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UCB Advances Psoriasis Pipeline with Positive Data at American Academy of Dermatology Annual Meeting (AAD 2018)

  • Oral presentation of Phase 2b findings for bimekizumab in the treatment of moderate-to-severe chronic plaque psoriasis patients will focus on the effects of dual neutralization of both IL-17A and IL-17F 
  • Three pooled sub-analyses from ongoing, Phase 3 studies CIMPASI-1, CIMPASI-2 and CIMPACT reflect potential versatility of CIMZIA® (certolizumab pegol) in the treatment of psoriasis 
  • Results from the largest cohort of pregnant women exposed to an anti-TNF for management of a chronic inflammatory disease highlight the value of CIMZIA for this underserved population
Brussels, Belgium – February 16, 2018 – UCB, a global biopharmaceutical company, will be presenting new data on CIMZIA® (certolizumab pegol) and one of UCB’s key pipeline molecules, bimekizumab, at the 2018 American Academy of Dermatology (AAD) Annual Meeting in San Diego, CA (February 16-20, 2018).  
 
“UCB is thrilled to participate in the important scientific exchange at AAD this week and to translate our learnings into improved patient care. We are committed to patients with psoriatic disease, through investment in underserved areas and breakthrough solutions that deliver unique outcomes,” said Emmanuel Caeymaex, Head of Immunology and Executive Vice President at UCB. “As our research at AAD shows, UCB is executing on its Patient Value Strategy to connect the unmet needs of patients with innovative science. People living with psoriasis often face a heavy disease burden and may experience significant physical discomfort. The studies presented this week explore the potential value of CIMZIA for psoriasis patient subpopulations, as well as the development of new approaches to treating inflammation associated with psoriasis, such as the neutralization of both IL-17A and IL-17F with bimekizumab.”
 
Full efficacy and safety findings from the Phase 2b BE ABLE study on the investigational molecule bimekizumab will highlight the dual neutralization of IL-17A and IL-17F, two key cytokines driving the inflammatory processes, as a novel and effective targeting approach in psoriasis. In July 2017, UCB announced positive topline results from the BE ABLE study demonstrating that 79% of patients achieved at least 90% skin clearance in the psoriasis area and severity index (PASI90) and up to 60% of patients achieved complete skin clearance (PASI100) at week 12. 
 
Additional data highlights include presentations on the treatment effect of CIMZIA in adults with moderate-to-severe chronic plaque psoriasis. Results will be presented from a pooled sub-analysis of the ongoing, Phase 3 studies CIMPASI-1, CIMPASI-2 and CIMPACT, exploring the effect of CIMZIA in psoriasis patients who had been previously exposed to systemic therapy, including biologics. A separate pooled sub-analysis of the three studies analyzes the potential treatment effect across demographic and baseline disease subgroups, including age, gender, weight/BMI, and disease severity. A third sub-analysis explores the treatment effect of CIMZIA in psoriasis patients both with and without self-reported concurrent psoriatic arthritis. CIMZIA is not currently approved by the U.S. Food and Drug Administration or other health authorities to treat psoriasis. 
Prospective and retrospective data showcasing the characteristics and outcomes from 1,541 maternal CIMZIA-exposed pregnancies -- the largest cohort of pregnant women exposed to an anti-TNF for management of a chronic inflammatory disease -- will also be presented this week. Women surveyed in this study were living with psoriatic arthritis, Crohn’s disease, rheumatoid arthritis, and ankylosing spondylitis, among others (excluding psoriasis).  
 
