Publications by authors named "Bassem Yamout"

55 Publications

The Brief International Cognitive Assessment in Multiple Sclerosis (BICAMS): Validation in Arabic and Lebanese Normative Values.

J Int Neuropsychol Soc 2021 Feb 10:1-10. Epub 2021 Feb 10.

American University of Beirut, P.O.Box 11-0236, Riad El-Solh / Beirut 1107 2020, Lebanon.

Objective: Multiple sclerosis (MS) is often associated with cognitive deficits. Accurate evaluation of the MS patients' cognitive performance is essential for diagnosis and treatment recommendation. The Brief International Cognitive Assessment in Multiple Sclerosis (BICAMS), widely used cognitive testing battery, examines processing speed, verbal and visuospatial learning, and memory. Our study aims to examine the psychometric properties of an Arabic version of the BICAMS and to provide normative values in a Lebanese sample.

Method: The BICAMS, comprised of the Symbol Digit Modalities Test (SDMT), Brief Visuospatial Memory Test-Revised (BVMT-R), and a newly developed verbal learning/memory test, the Verbal Memory Arabic Test (VMAT), were administered on healthy subjects and MS patients. The sample consisted of 180 healthy individuals, of whom 63 were retested after 2-3 weeks. Forty-three MS patients matched with 43 healthy subjects based on age, sex, and years of education were assessed. A sample of 10 MS patients was also examined on two occasions. Test-retest reliability and criterion-related validity were examined, and regression-based norms were derived.

Results: The test-retest correlations showed good evidence of reliability with coefficients ranging between 0.64 and 0.73 in the healthy sample, and between 0.43 and 0.92 in the MS sample. The BICAMS was able to discriminate between MS patients and matched healthy participants on the SDMT and BVMT-R. Normative data were comparable to other studies.

Conclusions: This new Arabic version of the BICAMS shows initial good psychometric properties. While good evidence of VMAT's reliability was shown in the healthy participants, less test-retest reliability in this tool was seen in the MS group, and partial criterion-related validity was evident. This renders further examination of the VMAT. We provide regression-based norms for a Lebanese sample and encourage the use of this battery in both research and clinical settings.
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http://dx.doi.org/10.1017/S1355617721000102DOI Listing
February 2021

Expert opinion on the use of cladribine tablets in clinical practice.

Ther Adv Neurol Disord 2020 24;13:1756286420935019. Epub 2020 Jun 24.

Department of Neurology, Center for Clinical Neuroplasticity, Medical Park Loipl, Bischofswiesen, University of Erlangen, Germany.

Background: Gaps in current product labels and a lack of detailed clinical guidelines leaves clinicians' questions on the practical management of patients receiving cladribine tablets for the treatment of relapsing multiple sclerosis (MS) unanswered. We describe a consensus-based programme led by international MS experts with the aim of providing recommendations to support the use of cladribine tablets in clinical practice.

Methods: A steering committee (SC) of nine international MS experts led the programme and developed 11 clinical questions concerning the practical use of cladribine tablets. Statements to address each question were drafted using available evidence, expert experiences and perspectives from the SC and an extended faculty of 33 MS experts, representing 19 countries. Consensus on recommendations was achieved when ⩾75% of respondents expressed an agreement score of 7-9, on a 9-point scale.

Results: Consensus was achieved on 46 out of 47 recommendations. Expert-agreed practical recommendations are provided on topics including: the definition of highly active disease; patterns of treatment response and suboptimal response with cladribine tablets; management of pregnancy planning and malignancy risk, infection risk and immune function, and switching to and from cladribine tablets.

Conclusion: These expert recommendations provide up-to-date relevant guidance on the use of cladribine tablets in clinical practice.
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http://dx.doi.org/10.1177/1756286420935019DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7318823PMC
June 2020

Disability outcomes of early cerebellar and brainstem symptoms in multiple sclerosis.

Mult Scler 2021 Apr 15;27(5):755-766. Epub 2020 Jun 15.

CORe, Department of Medicine, The University of Melbourne, Melbourne, VIC, Australia; Department of Neurology, The Royal Melbourne Hospital, Melbourne, VIC, Australia.

Background: Cerebellar and brainstem symptoms are common in early stages of multiple sclerosis (MS) yet their prognostic values remain unclear.

Objective: The aim of this study was to investigate long-term disability outcomes in patients with early cerebellar and brainstem symptoms.

