BACKGROUND: Fingolimod is an oral sphingosine-1-phosphate-receptor modulator, which has demonstrated efficacy in clinical trials and has recently been approved for multiple sclerosis (MS) treatment in Kuwait. Post-marketing studies are important to demonstrate real-life efficacy and safety. OBJECTIVE: The objective of this study was to examine the efficacy and safety of fingolimod treatment in a clinical setting. METHODS: Using the national Kuwait MS registry, relapsing remitting MS patients who had been prescribed fingolimod for ≥6 months were retrospectively identified. Three-monthly clinical evaluations and 6-monthly magnetic resonance imagings (MRIs) were performed. Patient status pre- and post-treatment was compared using chi-square and Student t-tests. RESULTS: A total of 175 patients were included: 75.4 % female (n = 132); mean age 33.3 ± 9.2 years; mean disease duration 7.2 ± 5.2 years; mean fingolimod use 21.7 ± 9.1 months. Most had used previous disease-modifying therapy (78.9 %; n = 138), mainly interferons (66.9 %; n = 117). Twenty-three patients (11.4 %) discontinued/withdrew fingolimod; of whom eight had relapses. The proportion of relapse-free patients improved significantly (86.3 % vs. 32.6 %; p < 0.001), while the proportion of patients with MRI activity decreased (18.3.6 % vs. 77.7 %; p < 0.001). Mean expanded disability status scale (EDSS) score at the last visit improved when compared with pre-treatment (2.26 ± 1.49 vs. 2.60 ± 1.44; p = 0.03). Forty-three (24.6 %) patients experienced adverse events; headaches and lymphopenia were the most commonly reported adverse events. CONCLUSION: Fingolimod treatment was associated with reduced relapse and MRI activity, and an improved EDSS score. Discontinuation/withdrawal rates and adverse events were low. Fingolimod presents a promising treatment for MS in Kuwait.
BACKGROUND: Fingolimod is an oral sphingosine-1-phosphate-receptor modulator, which has demonstrated efficacy in clinical trials and has recently been approved for multiple sclerosis (MS) treatment in Kuwait. Post-marketing studies are important to demonstrate real-life efficacy and safety. OBJECTIVE: The objective of this study was to examine the efficacy and safety of fingolimod treatment in a clinical setting. METHODS: Using the national Kuwait MS registry, relapsing remitting MS patients who had been prescribed fingolimod for ≥6 months were retrospectively identified. Three-monthly clinical evaluations and 6-monthly magnetic resonance imagings (MRIs) were performed. Patient status pre- and post-treatment was compared using chi-square and Student t-tests. RESULTS: A total of 175 patients were included: 75.4 % female (n = 132); mean age 33.3 ± 9.2 years; mean disease duration 7.2 ± 5.2 years; mean fingolimod use 21.7 ± 9.1 months. Most had used previous disease-modifying therapy (78.9 %; n = 138), mainly interferons (66.9 %; n = 117). Twenty-three patients (11.4 %) discontinued/withdrew fingolimod; of whom eight had relapses. The proportion of relapse-free patients improved significantly (86.3 % vs. 32.6 %; p < 0.001), while the proportion of patients with MRI activity decreased (18.3.6 % vs. 77.7 %; p < 0.001). Mean expanded disability status scale (EDSS) score at the last visit improved when compared with pre-treatment (2.26 ± 1.49 vs. 2.60 ± 1.44; p = 0.03). Forty-three (24.6 %) patients experienced adverse events; headaches and lymphopenia were the most commonly reported adverse events. CONCLUSION: Fingolimod treatment was associated with reduced relapse and MRI activity, and an improved EDSS score. Discontinuation/withdrawal rates and adverse events were low. Fingolimod presents a promising treatment for MS in Kuwait.
Authors: B Yamout; R Alroughani; M Al-Jumah; S Khoury; N Abouzeid; M Dahdaleh; I Alsharoqi; J Inshasi; S Hashem; M Zakaria; K ElKallab; T Alsaadi; T Tawfeek; S Bohlega Journal: Curr Med Res Opin Date: 2013-04-22 Impact factor: 2.580
Authors: Georg Pilz; Andrea Harrer; Peter Wipfler; Katrin Oppermann; Johann Sellner; Franz Fazekas; Eugen Trinka; Joerg Kraus Journal: Neurology Date: 2013-10-04 Impact factor: 9.910
Authors: L D Jacobs; D L Cookfair; R A Rudick; R M Herndon; J R Richert; A M Salazar; J S Fischer; D E Goodkin; C V Granger; J H Simon; J J Alam; D M Bartoszak; D N Bourdette; J Braiman; C M Brownscheidle; M E Coats; S L Cohan; D S Dougherty; R P Kinkel; M K Mass; F E Munschauer; R L Priore; P M Pullicino; B J Scherokman; R H Whitham Journal: Ann Neurol Date: 1996-03 Impact factor: 10.422
Authors: Neetu Agashivala; Ning Wu; Safiya Abouzaid; You Wu; Edward Kim; Luke Boulanger; David W Brandes Journal: BMC Neurol Date: 2013-10-04 Impact factor: 2.474
Authors: Tjalf Ziemssen; Michael Lang; Björn Tackenberg; Stephan Schmidt; Holger Albrecht; Luisa Klotz; Judith Haas; Christoph Lassek; C Anne-Marie Couto; John A Findlay; Christian Cornelissen Journal: Neurol Neuroimmunol Neuroinflamm Date: 2019-03-07