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New data for Cimzia® (certolizumab pegol) showed a rapid and sustained response in Japanese rheumatoid arthritis (RA) patients unresponsive to or unable to take methotrexate (MTX) therapy

  • Data from the J-RAPID and HIKARI studies demonstrated a significant response with Cimzia®, compared to placebo, as early as Week 1 and sustained to Week 24 in a range of adult Japanese patients with active RA1,2
  • Cimzia® was associated with significant inhibition of structural joint damage progression and significant improvements in physical function compared to placebo1,2
  • Results presented from patients taking Cimzia® in combination with MTX, who were unresponsive to MTX alone (J-RAPID), and in patients taking Cimzia® as monotherapy or with concomitant DMARDs, who were unable to take MTX (HIKARI)1,2

BRUSSELS/CHICAGO, 8th November 2011 – UCB today announced data from two studies of Japanese rheumatoid arthritis (RA) patients, which showed treatment with Cimzia® (certolizumab pegol) was associated with a rapid and sustained clinical response in patients unresponsive to standard methotrexate (MTX) therapy (J-RAPID) or either unable to take or unresponsive to MTX (HIKARI).1,2 The results are the first to assess the efficacy of Cimzia® up to 24 weeks in a Japanese patient population, and were presented during the American College of Rheumatology’s (ACR) 2011 Annual Scientific Meeting in Chicago, November 5-9.

In the J-RAPID study, certolizumab pegol plus MTX was associated with a rapid and sustained reduction in RA signs and symptoms compared to placebo plus MTX in Japanese RA patients with an inadequate response to MTX.1 In a second study (HIKARI) of Japanese patients in whom MTX was not tolerated, treatment with certolizumab pegol demonstrated a significantly improved clinical response compared to placebo.2 In the HIKARI study, the positive clinical response was observed both in patients receiving certolizumab pegol as monotherapy and in those receiving concomitant disease modifying antirheumatic drugs (DMARDs) other than MTX.2

“While methotrexate remains an important standard therapy for rheumatoid arthritis patients, it is essential that physicians have options when it is no longer effective alone, or when patients are unable to take it,” said lead investigator Professor Kazuhiko Yamamoto, Department of Allergy and Rheumatology, Graduate School of Medicine, University of Tokyo. “Certolizumab pegol has been studied extensively among a broad range of RA patients and this data from Japanese patient populations reinforces both the breadth of experience and importance of certolizumab pegol as a potential treatment for patients with an inadequate response to standard therapy.”

In the J-RAPID study, RA patients were randomised to either certolizumab pegol 100mg (n=72), 200mg (n=82), 400mg (n=85) or placebo (n=77), once every two weeks, plus MTX. Those within the certolizumab pegol groups received an induction dose of 200mg (100mg group) or 400mg (200mg and 400mg groups) at Weeks 0, 2 and 4. The primary end point of ACR20 response rates at Week 12 was significantly higher in all certolizumab pegol groups vs placebo (p<0.001) and differences were sustained to the end of the study at Week 24. Similarly ACR50 response rates were significantly higher in each certolizumab pegol group vs placebo at Weeks 12 and 24. The differences in certolizumab pegol ACR20 response rates compared to placebo were observed as early as Week 1 across all doses.1

At Week 12 the 200mg dose of certolizumab pegol showed higher ACR20 response rates than 100mg (76.8% vs 62.5% respectively) and support findings from previous Phase III studies, consistent with EU and FDA certolizumab pegol licenses of 200mg every 2 weeks. The ACR20 response seen with the 200mg dose was similar to the 400mg dose.

In the HIKARI study, RA patients in whom MTX could not be administered were randomised to either certolizumab pegol 200mg (n=116) every two weeks, following an induction dose of 400mg at Weeks 0, 2, and 4, or placebo (n=114) with concomitant DMARDs other than MTX. ACR20 responses were significantly higher in the certolizumab pegol group than with placebo at Week 12 (67.2% vs 14.9% respectively) and Week 24 (63.8% vs 11.4%). ACR50 responses in patients treated with certolizumab pegol were significantly higher than placebo at Weeks 12 (37.9% vs 6.1%) and 24 (46.6% vs 6.1%), while ACR70 responses were also higher at Week 24 (25.9% vs 0.9%). Significant differences in ACR20 responses were seen as early as Week 1 and sustained to Week 24, compared to placebo. Importantly, these results were consistent regardless of use of concomitant DMARDs.2

“These Japanese data confirm our previous findings that Cimzia® demonstrates a rapid and sustained response in adult patients with active RA,” explained Professor Dr Iris Loew-Friedrich, Chief Medical Officer of UCB, Belgium. “This data will form an important part of our submission for Cimzia® marketing authorisation in Japan, which is scheduled for early 2012.”

