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Study Showed Treatment With COPAXONE(R) is Associated With Significantly Fewer Days Missed From Work in Multiple Sclerosis Patients; Non-Treatment and Treatment With Avonex(R) or Betaseron(R) Had No Significant Impact on Days Missed

Posted on: Tuesday, 12 September 2006, 09:01 CDT

A retrospective analysis of multiple sclerosis (MS) patients comparing patients treated with immunomodulatory agents with untreated patients revealed that only treatment with COPAXONE(R) (glatiramer acetate injection) was associated with significantly fewer days missed from work compared to untreated patients. Neither treatment with Avonex(R) (Interferon beta-1a IM) nor Betaseron(R) (Interferon beta-1b) was associated with significantly fewer days missed from work in comparison to untreated patients. The findings of this study, "Effect of immunomodulatory therapy and other factors on employment loss time in multiple sclerosis," were published in the September issue of the journal WORK.

"Being able to pursue a satisfying work life is an important part of life for most people, yet the symptoms of relapsing-remitting multiple sclerosis (RRMS) and the up and down nature of the disease can make this a challenge for many patients," said MerriKay Oleen-Burkey, PhD, director of Outcomes Research at Teva Neuroscience and a study investigator. "After diagnosis, an estimated 70 to 80 percent of MS patients in the United States leave the workforce. A major goal in the treatment of RRMS is to reduce disease relapses and to provide patients the ability to go on with their lives despite the disease."

Disease relapses in MS can be associated with hospitalization, interference with employment and accumulated disability, leading researchers to suggest that reducing relapse rates may be associated with a reduction in lost work time.

"The results of this study suggest that COPAXONE(R) might be a contributor in helping to keep MS patients participating in the workplace for as long as possible," said Oleen-Burkey. "It is important to consider the results of this study in context given various study limitations, including the retrospective design and a relatively small sample size. It is also important to continue searching for the optimal combination of factors for preserving the working life of MS patients."

About the Study

The purpose of the study was to examine the factors that potentially affect time missed from work for individuals diagnosed with MS. The study observed the impact of patient demographics, prior medical history, comorbid diagnoses, medications and the use of and type of immunomodulatory treatment on work attendance.

The study analyzed two MedStat databases - Health and Productivity Management (HPM) and MarketScan Commercial Claims and Encounters (CCE). Patients followed in the study included those diagnosed with MS between 2000 and 2002, who were continuously insured six months prior to the year of diagnosis and throughout the year following diagnosis, and with work records containing days missed from work, short-term disability and worker's compensation data (n=284).

Comparing work attendance of patients treated with the immunomodulatory agents COPAXONE(R) (glatiramer acetate injection, n=28), Avonex(R) (interferon beta-1a IM, n=74) or Betaseron(R) (interferon beta-1b, n=16) to those who did not receive immunomodulatory therapy (n=166), only patients taking COPAXONE(R) had significantly fewer missed days of work for short-term disability (18.24 fewer days, P less than 0.03), worker's compensation (29.50 fewer days, P less than 0.04) or any reason (53.70 fewer days, P less than 0.003) compared to untreated patients.

About COPAXONE(R)

Current data suggest COPAXONE(R) is a selective MHC class II modulator. COPAXONE(R) is indicated for the reduction of the frequency of relapses in RRMS. The most common side effects of COPAXONE(R) are redness, pain, swelling, itching, a lump or an indentation at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.

COPAXONE(R) is now approved in 44 countries worldwide, including the United States, Canada, Mexico, Australia, Israel and all European countries. In Europe, COPAXONE(R) is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, COPAXONE(R) is marketed by Teva Neuroscience, Inc.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80% of Teva's sales are in North America and Europe.

Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva`s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to Teva's ability to rapidly integrate Ivax Corporation's operations and achieve expected synergies, Teva`s ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic products, the impact of competition from brand-name companies that sell or license their own brand products under generic trade dress and at generic prices (so called "authorized generics") or seek to delay the introduction of generic product, the impact of consolidation of our distributors and customers, regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding litigation, including that relating to the generic versions of Allegra(R), Neurontin(R), Oxycontin(R) and Zithromax(R), the effects of competition on Copaxone(R) sales, including as a result of the expected reintroduction of Tysabri(R) into the market, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, Teva's ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism or major hostilities, environmental risks, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

Source: Business Wire

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