Study Observed Association between JANSSEN® CONNECT® Injection Centers and Increased Adherence to Healthcare Provider-Ordered Janssen Long-Acting Treatment for People with Schizophrenia

TITUSVILLE, N.J., Sept. 24, 2014 /PRNewswire/ -- Janssen Pharmaceuticals, Inc. announced the results of a first-of-its-kind study, The Impact of JANSSEN^® CONNECT^® Injection Centers on Adherence to an Atypical Long-Acting Injectable Antipsychotic among Patients with Schizophrenia Enrolled in a Support Program. Results of this retrospective, observational research were presented at the 27^th Annual U.S. Psychiatric and Mental Health Congress Conference and Exhibition in Orlando on Sept. 20-23.

The study showed that JANSSEN^® CONNECT^® patients who received their Janssen long-acting treatment (JLAT) at an injection center, typically a pharmacy, and remained in the program for more than six months were 4.5 times more likely to be adherent to their medication than those within the program who did not select this offering (aOR: 4.55; 95% CI: 2.98 to 6.95).

"The JANSSEN^® CONNECT^® program was born out of our dedication to helping people living with schizophrenia navigate through the difficulties of living with the disease and staying on medication as prescribed by their healthcare provider," Catherine Tak Piech, Vice President, Health Economics and Outcomes Research, Janssen Scientific Affairs, LLC, said. "People living with schizophrenia can live productive and meaningful lives, and these results are proof that we're moving in the right direction to help them do just that."

For individuals living with schizophrenia, non-adherence to antipsychotic medication can be a barrier to successful treatment, as those who are non-adherent are at increased risk of relapse and hospitalization, possibly leading to disability, homelessness, incarceration and other serious consequences. Within five years, about 80 percent of patients with schizophrenia who responded to treatment of their first episode, experience a relapse. Additional assistance may be needed for those transitioning from inpatient settings and for those at high risk for non-adherence.

The study further showed that 87 percent of patients enrolled in JANSSEN^® CONNECT^® who received their medication through the program achieved medication adherence.

This analysis included 9,354 individuals diagnosed with schizophrenia who enrolled in JANSSEN^® CONNECT^® from December 2010 to April 2014 with documented referral dates and were prescribed INVEGA^® SUSTENNA^® (paliperidone palmitate). To evaluate adherence, the study used JANSSEN^® CONNECT^® administrative files and compared patient characteristics and adherence among JANSSEN^® CONNECT^® patients who requested the injection center offering to those who did not request the offering. For the adherence analysis, participants enrolled up to October 2013 who had at least two injections and were enrolled for at least 60 days in the program were analyzed.

Patients were considered to be adherent if they were covered by their medication at least 80 percent of the time, which is consistent with Healthcare Effectiveness Data and Information Set (HEDIS) quality standards. Higher achievement of the proportion of days covered by medication, may or may not directly translate to improvement in patient outcomes. The data sources were designed for the implementation of the program, not research purposes. This analysis is limited to patients receiving INVEGA^® SUSTENNA^®, which is indicated for schizophrenia. The analysis may be subject to inherent limitations of the source administrative data, such as coding errors or diagnosis entered for administrative processing rather than clinical completeness. Due to design limitations inherent in any real-world study, results may not be solely attributed to the drug or program.

Janssen created the JANSSEN^® CONNECT^® program to help patients overcome barriers to receiving the JLAT that their health care professional (HCP) has prescribed for them. The nationwide program offers comprehensive information and assistance to help participating patients with schizophrenia initiate and maintain their JLAT after it has been determined by their HCP to be the most clinically appropriate treatment option. One of the many JANSSEN^® CONNECT^® offerings includes the option to identify injection centers, often pharmacies, where patients can receive HCP-ordered JLATs at a more convenient location.

In addition to having the option of receiving their treatment at one of these locations, JANSSEN^® CONNECT^® patients receive reminder alerts the day before their appointments. Their visits are documented, and their HCPs are notified if they miss their injection appointments. While the effect of locations for long-acting injections on reduction of barriers to health care professional-ordered injections is unknown, this study helps support the option that the injection center locations may be helpful to patients.

