Real-World Evidence Shows Oral INVOKANA® 300 mg Demonstrates Comparable A1C Reduction and Control to Injectable GLP-1 Receptor Agonists

Patients Taking INVOKANA® 300 mg Were Significantly Less Likely to Discontinue the Medication or Be Prescribed a New Antihyperglycemic Agent

Note: This release corresponds to American Association of Clinical Endocrinologists Annual Scientific & Clinical Congress Poster No. 290

TITUSVILLE, NJ, May 5, 2017 – Janssen Pharmaceuticals, Inc. (Janssen), today announced real-world evidence showing people with type 2 diabetes initiated on oral INVOKANA® (canagliflozin) 300 mg (INVOKANA®) were as likely as matched patients initiated on injectable GLP-1 receptor agonists (GLP-1 RAs) to achieve the recognized HEDIS standard of blood glucose control of A1C less than 8.0 percent.[1] Patients on INVOKANA® were also less likely to discontinue their medication or be prescribed a new antihyperglycemic agent (AHA). These findings with INVOKANA®, a sodium glucose co-transporter 2 (SGLT2) inhibitor, were presented at the American Association of Clinical Endocrinologists’ 26th Annual Scientific & Clinical Congress on May 3-7 in Austin, Texas.

“These findings show INVOKANA®, an oral SGLT2 inhibitor, reduces A1C levels comparably to injectable GLP-1 receptor agonists,” said study investigator Carol Wysham, MD, Section Head of the Department of Diabetes and Endocrinology at Rockwood Clinic in Spokane, Washington. “And because real-world data reflect everyday clinical practice, these results are particularly relevant for physicians to consider when evaluating how best to support their patients in reaching and maintaining treatment goals.”

In the analysis, which matched INVOKANA® and GLP-1 RA patients based on their demographic and clinical characteristics, patients taking INVOKANA® and those taking GLP-1 RAs were as likely to reach and maintain A1C below 8.0 percent; INVOKANA® patients were 30 percent less likely to discontinue the drug, and 28 percent less likely to be prescribed a new AHA.

The investigators used prescribing of a new AHA (e.g., adding or switching to a new AHA therapy) as a proxy for treatment failure. A1C, or hemoglobin A1C, is a measure of average blood glucose control over the past two to three months. The Healthcare Effectiveness Data and Information Set (HEDIS) defines A1C control as less than 8.0 percent.1 Up to half of patients with type 2 diabetes do not meet individualized targets for blood glucose control and other health measures.[2]

“Type 2 diabetes is a complex disease, and with so many patients not at individual treatment goals, it’s important we provide solutions to help patients effectively manage their condition,” said Paul Burton, MD, PhD, FACC, Vice President, Medical Affairs, Janssen. “With this analysis, we are proud to expand the body of real-world evidence for INVOKANA® and to further establish its benefits in everyday patient care.”

INVOKANA® is used along with diet and exercise to lower blood glucose in adults with type 2 diabetes. INVOKANA® is not for weight loss, but may help people lose weight—on average 3 percent. Results may vary by dose and when used with certain other diabetes medications. INVOKANA® was also shown in clinical trials to reduce systolic blood pressure, though it is not indicated as antihypertensive treatment. The most common side effects of INVOKANA® include genital yeast infections, urinary tract infection, and changes in urination. These specific adverse events were generally mild to moderate in intensity in clinical studies.

The Presentation
Real-world HbA1c Levels in the Context of Persistence, Treatment Progression, and Durability of HbA1c Control in Patients with Type 2 Diabetes Mellitus Initiated on Canagliflozin or a Glucagon-Like Peptide-1 Receptor Agonist (Poster No. 290): Dr. Wysham presented findings comparing the achievement of A1C goals in patients taking INVOKANA® versus GLP-1 RAs, and adding or switching medications based on real-world data from an electronic medical record (EMR) database.

The analysis showed:

• Patients with A1C levels of 8.0 percent or greater before starting either therapy had similar A1C levels at each 3-month interval post-index
• Time to reach A1C below 8.0 percent was comparable with INVOKANA® and GLP-1 RAs (12.4 months vs. 13.1 months, hazard ratio [HR] 0.98, p=0.642)
• INVOKANA® patients were 30 percent less likely to discontinue initial therapy compared to those initiating GLP-1 RAs (HR 0.70, p<0.001), with a median time to discontinuation of 12.4 vs. 8.6 months, respectively
• INVOKANA® patients were 28 percent less likely to be prescribed a new AHA (HR 0.72, p<0.001; median 21.3 vs. 15.1 months)

The analysis, based on the QuintilesIMS EMR US database, included weighted samples of adults with type 2 diabetes newly initiated on INVOKANA® 300 mg (11,435 patients) or a GLP-1 RA (11,582 patients) between March 29, 2012 and April 30, 2016. The treatment cohorts were matched using the inverse probability of treatment weighting, to account for differences in baseline characteristics and to simulate randomization. After matching, baseline characteristics and A1C levels were well balanced. Mean A1C levels were evaluated using 3-month rolling averages and compared using generalized estimating equation models with normal distributions to account for multiple measures per patient. Time-to-event outcomes were compared using weighted Cox models and Kaplan-Meier curves.