In both studies, treatment with certolizumab pegol showed significant inhibition of structural joint damage progression, which was measured as a change from baseline in modified Total Sharp Score (mTSS). At Week 24 of the J-RAPID study the mean mTSS change from baseline was 1.04, 0.21 and 0.65 for certolizumab pegol patients (100mg, 200mg and 400mg respectively) compared with a change of 2.78 in placebo patients (p<0.001 for 200mg and p<0.01 for 400mg vs placebo and MTX). All doses significantly reduced joint erosion and the 200mg dose reduced joint space narrowing significantly compared to placebo (0.18 (p<0.05 vs placebo and MTX) vs 0.82).1 From post-hoc analysis of the HIKARI study, the mean mTSS change at Week 24 was 0.48 for the certolizumab pegol 200mg treated group and 2.45 for the placebo group (p<0.001). Mean mTSS change at Week 24 was 0.68 for certolizumab pegol monotherapy vs 3.65 for placebo (p=0.01), and 0.24 for certolizumab pegol plus concomitant DMARDs vs 1.61 for placebo (p=0.01).2 Furthermore, significant improvements were also observed in disease activity and physical function in the certolizumab pegol groups vs placebo, as early as Week 1 in both studies.1,2

In terms of safety, the two certolizumab pegol studies identified no new safety signals. The most frequently reported Adverse Events (AEs) in J-RAPID were nasopharyngitis (all groups), pharyngitis (certolizumab pegol 100mg and 200mg) and upper respiratory tract infection (certolizumab pegol 100mg). In HIKARI, the most frequently reported AE in both groups was nasopharyngitis, occurring in 17.2% and 14.0% of patients of patients receiving certolizumab pegol and placebo respectively. In both studies Serious Adverse Events (SAEs) were infrequent and included infections and infestations.

For further Information:
Scott Fleming, Global Communications Manager – Immunology
T +44 770.277.7378,
scott.fleming@ucb.com

Antje Witte, Investor Relations, UCB
T +32.2.559.9414,
antje.witte@ucb.com

Michael Tuck-Sherman, Investor Relations, UCB
T +32.2.559.9712,
Michael.tuck-sherman@ucb.com

About CIMZIA®
Cimzia® is the only PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia® 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 Cimzia® 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 and for the treatment of adults with moderately to severely active rheumatoid arthritis. Cimzia® in combination with MTX, is approved in the EU for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying antirheumatic drugs (DMARDs) including MTX. Cimzia® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. UCB is also developing Cimzia® in other autoimmune disease indications. Cimzia® is a registered trademark of UCB PHARMA S.A.

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 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).

UCB has a collaboration with Otsuka Pharmaceuticals for Cimzia® (certolizumab pegol) in the Japanese market.

About Otsuka Pharmaceutical Co., Ltd.
Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: 'Otsuka-people creating new products for better health worldwide.’ Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases, and consumer products for the maintenance of everyday health. Otsuka is committed to being a corporation that creates global value, adhering to high ethical standards required of a company involved in human health and life, maintaining a dynamic corporate culture, and working in harmony with local communities and the natural environment.

Forward-looking statements
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.

Cimzia® (certolizumab pegol) in European Union/ EEA important safety information
Cimzia® was studied in 2367 patients with RA in controlled and open label trials for up to 57 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), asthenia, leukopaenia (including lymphopaenia, neutropaenia), eosinophilic disorder, pain (any sites), pyrexia, sensory abnormalities, hypertension, pruritis (any sites), hepatitis (including hepatic enzyme increase), injection site reactions. Serious adverse reactions include sepsis, opportunistic infections, tuberculosis, herpes zoster, lymphoma, leukaemia, solid organ tumours, angioneurotic edema, 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, 5% of patients discontinued taking Cimzia® due to adverse events vs. 2.5% 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, moderate to severe heart failure.

Before initiation of Cimzia®, evaluate patients for both active or inactive (latent) tuberculosis infection. Monitor patients for the development of signs and symptoms of infection during and after treatment with Cimzia®. If an infection develops, monitor carefully, and stop Cimzia® if infection becomes serious.

TNF blockers including Cimzia® may increase the risk: of reactivation of Hepatitis B Virus (HBV) in patients who are chronic carriers of the virus; 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 hematologic system, including medically significant cytopenia, 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 or attenuated 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.

Please consult the full prescribing information in relation to other side effects, full safety and prescribing information. European SmPC date of revision February 2011.

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001037/WC500069763.pdf

References

  1. Yamamoto K, Takeuchi T, Yamanaka H et al. Efficacy and Safety of Certolizumab Pegol Plus Methotrexate in Japanese Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate. 2011 American College of Rheumatology annual meeting. Poster #1218
  2. Yamamoto K, Takeuchi T, Yamanaka H et al. Efficacy and Safety of Certolizumab Pegol Without Methotrexate Co-Administration in Japanese Patients With Active Rheumatoid Arthritis. 2011 American College of Rheumatology annual meeting. Poster #1220

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