizumab Pegol Plus Methotrexate in Patients with Rheumatoid Arthritis: 3-year Data from the -- RAPID 2 Study Poster SAT0127, Saturday, June 19, 2010, 10:15 am, Fiera Roma Poster Area in Hall 6 Rapid improvements in ACR20, physical function, pain and fatigue of RA as early as Week 1 were found following treatment with certolizumab pegol, together with methotrexate, and was sustained up to 148 weeks. Inhibition of progression of structural joint damage (seen at Week 24) was sustained up to the last x-ray evaluation at 2.5 years. Efficacy was measured by ACR 20/50/70 responder rates and DAS28[ESR]. Patient-reported outcomes included physical function (assessed using the Health Assessment Questionnaire-Disability Index [HAQ-DI]) and pain (assessed on a 0-100-mm visual analogue scale [VAS]). For full study information, please see: https://b-com.mci-group.com/ AbstractList/EULAR10.aspx Certolizumab Pegol Monotherapy Provides Sustained Improvements in Household Productivity and Daily Activities -- in Patients with Active Rheumatoid Arthritis Over 2 Years Poster SAT0517, Saturday, June 19, 2010, 10:15 am, Fiera Roma Poster Area in Hall 5 The analysis of the open-label extension FAST4WARD study demonstrated that patients receiving certolizumab pegol 400 mg monotherapy reported a rapid improvement in productivity within the home. In as early as 4 weeks, patients reported a lower rate of RA interference with household productivity and increased participation in family, social and leisure activities. The Work Productivity Survey (WPS-RA), which features data from US respondents, was used in the study to evaluate a variety of measures, including household productivity, as well as the number of missed days of family, social and leisure activities. For full study information, please see: https://b-com.mci- group.com/AbstractList/EULAR10.aspx
About Rheumatoid Arthritis
RA affects more than 1.3 million Americans, and it is estimated that 5 million people suffer from RA globally. Prevalence is not split evenly between genders, since women are three times more likely to be affected than men. Although RA can affect people of all ages, the onset of the disease usually occurs between 35-55 years of age.
Certolizumab pegol is the only PEGylated anti-TNF (Tumor Necrosis Factor). It 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. The U.S. Food and Drug Administration (FDA) has approved certolizumab pegol for reducing signs and symptoms of Crohn’s Disease and maintaining clinical response in adult patients with moderate to severe active disease who have had an inadequate response to conventional therapy. It is also approved for the treatment of adults with moderately to severely active rheumatoid arthritis. Certolizumab pegol was approved in Switzerland for induction of a clinical response and for the maintenance of a clinical response and remission in patients with active Crohn’s Disease who have not responded adequately to conventional treatment in September 2007.
Please visit www.cimzia.com for full prescribing information for CIMZIAÃ‚®.
IMPORTANT SAFETY INFORMATION
Risk of Serious Infections and Malignancy
Patients treated with certolizumab pegol 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. Certolizumab Pegol 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 certolizumab pegol use and during therapy. Treatment for latent infection should be initiated prior to certolizumab pegol 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.
The risks and benefits of treatment with certolizumab pegol 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 certolizumab pegol, 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 certolizumab pegol is a member. Certolizumab pegol is not indicated for use in pediatric patients.
Serious and sometimes fatal infection due to bacterial, mycobacterial, invasive fungal, viral or other opportunistic pathogens has been reported in patients receiving TNF-blocking agents. Among opportunistic infections, tuberculosis, histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, listeriosis, and pneumocystosis were the most common. Treatment with certolizumab pegol should not be initiated in patients with an active infection, including clinically important localized infections. Certolizumab pegol should be discontinued if a patient develops a serious infection or sepsis. Patients who develop a new infection during treatment with certolizumab pegol 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.
During controlled and open-labeled portions of certolizumab pegol 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 certolizumab pegol-treated patients versus a rate of 0.6 per 100 patient-years among 1,319 placebo-treated patients. In studies of certolizumab pegol for Crohn’s Disease and other investigational uses, there was one case of lymphoma among 2,657 certolizumab pegol-treated patients and one case of Hodgkin lymphoma among 1,319 placebo-treated patients. In certolizumab pegol 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 certolizumab pegol 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.
Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. Certolizumab pegol has not been formally studied in patients with CHF. Exercise caution when using certolizumab pegol in patients who have heart failure and monitor them carefully.
Symptoms compatible with hypersensitivity reactions, including angioedema, dyspnea, hypotension, rash, serum sickness, and urticaria, have been reported rarely following certolizumab pegol administration. If such reactions occur, discontinue further administration of certolizumab pegol and institute appropriate therapy.
Hepatitis B Reactivation
Use of TNF blockers, including certolizumab pegol, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. Some cases have been fatal. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating certolizumab pegol therapy. Exercise caution in prescribing certolizumab pegol for patients identified as carriers of HBV, with careful evaluation and monitoring prior to and during treatment. In patients who develop HBV reactivation, discontinue certolizumab pegol and initiate effective anti-viral therapy with appropriate supportive treatment.
Use of TNF blockers, including certolizumab pegol, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease. Rare cases of neurological disorders, including seizure disorder, optic neuritis, and peripheral neuropathy have been reported in patients treated with certolizumab pegol. Exercise caution in considering the use of certolizumab pegol in patients with these disorders.
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 certolizumab pegol. 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 certolizumab pegol. Consider discontinuation of certolizumab pegol therapy in patients with confirmed significant hematologic abnormalities.
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 certolizumab pegol in these combinations. Therefore, the combination of certolizumab pegol with anakinra, abatacept, rituximab, or natalizumab is not recommended. Interference with certain coagulation assays has been detected in patients treated with certolizumab pegol. There is no evidence that certolizumab pegol therapy has an effect on in vivo coagulation. Certolizumab pegol may cause erroneously elevated aPTT assay results in patients without coagulation abnormalities.
Treatment with certolizumab pegol may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. Discontinue treatment if symptoms of lupus-like syndrome develop.
Do not administer live vaccines or attenuated vaccines concurrently with certolizumab pegol.
In controlled Crohn’s clinical trials, the most common adverse events that occurred in greater than or equal to 5% of certolizumab Pegol patients (n=620) and more frequently than with placebo (n=614) were upper respiratory infection (20% certolizumab pegol, 13% placebo), urinary tract infection (7% certolizumab pegol, 6% placebo), and arthralgia (6% certolizumab pegol, 4% placebo). The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 8% for certolizumab pegol and 7% for placebo.
In controlled RA clinical trials, the most common adverse events that occurred in greater than or equal to 3% of patients taking certolizumab pegol 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% certolizumab pegol, 2% placebo), headache (5% certolizumab pegol, 4% placebo), hypertension (5% certolizumab pegol, 2% placebo), nasopharyngitis (5% certolizumab pegol, 1% placebo), back pain (4% certolizumab pegol, 1% placebo), pyrexia (3% certolizumab pegol, 2% placebo), pharyngitis (3% certolizumab pegol, 1% placebo), rash (3% certolizumab pegol, 1% placebo), acute bronchitis (3% certolizumab pegol, 1% placebo), fatigue (3% certolizumab pegol, 1% placebo). Hypertensive adverse reactions were observed more frequently in patients receiving certolizumab pegol than in controls. These adverse reactions occurred more frequently among patients with a baseline history of hypertension and among patients receiving concomitant corticosteroids and nonsteroidal anti-inflammatory drugs. Patients receiving certolizumab pegol 400mg as monotherapy every 4 weeks in RA controlled clinical trials had similar adverse reactions to those patients receiving certolizumab pegol 200mg every other week. The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 5% for certolizumab pegol and 2.5% for placebo.
Please see full prescribing information at www.cimzia.com before prescribing.
For Further Information: Bert Kelly, Communications and Public Relations Manager, UCB T: 770.970.8491, Bert.Kelly@ucb.com
UCB, Brussels, Belgium (www.ucb.com) is a biopharmaceutical company dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing more than 9 000 people in over 40 countries, UCB produced revenue of EUR 3.1 billion in 2009. UCB is listed on Euronext Brussels (symbol: UCB).
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