About Schizophrenia

Schizophrenia is a complex brain disorder that affects one percent of the U.S. population, which is currently three million American adults. The disease typically manifests as hallucinations, delusions, and disorganized thoughts and behavior. Because there are currently no physical or laboratory tests that diagnose this condition, schizophrenia is diagnosed by the presence of symptoms. Researchers have identified various risk factors for this disease, including heredity, brain damage, and environmental factors, such as social stress, isolation and drug use.

About JANSSEN^® CONNECT^®

JANSSEN^® CONNECT^® is a nationwide program that offers comprehensive information and assistance to help participating patients with schizophrenia start and stay on their Janssen long-acting injectable atypical antipsychotic (JLAT) after it has been determined by their healthcare professional (HCP) to be the most clinically appropriate treatment option.

The program is available throughout the U.S. with at least one offering in every state.  The offerings provided by JANSSEN^® CONNECT^®, which vary by location, include:

• Aiding access and reimbursement understanding: JANSSEN^® CONNECT^® provides research about JLAT coverage status. Patients receive help to identify the lowest co-pay options for evaluation and to navigate the complexities of benefits investigation/prior authorization.
• Bridging the inpatient/outpatient appointment gap: In the transition between care settings – inpatient-outpatient and outpatient-outpatient – JANSSEN^® CONNECT^® provides information and assistance to help patients continue injections prescribed by their HCPs once they leave the hospital.
• Coordinating medication shipment: JANSSEN^® CONNECT^® provides assistance coordinating shipment of patient medication to the HCPs' offices so they can administer injections to patients.
• Determining additional injection center options: Through JANSSEN^® CONNECT^®, patients can receive HCP-ordered injections at a location that may be more conveniently located for them. HCPs will be notified if patients miss injection appointments and will receive documentation of their visits.
• Encouraging follow-through of HCP-directed treatment plan: JANSSEN^® CONNECT^® provides ongoing communication to patients and HCPs about patients' treatment follow-through.

About Janssen Pharmaceuticals, Inc.

Janssen Pharmaceuticals, Inc. is dedicated to addressing and resolving the major unmet medical needs of our time. Driven by our commitment to patients, healthcare professionals, and caregivers, we strive to develop sustainable and integrated healthcare solutions by working in partnership with all stakeholders on the basis of trust and transparency. Our daily work is guided by meeting goals of excellence in quality, innovation, safety, and efficacy in order to advance patient care.Our company provides medicines for an array of illnesses and disorders in several therapeutic areas. For more information on Janssen Pharmaceuticals, Inc., visit us at www.JanssenPharmaceuticalsInc.com or follow us on Twitter at www.twitter.com/JanssenUS and on YouTube at www.YouTube.com/JanssenUS.

INVEGA^® SUSTENNA^® (paliperidone palmitate) is indicated for the treatment of schizophrenia. Efficacy was established in four short-term studies and one longer-term study in adults.

IMPORTANT SAFETY INFORMATION FOR INVEGA^® SUSTENNA^® (paliperidone palmitate)

Contraindications: Paliperidone is contraindicated in patients with a known hypersensitivity to either paliperidone, risperidone, or to any components of the formulation.

Cerebrovascular Adverse Reactions: Cerebrovascular Adverse Reactions (e.g., stroke, transient ischemic attacks), including fatalities, were reported in placebo-controlled trials in elderly patients with dementia-related psychosis taking oral risperidone, aripiprazole, and olanzapine. The incidence of Cerebrovascular Adverse Reactions was significantly higher than with placebo. INVEGA^® SUSTENNA^® is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with the use of antipsychotic medications, including paliperidone. Clinical manifestations include muscle rigidity, fever, altered mental status, and evidence of autonomic instability (see full Prescribing Information). Management should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment and close medical monitoring, and treatment of any concomitant serious medical problems.

QT Prolongation: Paliperidone causes a modest increase in the corrected QT (QTc) interval. Avoid the use of drugs that also increase QTc interval and in patients with risk factors for prolonged QTc interval. Paliperidone should also be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias. Certain circumstances may increase the risk of the occurrence of torsades de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval.

