Healthcare Industry News:  Rebif 

Biopharmaceuticals Neurology

 News Release - November 7, 2007

BRIGHT Results Show Less Pain and Higher Patient Satisfaction with Betaseron(R) than with Rebif(R)

Study shows injection site pain can negatively influence patient satisfaction with treatment

WAYNE, N.J., Nov. 7 (HSMN NewsFeed) -- Patients with relapsing-remitting multiple sclerosis (MS) treated with 250 mcg Betaseron (interferon beta-1b) experienced less injection site pain and fewer injection site reactions than those treated with 44 mcg Rebif. Moreover, among those who experienced injection site pain, significantly more patients on Rebif versus Betaseron said that pain negatively influences their satisfaction with treatment. These results from the BRIGHT (Betaseron® versus Rebif® Investigating Higher Tolerability) study were published in this month's issue of Multiple Sclerosis.

"BRIGHT is the first large-scale study to compare injection site reactions and pain with two high-dose interferons," said Dr. Karl Baum, an author of the study, and Chief of Neurology, Hennigsdorf Clinic, Hennigsdorf, Germany. "Injection site reactions and pain occur in many patients using injection interferon therapies, and these results show that reducing pain helps to improve their satisfaction with treatment. This is important because greater patient satisfaction may improve patient adherence to therapy and consequently, its effectiveness."

"MS is a chronic disease that requires long-term treatment. An effective therapy with high tolerability and comprehensive patient support programs, like Betaseron, can greatly aid patients in achieving better outcomes," said Ludger Heeck, Ph.D., vice president and general manager, Specialized Therapeutics, Bayer HealthCare Pharmaceuticals. "The results of the BRIGHT study confirm the importance of good tolerability in achieving high patient satisfaction."

The prospective, non-randomized, observational study compared Betaseron (interferon beta-1b) 250 mcg (subcutaneous, every other day) with Rebif (interferon beta-1a) 44 mcg (subcutaneous, three times weekly). The valid case population of the study included 445 patients who were treated with 15 consecutive injections of either Betaseron or Rebif for an observation period of four to five weeks.

Significantly more Betaseron than Rebif patients were pain-free at all time points measured (immediately after injection, 30 minutes after injection, and 60 minutes after injection) over the course of 15 injections. Specifically, at 30 minutes after injection, 42.6 percent of Betaseron patients were pain-free, versus 19.7 percent of Rebif patients. At the conclusion of the study, more than half of the patients treated with Betaseron reported that they experienced no injection site reactions (51.8 percent) versus only one-third of the patients treated with Rebif (33.8 percent). The proportion of pain-free injections per patient was also greater with Betaseron than with Rebif at all time points. This was regardless of the needle size used for either product.

Among participants who used autoinjectors (92 percent), there were significantly more pain-free patients in the Betaseron group versus the Rebif group at all time points (e.g., at 30 minutes after injection, 40.2 percent versus 16.2 percent). Additionally, more patients treated with Betaseron either had no pain or stated that their injection-site pain had no influence on their satisfaction with treatment, compared to those treated with Rebif (76.9 percent versus 64.1 percent).

About the BRIGHT Study

BRIGHT is a multicenter, international, non-randomized, prospective, observational study comparing the tolerability of Betaseron (250mcg) with Rebif (44mcg). The study included 454 patients (306 patients on Betaseron and 148 patients on Rebif) from 76 centers in 13 countries. Patients started treatment within three months prior to recruitment and were on the full dose of therapy. Nine of the patients were excluded because they did not take the full dose of either study drug. Although this was a non-randomized trial, patients were well matched for demographic and clinical characteristics.

Patients self-injected and self-assessed injection site pain for 15 consecutive injections using a 0-100 mm visual analogue scale (VAS) diary immediately after injection, and 30 minutes and 60 minutes post-injection. Injection site reactions were professionally assessed and confirmed. To qualify for a "pain-free" status, a patient must have had an assessment of "no pain" (VAS=0) at all 15 injections.

At the 15th injection, patients also were asked to assess how much injection site pain influenced their overall satisfaction with treatment. Patients who used an autoinjector were asked to assess its ease of use. The use of autoinjectors was recommended in the study.

About Betaseron

Betaseron (Interferon beta-1b) is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.

Betaseron is the only high-dose, high-frequency interferon beta FDA approved for use in patients after the first attack suggestive MS.

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. Betaseron 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 Bayer HealthCare Pharmaceuticals

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. One of the world's leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the U.S., Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology and Oncology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

*Trademarks are the property of their respective owners: Betaseron® is a registered trademark of Bayer HealthCare Pharmaceuticals. Rebif® is a registered trademark of EMD Serono, Inc.


K. Baum, C. O'Leary, F. Coret Ferrer, E. Klimova, L. Prochazkova, J. Bugge. Comparison of injection site pain and injection site reactions in relapsing-remitting multiple sclerosis patients treated with interferon beta- 1a or 1b. Mult Scler 2007; 13; 1153.

This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Source: Bayer HealthCare

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