UCB Launches Wellness 4U, an Innovative and Comprehensive Health and Wellness Program for Patients with Immunologic Diseases

ATLANTA, March 15, 2017 /PRNewswire/ -- UCB, a global biopharmaceutical company focusing on immunology, neurology and bone treatments and research, has launched Wellness 4U™, an insights-driven health and wellness program that is dedicated to promoting healthier lifestyles. Wellness 4U is meant to inspire positive behavior change, increase commitment to wellness and help improve the overall well-being of people living with immunologic disorders who have high unmet needs.

Wellness 4U is a multi-channel health and wellness program that utilizes several initiatives aimed to elevate patient outcomes beyond therapeutic support for people living with immunologic disorders and their healthcare professionals. Key Wellness 4U programs include a Wellness 4U Activity Tracker, a health outcomes research collaboration with the IBD Support Foundation, a national wellness education panel speaker event series addressing the entire care team and a nurse practitioner/physician's assistant educational initiative. The program reinforces UCB's commitment to find novel ways to improve the health and lives of patients.

As part of Wellness 4U, UCB launched the Wellness 4U Activity Tracker pilot program that works with physicians to provide CIMZIA^® (certolizumab pegol)-treated patients living with moderate-to-severe rheumatoid arthritis (RA) a Garmin^® vivofit^® 2 activity tracker to monitor their daily steps and sleep patterns. Once enrolled in the program, patients can access the Wellness 4U online community platform that offers tracking capabilities for data sourced from their activity trackers and other healthy lifestyle tips and information to aid in improving overall wellness and physical health. Insights gathered through the Activity Tracker program should help enable healthcare professionals (HCPs) and patients to assess whether behavioral changes have impacted participant health.

"Patients with immunologic disorders are often at higher risk for other conditions such as cardiovascular events. Leading an active and healthy lifestyle may help to prevent this, but patients often aren't sure where to start," said Dr. Prashanth Sunkureddi, Clear Lake Rheumatology in Houston, TX. "Therefore, initiatives like Wellness 4U can be critical in empowering patients to have meaningful discussions with their physicians about their lifestyles and improving long-term health outcomes beyond their treatment plans alone. By tracking physical activity and sleeping habits through the Wellness 4U Activity Tracker, the first program of its kind for people with RA, patients can work with their physicians to track their progress and ultimately take an active role in their own wellness journey."

The Wellness 4U Activity Tracker program has commenced in four U.S. cities – Houston, Texas; Charlotte, North Carolina; Louisville, Kentucky; and Los Angeles, California – with approximately 50 patients enrolled to-date.

"At UCB, we aim to deliver the highest value for patients, including providing sustainable, positive outcomes for those living with immunologic disorders through our Wellness 4U initiatives this year and beyond. Providing patients with support means more than just therapeutic intervention. We are proud that we've been able to create Wellness 4U to equip patients and their healthcare team with tools to address mental, physical and social unmet needs. This overarching Wellness 4U platform and the unique relationships it is forging are representative of the larger UCB commitment to being a trusted collaborator, actively pioneering in subpopulations with remaining unmet patient and provider needs," said Todd Edwards, Vice President and Head of US Immunology at UCB.

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.

CIMZIA 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. In addition, it 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). 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

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.

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

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-Barré 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 live-attenuated vaccines concurrently with Cimzia^®.

Adverse Reactions

In controlled Crohn's clinical trials, the most common adverse events that occurred in ≥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 ≥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, and Wellness 4U™ is a trademark, of the UCB Group of Companies. Garmin^® and vivofit^® are registered trademarks of Garmin Limited or its subsidiaries.

For further information, UCB:

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 7700 people in approximately 40 countries, the company generated revenue of € 3.9 billion in 2015. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.

Forward looking statements - UCB 
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially 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, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. UCB is providing this information as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations.

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.

SOURCE UCB

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