First and Only Subcutaneous Biologic Treatment Approved to Reduce Signs and Symptoms, Achieve Sustained Clinical Remission and Improve Appearance of the Mucosa During Induction
TORONTO, Sept. 24, 2013 /CNW/ - Janssen Inc. announced today that Health Canada has approved SIMPONI® (golimumab) for the treatment of moderately to severely active ulcerative colitis (UC). SIMPONI® is the first and only subcutaneously administered anti-tumor necrosis factor (TNF)-alpha therapy approved in Canada to reduce signs and symptoms, induce clinical remission, achieve sustained clinical remission in induction responders and improve endoscopic appearance of the mucosa during induction in adult patients with moderately to severely active UC who have had an inadequate response to conventional therapy.1
"This approval is an important advance in the treatment of ulcerative colitis. In clinical studies, golimumab was shown to induce rapid and continuous clinical response in symptom control, which may help to optimize patient outcomes," said Dr. Brian Feagan, Professor of Medicine and Epidemiology and Biostatistics at the Western University in London, Ontario, and an expert in the field of inflammatory bowel disease. "In addition, self-administered subcutaneous delivery provides some physicians and patients with an option to tailor treatment based on individual circumstances."
Ulcerative colitis is a chronic inflammatory bowel disease (IBD) marked by ulcers in the lining of the colon.2 Canada has among the highest incidence of people with IBD, including Crohn's disease and UC, in the world. It is estimated that there are over 230,000 individuals living with IBD in Canada, including over 100,000 people living with UC.2 Symptoms of UC may include: bloody diarrhea, mild fever, abdominal pains and cramps, fatigue, loss of appetite, weight loss, and pain and swelling in the joints.2 UC can have a range of implications for people's quality of life, including a negative psycho-social impact and a substantial personal burden.2
The approval is supported by data from the Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment (PURSUIT) clinical trials, evaluating patients with moderately to severely active UC who had previously failed or were intolerant to conventional treatments. For the treatment of UC, the SIMPONI® dose regimen consists of 200 mg subcutaneously injected at week 0, followed by 100 mg at week 2 and then 50 mg every 4 weeks, thereafter. The maintenance dose of 100 mg every 4 weeks can be considered at the discretion of the treating physician. A significantly greater proportion of patients who received SIMPONI® 200 mg/100 mg achieved clinical response, clinical remission and improvement of the endoscopic appearance of the mucosa at week 6 compared with patients receiving placebo. Those patients who responded during induction were randomized into the maintenance study where they were assessed every four weeks for clinical response. The proportion of patients who maintained clinical response through week 54 was significantly greater in the SIMPONI® 50 mg group and 100 mg group compared with the placebo group. Additionally, the proportions of patients who were in continuous clinical response and maintained sustained remission (in remission at both weeks 30 and 54), and those who demonstrated sustained improvement of endoscopic appearance of the mucosa at both weeks 30 and 54 were significantly greater in the SIMPONI® 100 mg group compared with the placebo group.
"Effective treatment options are vital disease management tools for Canadians who are living with ulcerative colitis," said Gail Attara, President and CEO, Gastrointestinal Society. "Ensuring that these treatments are accessible to those who will likely have a vast health benefit from them is also of paramount importance."
Canadians living with UC and prescribed treatment with SIMPONI® will receive instruction and support from the BioAdvance®* Network of clinics, located in centres across Canada, or through home injection services delivered by BioAdvance® nurses.
The Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment (PURSUIT) included Phase 3 multicenter, randomized, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of subcutaneous induction and every-four-week maintenance regimens of SIMPONI® in adults with moderately to severely active UC. All trial patients had failed to respond to or tolerate treatment with 6-mercaptopurine (6-MP), azathioprine (AZA), corticosteroids and/or 5-aminosalicylate (5-ASA), or were corticosteroid dependent. Study participants were naïve to treatment with TNF inhibitors and had a baseline Mayo score between 6 and 12 and endoscopic subscore of 2 or more. The Mayo score is a 12-point clinical assessment and colonoscopy-based measure of disease activity, which assesses improvement in symptoms based on rectal bleeding, endoscopic findings, stool frequency and a physician's global assessment.
The PURSUIT-Induction trial had an adaptive design with a Phase 2 dose-finding portion followed by a Phase 3 dose-confirming component. The primary endpoint was clinical response at week 6. Secondary endpoints at week 6 included clinical remission and improved endoscopic appearance of the mucosa during induction. Overall, 1,065 patients were treated in the study; 761 of these patients were randomized into the Phase 3 component of the study.
Patients responding to induction treatment with SIMPONI® were eligible to be randomized in the Phase 3 PURSUIT-Maintenance study. The primary endpoint in this study was maintenance of clinical response through week 54, and secondary endpoints included clinical remission and improvement of endoscopic appearance of the mucosa at both weeks 30 and 54.
In both studies, clinical response, clinical remission and improvement of endoscopic appearance of the mucosa were defined based on the Mayo score, which consists of four subscores: stool frequency, rectal bleeding, findings of endoscopy, and physician's global assessment. Each subscore is rated on a scale from 0 to 3, indicating normal (0) to severe (3) activity. The Mayo score is the sum of the four subscores. Clinical response was defined as a decrease from week 0 of induction in the Mayo score of ≥ 30% and ≥ 3 points, accompanied by a decrease in the rectal bleeding subscore of ≥ 1 or rectal bleeding subscore of 0 or 1. Clinical remission was defined as a Mayo score ≤ 2 points, with no individual subscore >1. Improvement of endoscopic appearance of the mucosa was defined as a Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (erythema, decreased vascular pattern, mild friability).
The safety results of SIMPONI® observed in the PURSUIT studies were consistent with the known safety profile of SIMPONI® in labeled rheumatologic indications.
About SIMPONI® (golimumab)
First approved by Health Canada in April 2009, SIMPONI®, in combination with methotrexate, is also indicated for reducing signs and symptoms and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA), as well as inhibiting the progression of structural damage in adult patients with moderately to severely active RA who had not previously been treated with methotrexate. SIMPONI® is also approved for reducing signs and symptoms, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active psoriatic arthritis, as well as reducing signs and symptoms in adult patients with active ankylosing spondylitis who have had an inadequate response to conventional therapies.1
SIMPONI® can lower the body's ability to fight infections. Serious infections, including sepsis, tuberculosis, legionellosis (a serious form of bacterial pneumonia), listeriosis (an infection that usually develops after eating food contaminated by the bacteria listeria) and opportunistic infections (such as systemic fungal and bacterial infections) have been reported in patients receiving SIMPONI® and other similar medicines, and in some cases have been fatal.
Please refer to the SIMPONI® Product Monograph for additional safety information, including information regarding malignancies, congestive heart failure, neurologic events and hematologic warnings, and for complete prescribing information available at www.janssen.ca.
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.
*All trademark rights used under license.
1 SIMPONI® Product Monograph, Janssen Inc., 2013. Available at www.janssen.ca.
2 "The Impact of Inflammatory Bowel Disease (IBD) in Canada - 2012 Final Report and Recommendations," Crohn's and Colitis Foundation of Canada, accessed May 3, 2013, http://www.isupportibd.ca/pdf/ccfc-ibd-impact-report-2012.pdf
SOURCE: Janssen Inc.
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