Methods: This study used data from MSBase registry. Patients with early cerebellar/brainstem presentations were identified as those with cerebellar/brainstem relapse(s) or functional system score ⩾ 2 in the initial 2 years. Early pyramidal presentation was chosen as a comparator. Andersen-Gill models were used to compare cumulative hazards of (1) disability progression events and (2) relapses between patients with and without early cerebellar/brainstem symptoms. Mixed effect models were used to estimate the associations between early cerebellar/brainstem presentations and expanded disability status scale (EDSS) scores.

Results: The study cohort consisted of 10,513 eligible patients, including 2723 and 3915 patients with early cerebellar and brainstem symptoms, respectively. Early cerebellar presentation was associated with greater hazard of progression events (HR = 1.37,  < 0.001) and EDSS (β = 0.16,  < 0.001). Patients with early brainstem symptoms had lower hazard of progression events (HR = 0.89,  = 0.01) and EDSS (β = -0.06,  < 0.001). Neither presentation was associated with changes in relapse risk.

Conclusion: Early cerebellar presentation is associated with unfavourable outcomes, while early brainstem presentation is associated with favourable prognosis. These presentations may be used as MS prognostic markers and guide therapeutic approach.
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http://dx.doi.org/10.1177/1352458520926955DOI Listing
April 2021

A Patient with Combined CADASIL and MTHFR Homozygosity.

Case Rep Neurol Med 2020 17;2020:4980847. Epub 2020 Feb 17.

American University of Beirut Medical Center, Department of Neurology, Beirut, Lebanon.

Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL) is an inherited disorder caused by a mutation in the NOTCH 3 gene, characterized by early onset of subcortical lacunar infarcts in the absence of vascular risk factors and cerebral microbleeds. Homozygosity for the factor Methylenetetrahydrofolate Reductase (MTHFR) is also associated with lacunar stroke risk and cerebral small-vessel disease regardless of the homocysteine level. The coexistence of MTHFR C677T homozygosity and NOTCH 3 mutation has never been reported in the literature previously, and that brings up the challenge of antithrombotic treatment in the presence of cerebral microbleeds.
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http://dx.doi.org/10.1155/2020/4980847DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7048904PMC
February 2020

Serum vitamin D level is associated with speed of processing in multiple sclerosis patients.

J Steroid Biochem Mol Biol 2020 06 19;200:105628. Epub 2020 Feb 19.

Nehme and Therese Tohme Multiple Sclerosis Center, American University of Beirut Medical Center, PO Box 11 0236, Riad El-Solh 1107 2020 Beirut, Lebanon; Neurology Department, Faculty of Medicine, American University of Beirut, PO Box 11 0236, Riad El-Solh 1107 2020 Beirut, Lebanon.

Multiple Sclerosis (MS) is often associated with low serum 25(OH)D levels, as well as cognitive dysfunctions. The relationship between 25(OH)D and the most commonly affected cognitive domain in MS; processing speed, is poorly explored. The purpose of this study is to: (1) assess the effect of serum 25(OH)D change on processing speed in MS, and (2) explore the relationship between serum 25(OH)D and brain volume changes in MS. A retrospective chart review was conducted, data from 299 patients were extracted (baseline), of whom 163 had follow-up measurements (after at least a 9-month interval). The Symbol Digits Modalities Test (SDMT) was used as a measure of processing speed. MRI data was available from 78 individuals at baseline, and 70 at follow-up. SDMT scores and brain volumes (Cerebellum (total, grey, and white), intracranial, Grey Matter (GM), and White Matter (WM)) were compared based on 25(OH)D levels and their changes towards follow-up. Results indicated that patients with deficient 25(OH)D levels had lower SDMT scores when compared to those with sufficient levels, and SDMT scores improved as a function of 25(OH)D. For MRI measures, only patients with sufficient 25(OH)D levels during both assessment periods had significant changes in intracranial and total cerebellum volumes. We conclude that 25(OH)D levels seem to have an effect on processing speed in MS, thus the importance of clinical monitoring and supplementation in this regard is reinforced.
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http://dx.doi.org/10.1016/j.jsbmb.2020.105628DOI Listing
June 2020

Epidemiology and phenotypes of multiple sclerosis in the Middle East North Africa (MENA) region.

Mult Scler J Exp Transl Clin 2020 Jan-Mar;6(1):2055217319841881. Epub 2020 Jan 14.

University Tunis El Manar Faculty of Medicine, Laboratory of Research Neurodegenerative and Mental Diseases Tunis, Tunisia.

