Study Findings from M.Y. Smith et al Broaden Understanding of Multiple Sclerosis (Postmarketing Safety Profile of Subcutaneous Interferon Beta-1a…

Study Findings from M.Y. Smith et al Broaden Understanding of Multiple Sclerosis (Postmarketing Safety Profile of Subcutaneous Interferon Beta-1a Gven 3 Times Mekly: A Retrospective Administrative Claims Analysis)

By a News Reporter-Staff News Editor at Clinical Trials Week -- Current study results on Autoimmune Diseases and Disorders have been published. According to news reporting from Woodcliff Lake, New Jersey, by NewsRx journalists, research stated, "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 beta-1a SCtiw), which was approved in 2002 by the FDA for the treatment of relapsing-remitting multiple sclerosis (MS), has over a decade of postmarketing experience."

The news correspondents obtained a quote from the research, "To date, however, its postmarketing safety profile has not been described using a real-world evidence source such as administrative claims data. To describe the safety profile of IFN beta-1a SCtiw as presented in its US prescribing information (PI)for patients with MS initiating IFN beta-1a SC tiw therapy using data from US health care administrative claims databases. This study featured an observational and retrospective 'new start' cohort design using data from the Truven MarketScan Commercial and Medicare Supplemental health care administrative claims databases. Patients were eligible for inclusion if they were aged 18 years; had diagnosis for MS recorded between January 1, 2006, and Dacember 31, 2012; had 2 prescriptions for IFN beta-1a SCtiw; and had >= 90 days of continuous eligibility pre-index date and 180 days of continuous eligibility post-index date. Patients with a prescription for IFN beta-1a SCtiw without a MS diagnosis were excluded. Patients were followed from first prescription for IFN beta-1a SCtiw (index date) until date of therapy switch or discontinuation, end of insurance eligibility, or end of observation period. Adverse events (AEs) examined were those listed in the Warnings and Precautions, Adverse Raactions, and Postmarketing Experience sections of the 2014 U.S. PI. Outcomes of interest were identified at the Medical Dictionary for Regulatory Activities (version 17.1) Referred Term level and then coded to the corresponding IOD-9-CM criteria. Da analyses of patient demographic, health status, health care utilization, and adherence status were performed, and incidence rates (IRs) per 100 person-years of labeled Al with corresponding 95% as were calculated. The IRcalculation was based on events that presented after therapy initiation and that were not present in the 90 -day pre -index period. The top 6 AEs induded influenza -like symptoms (IR=15.65, 95% a=14.96-16.36); malaise (IR=15.33, 95% a=14.65-16.04; fatigue (IR=15.02, 95% a =14.35-15.72); abdominal pain (IR=10.18, 95% a=9.67-10.70); chest pain (IR=8.48, 95% a=8.03-8.95); and depression (IR=7.75, 95%a =7.32-8.20). In contrast, the 6 lowest Ilawere for maculo-papular rash (IR=0.01, 95% a=0.00-0.04; injection -site necrosis (IR=0.01, 95% a=0.00-0.03); erythema multiforme (IR=0.01, 95% a =0.00-0.04); hypoesthesia (IR=0.00, 95% a=0.00-0.02); Stevens Johnson Syndrome (IR=0.00, 95% a=0.00-0.02); and xerophthalmia (IR=0.00, 95% a=0.00-0.02). Study results show strong convergence between the real world safety profile of IFN beta-1a SCtiw and its US label."

According to the news reporters, the research concluded: "OUR findings demonstrate the value of using real-world evidence obtained from administrative claims to complement clinical trial and postmarketing surveillance data in order to characterize the safety profile of established products, such as IFN beta-1a SCtiw, in the postmarketing context."

For more information on this research see: Postmarketing Safety Profile of Subcutaneous Interferon Beta-1a Gven 3 Times Mekly: A Retrospective Administrative Claims Analysis. Journal of Managed Care & Specialty Pharmacy, 2015;21(8):650-660. Journal of Managed Care & Specialty Pharmacy can be contacted at: Acad Managed Care Pharmacy, 100 N Pitt St, 400, Alexandria, VA 22314-3134, USA (see also Autoimmune Diseases and Disorders).

Our news journalists report that additional information may be obtained by contacting M.Y. Smith, Genesis Grp, Woodcliff Lake, NJ, United States. Additional authors for this research include M. Samuelson, M. Sabido-Espin, A. Trochanov, S. Guedes, F.F. Richy and F.A. Corvino.

Keywords for this news article include: Therapy, Cytokines, New Jersey, Interferons, Legal Issues, United States, Woodcliff Lake, Multiple Sclerosis, North and Central America, Autoimmune Diseases and Disorders, Intercellular Signaling Peptides and Proteins

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