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      Quality of Life Assessment in Patients with Multiple Sclerosis Receiving Interferon Beta-1a: A Comparative Longitudinal Study of Avonex and Its Biosimilar CinnoVex

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          Abstract

          Background. Multiple sclerosis (MS) is an autoimmune inflammatory disease of central nervous system (CNS). MS affects quality of Life (QOL) due to physical disability and other associated problems. Disease-modifying agents like interferon beta (IFNB) have been widely utilized in this patient population; however, their frequency, route of administration, side effects, high cost, and also the question of whether they are truly beneficial for longer-term outcomes and QOL need to be further investigated. Objectives. To assess QOL in patients with multiple sclerosis receiving interferon beta-1a (Avonex or CinnoVex) and in order to compare QOL in groups receiving Avonex and CinnoVex, respectively, also, to evaluate whether the more cost-effective biosimilar form of IFNB (CinnoVex) has the same effect on QOL and can be substituted for Avonex. Methods. We conducted a 30-month, nonrandomized longitudinal study and recruited a total of 92 patients diagnosed with relapsing-remitting MS. The patients were distributed in Avonex and CinnoVex groups with 46 patients in each group. Quality of life was assessed by means of MSQOL-54 questionnaire, four times a year, at baseline and at months 4, 8, and 12 of the study. Results. Mean age ± SD was 30.5 ± 8.9 and 32.3 ± 9.0 years in Avonex and CinnoVex groups, respectively, and P value of gender was different ( P value : 0.036). The physical health composite scores were 61.8 and 59.8 ( P values 0.677 and 0.884) for Avonex and CinnoVex groups, in that order. The results of the study revealed no significant difference between the two groups with regard to physical health, health perception, energy, and role limitations due to physical problems, pain, sexual and social function, and physical health distress scores. Further, interferon therapy did not significantly impact patients' QOL after a year of treatment with either Avonex or CinnoVex. Conclusions. According to the present study, treatment with IFNB (Avonex or CinnoVex) did not affect QOL during a year of therapy. Further studies with longer follow-up periods are required to assess the value of interferons on long-term outcomes and patient's QOL.

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          A review about the impact of multiple sclerosis on health-related quality of life.

          There is increasing recognition that the global wellbeing of patients with chronic neurological disease is an important outcome in research and clinical practice alike. Many studies involving individuals with multiple sclerosis have demonstrated that the overall wellbeing is not a simple manifestation of impairment or disability. The strongest correlations with health-related quality of life appear to be patient rated emotional adjustment to illness and patient rated handicap. In recent years, health-related quality of life questionnaires that measure the physical, social, emotional, and occupational impact of illness have been developed and validated in populations with MS. Most questionnaires are now available in a range of languages. This development is likely to lead to increasing recognition of neuropsychiatric complications of MS in clinical practice and better quantification of treatment responses in clinical trials. Further work is required to decide which scale is most suited to which purpose. Assessment of multiple sclerosis-specific health-related quality of life should be included in future clinical trials to provide a complete picture of patients' health status.
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            Validation of the Multiple Sclerosis International Quality of Life questionnaire.

            This study aims to validate the Multiple Sclerosis (MS) International Quality of Life (MusiQoL) questionnaire, a multi-dimensional, self-administered questionnaire, available in 14 languages, as a disease-specific quality of life scale that can be applied internationally. A total of 1992 patients with different types and severities of MS from 15 countries were recruited. At baseline and day 21 +/- 7, each patient completed the MusiQoL, a symptom checklist and the short-form (SF)-36 QoL questionnaire. Neurologists also collected socio-demographic, MS history and outcome data. The database was randomly divided into two subgroups and analysed according to different patient characteristics. For each model, psychometric properties were tested and the number of items was reduced by various statistical methods. Construct validity, internal consistency, reproducibility and external consistency were also tested. Nine dimensions, explaining 71% of the total variance, were isolated. Internal consistency and reproducibility were satisfactory for all the dimensions. External validity testing revealed that dimension scores correlated significantly with all SF-36 scores, but showed discriminant validity by gender, socio-economic and health status. Significant correlations were found between activity in daily life scores and clinical indices. These results demonstrate the validity and reliability of the MusiQoL as an international scale to evaluate QoL in patients with MS.
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              Revised estimate of the prevalence of multiple sclerosis in the United States.

              Using three adjustments, we have revised a 1976 prevalence count for multiple sclerosis in the United States. The adjustments were made to data from a US national survey; they used 1990 population projections from the US Bureau of the Census, and results of investigations conducted in Weld and Larimer Countries, Colorado, and Olmsted County, Minnesota. It is estimated that approximately 250,000 to 350,000 persons in the United States in 1990 had physician-diagnosed multiple sclerosis.
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                Author and article information

                Journal
                ISRN Neurol
                ISRN Neurol
                ISRN.NEUROLOGY
                ISRN Neurology
                International Scholarly Research Network
                2090-5505
                2090-5513
                2012
                9 August 2012
                : 2012
                : 786526
                Affiliations
                1Neurology Department, Amiralam Hospital, Tehran University of Medical Sciences, Tehran 1145765111, Iran
                2Islamic Azad University, Tehran, Iran
                3Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran
                Author notes

                Academic Editors: P. Annunziata, B. Moreno-López, and Y. Ohyagi

                Article
                10.5402/2012/786526
                3423918
                22928117
                bfa59959-9e3b-4402-8032-033109ed9978
                Copyright © 2012 R. Abolfazli et al.

                This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 12 June 2012
                : 2 July 2012
                Categories
                Clinical Study

                Neurology
                Neurology

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