The Middle East North Africa (MENA) region falls in the low-to-moderate multiple sclerosis (MS) prevalence zone, with prevalence rates slightly lower than Southern Europe but much higher than sub-Saharan Africa. However, there is clearly a trend toward increased MS prevalence over the last few decades, consistent with the globally rising prevalence of the disease. We analyzed all data collected from the MENACTRIMS (Middle East North Africa Committee for Treatment and Research in Multiple Sclerosis) registry by the end of December 2018. A total of 6885 patients were eligible for the study. Overall, the clinical phenotype of MS in the MENA region was not different from the Western phenotype except for earlier age at onset and a more aggressive clinical course leading to earlier disability.
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http://dx.doi.org/10.1177/2055217319841881DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6961141PMC
January 2020

Treatment of multiple sclerosis in special populations: The case of refugees.

Mult Scler J Exp Transl Clin 2020 Jan-Mar;6(1):2055217319848466. Epub 2020 Jan 9.

Nehme and Therese Tohme Multiple Sclerosis Center, American University of Beirut Medical Center, Lebanon.

Multiple sclerosis was long considered a relatively rare entity in the Middle East, but research over the past 10 years and the publication of the Middle East North Africa Committee for Treatment and Research in Multiple Sclerosis guidelines for multiple sclerosis have allowed diagnosis and treatment to occur more efficiently. Most of the first and second-line disease-modifying therapies approved by the Food and Drug Administration and the European Medicine Agency are available in the Middle East. However, the availability of disease-modifying therapies is quite variable, with some countries having access to all multiple sclerosis disease-modifying therapies, while in others there is only one therapeutic option. Economic limitations remain a challenge for the management of multiple sclerosis, especially in countries of war. Moreover, the burden of multiple sclerosis treatment in Syrian and Palestinian refugees is likely high due to the non-availability of funds to cover the high cost of disease-modifying therapies.
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http://dx.doi.org/10.1177/2055217319848466DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6956602PMC
January 2020

Clinical and therapeutic predictors of disease outcomes in AQP4-IgG+ neuromyelitis optica spectrum disorder.

Mult Scler Relat Disord 2020 Feb 25;38:101868. Epub 2019 Nov 25.

CORe, Department of Medicine, University of Melbourne, Melbourne, Australia; Department of Neurology, Royal Melbourne Hospital, Melbourne, Australia; Department of Neurology, Royal Melbourne Hospital, Melbourne, Australia. Electronic address:

Background: Aquaporin-4-IgG positive (AQP4-IgG+) Neuromyelitis Optica Spectrum Disorder (NMOSD) is an uncommon central nervous system autoimmune disorder. Disease outcomes in AQP4-IgG+NMOSD are typically measured by relapse rate and disability. Using the MSBase, a multi-centre international registry, we aimed to examine the impact immunosuppressive therapies and patient characteristics as predictors of disease outcome measures in AQP4-IgG+NMOSD.

Method: This MSBase cohort study of AQP4-IgG+NMOSD patients examined modifiers of relapse in a multivariable proportional hazards model and expanded disability status score (EDSS) using a mixed effects model.

Results: 206 AQP4-IgG+ patients were included (median follow-up 3.7 years). Age (hazard ratio [HR] = 0.82 per decade, p = 0.001), brainstem onset (HR = 0.45, p = 0.009), azathioprine (HR = 0.46, p<0.001) and mycophenolate mofetil (HR = 0.09, p = 0.012) were associated with a reduced risk of relapse. A greater EDSS was associated with age (β = 0.45 (per decade), p<0.001) and disease duration (β = 0.07 per year, p<0.001). A slower increase in EDSS was associated with azathioprine (β = -0.48, p<0.001), mycophenolate mofetil (β = -0.69, p = 0.04) and rituximab (β = -0.35, p = 0.024).

Interpretation: This study has demonstrated that azathioprine and mycophenolate mofetil reduce the risk of relapses and disability progression is modified by azathioprine, mycophenolate mofetil and rituximab. Age and disease duration were the only patient characteristics that modified the risk of relapse and disability in our cohort.
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http://dx.doi.org/10.1016/j.msard.2019.101868DOI Listing
February 2020

Redefining the Multiple Sclerosis Severity Score (MSSS): The effect of sex and onset phenotype.

Mult Scler 2020 11 31;26(13):1765-1774. Epub 2019 Oct 31.

Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.

Background: The Multiple Sclerosis Severity Score (MSSS) is a widely used measure of the disability progression rate. However, the global MSSS may not be the best basis for comparison between all patient groups.

Objective: We evaluated sex-specific and onset phenotype-specific MSSS matrices to determine if they were more effective than the global MSSS as a basis for comparison within these subsets.

Methods: Using a large international dataset of multiple sclerosis (MS) patient records and the original MSSS algorithm, we constructed global, sex-specific and onset phenotype-specific MSSS matrices. We compared matrices using permutation analysis.

