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Health Canada Approves Expanded Indication For SIMPONI®* To Include Inhibition Of Structural Damage In The Treatment Of Moderately To Severely Active Rheumatoid Arthritis
Health Canada Approves Expanded Indication For SIMPONI®* To Include Inhibition Of Structural Damage In The Treatment Of Moderately To Severely Active Rheumatoid Arthritis
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SIMPONI® Indication Also Expanded To Include Improvement In Physical Function

TORONTO, Canada (September 22, 2011) – Janssen Inc. announced today that Health Canada has expanded the approved indication for SIMPONI® (golimumab), in combination with methotrexate, to include the inhibition of progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis who had not previously been treated with methotrexate. Health Canada also approved an expanded indication in the improvement of physical function in adult patients with moderately to severely active rheumatoid arthritis.[1]  Rheumatoid arthritis is an inflammatory condition that if left untreated, can lead to permanent damage such as joint deformity and disability.[2]

“This is an exciting and welcome development for Canadians with moderate to severe rheumatoid arthritis,” said Dr. Edward Keystone, Professor, Faculty of Medicine, University of Toronto and one of the principal investigators of the studies on which the approval was based. “Inhibiting the progression of the disease and improving physical function, allowing patients to retain their ability to carry out daily tasks, are key considerations in managing this potentially debilitating autoimmune condition.”

The new approval is based on data from the Phase 3 GOlimumab Before Employing methotrexate as the First-line Option in the treatment of Rheumatoid arthritis of Early onset (GO-BEFORE) trial that showed the efficacy of SIMPONI®, in a methotrexate-naïve patient population, in reducing the rate of joint damage as evaluated by X-ray; and on data from the Phase 3 GOlimumab FOR subjects With Active RA Despite Methotrexate (GO-FORWARD) trial that showed sustained improvement, in physical function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI).[3,4,5]

A chronic inflammatory condition and autoimmune disease, rheumatoid arthritis affects approximately 300,000 Canadians, with three times as many women as men having the disease.[2]  It most often develops in young adulthood (ages 25 to 50) and is characterized by symptoms of joint inflammation, stiffness and pain that over time involves more joints on both sides of the body.[2] SIMPONI® was first approved in Canada in 2009 for the  treatment of moderately to severely active rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis.  SIMPONI® is a 50 mg once-monthly, subcutaneously-administered anti-tumor necrosis factor (TNF)-alpha treatment.[1]

About GO-BEFORE
GO-BEFORE, a Phase 3, multi-centre, double-blind, placebo-controlled study included 637 methotrexate-naïve adults with rheumatoid arthritis and was designed to compare American College of Rheumatology (ACR) 50 response (a primary endpoint, ≥ 50% improvement in response criteria) at week 24 in patients receiving SIMPONI® plus methotrexate compared with patients receiving placebo plus methotrexate.  Patients with active rheumatoid arthritis who had at least four tender joints and at least four swollen joints were included in the multi-centre study.  Patients were randomly assigned into four groups: Group 1 included patients receiving placebo every four weeks plus methotrexate starting at 10 mg per week and escalating to 20 mg per week; Group 2 included patients receiving SIMPONI® 100 mg every four weeks plus placebo every week; Group 3 included patients receiving SIMPONI® 50 mg every four weeks plus methotrexate starting at 10 mg per week and escalating to 20 mg per week; Group 4 included patients receiving SIMPONI® 100 mg every four weeks plus methotrexate starting at 10 mg per week and escalating to 20 mg per week.  The study was also designed to assess the inhibition of structural damage at 52 weeks (a co-primary endpoint). The safety profile of SIMPONI®, as well as other secondary endpoints was also assessed. The long-term extension study started at Week 52, with 104-week results now available. GO-BEFORE will provide up to five years of efficacy and safety data.[3,4,5]