Abstracts of all accepted presentations can be accessed on the American Association of Clinical Endocrinologists’ website here.

About Type 2 Diabetes
Of the approximately 29 million people who have diabetes in the United States, 90 to 95 percent of them have type 2 diabetes, which is chronic and affects the body’s ability to metabolize sugar (glucose), and is characterized by the inability of pancreatic beta cell function to keep up with the body’s demand for insulin.

WHAT IS INVOKANA®?
INVOKANA® is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. INVOKANA® is not for people with type 1 diabetes or with diabetic ketoacidosis (increased ketones in blood or urine). It is not known if INVOKANA® is safe and effective in children under 18 years of age.

IMPORTANT SAFETY INFORMATION

INVOKANA® can cause important side effects, including:

• Dehydration. INVOKANA® can cause some people to become dehydrated (the loss of too much body water), which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at higher risk of dehydration if you have low blood pressure, take medicines to lower your blood pressure (including diuretics [water pills]), are on a low sodium (salt) diet, have kidney problems, or are 65 years of age or older
• Vaginal yeast infection. Women who take INVOKANA® may get vaginal yeast infections. Symptoms include: vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or vaginal itching
• Yeast infection of the penis (balanitis or balanoposthitis). Men who take INVOKANA® may get a yeast infection of the skin around the penis. Symptoms include: redness, itching, or swelling of the penis; rash of the penis; foul-smelling discharge from the penis; or pain in the skin around penis

Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis.

Do not take INVOKANA® if you:

• are allergic to canagliflozin or any of the ingredients in INVOKANA®. Symptoms of allergic reaction may include: rash; raised red patches on your skin (hives); or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing
• have severe kidney problems or are on dialysis

Before you take INVOKANA®, tell your doctor if you have kidney problems; liver problems; history of urinary tract infections or problems with urination; are on a low sodium (salt) diet; are going to have surgery; are eating less due to illness, surgery, or change in diet; pancreas problems; drink alcohol very often (or drink a lot of alcohol in short-term); ever had an allergic reaction to INVOKANA®; or have other medical conditions.

Tell your doctor if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed. INVOKANA® may harm your unborn baby. If you become pregnant while taking INVOKANA®, tell your doctor right away. INVOKANA® may pass into your breast milk and may harm your baby. Do not breastfeed while taking INVOKANA®.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take diuretics (water pills), rifampin (used to treat or prevent tuberculosis), phenytoin or phenobarbital (used to control seizures), ritonavir (Norvir®, Kaletra® – used to treat HIV infection), or digoxin (Lanoxin®– used to treat heart problems).

Possible Side Effects of INVOKANA®

INVOKANA® may cause serious side effects, including:

• Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 or type 2 diabetes, during treatment with INVOKANA®. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with INVOKANA® even if your blood sugar is less than 250 mg/dL. Stop taking INVOKANA® and call your doctor right away if you get any of the following symptoms: nausea, vomiting, stomach-area pain, tiredness, or trouble breathing
• Kidney problems. Sudden kidney injury has happened to people taking INVOKANA®. Talk to your doctor right away if you: 1) reduce the amount of food or liquid you drink, if you are sick, or cannot eat or 2) you start to lose liquids from your body from vomiting, diarrhea, or being in the sun too long
• A high amount of potassium in your blood (hyperkalemia)
• Serious Urinary Tract Infections: may lead to hospitalization and have happened in people taking INVOKANA®. Tell your doctor if you have signs or symptoms of a urinary tract infection such as: burning feeling while urinating, need to urinate often or right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Some people may also have high fever, back pain, nausea, or vomiting
• Low blood sugar (hypoglycemia). If you take INVOKANA® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take INVOKANA®

Signs and symptoms of low blood sugar may include: headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking, or feeling jittery.

Serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking INVOKANA® and call your doctor right away or go to the nearest hospital emergency room.

Broken Bones (fractures): Bone fractures have been seen in patients taking INVOKANA®. Talk to your doctor about factors that may increase your risk of bone fracture.

The most common side effects of INVOKANA® include: vaginal yeast infections and yeast infections of the penis; changes in urination, including urgent need to urinate more often, in larger amounts, or at night.

Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Janssen Scientific Affairs, LLC at 1-800-526-7736.

Please see full Product Information and Medication Guide.
Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation.
Trademarks are those of their respective owners.
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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 at @JanssenUS.

References

[1] NCQA (National Committee for Quality Assurance). Comprehensive diabetes care: the HEDIS (Healthcare Effectiveness Data and Information Set) measures. Available at: http://www.ncqa.org/report-cards/health-plans/state-of-health-care-quality/2016-table-of-contents/diabetes-care. Accessed April 20, 2017.
[2] Ali MK, Bullard KM, Saaddine JB, et al. Achievement of goals in U.S. diabetes care, 1999-2010. N Engl J Med 2013;368:1613-24.

SOURCE: Johnson & Johnson