Publicado 07/06/2018 07:01
- Comunicado -

New UCB Data Presented at the Annual European Congress of Rheumatology (EULAR 2018) Serves Key Patient Populations Inclu

TNF-antagonists including CIMZIA(R) 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(R) 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(R).

Adverse reactions of the haematologic system, including medically significant cytopaenia, have been infrequently reported with CIMZIA(R). 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(R). Consider discontinuation of CIMZIA(R) therapy in patients with confirmed significant haematological abnormalities.

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

CIMZIA(R) 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(R) was consistent with the safety profile in RA and previous experience with CIMZIA(R).

Please consult the full prescribing information in relation to other side effects, full safety and prescribing information. European SmPC date of revision January 2018. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_... 37/WC500069763.pdf [https://na01.safelinks.protection.outloo... ]  

CIMZIA(R) is a registered trademark of the UCB Group of Companies.

For further information, UCB:   

Corporate Communications Investor Relations Brand Communications France Nivelle, Antje Witte, Andrea Levin Christopher, Global Communications, UCB Investor Relations, UCB Immunology Communications, UCB T +32-2-559-9178, T +32-2-559-94-14, T +1-404-483-7329 france.nivelle@ucb.com antje.witte@ucb.com andrea.christopher@ucb.com Laurent Schots, Media Relations, UCB T +32-2-559-92-64, laurent.schots@ucb.com

About UCB  

UCB, Brussels, Belgium (http://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 in immunology or neurology. With more than 7,500 people in approximately 40 countries, the company generated revenue of EUR 4.5 billion in 2017. UCB is listed on Euronext Brussels . 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.

[i]. 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.

[ii]. 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).

[iii]. 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.

HQ/0518/MPR/00007 June 2018

Photo: https://mma.prnewswire.com/media/683106/...

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