Two Studies Reveal Differences In Real-World Treatment Patterns In Rheumatoid Arthritis Patients Taking REMICADE® (infliximab) Compared To CT-P13 (infliximab biosimilar)

WASHINGTON, Nov. 14, 2016 /PRNewswire/ -- Janssen Biotech, Inc. announced today findings from two claims database studies examining treatment patterns in patients with rheumatoid arthritis (RA). The first study compared treatment patterns in patients newly beginning therapy with REMICADE^® (infliximab) and patients newly beginning therapy with an infliximab biosimilar (CT-P13). A second study examined treatment patterns in stable patients who maintained treatment with REMICADE^®, compared to stable patients who switched from REMICADE^® to CT-P13. In both studies, higher rates of treatment discontinuation were observed in patients treated with CT-P13 compared to patients treated with REMICADE^®.

Both claims studies analyzed patient data from the Turkish National Ministry of Health database, which contains medical billing information for approximately 80 percent of the Turkish population. The studies were presented at the 2016 ACR/ARHP Annual Meeting.

"These interesting findings indicate a need for further investigation to better understand factors that may lead to higher treatment discontinuation in patients taking the biosimilar CT-P13 compared to patients taking REMICADE^®," said Dr. Yusuf Yazici, study author and rheumatologist at the New York University Hospital for Joint Diseases.

"A Descriptive Analysis of Real-World Treatment Patterns of Innovator Infliximab (REMICADE^®) and Biosimilar Infliximab in a Treatment Naïve Turkish Rheumatologic Disease Population"
[Presentation 1233]
The first study, entitled "A Descriptive Analysis of Real-World Treatment Patterns of Innovator Infliximab (REMICADE^®) and Biosimilar Infliximab in a Treatment Naïve Turkish Rheumatologic Disease Population," analyzed medical billing records from 1,044 Turkish patients with rheumatoid arthritis who were newly beginning treatment with REMICADE^® or CT-P13, to evaluate medication persistency, switching patterns and discontinuation rates.

Among the 1,044 patients who initiated treatment between July 1, 2014 and June 30, 2015, the majority (80 percent) were prescribed REMICADE^® versus 20 percent who were prescribed CT-P13. Six months after beginning therapy, treatment discontinuation was noted in 44 percent of patients treated with CT-P13 compared to 27 percent of patients treated with REMICADE^®. The data also revealed that switching patterns differed in patients who started on REMICADE^® compared to CT-P13. Patients who began therapy with CT-P13 were most often switched to REMICADE^®, while patients who began treatment with REMICADE^® were most often switched to an alternate biologic therapy.

"A Descriptive Analysis of Real-World Treatment Patterns in a Turkish Rheumatology Population that Continued Innovator Infliximab (REMICADE^®) Therapy or Switched to Biosimilar Infliximab" [Presentation 2240]
The second study, entitled "A Descriptive Analysis of Real-World Treatment Patterns in a Turkish Rheumatology Population that Continued Innovator Infliximab (REMICADE^®) Therapy or Switched to Biosimilar Infliximab," evaluated 3,018 Turkish rheumatology patients who were maintained on long-standing REMICADE^® therapy. The study sought to determine the extent to which patients treated between July 1, 2014 and June 30, 2015 were switched to an infliximab biosimilar (CT-P13) in Turkey. The study also compared medication persistency and discontinuation rates for at least six months in patients who continued on REMICADE^® and those who were switched to CT-P13.

The study found that 148 patients were switched from maintenance on REMICADE^® to CT-P13. In the patients who were switched, 70 percent discontinued treatment with CT-P13 within six months. In comparison, only 24 percent of patients who maintained treatment with REMICADE^® discontinued therapy over a similar observation period. Time to CT-P13 discontinuation occurred at an average of 108 days after the switch. Of those patients who discontinued CT-P13, 85 percent switched back to REMICADE^®.

"This real world evidence study raises important questions regarding the impact to patients and their healthcare professionals when patients who are stable on REMICADE^® are switched to a biosimilar," said Andrew Greenspan, M.D., vice president of medical affairs at Janssen Biotech, Inc. "Both of these studies were not randomized and, therefore, it is not known what role selection bias or the switching process itself may have played in discontinuation rates. Nonetheless, fewer patients receiving appropriate treatment for a serious chronic condition is concerning and warrants further study. Patient well-being is our top priority, and we believe the decision to switch from REMICADE^® to a biosimilar should be made by the treating physician in consultation with the patient."

About Biosimilars
A biosimilar is a follow-on form of a biologic that is not identical to its innovator biologic. It is important to note that the infliximab biosimilar, CT-P13, is not approved for interchangeability. To be deemed interchangeable by the U.S. Food & Drug Administration, a biosimilar must demonstrate it can be expected to produce the same clinical result as the innovator product in any given patient, and prove that the risk of alternating or switching between the products (in terms of safety or diminished efficacy) is no greater than the risk of using the innovator product without alternating or switching.

