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

Nov 07, 2007, 00:00 ET from Bayer HealthCare Pharmaceuticals

    WAYNE, N.J., Nov. 7 /PRNewswire/ -- 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(R) versus Rebif(R) Investigating
 Higher Tolerability) study were published in this month's issue of Multiple
     "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(R)
 is a registered trademark of Bayer HealthCare Pharmaceuticals. Rebif(R) 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 Pharmaceuticals