Fewer injection site reactions in patients using Avonex

Data from an observational phase IV study of 499 patients entitled The Swiss MS Skin Project show that multiple sclerosis (MS) patients taking AVONEX (interferon beta-1a IM) reported significantly fewer injection site reactions (ISRs) compared to patients on Betaferon® (interferon beta-1b), Copaxone® (glatiramer Acetate) or Rebif ® (interferon beta-1a). The study also showed AVONEX patients were less likely to have missed a dose due to an injection site reaction in the four weeks prior to first assessment than those patients on other interferon therapies. These data were presented as a poster at the 25th Annual European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in Düsseldorf, Germany.

“This study showed that treatment with AVONEX leads to fewer injection site reactions which is an important factor in improving compliance. As the only once-weekly injection treatment, AVONEX offers people with relapsing MS an easy-to-use and highly effective treatment option,” said Dr. Karsten Beer, lead investigator for the study and private neurologist in Wil, Switzerland. “Convenience of an MS therapy is an important consideration for patients, as they do not want a therapy that will interfere with their daily lives.”

The Swiss MS Skin Project was designed to determine the frequency of injection site reactions, including skin necrosis and lipoatrophy, in patients taking AVONEX, Betaferon, Copaxone, or Rebif (ABCRs). These data are important as ISRs are thought to reduce treatment compliance among patients. The study enrolled nearly 500 patients on ABCRs for a minimum of two years (mean treatment duration of 5.9 years) and followed patients for a total of one year. Study findings include:

  * At the first assessment, significantly fewer AVONEX patients experienced ISRs (13.4% vs 57.7% for Betaferon [p < .0001], 30.4% for Copaxone [p = 0.056], 67.9% for Rebif [p < 0.001]), necrosis (0.0% vs 5.7% for Betaferon [p = 0.0279], 0.0% for Copaxone [p = NS], 6.0% for Rebif [p = 0.0201]) and lipoatrophy (1.2 % vs 8.9% for Betaferon [p = 0.0210], 13.0% for Copaxone [p = 0.0322], 10.3% for Rebif [p = 0.0093]);
* No AVONEX patients missed a dose in the four weeks prior to first assessment due to ISRs (vs 5.7% for Betaferon [p = 0.44], 4.3% for Copaxone [p = NS], and 7.1% for Rebif [p = 0.011]). These percentages were statistically significant versus Betaferon and Rebif; and
* Significantly more patients remained on AVONEX over the one year trial (86.6% vs 79.7% for Betaferon, 60.9% for Copaxone, and 83.2% for Rebif [overall p = 0.0364]) than any other treatment.

The poster describing the study entitled 'An Evaluation of Adverse Skin Reactions in Patients with Multiple Sclerosis on Disease-Modifying Therapies' (P 787) is available for viewing on September 11, 2009 at 3:30pm local time.

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About AVONEX® (interferon beta-1a)

Approximately 135,000 patients are on AVONEX therapy for relapsing forms of multiple sclerosis (MS). It was launched in the U.S. in 1996 and in Europe in 1997 for the treatment of relapsing forms of MS to slow the progression of disability and reduce relapses. AVONEX has been proven effective in clinical trials for up to three years. AVONEX is marketed internationally in more than 90 countries. AVONEX was the first treatment approved for patients who have their first clinical MS attack and have MRI features consistent with MS; this use was approved in Europe in 2002 and in the U.S. in 2003.

Important Information about AVONEX

Indication

AVONEX is indicated for the treatment of patients with relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease 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.

Important Safety Information about AVONEX

Potential serious side effects

  * AVONEX should be used with caution in patients with depression or other mood disorders. Patients treated with AVONEX should be advised to report immediately any symptoms of depression and/or suicidal ideation to their prescribing physician.
  * Rare cases of anaphylaxis have been reported. Other allergic reactions have included dyspnea, orolingual edema, skin rash, and urticaria.
  * Decreased peripheral blood counts in all cell lines, including rare pancytopenia and thrombocytopenia, have been reported from post-marketing experience.
  * Severe hepatic injury, including cases of hepatic failure, has been reported rarely in patients taking AVONEX. Patients should be monitored for signs of hepatic injury and caution exercised when AVONEX is used concomitantly with other drugs associated with hepatic injury.

Precautions should be taken with the following

  * Caution should be exercised when administering AVONEX to patients with pre-existing seizure disorders.
  * Patients with cardiac disease, such as angina, congestive heart failure, or arrhythmia, should be closely monitored for worsening of their clinical condition during treatment with AVONEX.
  * Routine periodic blood chemistry and hematology tests are recommended during treatment with AVONEX.
  * AVONEX is not recommended for use in pregnant women. If a woman becomes pregnant or plans to become pregnant while taking AVONEX, she should be informed of the potential hazards to the fetus, and discontinuation of AVONEX therapy should be considered.

Common Side Effects

The most common side effects associated with AVONEX treatment are flu-like symptoms, including myalgia, fever, fatigue, headache, chills, nausea, vomiting, pain, and asthenia.

Please see complete prescribing information available at http://www.AVONEX.com.

Contact: Kathy Vigneault
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617-369-8786
Manning Selvage & Lee