About GO-FORWARD
GO-FORWARD, a Phase 3, multi-centre, double-blind, placebo-controlled study included 444 methotrexate-experienced adults with rheumatoid arthritis and was designed to compare ACR 20 response (≥20% improvement in ACR response criteria) at week 14 and the improvement from baseline in the HAQ-DI score at week 24 in patients receiving SIMPONI® plus methotrexate compared with patients receiving placebo plus methotrexate.  Patients with active rheumatoid arthritis who had at least four tender joints and at least four swollen joints were included in the multi-centre study. Patients had been on a stable dose of methotrexate (≥15 mg/week and ≤25 mg/week) during the four-week period immediately prior to screening. Patients were randomly assigned in a 3:3:2:2 ratio into four groups: Group 1 included patients receiving placebo every four weeks plus methotrexate every week; Group 2 included patients receiving SIMPONI® 100 mg every four weeks plus placebo every week; Group 3 included patients receiving SIMPONI® 50 mg every four weeks plus methotrexate every week; Group 4 included patients receiving SIMPONI® 100 mg every four weeks plus methotrexate every week. All patients continued their initial stable doses of methotrexate throughout the study except for patients in Group 2 who were switched from active methotrexate to placebo at randomization without any washout period before study entry. The study was designed to assess the ACR 20 response at week 14 and the change from baseline in HAQ-DI score at week 24 (co-primary endpoints). The safety profile of SIMPONI® and other secondary endpoints were also assessed. The long-term extension study started at Week 52. GO-FORWARD will provide up to five years of efficacy and safety data.[3,6]

About SIMPONI®
SIMPONI® is a human monoclonal antibody that targets and neutralizes excess TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases, can cause inflammation and damage to bones, cartilage and tissue. SIMPONI® was first approved in Canada in 2009 for the treatment of moderately to severely active rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis.  SIMPONI® is a 50 mg once-monthly, subcutaneously-administered anti-tumor necrosis factor (TNF)-alpha treatment available either through the SIMPONI® SmartJect™ autoinjector or a pre-filled syringe. Janssen Biotech, Inc. discovered and developed SIMPONI® and markets the product in the United States. Janssen Inc. markets SIMPONI® in Canada.

SIMPONI® Safety Information
SIMPONI® is contraindicated in patients with severe infections such as sepsis, tuberculosis and opportunistic infections and in patients who are hypersensitive to golimumab, latex or any other ingredient in the formulation or component of the container.  Serious infections leading to hospitalization or death, including sepsis, tuberculosis, invasive fungal and other opportunistic infections have been observed with the use of TNF antagonists including SIMPONI®. Lymphoma and other malignanices, some fatal, have been reported in children and adolescent patients treated with TNF-blockers.  The potential role of TNF-blocking therapy in the development of malignancies is not known.  Please refer to the SIMPONI® Product Monograph for safety information regarding congestive heart failure, neurologic events and hematologic warnings, and for complete prescribing information.[1]

SIMPONI® (golimumab) is a prescription medicine. SIMPONI® can lower the body’s ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal.[1]

About Janssen Inc.
As a member of the Janssen Pharmaceutical Companies, Janssen Inc. is dedicated to addressing and solving the most important unmet medical needs in pain management, psychiatry, oncology, immunology, psoriasis, virology, anemia, attention deficit hyperactivity disorder, gastroenterology and women’s health. Driven by our commitment to the passionate pursuit of science for the benefit of patients, we work together to bring innovative ideas, products and services to patients around the world.

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For more information or to arrange an interview, please contact:

Kate Hanna
Janssen Inc.
416-382-5017
khanna7@its.jnj.com

Michelle Marchione
Hill and Knowlton
416-413-4613
michelle.marchione@hillandknowlton.ca

*All trademark rights used under license.

References:

[1] SIMPONI® Product Monograph, Janssen Inc., 2011.

[2] The Arthritis Society.  Available at: http://www.arthritis.ca/local/files/pdf%20documents/Types%20of%20Arthritis/TAS_RA_eBROCH_ENG.pdf

[3] Emery P, Fleischmann, RM, et al.  The effects of golimumab on radiographic progression in rheumatoid arthritis: Results of randomized controlled studies of golimumab before methotrexate therapy and golimumab after methotrexate therapy. Arthritis & Rheumatism. 2011: 63(5):1200-1210.

[4] Fleischmann RM, Emery P, et al. Long-term efficacy and safety of golimumab, a human anti-TNF alpha monoclonal antibody, in methotrexate-naïve rheumatoid arthritis patients: Results from the GO-BEFORE study. Annals of the Rheumatic Diseases. 2010; 69(Suppl3): 681. Abstract 0325: presented at the European League Against Rheumatism (EULAR) congress, Rome, Italy, June 16-19, 2010.

[5] SIMPONI® (golimumab) Rheumatoid Arthritis Synopsis (C0524T05 GO-BEFORE). Janssen Inc. data on file. 2009: Module 5.3 (104-Weeks). 

[6] Keystone EC, Genovese MC, Klareskog L, et al. Golimumab, a human antibody to tumour necrosis factor a given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study. Annals of the Rheumatic Diseases. 2009; 68(6):789-796.

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