Immune reconstitution therapy (IRT) is an emerging management concept for multiple sclerosis, whereby a short course of treatment provides long-lasting suppression of disease activity. ''Cladribine tablets 10 mg'' refers to a total cumulative dose of cladribine given over 2 years (henceforth referred to as cladribine tablets 3.5 mg/kg); it is a relatively new treatment option that is hypothesised to act as an
Few studies examine health-related quality of life (HRQoL) in Arabic-speaking multiple sclerosis (MS) patients. However, HRQoL tools such as the Short Form-36 QoL instrument (SF-36) and the Multiple Sclerosis International QoL (MusiQoL) questionnaire have been validated in other languages. The primary objective of this study was to prospectively assess HRQoL using the MusiQoL questionnaire among Arabic-speaking MS patients treated with subcutaneous interferon (sc IFN β-1a) over 12 months, as part of a prospective, multinational, multicenter cohort study. Patients’ clinical parameters and HRQoL were assessed at baseline, 6 months, and 12 months. Changes in MusiQoL total and subdomain scores were compared using a Friedman test. Correlation between MusiQoL total score and Expanded Disability Status Score (EDSS) was also evaluated. In total, 439 patients from four Arabic-speaking countries were included. The mean age was 32.44 (±0.34) years, 71.5% were female, and 63.1% had an education level of university or above. The mean MS duration was 4.13 (±0.12) years, mean age at first attack was 27.35 (±0.26) years, and mean baseline EDSS score was 2.05 (±0.04). MusiQoL total score significantly improved at 6 months; however, this diminished at 12 months (
65.67
±
0.8
at baseline vs.
67.21
±
0.79
at 6 months and
65.75
±
0.8
at 12 months;
p
=
0.0015
). Several aspects of patients’ HRQoL including activity of daily living, physical well-being, symptoms, and coping improved. Overall HRQoL measured using SF-36 remained generally unchanged over time (
p
=
0.215
). There was a statistically significant inverse relationship between change in EDSS score over time and change in overall MusiQoL score over time. In summary, findings confirm the utility of using MusiQoL for assessing changes in HRQoL during treatment with sc IFN β-1a in Arabic-speaking patients with MS.
Latest diagnostic criteria have increased the speed and accuracy of multiple sclerosis diagnosis. Early diagnosis of multiple sclerosis and early treatment initiation help in achieving better clinical outcomes. Accordingly, recent clinical studies include patients with less severe multiple sclerosis as compared to older studies, and in this milder multiple sclerosis population, many patients do not progress over 2 years. Interferon beta‐1a has been used for the treatment of relapsing multiple sclerosis for more than 20 years and has been assessed in multiple clinical trials of varying lengths. Clinical trials of subcutaneous interferon beta‐1a show efficacy in terms of relapse rate, magnetic resonance imaging outcomes, and long‐term disability measures in relapsing multiple sclerosis patients with different disease activity profiles. This article discusses multiple sclerosis experts’ opinions on the level of disease activity of the patient populations used in the clinical trials of subcutaneous interferon beta‐1a and on the effectiveness of subcutaneous interferon beta‐1a in these patient populations. Based on experts’ opinions, it can be concluded that patients with mild or moderate disease activity have a high potential of benefiting from high‐dose subcutaneous interferon beta‐1a.
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