About REMICADE^®
REMICADE^® was approved in August 1998 and was the first anti-TNF-alpha treatment approved in the United States and the first TNF inhibitor to be approved in three different therapeutic areas: gastroenterology, rheumatology and dermatology. REMICADE^® has demonstrated broad clinical utility with indications in Crohn's disease (CD), rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, ulcerative colitis (UC), pediatric Crohn's disease, psoriasis, and pediatric UC. It remains the only product approved for both pediatric CD and UC. The safety and efficacy of REMICADE^® have been well established in clinical trials over the past 22 years and through commercial experience with more than 2.6 million patients treated worldwide.

In the U.S., REMICADE^® is a tumor necrosis factor (TNF) blocker indicated for:

• Crohn's Disease:
  • reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
  • reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease.
• Pediatric Crohn's Disease:
  • reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
• Ulcerative Colitis:
  • reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
• Pediatric Ulcerative Colitis:
  • reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
• Rheumatoid Arthritis in combination with methotrexate:
  • reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active disease.
• Ankylosing Spondylitis:
  • reducing signs and symptoms in patients with active disease.
• Psoriatic Arthritis:
  • reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function.
• Plaque Psoriasis:
  • treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

REMICADE^® is unique among available anti-TNF-alpha biologic therapies, and is one of the only anti-TNF-alpha biologic administered directly by caregivers in the clinic or office setting. REMICADE^® is a two-hour infusion administered every 6 or 8 weeks (indication-dependent), following a standard induction regimen that requires treatment at weeks 0, 2 and 6. As a result, REMICADE^® patients may require as few as six treatments each year as maintenance therapy.

Janssen Biotech, Inc. discovered and developed REMICADE^® and markets the product in the United States. The Janssen Pharmaceutical Companies market REMICADE^® in Canada, Central and South America, the Middle East, Africa, and Asia Pacific. 

In Japan, Indonesia, and Taiwan, Janssen Biotech, Inc. licenses distribution rights to REMICADE^® to Mitsubishi Tanabe Pharma Corporation. In Europe, Russia and Turkey, Janssen Biotech, Inc. licenses distribution rights to REMICADE^® to Schering-Plough (Ireland) Company, a subsidiary of Merck & Co, Inc. 

Important Safety Information 
Only a doctor can recommend a course of treatment after checking a patient's health condition. REMICADE^® (infliximab) can cause serious side effects such as lowering your ability to fight infections. There are reports of serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with REMICADE^®.

Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. A rare form of fatal lymphoma has occurred mostly in teenage or young adult males with Crohn's disease or ulcerative colitis who were taking REMICADE^® and azathioprine or 6-mercaptopurine. For children and adults taking TNF blockers, including REMICADE^®, the chances of getting lymphoma or other cancers may increase.

Patients should discuss any concerns about their health and medical care with their doctor.

Patients should let their doctors know if they have or ever had any of the following:

• Tuberculosis (TB) or have been near someone who has TB. Your doctor will check you for TB with a skin test. If you have latent (inactive) TB, you will begin TB treatment before you start REMICADE^®.
• Lived in a region where certain fungal infections like histoplasmosis or coccidioidomycosis are common.
• Infections that keep coming back, have diabetes or an immune system problem.
• Any type of cancer or a risk factor for developing cancer, for example, chronic obstructive pulmonary disease (COPD) or had phototherapy for psoriasis.
• Heart failure or any heart condition. Many people with heart failure should not take REMICADE^®.
• Hepatitis B virus (HBV) infection or think you may be a carrier of HBV.
• Nervous system disorders (like multiple sclerosis or Guillain-Barre syndrome).  Also tell your doctor about any medications you are taking, including vaccines or KINERET (anakinra), ORENCIA (abatacept) and ACTEMRA (tocilizumab) and if you are pregnant, plan to become pregnant or are nursing.  Adults and children should not receive a live vaccine while taking REMICADE^®.

The following serious (sometimes fatal) side effects have been reported in people taking REMICADE^®.  Patients should tell their doctors right away if you have any of the signs listed below:

• Infections (like TB, blood infections, pneumonia) – fever, tiredness, cough, flu, or warm, red or painful skin or any open sores. REMICADE^® can make you more likely to get an infection or make any infection that you have worse.
• Lymphoma, or any other cancers in adults and children.  
• Heart failure – new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
• Reactivation of HBV – feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.
• Liver injury – jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe tiredness.
• Blood disorders – fever that doesn't go away, bruising, bleeding, or severe paleness.
• Nervous system disorders – numbness, weakness, tingling, changes in your vision, or seizures.
• Allergic reactions during or after the infusion – hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills.
• Lupus-like syndrome – chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on the cheeks or arms that gets worse in the sun.  The more common side effects with REMICADE^® are respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing and stomach pain.
• Psoriasis – new or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus.  

Please read important information about REMICADE^®, including full U.S. prescribing information and Medication Guide, at www.remicade.com.

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. Follow us on Twitter at https://twitter.com/JanssenGlobal.

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SOURCE Janssen Biotech, Inc.

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