Results: Our final dataset included 30,203 MS cases, with 28.9% males and 6.5% progressive-onset cases. Our global MSSS matrix did not differ from previously published data ( > 0.05). The progressive-onset-specific matrix differed significantly from the relapsing-onset-specific matrix ( < 0.001), with lower MSSS attributed to cases with the same Expanded Disability Status Score (EDSS) and disease duration. When evaluated with a simulation, using an onset-specific MSSS improved statistical power in mixed cohorts. There were no significant differences by sex.

Conclusion: The differences in the disability accrual rate between progressive- and relapsing-onset MS have a significant effect on MSSS. An onset-specific MSSS should be used when comparing the rate of disability progression among progressive-onset cases and for mixed cohorts.
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http://dx.doi.org/10.1177/1352458519881994DOI Listing
November 2020

Skin warts during fingolimod treatment in patients with multiple sclerosis.

Mult Scler Relat Disord 2019 Nov 7;36:101437. Epub 2019 Oct 7.

Multiple Sclerosis Certified Specialist, Nehme and Therese Tohme Multiple Sclerosis Center, American University of Beirut Medical Center, Riad El-Soloh 1107 2020, Beirut, Lebanon.

Background: Fingolimod is associated with different infections including lower respiratory tract, herpes virus, cryptococcal meningitis, histoplasmosis, progressive multifocal leukoencephalopathy, atypical mycobacterial infections, kaposi sarcoma and reactivation of hepatitis c.

Objectives: To describe five cases of skin warts in MS patients treated with fingolimod at the American University of Beirut Medical Center (AUBMC) MS center (MSC).

Methods: We reviewed all MS patients treated with fingolimod at our MSC and identified patients who developed skin warts during treatment. We also reviewed a control group of patients treated with different interferons matched for age and sex.

Results: Of 220 patients treated with fingolimod at our MSC, 5 (2.2%) developed skin warts. In 220 patients treated with different interferons and matched for age and sex, no cases of skin warts could be detected.

Conclusions: In conclusion, we report five patients who developed skin warts during fingolimod therapy, especially HPV-related, for an overall incidence of 2.2%. Larger cohorts are needed to confirm this proposed higher susceptibility of fingolimod-treated patients to HPV infections.
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http://dx.doi.org/10.1016/j.msard.2019.101437DOI Listing
November 2019

Risk of secondary progressive multiple sclerosis: A longitudinal study.

Mult Scler 2020 01 9;26(1):79-90. Epub 2019 Aug 9.

CORe, Department of Medicine, The University of Melbourne, Melbourne, VIC, Australia/Department of Neurology, Royal Melbourne Hospital, Melbourne, VIC, Australia/L4 Centre, Melbourne Brain Centre at Royal Melbourne Hospital, Parkville, VIC, Australia.

Background: The risk factors for conversion from relapsing-remitting to secondary progressive multiple sclerosis remain highly contested.

Objective: The aim of this study was to determine the demographic, clinical and paraclinical features that influence the risk of conversion to secondary progressive multiple sclerosis.

Methods: Patients with adult-onset relapsing-remitting multiple sclerosis and at least four recorded disability scores were selected from MSBase, a global observational cohort. The risk of conversion to objectively defined secondary progressive multiple sclerosis was evaluated at multiple time points per patient using multivariable marginal Cox regression models. Sensitivity analyses were performed.

Results: A total of 15,717 patients were included in the primary analysis. Older age (hazard ratio (HR) = 1.02,  < 0.001), longer disease duration (HR = 1.01,  = 0.038), a higher Expanded Disability Status Scale score (HR = 1.30,  < 0.001), more rapid disability trajectory (HR = 2.82,  < 0.001) and greater number of relapses in the previous year (HR = 1.07,  = 0.010) were independently associated with an increased risk of secondary progressive multiple sclerosis. Improving disability (HR = 0.62,  = 0.039) and disease-modifying therapy exposure (HR = 0.71,  = 0.007) were associated with a lower risk. Recent cerebral magnetic resonance imaging activity, evidence of spinal cord lesions and oligoclonal bands in the cerebrospinal fluid were not associated with the risk of conversion.

Conclusion: Risk of secondary progressive multiple sclerosis increases with age, duration of illness and worsening disability and decreases with improving disability. Therapy may delay the onset of secondary progression.
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http://dx.doi.org/10.1177/1352458519868990DOI Listing
January 2020

Risk of relapses during pregnancy among multiple sclerosis patients.

Mult Scler Relat Disord 2019 Sep 10;34:9-13. Epub 2019 Jun 10.

