Assessment of malignancy risk in patients with multiple sclerosis treated with intramuscular interferon beta-1a: retrospective evaluation using a health insurance claims database and postmarketing surveillance data

نویسندگان

  • Gary Bloomgren
  • Bjørn Sperling
  • Kimberly Cushing
  • Madé Wenten
چکیده

BACKGROUND Intramuscular interferon beta-1a (IFNβ-1a), a multiple sclerosis (MS) therapy that has been commercially available for over a decade, provides a unique opportunity to retrospectively assess postmarketing data for evidence of malignancy risk, compared with relatively limited data available for more recently approved therapies. Postmarketing and claims data were analyzed to determine the risk of malignancy in MS patients treated with intramuscular IFNβ-1a. MATERIALS AND METHODS The cumulative reporting rates of suspected adverse drug reactions coded to malignancy in the intramuscular IFNβ-1a global safety database were compared with malignancy incidence rates in the World Health Organization GLOBOCAN database. In addition, using data from a large US claims database, the cumulative prevalence of malignancy in MS patients treated with intramuscular IFNβ-1a was compared with non-MS population controls, MS patients without intramuscular IFNβ-1a use, and untreated MS patients. Mean follow-up was approximately 3 years for all groups, ie, 3.1 years for the intramuscular IFNβ-1a group (range 0.02-6.0 years), 2.6 years for non-MS population controls (range 0-6.0 years), 2.6 years for the intramuscular IFNβ-1a nonuse group (range 0.01-6.0 years), and 2.4 years for the untreated MS group (range 0.01-6.0 years). RESULTS An estimated 402,250 patients received intramuscular IFNβ-1a during the postmarketing period. Cumulative reporting rates of malignancy in this population were consistent with GLOBOCAN incidence rates observed within the general population. The claims database included 12,894 MS patients who received intramuscular IFNβ-1a. No significant difference in malignancy prevalence was observed in intramuscular IFNβ-1a users compared with other groups. CONCLUSION Results from this evaluation provide no evidence of an increased risk of malignancy with intramuscular IFNβ-1a use.

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Acute Liver Dysfunction Associated With Interferon-Beta-1a (Avonex®) Use in A Young Female Patient with Relapsing-Remitting Multiple Sclerosis (RRMS)

Background: It has been reported that liver function alterations occur in 8–38% of patients with relapsing-remitting multiple sclerosis (RRMS) treated with interferon-beta in controlled clinical trials or in prospective but non-controlled studies. We report herein a case of symptomatic liver dysfunction associated with two-year-period of regular interferon-beta-1a (Avonex®) intramuscular inje...

متن کامل

Postmarketing Safety Profile of Subcutaneous Interferon Beta-1a Given 3 Times Weekly: A Retrospective Administrative Claims Analysis.

BACKGROUND Health insurance administrative claims databases represent a valuable source of information regarding the safety profile of marketed products as used in actual clinical practice in a broader range of patients than that assessed in clinical trials. Interferon beta-1a administered subcutaneously 3 times weekly (IFN β-1a SC tiw), which was approved in 2002 by the FDA for the treatment o...

متن کامل

Fingolimod versus High Dose Interferon Beta-1a in Multiple Sclerosis: A Randomized Clinical Trial

Background: High dose Interferon Beta and Fingolimod are efficient in Multiple Sclerosis. Objectives: Comparison the efficacy of these two drugs in patients with treatment failure on low dose interferon beta. Materials and Methods: The MS patients (McDonald criteria 2010) with the history of unbeneficial treatment on low dose interferon beta participated in this randomized clinical trial ...

متن کامل

An Economic Evaluation of Subcutaneous and Intramuscular Interferon Beta-1a in Multiple Sclerosis Using a Direct Head-To-Head Study.

Objectives: To use health economic modeling techniques to quantify and compare the clinical and economic outcomes associated with the use of subcutaneous interferon beta-1a (scIFNβ 1a) vs. intramuscular interferon beta-1a (imIFNβ 1a) over 2 years in the management of relapsing forms of multiple sclerosis (MS) from a US health care payer perspective. MethOds: The 2-year decision analytic model w...

متن کامل

A Comparison Study of Efficacy and Safety of a Biosimilar Form of Intramuscular Βeta-interferon I-a Versus the Reference Product: A Randomized Controlled Clinical Trial in Iran

We compared the efficacy and safety of a biosimilar form of beta-interferon-1a (Actovex) versus the reference product in the treatment of relapsing remitting multiple sclerosis (RRMS). In a double blind, randomized phase 3 clinical trial, we evaluated 138 patients with RRMS that were allocated to receive the biosimilar medication and the reference treatment (30 μg intramuscular, weekly for one ...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:

دوره 8  شماره 

صفحات  -

تاریخ انتشار 2012