Following is a guide to the UCB-sponsored data presentations:
 
Presentations on UCB's Investigational Pipeline:
 
Bimekizumab
 
[F061] Dual Neutralization of Interleukin (IL)-17A and IL-17F with Bimekizumab in Moderate-to-severe
Psoriasis: Results from a Phase 2b, Randomized, Double-blinded, Placebo-controlled, Dose-ranging Study
Papp, K. A. et al. 
Date/Time: Saturday, February 17 at 1:00 PM - 3:00 PM PT 
Session Information: Late-breaking Research: Clinical Trials - Ballroom 20A
 
Presentations on Investigational Studies of CIMZIA®
 
Psoriasis
 
[7774] Certolizumab Pegol is Effective for Chronic Plaque Psoriasis Regardless of Previous Exposure to Systemic Therapy: A Pooled Subanalysis of Ongoing, Phase 3 Studies (CIMPASI-1, CIMPASI-2, CIMPACT)
Blauvelt, A. et al.
Date/Time: Friday, February 16 at 7:00AM PT
Session Information: ePoster only
 
[7692] Certolizumab Pegol is Effective for Chronic Plaque Psoriasis Across Patient Subgroups: A Pooled Subanalysis From Ongoing, Phase 3 Studies (CIMPASI-1, CIMPASI-2, CIMPACT)
Reich, K. et al.
Date/Time: Saturday, February 17 at 4:35 PM - 4:40 PM PT
Session Information: ePoster Presentation Center 1
 
[7773] A Pooled Subanalysis of the Efficacy of Certolizumab Pegol in Patients with Self-Reported Psoriatic Arthritis in Ongoing, Phase 3 Psoriasis Studies (CIMPASI-1, CIMPASI-2, CIMPACT)
Gottlieb, A. B. et al.
Date/Time: Friday, February 16 at 7:00AM PT
Session Information: ePoster only
 
Women of Childbearing Age
[7094] Characteristics and Outcomes of Prospectively Reported Pregnancies Exposed to Certolizumab Pegol from a Safety Database 
Kimball, A. B. et al.
Date/Time: Friday, February 16 at 1:10 PM - 1:15PM PT 
Session Information: ePoster Presentation Center 1
 
About Bimekizumab 
Bimekizumab is a novel humanized monoclonal IgG1 antibody that potently and selectively neutralizes both IL-17A and IL-17F, two key cytokines driving inflammatory processes. IL-17A and IL-17F have overlapping pro-inflammatory functions and independently cooperate with other inflammatory mediators to drive chronic inflammation and damage across multiple tissues. 
 
Previous early Phase clinical studies in psoriasis and psoriatic arthritis have suggested that dual neutralization of both IL-17A and IL-17F with bimekizumab may provide a new targeted approach for the treatment of immune-mediated inflammatory diseases. Preclinical results in disease-relevant cells have shown that dual neutralization of both IL-17A and IL-17F reduces skin and joint inflammation, as well as pathological bone formation to an extent greater than inhibition of IL-17A or IL-17F alone.1,2,3 
 
UCB is studying bimekizumab in psoriasis, psoriatic arthritis and ankylosing spondylitis. Bimekizumab is not approved by any regulatory authority worldwide. 
 
About Cimzia® In the US
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 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
 
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 of the UCB Group of Companies.
 
About CIMZIA® in the EU/EEA

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 anti-rheumatic drugs (DMARDs) including MTX. 

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 also indicated for the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs.

CIMZIA has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX.

CIMZIA, in combination with MTX, is also 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 MTX or when continued treatment with MTX is inappropriate.

CIMZIA is also indicated in the EU for the treatment of adult patients with severe active axial spondyloarthritis (axSpA), comprising: 
  • 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.
About CIMZIA® in Fertility, Pregnancy and Lactation in the EU/EEA
 
Women of childbearing potential 
The use of adequate contraception should be considered for women of childbearing potential. For women planning pregnancy, continued contraception may be considered for 5 months after the last CIMZIA® dose due to its elimination rate, but the need for treatment of the woman should also be taken into account (see below).

Pregnancy
Data from more than 500 prospectively collected pregnancies exposed to CIMZIA® with known pregnancy outcomes, including more than 400 pregnancies exposed during the first trimester, does not indicate a malformative effect of CIMZIA. However, the available clinical experience is too limited to, with a reasonable certainty, conclude that there is no increased risk associated with CIMZIA administration during pregnancy.