Nehme and Therese Tohme Multiple Sclerosis Center, American University of Beirut, Beirut, Lebanon.

Background: Relapse rate in women with Multiple Sclerosis (MS) is reduced during pregnancy especially in the third trimester according to the previous studies.

Objectives: To measure the annual relapse rate (ARR) in women with MS during pregnancy.

Methods: A retrospective study was conducted using prospectively collected data from two MS registries in Kuwait and Lebanon. Demographics, clinical characteristics including relapses, disease modifying therapies (DMTs) and their washout periods were extracted. The annual relapse rates pre and post pregnancies were compared and the relationship between relapses and prior use of different DMTs was assessed.

Results: Data of 164 pregnancies (132 MS patients) was reviewed. Mean age and disease duration at the time of pregnancy confirmation were 32.4 ± 5.3 and 7.8 ± 4.7 years respectively. Most patients (91.7%; n = 121) were on DMTs in the year prior to pregnancy. The pre-pregnancy ARR was 0.10 (95% CI: 0.04 - 0.13), which increased to 0.20 (95% CI: 0.13- 0.29) during pregnancy. Most relapses occurred either during the 1 (ARR = 0.24; 95% CI: 0.12 - 0.44) or 3 (ARR = 0.32; 95%CI: 0.17 - 0.53) trimesters. Fingolimod (31.8%) and natalizumab (22.7%) were the most commonly prescribed DMTs in patients who sustained relapses during pregnancy. The mean washout period was significantly longer among subjects with relapses (9.3 ± 6.6 vs. 2.5 ± 3.9; p < 0.001) than those of without relapses.

Conclusions: Relapse rate during pregnancy was higher than previous studies conducted in patients on platform therapies or untreated. Longer washout period prior to conception was associated with increased relapses especially in fingolimod and natalizumab treated patients.
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http://dx.doi.org/10.1016/j.msard.2019.06.007DOI Listing
September 2019

Impact of Low Ankle-Brachial Index on the Risk of Recurrent Vascular Events.

Stroke 2019 04;50(4):853-858

Department of Neurology and Stroke Center (H.A., J.L., L.M.T., P.A.), Bichat University Hospital, Paris, France.

Background and Purpose- Low ankle-brachial index (ABI) identifies a stroke subgroup with high risk of recurrent stroke, cardiovascular events, and death. However, limited data exist on the relationship between low ABI and stroke in low and middle-income countries. Therefore, we evaluated the prevalence of ABI ≤0.90 (which is diagnostic of peripheral artery disease) in nonembolic stroke patients or transient ischemic attack and assessed the correlation of low ABI with stroke risk, factors, and recurrent vascular events and death. Methods- Patients ≥45 years with acute transient ischemic attack or minor ischemic strokes were recruited consecutively from over 17 low-income and middle-income countries (Latin America [1543 patients], Middle East [1041 patients], North Africa [834 patients], and South Africa [217 patients]). The ABI measurement was performed at a single visit. Stroke recurrence and risk of new vascular events were assessed after 24 months of follow-up. Results- Among 3487 enrolled patients, abnormal ABI (<0.9) was present in 22.3 %. Patients with an ABI of ≤0.9 were more likely ( P<0.05) to be male, older, and have a history of peripheral artery disease, hypertension, and diabetes mellitus. During 2-year follow-up, the rate of major cardiovascular event was higher in patients with ABI <0.9 than those with ABI ≥0.9 (Kaplan-Meier estimates, 22.5%; 95% CI, 19.6-25.8 versus 13.7%; 21.4-15.1; P<0.001), and when ABI was categorized into 4 groups (≤0.6; 95% CI, 0.6-0.9; 0.9-1; 1-1.4), the rate of major cardiovascular event was higher in those with ABI ≤0.6 than the other groups (Kaplan-Meier estimates, 32.6%; 95% CI, 21.0-48.3 for ABI≤0.6 versus 21.7%; 95% CI, 18.8-25.0 for ABI 0.6-0.9 versus 14.3%; 95% CI, 12.4-16.6 for ABI 0.9-1 versus 13.3%; 95% CI, 11.6-15.2 for ABI 1-1.4; P<0.001). Conclusions- Among patients with nonembolic ischemic stroke or transient ischemic attack, those with low ABI had a higher rate of vascular events and death in this population. Screening for ABI in stroke patients may help identify patients at high risk of future events.
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http://dx.doi.org/10.1161/STROKEAHA.118.022180DOI Listing
April 2019

Comparison of fingolimod, dimethyl fumarate and teriflunomide for multiple sclerosis.

