SIMPONI®* I.V. (golimumab) becomes first fully human Anti-TNF infusion therapy approved for treatment of moderately to severely active rheumatoid arthritis

TORONTO, Dec. 2, 2013 /CNW/ - Janssen Inc. announced today that Health Canada has approved SIMPONI^® I.V. (golimumab) for infusion for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate.¹ SIMPONI^® I.V. is the first and only fully human anti-tumour necrosis factor (TNF)-alpha infusible therapy approved in Canada to treat moderately to severely active RA.^{1,2,3,4,5,6,7,8,9}

"The approval of golimumab for infusion offers patients living with moderately to severely active RA a new and effective treatment option with an infusion time of 30 minutes. In addition, it is dosed based on weight, which means it can offer patients a more tailored option," said Dr. Edward Keystone**, Mount Sinai Hospital. "Having an additional treatment that addresses the signs and symptoms of the disease and can also inhibit the progression of structural damage is critical for rheumatologists in meeting the needs of people living with this potentially disabling disease."

Approximately 300,000 Canadians are living with RA, a chronic, systemic inflammatory condition.¹ RA is often characterized by symptoms of joint inflammation, stiffness and pain that, over time, spread to more joints.¹⁰ It most often develops between ages 25 to 50 with three times as many women as men having the disease.¹⁰

The approval of SIMPONI^® I.V. is supported by findings from the Phase 3 Trial of Golimumab, an Anti-TNF-alpha Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy (GO-FURTHER), which evaluated 592 patients diagnosed with moderately to severely active RA who had at least six tender and six swollen joints at screening and baseline, had elevated C-reactive protein (CRP) levels at screening, and who had been receiving background methotrexate for at least three months.¹¹

Results from the trial revealed 59 per cent (n = 231/395) of patients receiving treatment with SIMPONI^® I.V. plus methotrexate versus 25 per cent of patients receiving placebo plus methotrexate (n = 49/197) (p<0.001) experienced significant improvements in signs and symptoms at week 14, as demonstrated by at least 20 per cent improvement in American College of Rheumatology criteria (ACR 20), the study's primary endpoint.¹¹ A higher proportion of patients receiving SIMPONI^® I.V. plus methotrexate achieved at least a 50 per cent improvement in ACR criteria (ACR 50) compared with patients receiving placebo plus methotrexate at week 14 (30 per cent versus nine per cent, respectively, p<0.001).¹¹ Significant improvements as measured by percentage of patients achieving the ACR 20 response were observed as early as week two, after a single SIMPONI^® I.V. infusion (33 per cent versus 12 per cent of patients receiving placebo).¹¹

SIMPONI^® I.V. was shown to inhibit the progression of structural joint damage in adult patients with moderately to severely active RA.¹² Radiographic progression of the hands and feet were assessed by the change from baseline in van der Heijde-Sharp (vdH-S) scores, an X-ray measure of joint destruction, including joint erosion and joint space narrowing in which higher scores indicate greater structural damage.¹² At week 24, patients receiving SIMPONI^® I.V. plus methotrexate had a mean change in total vdH-S score of 0.03 from baseline, compared with a mean change of 1.09 in the placebo plus methotrexate group (P<0.001).¹² At week 52, the mean change in total vdH-S score from baseline was 0.13 in SIMPONI^® I.V. treated patients versus 1.20 in placebo patients who crossed over to SIMPONI^® I.V. at either week 16 or 24.¹² Inhibiting radiographic progression is critical for preventing irreversible joint damage and hence disability, as well as maintaining quality of life for patients.

Through week 24 of the GO-FURTHER trial, adverse events (AEs) occurred in 53 per cent of patients receiving SIMPONI^® I.V. and 49 per cent of patients receiving placebo, and serious AEs were reported in more SIMPONI^® I.V. treated patients (four per cent) than placebo-treated patients (two per cent).¹¹ In the controlled phase of the trial through week 16, infections were observed in two per cent of SIMPONI^® I.V. treated patients compared with 14 per cent of placebo-treated patients; through week 24, serious infections were observed in 0.9 per cent of SIMPONI^® I.V. treated patients and 0.0 per cent of placebo-treated patients.¹¹ One case of tuberculosis and one death, a myocardial infarction secondary to community-acquired pneumonia, were reported in the SIMPONI^® I.V. group.¹¹ In addition, one death was reported among placebo-treated patients through week 24.¹¹ Through week 24, the proportions of infusions with infusion reactions were 1.1 per cent in the SIMPONI^® I.V. group and 0.2 per cent in the placebo group, respectively.¹¹

About SIMPONI^® I.V. (golimumab) for infusion
SIMPONI^® I.V. is an infusible, fully human anti-TNF monoclonal antibody that targets both soluble and transmembrane bioactive forms of TNF-alpha, a protein that, when overproduced in the body due to chronic inflammatory diseases, can cause inflammation and damage to bones, cartilage and lining tissue in the joints.¹ By binding with and blocking TNF-alpha, SIMPONI^® I.V. helps control inflammation and also helps to inhibit the progression of joint damage.¹ SIMPONI^® I.V. is approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate.¹

The SIMPONI^® I.V. dose regimen is 2 mg/kg given as an intravenous infusion at weeks 0 and four, and every eight weeks thereafter.¹ The infusion is given over a 30-minute period.¹

Janssen Biotech, Inc. discovered and developed SIMPONI^® I.V.

Please refer to the SIMPONI^® I.V. Product Monograph for additional safety information. Complete prescribing information is available at www.janssen.ca.

About Janssen Inc.
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, metabolic and chronic diseases and women's health. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen Inc. is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen.ca for more information.

*All trademarks used under license.

**Dr. Keystone was not compensated for any media work. He has been a paid consultant to Janssen Inc.

References:
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¹ SIMPONI^® I.V. Product Monograph, Janssen Inc., 2013. Available at www.janssen.ca.
² REMICADE^® Product Monograph, Janssen Inc., 2012. Available at www.janssen.ca.
³ ACTEMRA^® Product Monograph, Roche Canada, 2010. Available at  www.rochecanada.com.
⁴ ENBREL^® Product Monograph, Amgen Canada Inc, 2013. Available at www.amgen.ca.
⁵ HUMIRA^®, Product Monograph, Abbott Laboratories, Limited, 2011. Available at www.abbott.ca.
⁶ KINERET^® Product Monograph, Amgen Canada Inc., 2008. Available at www.amgen.ca.
⁷ ORENCIA^® Product Monograph, Bristol-Myers Squibb Canada, 2013. Available at www.bmscanada.ca.
⁸ RITUXAN^® Product Monograph, Hoffmann-La Roche Ltd., 2009. Available at www.rochecanada.com.
⁹ CIMZIA^® Product Monograph, Health Canada, 2013. Available at http://webprod5.hc-sc.gc.ca/dpd-bdpp/info.do?code=81737&lang=eng.
¹⁰ The Arthritis Society. Available at: http://www.arthritis.ca/local/files/pdf%20documents/Types%20of%20Arthritis/TAS_RA_eBROCH_ENG.pdf. Accessed October 1, 2013.
¹¹ Weinblatt et al. Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomized, multicenter, double-blind, placebo-controlled GO-FURTHER trial. Ann Rheum Dis 2013;72:381-389.
¹² Weinblatt et al. Radiographic benefit and maintenance of clinical benefit with intravenous golimumab therapy in patients with active rheumatoid arthritis despite methotrexate therapy: results up to 1 year of the phase 3, randomized, multicenter, double-blind, placebo controlled GO-FURTHER trial. Ann Rheum Dis 2013;0:1-8.

SOURCE: Janssen Inc.

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