Animal studies using a rodent anti-rat TNFα did not reveal evidence of impaired fertility or harm to the foetus. However, these are insufficient with respect to human reproductive toxicity. Due to its inhibition of TNFα, CIMZIA administered during pregnancy could affect normal immune response in the newborn. 

CIMZIA should only be used during pregnancy if clinically needed. Non-clinical studies suggest low or negligible level of placental transfer of a homologue Fab-fragment of certolizumab pegol (no Fc region). 

In a clinical study 16 women were treated with certolizumab pegol (200 mg every 2 weeks or 400 mg every 4 weeks) during pregnancy. Certolizumab pegol plasma concentrations measured in 14 infants at birth were Below the Limit of Quantification (BLQ) in 13 samples; one was 0.042 µg/ml with an infant/mother plasma ratio at birth of 0.09%. At Week 4 and Week 8, all infant concentrations were BLQ. The clinical significance of low levels certolizumab pegol for infants is unknown. It is recommended to wait a minimum of 5 months following the mother’s last CIMZIA administration during pregnancy before administration of live or live-attenuated vaccines (e.g. BCG vaccine), unless the benefit of the vaccination clearly outweighs the theoretical risk of administration of live or live-attenuated vaccines to the infants.

Breastfeeding
In a clinical study in 17 lactating women treated with CIMZIA®, minimal transfer of certolizumab pegol from plasma to breast milk was observed. The percentage of the maternal certolizumab pegol dose that was reaching an infant during a 24 hour period was estimated to 0.04% to 0.30%. In addition, since certolizumab pegol is a protein that is degraded in the gastrointestinal tract after oral administration, the absolute bioavailability is expected to be very low in a breastfed infant. Consequently, CIMZIA can be used during breastfeeding.

Important Safety Information about CIMZIA® in the EU/EEA 
CIMZIA® was studied in 4,049 patients with rheumatoid arthritis (RA) in controlled and open label trials for up to 92 months. The commonly reported adverse reactions (1-10%) in clinical trials with CIMZIA® and post-marketing were viral infections (includes herpes, papillomavirus, influenza), bacterial infections (including abscess), rash, headache (including migraine), asthaenia, leukopaenia (including lymphopaenia, neutropaenia), eosinophilic disorder, pain (any sites), pyrexia, sensory abnormalities, hypertension, pruritus (any sites), hepatitis (including hepatic enzyme increase), injection site reactions, and nausea. Serious adverse reactions include sepsis, opportunistic infections, tuberculosis, herpes zoster, lymphoma, leukaemia, solid organ tumours, angioneurotic oedema, cardiomyopathies (includes heart failure), ischemic coronary artery disorders, pancytopaenia, hypercoagulation (including thrombophlebitis, pulmonary embolism), cerebrovascular accident, vasculitis, hepatitis/hepatopathy (includes cirrhosis), and renal impairment/nephropathy (includes nephritis). In RA controlled clinical trials, 4.4% of patients discontinued taking CIMZIA® due to adverse events vs. 2.7% for placebo.

CIMZIA® is contraindicated in patients with hypersensitivity to the active substance or any of the excipients, active tuberculosis or other severe infections such as sepsis or opportunistic infections or moderate-to-severe heart failure.

Serious infections including sepsis, tuberculosis and opportunistic infections have been reported in patients receiving CIMZIA®. Some of these events have been fatal. Monitor patients closely for signs and symptoms of infections including tuberculosis before, during, and after treatment with CIMZIA®. Treatment with CIMZIA® must not be initiated in patients with a clinically important active infection. If an infection develops, monitor carefully and stop CIMZIA® if infection becomes serious. Before initiation of therapy with CIMZIA®, all patients must be evaluated for both active and inactive (latent) tuberculosis infection. If active tuberculosis is diagnosed prior to or during treatment, CIMZIA® therapy must not be initiated and must be discontinued. If latent tuberculosis is diagnosed, appropriate anti-tuberculosis therapy must be started before initiating treatment with CIMZIA®. Patients should be instructed to seek medical advice if signs/symptoms (e.g. persistent cough, wasting/weight loss, low grade fever, listlessness) suggestive of tuberculosis occur during or after therapy with CIMZIA®.

Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including CIMZIA® who are chronic carriers of the virus (i.e. surface antigen positive). Some cases have had a fatal outcome. Patients should be tested for HBV infection before initiating treatment with CIMZIA®. Carriers of HBV who require treatment with CIMZIA® should be closely monitored and in the case of HBV reactivation CIMZIA® should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.

TNF-antagonists including CIMZIA® may increase the risk of new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease; of formation of autoantibodies and uncommonly of the development of a lupus-like syndrome; of severe hypersensitivity reactions. If a patient develops any of these adverse reactions, CIMZIA® should be discontinued and appropriate therapy instituted.

With the current knowledge, a possible risk for the development of lymphomas, leukaemia or other malignancies in patients treated with a TNF-antagonist cannot be excluded. Rare cases of neurological disorders, including seizure disorder, neuritis and peripheral neuropathy, have been reported in patients treated with CIMZIA®.

Adverse reactions of the haematologic system, including medically significant cytopaenia, have 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 haematological abnormalities.

The use of CIMZIA® in combination with anakinra or abatacept is not recommended due to a potential increased risk of serious infections. As no data are available, CIMZIA® should not be administered concurrently with live vaccines. The 14-day half-life of CIMZIA® should be taken into consideration if a surgical procedure is planned. A patient who requires surgery while on CIMZIA® should be closely monitored for infections.

CIMZIA® was studied in 325 patients with active axial spondyloarthritis (axSpA) in a placebo-controlled clinical trial for up to 30 months and in 409 patients with psoriatic arthritis (PsA) in a placebo-controlled clinical trial for up to 30 months. The safety profile for axSpA and PsA patients treated with CIMZIA® was consistent with the safety profile in RA and previous experience with CIMZIA®.

Please consult the full prescribing information in relation to other side effects, full safety and prescribing information. European SmPC date of revision December 2017. 

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001037/WC500069763.pdf  
CIMZIA® is a registered trademark of the UCB Group of Companies.
 
For further information, UCB: 
 
Corporate Communications
France Nivelle  
Global Communications, UCB
T +32.2.559.9178 france.nivelle@ucb.com
 
Laurent Schots 
Media Relations, UCB  
T+32.2.559.92.64  Laurent.schots@ucb.com 
 
Investor Relations
Antje Witte          
Investor Relations, UCB
T +32.2.559.94.14 antje.witte@ucb.com
 
Isabelle Ghellynck,
 Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com 
 
Brand Communications
 
Andrea Levin Christopher,
Immunology Communications, UCB
T +1.404.483.7329, andrea.levin@ucb.com 
 
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 7 500 people in approximately 40 countries, the company generated revenue of € 4.2 billion in 2016. 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.
 
References:

1. Glatt S, Baeten D, Baker T, et al. Dual IL-17A and IL-17F neutralisation by bimekizumab in psoriatic arthritis: evidence from preclinical experiments and a randomized placebo-controlled clinical trial that IL-17F contributes to human chronic tissue inflammation. Ann Rheum Dis. In Press.

2. Shah M, Maroof A, Al-Hosni R, Gikas P, Gozzard N, Shaw S, Roberts S. Bimekizumab Blocks T Cell-Mediated Osteogenic Differentiation of Periosteal Stem Cells: Coupling Pathological Bone Formation to IL-17A and IL-17F Signaling [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10).

UCB Data on File. July 2017.

3. Maroof A, Okoye R, Smallie T, et al. Bimekizumab dual inhibition of IL-17A and IL-17F provides evidence of IL-17F contribution to chronic inflammation in disease-relevant cells. Ann Rheum Dis. 201706;76 (suppl.2):213-213.

 
 

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