Betaferon(R) 250 mcg de optimale dosis voor de behandeling van MS
31/10/2007 09:59
Bayer BV
Behandeling van multiple sclerose
BEYOND studie:
Betaferon(R) 250 mcg de optimale dosis voor de behandeling van MS
Betaferon(R) 250 mcg is de optimale Betaferon(R) dosis vanwege de hoge effectiviteit en uitstekende verdraagzaamheid.
Beyond studie laat geen superioriteit zien van Betaferon(R) 500 mcg ten opzichte van Betaferon 250(R) mcg en Copaxone(R)
Mijdrecht, 31 oktober, 2007 - Bayer Schering Pharma kondigt vandaag de resultaten van de BEYOND (Betaferon Efficacy Yielding Outcomes of a New Dose) studie, een grote gerandomiseerde studie van mensen met relapsing-remitting multiple sclerose (MS) aan. De studie werd opgezet om de werkzaamheid, verdraagbaarheid en veiligheid van een 500 mcg dosering van Betaferon(R) (interferon beta-1b) te vergelijken met de standaard 250 mcg Betaferon(R) dosering en met Copaxone(R) (glatiramer acetate). De studie liet zien dat 250 mcg Betaferon(R) even werkzaam was als 500 mcg Betaferon(R) en als Copaxone(R). Het risico op relapses, het primaire eindpunt van de studie, was vergelijkbaar in de drie studie-armen. The relapse rate was zeer laag in de gehele studiepopulatie, en wijkt daarmee af van die in eerdere trials. Daarnaast liet 250 mcg Betaferon(R) zien dat mensen de therapie trouw bleven (87%).
Bayer Schering Pharma zet zich in voor optimale behandeling van multiple sclerose, door Betaferon(R) en het Betaject(R) toedieningssysteem continu te verbeteren waar dit mogelijk is. Onderzoek met Betaferon en andere potentiële therapieën onderbouwen deze commitment aan hoogeffectieve en veilige behandeling van MS. Een 500mcg dosering Betaferon(R) heeft volgens de BEYOND studie geen meerwaarde ten opzichte van 250mcg. Er wordt dan ook geen registratie voor aangevraagd.
Deelnemers in de studie moesten klinische tekenen van de ziekte MS vertonen in het afgelopen jaar, om deel te kunnen nemen. Betaferon(R) 250mcg heeft een reductie van 78% van het aantal relapses laten zien vergeleken met het jaar voor studiedeelname, over de observatieperiode die tot 3,5 jaar duurde (Betaferon(R) 500 mcg: 79%, Copaxone(R) 79%).
De BEYOND-studie kijkt ook naar verdraagbaarheid en acceptatie van verschillende behandelingen. Slechts 13% van de mensen die Betaferon(R) 250mcg gebruikten in de studie, stopte met de behandeling. Voor de vergelijkende andere producten is dit percentage respectievelijk 19% (Betaferon(R) 500mcg) en 17% (Copaxone(R) ) Uit de klinische praktijk kwam al naar voren dat gebruik maken van een auto-injector, geleidelijk ophogen van de dosering, en pijnstillende medicatie, leiden tot uitstekende verdraagbaarheid van Betaferon(R) 250mcg.
"Resultaten uit de BEYOND studie bevestigen de hoge werkzaamheid, goede verdraagzaamheid en de hoge therapietrouw voor Betaferon(R). De standaard dosering Betaferon(R) 250 mcg is de optimale Betaferon(R) dosis voor MS-patiënten die voor het eerst therapie krijgen," zegt Dr. Douglas S Goodin, Professor of Neurology aan de University of California, San Francisco (UCSF) en lid van het Steering Committee van de BEYOND studie.
Darlene Jody MD, Senior Vice President en President van Bayer HealthCare's Specialized Therapeutics Global Business Unit: "De resultaten van de BENEFIT studie hebben al laten zien dat vroege behandeling met Betaferon(R) het risico op permanente beschadiging als gevolg van aanvallen van MS met 40% vermindert vergeleken met uitgestelde behandeling. BEYOND ondersteunt de BENEFIT resultaten door aan te tonen dat Betaferon(R) 250mcg de optimale dosis is voor mensen met MS die de behandeling voor het eerst starten vanwege de sterke effectiviteit en de uitstekende verdraagbaarheid."