J Neurol Neurosurg Psychiatry 2019 04 13;90(4):458-468. Epub 2019 Jan 13.

Central Clinical School, Monash University, Melbourne, Victoria, Australia.

Objective: Oral immunotherapies have become a standard treatment in relapsing-remitting multiple sclerosis. Direct comparison of their effect on relapse and disability is needed.

Methods: We identified all patients with relapsing-remitting multiple sclerosis treated with teriflunomide, dimethyl fumarate or fingolimod, with minimum 3-month treatment persistence and disability follow-up in the global MSBase cohort study. Patients were matched using propensity scores. Three pairwise analyses compared annualised relapse rates and hazards of disability accumulation, disability improvement and treatment discontinuation (analysed with negative binomial models and weighted conditional survival models, with pairwise censoring).

Results: The eligible cohorts consisted of 614 (teriflunomide), 782 (dimethyl fumarate) or 2332 (fingolimod) patients, followed over the median of 2.5 years. Annualised relapse rates were lower on fingolimod compared with teriflunomide (0.18 vs 0.24; p=0.05) and dimethyl fumarate (0.20 vs 0.26; p=0.01) and similar on dimethyl fumarate and teriflunomide (0.19 vs 0.22; p=0.55). No differences in disability accumulation (p≥0.59) or improvement (p≥0.14) were found between the therapies. In patients with ≥3-month treatment persistence, subsequent discontinuations were less likely on fingolimod than teriflunomide and dimethyl fumarate (p<0.001). Discontinuation rates on teriflunomide and dimethyl fumarate were similar (p=0.68).

Conclusion: The effect of fingolimod on relapse frequency was superior to teriflunomide and dimethyl fumarate. The effect of the three oral therapies on disability outcomes was similar during the initial 2.5 years on treatment. Persistence on fingolimod was superior to the two comparator drugs.
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http://dx.doi.org/10.1136/jnnp-2018-319831DOI Listing
April 2019

Safety and Efficacy of Rituximab in Multiple Sclerosis: A Retrospective Observational Study.

J Immunol Res 2018 12;2018:9084759. Epub 2018 Nov 12.

Nehme and Therese Tohme Multiple Sclerosis Center, American University of Beirut Medical Center, Beirut, Lebanon.

Objective: To evaluate the efficacy and safety of rituximab in multiple sclerosis in a clinical practice setting.

Methods: Clinical data for all adult patients with multiple sclerosis (MS) treated with off-label rituximab at a single MS center in Lebanon between March 2008 and April 2017 were retrospectively collected from medical charts. The main efficacy outcomes assessed were annualized relapse rate (ARR) and proportion of patients free from relapses, disability progression, or magnetic resonance imaging (MRI) activity.

Results: A total of 89 rituximab-treated patients were included: 59 relapsing-remitting MS (RRMS) and 30 progressive MS (PMS). Patients were treated with 1000 or 2000 mg rituximab IV every 6-12 months for a mean duration of 22.2 ± 24.8 months. The subjects were 65.2% females with a mean age of 40.5 ± 12.3 years and a mean disease duration of 7.9 ± 6.2 years. During treatment, the ARR decreased from 1.07 at baseline to 0.11 in RRMS ( < 0.0001) and from 0.25 to 0.16 in PMS patients ( = 0.593). The mean Expanded Disability Status Scale (EDSS) remained unchanged in both RRMS and PMS patients. Between baseline and the last follow-up, the percent of patients free from any new MRI lesions increased from 18.6% to 92.6% in the RRMS group and from 43.3% to 82% in the PMS group. No evidence of disease activity (NEDA) was achieved in 74% of patients at 1 year of treatment. A total of 64 adverse events (AEs) (71.9%) were recorded with the most common being infusion-related reactions in 25.8% of patients, all mild in nature. Two of our rituximab-treated patients experienced serious AEs requiring surgical interventions: pyoderma gangrenosum vaginalis with perianal abscess and fistula and an increase in the size of a meningioma. No case of progressive multifocal leukoencephalopathy (PML) was detected.

Conclusion: In our real-world cohort, rituximab was well-tolerated and effective in reducing relapse rate and disability progression in relapsing-remitting and progressive MS patients.
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http://dx.doi.org/10.1155/2018/9084759DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6260423PMC
January 2019

Gadoterate Meglumine Administration in Multiple Sclerosis has no Effect on the Dentate Nucleus and the Globus Pallidus Signal Intensities.

Acad Radiol 2019 10 6;26(10):e284-e291. Epub 2018 Dec 6.

