Monday, 10 August 2015

Insurance company view of side-effects of Beta Interferon

Smith MY, Sabidó-Espin M, Trochanov A, Samuelson M, Guedes S, Corvino FA, Richy FF. Postmarketing Safety Profile of Subcutaneous Interferon Beta-1a Given 3 Times Weekly: A Retrospective Administrative Claims Analysis. J Manag Care Spec Pharm. 2015;21(8):650-60.

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 of relapsing-remitting multiple sclerosis (MS), has over a decade of post-marketing experience. To date, however, its post-marketing safety profile has not been described using a real-world evidence source such as administrative claims data.
OBJECTIVE:To describe the safety profile of IFN β-1a SC tiw as presented in its U.S. prescribing information (PI) for patients with MS initiating IFN β-1a SC tiw therapy using data from U.S. health care administrative claims databases.
RESULTS: The top 6 AEs included influenza-like symptoms (IR = 15.65, 95% CI = 14.96-16.36); malaise (IR = 15.33, 95% CI = 14.65-16.04; fatigue (IR = 15.02, 95% CI = 14.35-15.72); abdominal pain (IR = 10.18, 95% CI = 9.67-10.70); chest pain (IR = 8.48, 95% CI = 8.03-8.95); and depression (IR = 7.75, 95% CI = 7.32-8.20). In contrast, the 6 lowest IRs were for maculo-papular rash (red skin rash. IR = 0.01, 95% CI = 0.00-0.04; injection-site necrosis (death of skin tissue around the injection site. IR = 0.01, 95% CI = 0.00-0.03); erythema multiforme (skin problem due to immune complex.IR = 0.01, 95% CI = 0.00-0.04); hypoesthesia (reduced sense of touch IR = 0.00, 95% CI = 0.00-0.02); Stevens-Johnson Syndrome (skin problem/dying skin problem IR = 0.00, 95% CI = 0.00-0.02); and xerophthalmia (dry eyes. IR = 0.00, 95% CI = 0.00-0.02).
CONCLUSIONS:Study results show strong convergence between the real-world safety profile of IFN β-1a SC tiw and its U.S. label. Our findings demonstrate the value of using real-world evidence obtained from administrative claims to complement clinical trial and post-marketing surveillance data in order to characterize the safety profile of established products, such as IFN β-1a SC tiw, in the post-marketing context.

After launch  pharma  have to monitor for side effects, but in this study they look at data from insurance claims  centre and come up with similar conclusions.
CoI: None

No comments:

Post a Comment

Please note that all comments are moderated and any personal or marketing-related submissions will not be shown.