Contact:
Hélène de Kruijs, telefoon 0297 280 426
E-mail: helenede.kruijs@bayer.nl
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About the BEYOND study
The BEYOND study is a phase III, randomized, multi-centered trial that compared the relative efficacy of high-dose, high-frequency Betaferon(R) 250 mcg every other day to a 500 mcg dose of Betaferon(R) every other day and to glatiramer acetate 20 mcg administered subcutaneously every day. The study enrolled 2,244 patients with relapsing-remitting MS from 198 sites in 26 countries who had not been previously treated with MS therapy, and were randomized to one of the three study arms. It is one of a number of wide-ranging clinical MS studies from Bayer Schering Pharma that seek to further improve treatment options for MS patients.
About the BENEFIT study
BENEFIT is a multi-center trial conducted at 98 sites in 20 countries and included patients presenting with a first clinical episode suggestive of MS and typical MRI findings. The primary outcome measures were time to diagnosis of CDMS (Clinically Definite MS), time to confirmed EDSS (Expanded Disability Status Scale) progression and patient reported Quality of Life outcomes (FAMS-TOI). A total of 468 patients were randomized to receive either 250 micrograms of interferon beta-1b (Betaferon(R)) every other day or placebo as a subcutaneous injection in a double-blind fashion. The placebo-controlled treatment period lasted up to 24 months or up to the time when patients experienced a second attack and were diagnosed with clinically definite MS. All study participants were then invited to participate in a follow-up study with Betaferon(R) to prospectively assess the impact of such early versus delayed treatment with Betaferon(R) on the long-term course of the disease for a total observation time of five years. The results reported in the Lancet are from a pre-planned analysis at three years.
Previous published studies in this patient population have been criticised as less scientifically rigorous, because of their retrospective nature, unblinded assessments and the high number of patients lost to follow-up. The BENEFIT study was the first study in early MS patients designed to overcome these shortcomings.
About the 16-Year Long-Term Follow-up Study
The 16-Year Long-Term Follow-up Study provides clinical assessment of patients who first enrolled in the Betaferon(R) pivotal trial between 1988 and 1990. Of the original 372 patients involved in the pivotal trial, 328 (88.2 percent) have been identified. It is a multicenter, open-label, observational study designed to evaluate the impact of Betaferon(R) treatment on long-term outcomes in patients with relapsing forms of MS. The study constitutes the longest follow up for any disease-modifying therapy in MS.
The Betaferon(R) pivotal trial was the first large, randomized, placebo-controlled study of any therapy in MS. This groundbreaking study was conducted in North America and led to the approval of Betaferon(R), the first disease-modifying agent for MS, in 1993. Patients were randomly assigned to one of three study arms, Betaferon(R) 50mcg, Betaferon(R) 250mcg or placebo, with a median duration of observation of 45 months. Analysis after two years demonstrated that significantly more patients receiving Betaferon(R) were relapse-free, that those relapses that occurred were less frequent and less severe and that hospitalizations for MS were cut nearly in half. These results were confirmed at five years.
About Betaferon(R) / Betaseron(R)
Betaferon(R), which is marketed in the U.S. and Canada under the trademark Betaseron(R), was the first disease-modifying drug introduced for MS and is a well-established treatment around the world. In the U.S., Europe and Japan, Betaferon(R) has been approved for all relapsing forms of MS. Sixteen years' follow-up of people treated with Betaferon(R) has shown that it is safe and well tolerated.
The most commonly reported adverse reactions are lymphopenia, injection-site reaction, asthenia, flu-like symptom complex, headache and pain. Gradual dose titration and use of analgesics during treatment initiation may help reduce flu-like symptoms. Betaferon(R) should be used with caution in patients with depression. Injection-site necrosis has been reported in four 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 full Prescribing Information.
About Multiple Sclerosis
MS is a chronic, progressive disease of the central nervous system and the likelihood of disability increases the longer someone has MS. Symptoms of MS vary from person to person and can be unpredictable. They may include: Fatigue or tiredness, dimness of vision in one or both eyes, weakness in one or more extremities, numbness and tingling in the face, arms, legs and trunk of the body, spasticity (muscle stiffness), dizziness, double vision, slurred speech and loss of bladder control.
About Bayer Healthcare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany.The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.
About Bayer Schering Pharma AG
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.
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