Patients Who Switched to Betaseron Cite Efficacy, Tolerability Concerns With Other MS Therapies
June 4, 2004
Source: Berlex, Inc.
Berlex, Inc., a U.S. affiliate of Schering AG Germany, today announced that a study of more than 6,400 multiple sclerosis (MS) patients taking high-dose, high-frequency Betaseron(R) (interferon beta-1b) for SC injection shows that adherence to therapy is high, with only a small proportion of patients discontinuing treatment due to injection-site reactions and pain, flu-like symptoms or lack of efficacy. In contrast, a majority of patients who switched to Betaseron from Rebif(R) (interferon beta-1a), another high-dose, high-frequency interferon, said injection site pain and injection site reactions were the main reason they changed therapies. The data were presented at the 18th Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC), in Toronto.
Patients were enrolled in the B.E.T.A.(SM) (Betaseron(R) Education, Training and Assistance) Nurse Program, which offers individualized MS nurse support and assistance for people with MS, particularly those on Betaseron. Results presented at last year's CMSC annual meeting showed that nearly nine in 10 patients supervised by a B.E.T.A. Nurse remained on Betaseron 13 months after beginning treatment. (1) This compares with a retention rate of 63% in historic controls. (2)
"The unpredictable nature of MS, coupled with tolerability issues relating to the need for chronic injections, can affect patient adherence to therapy," said Ralph Makar, Vice President and General Manager, Therapeutics, Berlex, Inc. "Knowledge gained over more than a decade of Betaseron use has led to the adoption of simple techniques to help minimize these issues. B.E.T.A. Nurses can teach these critical skills to patients who are new to Betaseron treatment and provide ongoing, individualized training to help patients stay with their doctor-prescribed regimen."
About the study
The study examined adherence to Betaseron among patients in the B.E.T.A. Nurse Program. Nurses monitored and recorded patients' progress regarding the management of any adverse events as well as their tolerance to therapy over time. Results of 6,463 patients enrolled in the program during December 2002 to December 2003 were presented. 3.1% of patients reported discontinuation due to injection-site reactions or injection site pain, 2.8% discontinued because of perceived lack of efficacy or exacerbations, and 2.2% stopped because of flu-like symptoms.
In addition, nurses asked why patients had switched from another MS drug to Betaseron. (When a person enrolls in the B.E.T.A. Nurse program, he or she is asked why they've begun treatment with Betaseron.) The findings revealed that more than half of patients (59%, 104/177) who switched from Rebif(R) to Betaseron did so because of painful injections, injection site reactions or other injection reactions (e.g., burning or stinging feeling at the injection site). Patients who formerly took Avonex(R) (interferon beta 1-a) or Copaxone(R) (glatiramer acetate) switched mostly because of a perceived lack of efficacy or exacerbations (nearly eight in 10 Avonex users (532/675) and nearly seven in 10 Copaxone users (293/422) gave this reason).
Betaseron has a neutral pH (mean 7.4) formulation, while Rebif has a lower pH (mean 3.8 +/-0.5). This may contribute to the higher incidence of injection site pain and reactions associated with Rebif. In addition, Betaseron is the first and only interferon therapy available as a room temperature formulation with a pre-filled-diluent syringe,(3) offering greater convenience to MS patients. The Betaseron pre-filled diluent syringe system maintains a neutral pH formulation to help minimize stinging on injection.
About the B.E.T.A.(SM) Nurse Program
The B.E.T.A.(SM) (Betaseron(R) Education, Training and Assistance) Nurse Program consists of 34 dedicated MS-specialist registered nurses throughout the United States who help patients begin and maintain treatment with Betaseron. An additional 34 B.E.T.A. Nurses also are available 24 hours a day, seven days a week to help answer patients' questions and offer additional support. B.E.T.A. Nurses provide supervised, one-on-one injection training as well as consistent follow up to help patients manage therapy. Nine B.E.T.A. Centers -- the first and only privately sponsored centers in the United States that cater specifically to people with MS -- provide a warm and inviting environment for patients, families and caregivers, and offer free educational and wellness seminars. The B.E.T.A. Nurse Program is an extension of MS Pathways(SM), a support program founded by Berlex, Inc. for everyone touched by MS.
MS is a disease of the central nervous system affecting the brain and spinal cord. It is estimated to affect more than 400,000 people in the United States and is the major acquired neurologic disease in young adults. People who develop MS may not immediately recognize their condition, because the symptoms of MS are nonspecific and may be similar to those of other diseases. Common signs and symptoms of MS include fatigue, psychological and cognitive changes, weakness or paralysis of limbs, numbness, vision problems, speech difficulties, problems with walking or motor skills, bladder problems, and sexual dysfunction.
Relapsing-remitting forms of MS are characterized by periods of attacks, interspersed with stable periods. Most symptomatic patients are classified at onset with the relapsing-remitting form of the disease. About 50 percent of patients with relapsing-remitting disease advance into the secondary progressive form within ten years. At this stage, after periods of intermittent attacks and remissions, the disease begins a course of steady progression.
Chiron Corporation and Berlex jointly developed Betaseron(R). It is manufactured by Chiron and sold in the United States and Canada by Berlex.
Betaseron was the first therapy approved in the United States to treat relapsing-remitting MS. Betaseron is indicated for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations. Relapses are repeat attacks during which new symptoms appear or existing symptoms worsen, followed by periods of recovery. Relapsing forms of MS include relapsing-remitting, the most common form, and secondary progressive MS with relapses.
In January 2002, the FDA approved a new room-temperature-stable formulation of Betaseron. Betaseron is the first and only interferon therapy available in the United States that is stable at room temperature (25 degrees C/77 degrees F) for more than 30 days, providing a convenient option for MS patients. Injections for this formulation should be administered immediately after preparation. If the injection is delayed, the solution should be refrigerated and injected within a three-hour time period.
The recommended dose of Betaseron (interferon beta-1b) is 250 mcg (8 MIUs) every other day, which delivers an average total of 875 mcg (28 MIUs) per week.
The most commonly reported adverse reactions are lymphopenia, injection site reaction, asthenia, flu-like symptom complex, headache, and pain. Betaseron should be used with caution in patients with depression. Injection site necrosis has been reported in 5 percent of patients in controlled trials. Patients should be advised of the importance of rotating injection sites. Female patients should be warned about the potential risk to pregnancy. Cases of anaphylaxis have been reported rarely. (See "Warnings," "Precautions," and "Adverse Reactions" sections of Prescribing Information.)
Committed to developing novel diagnostics and therapeutics that address unmet medical needs, Berlex, Inc., a U.S. affiliate of Schering AG, Germany, develops and markets diagnostic imaging agents and treatments in the areas of female healthcare and dermatology, as well as specialized therapeutics for life-threatening and disabling diseases in the fields of the central nervous and cardiovascular systems, oncology and gastroenterology. Berlex has business operations in New Jersey, California and Washington. For more information, please visit www.berlex. com.
Certain statements in this press release that are neither reported financial results nor other historical information are forward-looking statements, including but not limited to, statements that are predictions of or indicate future events, trends, plans or objectives. Undue reliance should not be placed on such statements because, by their nature, they are subject to known and unknown risks and uncertainties and can be affected by other factors that could cause actual results and Schering AG's plans and objectives to differ materially from those expressed or implied in the forward-looking statements. Certain factors that may cause such differences are discussed in our Form 20-F and Form 6-K reports filed with the U.S. Securities and Exchange Commission. Schering AG undertakes no obligation to update publicly or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise.
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