Department of Diagnostic Radiology, American University of Beirut Medical Center, Beirut, Lebanon. Electronic address:

Rationale And Objectives: Previous studies on possible accumulation of gadolinium-based contrast agents (GBCA) in the brain suggest that macrocyclic GBCA are less likely to accumulate than linear GBCA. However, conflicting results have been reported, especially in MS. The aim of this study is to investigate retrospectively the correlation between gadoterate-meglumine (macrocyclic GBCA) use and T1 signal intensity changes (SI) in the dentate nucleus and the GP on unenhanced T1-weighted images in a large cohort of MS patients.

Materials And Methods: Unenhanced T1-weighted images of 232 MS patients who previously received multiple intravenous administrations of 0.1 mmol/kg of gadoterate-meglumine were reviewed. The change in T1 SI ratios of dentate nucleus/central pons (DN/CP) and globus pallidus/centrum semiovale (GP/CSO) was calculated between the first and last MRIs and correlated with age, number of injections, time interval between MRIs, disease duration, activity, and therapy.

Results: DN/CP ratio showed no significant changes whereas the GP/CSO ratio showed a significant decrease (p < 0.0001) between the first and last MRIs. Multivariable analyses of both ratios, controlling for age, disease duration, and time interval between MRIs, showed no significant correlation between the number of gadolinium injections and the differences in DN/CP (standardized beta = -0.018, p = 0.811) or GP/CSO SI ratios (standardized beta = -0.049, p = 0.499).

Conclusion: Repeated administration of gadoterate-meglumine in MS patients did not result in increased T1 SI in the DN or the GP. The significant decrease of GP/CSO ratio between the first and last MRIs is not due to gadolinium accumulation but rather to varying MR parameters.
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http://dx.doi.org/10.1016/j.acra.2018.11.010DOI Listing
October 2019

The Bayesian risk estimate at onset (BREMSO) correlates with cognitive and physical disability in patients with early multiple sclerosis.

Mult Scler Relat Disord 2018 Nov 13;26:96-102. Epub 2018 Sep 13.

Nehme and Therese Tohme Multiple Sclerosis Center, American University of Beirut Medical Center, PO Box: 11-0236, Riad El Solh, Beirut 1107 2020, Lebanon; Abu-Haidar Neuroscience Institute, American University of Beirut Medical Center, PO Box: 11-0236, Riad El Solh, Beirut 1107 2020, Lebanon. Electronic address:

Background: Prevention of long-term disability is the goal of therapeutic intervention in Relapsing Remitting MS (RRMS). The Bayesian Risk Estimate for MS at Onset (BREMSO) gives an individual risk score predicting disease evolution into Secondary Progressive MS (SPMS). We investigated whether BREMSO correlates with physical disability, cognitive dysfunction, and regional brain atrophy early in MS.

Methods: One hundred RRMS patients with at least two years of follow-up were enrolled. BREMSO score as well as Symbol Digit Modalities Test (SDMT) and Multiple Sclerosis Severity Score (MSSS), Timed 25-Foot Walk Test (T25-FW) and 9-Hole Peg Test (9-HPT), were assessed. Intracranial volume (ICV), subcortical gray matter structures and corpus callosum (CC) were automatically segmented on MRI images and their volumes measured.

Results: BREMSO score correlated negatively with SDMT at visit1 (β = -0.33, p = 0.019), visit2 (β = -0.34, p = 0.017) and visit3 (β = -0.34, p = 0.014), and positively with MSSS at visit1 (r = 0.38, p = 0.006), visit2 (r = 0.47, p < 0.0001) and visit3 (r = 0.42, p = 0.002), but not with T25-FW and 9-HPT. BREMSO negatively correlated with CC volume at baseline (p < 0.03). No correlations were found with ICV and subcortical gray matter.

Conclusions: BREMSO score at onset correlated with physical disability (MSSS), cognitive function (SDMT) and CC volume measurements in patients with early MS.
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http://dx.doi.org/10.1016/j.msard.2018.09.003DOI Listing
November 2018

Gadolinium effect on thalamus and whole brain tissue segmentation.

Neuroradiology 2018 Nov 21;60(11):1167-1173. Epub 2018 Aug 21.

Department of Diagnostic Radiology, American University of Beirut Medical Center, Riad El Solh 1107 2020, P.O.Box: 11-0236, Beirut, Lebanon.

Purpose: Gadolinium-based contrast agent (GBCA) effect on automated segmentation algorithms of subcortical gray matter (GM) is not fully known. The aim of this study is to determine gadolinium effect on the segmentation of the thalamus and whole brain tissue using different automated segmentation techniques.

