COMUNICADO: Janssen Presents Long Term Phase 3 Efficacy and Safety Data of Sirukumab in Rheumatoid Arthritis Patients Who had an Ina

 

COMUNICADO: Janssen Presents Long Term Phase 3 Efficacy and Safety Data of Sirukumab in Rheumatoid Arthritis Patients Who had an Ina

Publicado 14/06/2017 17:28:51CET

Sirukumab is a fully human monoclonal IgG1 kappa antibody that selectively blocks circulating IL-6, a naturally occurring protein that is believed to play a role in autoimmune conditions like RA. It is not approved as a treatment for rheumatoid arthritis or any other indication anywhere in the world. Sirukumab is different from other interleukin (IL)-6 inhibitors currently approved for the treatment of RA as it targets the IL-6 cytokine, whereas other agents target the IL-6 receptor.

In December 2011, Janssen and GSK entered into a licensing and co-development agreement with respect to sirukumab. Under the terms, Janssen retains exclusive rights to commercialise sirukumab in Europe, the Middle East, Africa and Asia Pacific, while GSK has commercialisation rights in North, Central and South America. The agreement gives both companies the option to investigate sirukumab for other indications beyond RA. Sirukumab is currently being evaluated by health authorities in Europe [http://www.janssen.com/janssen-submits-application-seeking-approval-sirukumab-european-union-rheumatoid-arthritis ] , the US and Japan as a subcutaneous therapy for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

About Rheumatoid Arthritis Rheumatoid arthritis is a chronic, systemic inflammatory condition that is characterised by pain, joint swelling, stiffness and loss of function[8]; it can lead to rapid irreversible joint destruction, permanent disability and increased mortality.[9] It is estimated that approximately 6.2 million Europeans are affected by the condition, for which there is no cure.[10]

In clinical studies patient-reported outcomes are measured by a number of self-assessed tools. The SIRROUND clinical programme included SF-36 and HAQ-DI. The short-form 36 (SF-36) survey is a patient-reported health quality assessment which assesses eight aspects of health ranging from physical limitations to general perceptions of vitality and mental well-being. As a general health assessment tool, it is often paired with a disease-specific assessment tool. The Health Assessment Questionnaire Disability Index (HAQ-DI) is a questionnaire for the assessment of rheumatoid arthritis. The questionnaire is a patient-reported outcome (PRO) which is usually self-administered by the patient.

About the Janssen Pharmaceutical Companies 

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com [http://www.janssen.com ]. Follow us at Twitter.com/JanssenEMEA [http://Twitter.com/JanssenEMEA ].

Cautions Concerning Forward-Looking Statements 

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the potential of sirukumab and expectations for its further development. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; manufacturing difficulties or delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including under "Item 1A. Risk Factors," its most recently filed Quarterly Report on Form 10-Q, including under the caption "Cautionary Note Regarding Forward-Looking Statements,"  and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

References 

1. Aletaha, D., et al. Efficacy and safety of sirukumab in patients with active rheumatoid arthritis refractory to anti-TNF therapy (SIRROUND-T): a randomised, double-blind, placebo-controlled, parallel-group, multinational, phase 3 study. Lancet. 2017 Mar 25;389(10075):1206-1217. 

2. Rubbert-Roth, A., Finckh, A. Treatment options in patients with rheumatoid arthritis failing initial TNF inhibitor therapy: a critical review. Arthritis Research & Therapy. 2009;11(Suppl1):S1. 

3. Loza, M., et al. Sirukumab Treatment Reduces Levels of Iron-Regulatory Proteins and Ameliorates Inflammation-Associated Anemia in Rheumatoid Arthritis Patients. Abstract presented at the Annual European Congress of Rheumatology (EULAR) 2017 in Madrid, Spain. Abstract number: FRI0243. 

4. Strand, V., et al. Sirukumab Leads To Significant And Clinically Meaningful Improvements In Health-Related Quality Of Life That Meet Or Exceed Normative Values In Patients With Rheumatoid Arthritis Refractory To TNF Inhibitors In Post Hoc Analyses Of A Phase 3 Trial. Abstract presented at the Annual European Congress of Rheumatology (EULAR) 2017 in Madrid, Spain. Abstract number: SAT0182. 

5. Strand, V., et al. Improvements In Health-Related Quality Of Life With Sirukumab Are Statistically Significant, Clinically Meaningful, And Meet Or Exceed Normative Values In Rheumatoid Arthritis Patients With Inadequate Response To Disease-Modifying Antirheumatic Drugs: Post Hoc Analyses Of A Phase 3 Trial. Abstract presented at the Annual European Congress of Rheumatology (EULAR) 2017 in Madrid, Spain. Abstract number: FRI0246. 

6. Dasgupta, B., et al. The Effect Of Sirukumab Plus Methotrexate On Circulating Biomarkers Of Joint Destruction In Moderate To Severe Rheumatoid Arthritis Patients From The SIRROUND-D Phase 3 Study. Abstract presented at the Annual European Congress of Rheumatology (EULAR 2017) in Madrid, Spain. Abstract number: OP0103.  

7. Tanaka, Y., et al. Efficacy of Sirukumab, an Anti-IL-6 Cytokine Monoclonal Antibody, Based upon Prior Use of Non-Anti-TNF Biologics in Patients with Active Rheumatoid Arthritis Despite Anti-TNF Therapy: Results from a Global Phase 3 Study, Annual Meeting of the American College of Rheumatology/Association for Rheumatology Health Professionals Meeting (ACR/ARHP 2016), Abstract 59315. 

8. Suresh E. Diagnosis of early rheumatoid arthritis: what the non-specialist needs to know. Journal of the Royal Society of Medicine. 2004;97(9):421-424. 

9. Kavuncu, V., Evcik, D. Physiotherapy in Rheumatoid Arthritis. Medscape General Medicine. 2004;6(2):3. 

10. World Health Organization. "The Global Burden of Disease: 2004 Update," p. 32. Available at: http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf. Accessed 08 November 2016. 

PHEM/SIR/0517/0006  June 2017 

CONTACT: Emily Bone, 14 Jun. (0) - 7876-394360, ebone1@its.jnj.com, Brian Kenney,+1-215-628-7010, bkenney1@its.jnj.com, Investor Contacts, Lesley Fishman,Johnson & Johnson, +1-732-524-3922, Joseph J. Wolk, Johnson & Johnson,+1-732-524-1142

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