Tardive Dyskinesia (TD): TD is a syndrome of potentially irreversible, involuntary, dyskinetic movements that may develop in patients treated with antipsychotic medications. The risk of developing TD and the likelihood that dyskinetic movements will become irreversible are believed to increase with duration of treatment and total cumulative dose, but can develop after relatively brief treatment at low doses. Elderly female patients appeared to be at increased risk for TD, although it is impossible to predict which patients will develop the syndrome. Prescribing should be consistent with the need to minimize the risk of TD (see full Prescribing Information). Discontinue drug if clinically appropriate. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.

Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and body weight gain. While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile.

Hyperglycemia and Diabetes Mellitus: Hyperglycemia and diabetes mellitus, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death have been reported in patients treated with all atypical antipsychotics (APS). Patients starting treatment with APS who have or are at risk for diabetes mellitus should undergo fasting blood glucose testing at the beginning of and during treatment. Patients who develop symptoms of hyperglycemia during treatment should also undergo fasting blood glucose testing. All patients treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia. Some patients require continuation of antidiabetic treatment despite discontinuation of the suspect drug.

Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics.

Weight Gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.

Orthostatic Hypotension and Syncope: INVEGA^® SUSTENNA^® may induce orthostatic hypotension in some patients due to its alpha-blocking activity. INVEGA^® SUSTENNA^® should be used with caution in patients with known cardiovascular disease, cerebrovascular disease or conditions that would predispose patients to hypotension (e.g., dehydration, hypovolemia, treatment with antihypertensive medications). Monitoring should be considered in patients for whom this may be of concern.

Leukopenia, Neutropenia and Agranulocytosis have been reported with antipsychotics, including paliperidone. Patients with a history of clinically significant low white blood cell count (WBC) or drug-induced leukopenia/neutropenia should have frequent complete blood cell counts during the first few months of therapy. At the first sign of a clinically significant decline in WBC, and in the absence of other causative factors, discontinuation of INVEGA^® SUSTENNA^® should be considered. Patients with clinically significant neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. Patients with severe neutropenia (absolute neutrophil count <1000/mm3) should discontinue INVEGA^® SUSTENNA^® and have their WBC followed until recovery.

Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, INVEGA^® SUSTENNA^® elevates prolactin levels and the elevation persists during chronic administration. Paliperidone has a prolactin-elevating effect similar to risperidone, which is associated with higher levels of prolactin elevation than other antipsychotic agents.

Potential for Cognitive and Motor Impairment: Somnolence, sedation, and dizziness were reported as adverse reactions in subjects treated with INVEGA^® SUSTENNA^®. INVEGA^® SUSTENNA^® has the potential to impair judgment, thinking, or motor skills. Patients should be cautioned about performing activities that require mental alertness such as operating hazardous machinery, including motor vehicles, until they are reasonably certain that INVEGA^® SUSTENNA^® does not adversely affect them.

Seizures: INVEGA^® SUSTENNA^® should be used cautiously in patients with a history of seizures or with conditions that potentially lower seizure threshold. Conditions that lower seizure threshold may be more prevalent in patients 65 years or older.

Administration: For intramuscular injection only. Care should be taken to avoid inadvertent injection into a blood vessel.

Drug Interactions: Strong CYP3A4/P-glycoprotein (P-gp) inducers: It may be necessary to increase the dose of INVEGA^® SUSTENNA^® when a strong inducer of both CYP3A4 and P-gp (e.g. carbamazepine, rifampin, St. John's wort) is co-administered. Conversely, on discontinuation of the strong inducer, it may be necessary to decrease the dose of INVEGA^® SUSTENNA^®.

Pregnancy/Nursing: Patients should be advised to notify their physician if they become pregnant/intend to become pregnant or intend to nurse during treatment with INVEGA^® SUSTENNA^®.

Commonly Observed Adverse Reactions for INVEGA^® SUSTENNA^®: The most common adverse reactions in clinical trials in patients with schizophrenia (≥5% and twice placebo) were injection site reactions, somnolence/sedation, dizziness, akathisia and extrapyramidal disorder.

Please see full Prescribing Information including Boxed Warning for INVEGA^® SUSTENNA^® (paliperidone palmitate) and INVEGA^® (paliperidone) at www.InvegaSustenna.com and www.Invega.com.

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SOURCE Janssen Pharmaceuticals, Inc.