New Data on Cimzia® (certolizumab pegol) to be Presented at ACG Meeting Highlights Role of Inflammatory Biomarkers in Treatment for Moderate to Severe Crohn's Disease

ATLANTA, Oct. 31, 2011 /PRNewswire/ -- UCB, a leading biopharmaceutical company at the forefront of immunology treatment and research, will present new data on Cimzia® (certolizumab pegol) at the American College of Gastroenterology (ACG) Annual Scientific Meeting, taking place in Washington D.C. from October 28 to November 2.  

"Cimzia data presented this year at ACG highlights the role that inflammatory biomarkers may play in increasing the understanding of the progression of Crohn's disease and improving treatment," said William Sandborn, MD, University of California San Diego, La Jolla, CA.  "This growing body of evidence indicates that we should further examine the role of biomarkers in Crohn's disease and the use of Cimzia as a treatment to manage moderate to severe Crohn's disease."

Cimzia is indicated for reducing the 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.  Individuals with moderate to severe Crohn's disease can experience painful symptoms that interfere with daily life such as diarrhea, abdominal cramps, rectal bleeding and high fevers.

Following is a guide to Cimzia research being exhibited during ACG.  Posters will be presented at various times from Sunday, October 30 to Monday, October 31, 2011.

• Inflammatory Biomarkers and Clinical Remission in Patients with Active Crohn's Disease: Results from PRECiSE 2
  • In Crohn's disease (CD) patients receiving Cimzia (CZP), high levels of C-reactive protein (CRP) concentrations and fecal calprotectin coincide with lower remission rates.  Additionally, high CRP, with or without high fecal calprotectin, may be associated with lower CZP plasma concentrations.  These findings suggest that high CRP or high fecal calprotectin levels at baseline may be useful in predicting long-term remission and indicate that further work on understanding normalization of biomarkers in CD by adjusting anti-TNF therapy is warranted.  
  • Poster 712, October 31, 12:45 – 2:15 pm, Prince Georges Exhibit Hall

• Baseline C-Reactive Protein (CRP) and Plasma Anti-TNF Concentration in Patients with Active Crohn's Disease Treated with Certolizumab Pegol (CZP)
  • In patients with active CD, a trend toward lower plasma CZP levels at week six was observed in patients with high baseline CRP levels.  This finding suggests that further studies can help clarify the relationship between CZP and CRP.  
  • Poster 280, October 30, 3:30 – 7:00 pm, Prince Georges Exhibit Hall

• Antibodies Against Certolizumab Pegol (CZP), Plasma Concentrations of CZP, and Efficacy in Patients with Crohn's Disease Receiving Continuous CZP Therapy With or Without Concomitant Immunosuppressants
  • The presence of anti-CZP antibodies was evaluated in patients in the PRECiSE 2 and PRECiSE 3 studies who received continuous CZP therapy over 52 weeks with and without concomitant immunosuppressants.  Concomitant immunosuppressants at baseline were associated with low rates of anti-CZP antibody formation in patients with CD receiving continuous therapy with CZP.
  • Poster 713, October 31, 12:45 – 2:15 pm, Prince Georges Exhibit Hall

• Formation of Autoantibodies in Patients with Moderate to Severe Crohn's Disease, Receiving Continuous and Interrupted Certolizumab Pegol (CZP) Therapy With or Without Concomitant Immunosuppressants  
  • The rate of anti-nuclear antibodies and anti-double stranded DNA antibody formation was low in patients with active CD receiving continuous or interrupted CZP therapy over 52 weeks, regardless of concomitant immunosuppressants use at baseline.  
  • Poster 726, October 31, 12:45 – 2:15 pm, Prince Georges Exhibit Hall

Following is a guide to additional Cimzia presentations at ACG:

• Fecal Calprotectin Concentration and Clinical Remission in Patients with Active Crohn's Disease Treated with Certolizumab Pegol: Results from PRECiSE 1
  • Poster 282, October 30, 3:30 – 7:00 pm, Prince Georges Exhibit Hall

• Fecal Calprotectin Concentration and Clinical Response to Certolizumab Pegol in Patients with Active Crohn's Disease: Results from PRECiSE 2
  • Poster 711, October 31, 12:45 – 2:15 pm, Prince Georges Exhibit Hall

• Use of Certolizumab Pegol in the Management of Acute Extraintestinal Manifestations of Active Crohn's Disease
  • Poster 740, October 31, 12:45 – 2:15 pm, Prince Georges Exhibit Hall

To view a full schedule of presentations and poster sessions, please click here.  To schedule an interview with Cem Kayhan, MD, Medical Director at UCB or PRECiSE investigator, William Sandborn, MD (University of California San Diego, La Jolla, CA) please contact Andrea Levin at (770) 970-8352 or [email protected].

About Crohn's Disease

Crohn's disease is a chronic, progressive, destructive disorder that causes inflammation of the gastrointestinal (GI) tract, most commonly at the end of the small intestine (the ileum) and beginning of the large intestine (the colon).   If not effectively treated, it may result in the need for surgery and hospitalization. Crohn's disease has been estimated to affect as many as half a million Americans.  People with Crohn's can experience an ongoing cycle of flare-up and remission throughout their lives.

About Cimzia

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 CIMZIA®.

Important Safety Information

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 less than or equal to 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.

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. If such reactions occur, discontinue further administration of CIMZIA and institute appropriate therapy.

Hepatitis B Reactivation

Use of TNF blockers, including CIMZIA, 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 CIMZIA therapy. 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. CIMZIA may cause erroneously elevated aPTT assay results in patients without coagulation abnormalities.

Autoimmunity

Treatment with CIMZIA 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.

Immunizations

Do not administer live vaccines or attenuated vaccines concurrently with CIMZIA.

Adverse Reactions

In controlled Crohn's clinical trials, the most common adverse events that occurred in greater than or equal to 5% of CIMZIA patients (n=620) and more frequently than with placebo (n=614) were upper respiratory infection (20% CIMZIA, 13% placebo), urinary tract infection (7% CIMZIA, 6% placebo), and arthralgia (6% CIMZIA, 4% placebo). The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 8% for CIMZIA 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 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 400mg as monotherapy every 4 weeks in RA controlled clinical trials had similar adverse reactions to those patients receiving CIMZIA 200mg 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.

Please see full prescribing information at www.cimzia.com before prescribing.

For further Information:
Andrea Levin, Senior Manager, Communications & PR
(770) 970-8352, [email protected]

Dena Koklanaris, Cooney/Waters Group
(212) 886-2228, [email protected]

About UCB
UCB, Brussels, Belgium (www.ucb-usa.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 3.2 billion in 2010. UCB is listed on Euronext Brussels (symbol: UCB).

For further information on UCB products, please visit www.ucb-usa.com .

Forward looking statement
This press release contains forward-looking statements based on current plans, estimates and beliefs of management.  Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.

SOURCE UCB