Methods: Eighty-four multiple sclerosis (MS) patients underwent an MRI acquisition of two 3DT1-weighted sequences with and without gadolinium injection among which 10 were excluded after image quality check. Manual thalamic segmentation considered as gold standard was performed on unenhanced T1 images. volBrain and FSL-Anat were used to automatically segment the thalamus on both enhanced and unenhanced T1 and the degree of similitude (DICE) values were compared between manual and automatic segmentations. Whole brain tissue segmentation (GM, white matter (WM), and lateral ventricles (LV)) was also performed using SIENAX. A paired samples t test was applied to test the significance of DICE value differences between the thalamic manual and automatic segmentations of both enhanced and unenhanced T1 images.

Results: Significant differences (FSL-Anat 1.474% p < 0.001 and volBrain 1.990% p < 0.001) in DICE between thalamic manual and automatic segmentations on both enhanced and unenhanced images were observed. Automatic tissue segmentation showed a mean DICE of 81.5%, with LV having the lowest DICE value (74.2%). When compared to tissue segmentations, automatic thalamic segmentations by FSL-Anat or volBrain demonstrated a higher degree of similitude (FSL-Anat = 91.7% and volBrain = 90.7%).

Conclusion: Gadolinium has a significant effect on subcortical GM segmentation. Although significant, the observed subtle changes could be considered acceptable when used for region-based analysis in perfusion or diffusion imaging.
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http://dx.doi.org/10.1007/s00234-018-2082-5DOI Listing
November 2018

Efficacy and safety of natalizumab extended interval dosing.

Mult Scler Relat Disord 2018 Aug 5;24:113-116. Epub 2018 Jul 5.

Nehme and Therese Tohme Multiple Sclerosis Center, American University of Beirut Medical Center, Beirut, Lebanon.

Objective: It is postulated that extending the dosing interval of natalizumab (NTZ) from 4 to 5-8 weeks might decrease the risk of progressive multifocal leukoencephalopathy (PML). The aim of this study was to assess the effect of extended interval dosing (EID) on the therapeutic efficacy of natalizumab.

Methods: We reviewed 85 patients treated at two MS centers in the Middle East with natalizumab for at least 6 months using EID. Patients were shifted after an initial treatment period at standard interval dosing (SID) to an EID ranging from 5-8 weeks.

Results: The mean treatment duration on SID and EID was 15.4 ± 11.9 and 11.8 ± 7.0 months, respectively. By the end of SID and EID treatment 95.3% and 93.9% of patients were free of relapses (P = 0.41) with an annualized relapse rate (ARR) of 0.0006 and 0.001 respectively (P = 0.42). The mean EDSS at the end of SID and EID periods was 2.56 ± 1.62 and 2.59 ± 1.61 respectively (P = 0.84). A total of 97.6% and 94.7% of patients had no enhancing lesions on MRI during the SID and EID periods respectively (P = 0.18). There were no cases of PML and the rate of infections was lower during the EID period.

Conclusion: In patients treated with natalizumab, shifting from SID to EID has no negative effect on efficacy as evidenced by relapse rate, disability progression and MRI activity.
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http://dx.doi.org/10.1016/j.msard.2018.06.015DOI Listing
August 2018

Multiple Sclerosis.

Semin Neurol 2018 04 23;38(2):212-225. Epub 2018 May 23.

Division of Neurology, Department of Medicine, Al-Amiri Hospital, Kuwait City, Kuwait.

Multiple sclerosis (MS) is a chronic central nervous system inflammatory disease of autoimmune etiology, mediated by activated T cells with evolving evidence of a significant contribution from B cells and cells of the innate immune system. The disease is thought to be due to a complex interaction between different genetic and environmental factors. The prevalence of MS is rising all over the world, due on one hand to earlier diagnosis and prolonged survival, and on the other to a true increase in incidence of the disease. The diagnosis of MS remains clinical despite recent advances in diagnostics and relies on demonstrating dissemination in space and time while excluding alternative diagnoses. The Mc Donald diagnostic criteria, with their recent 2017 revision, are currently widely accepted in the MS community. Although no cure is yet available, many disease-modifying therapies (DMTs) have shown different levels of efficacy in preventing relapses, accumulation of lesions on magnetic resonance imaging (MRI), and disability progression. Current treatment strategies include gradual escalation based on clinical and radiological criteria that determine treatment response, or initial induction with high efficacy DMTs especially in patients with an early aggressive course.
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http://dx.doi.org/10.1055/s-0038-1649502DOI Listing
April 2018

Effectiveness of alternative dose fingolimod for multiple sclerosis.

Neurol Clin Pract 2018 Apr;8(2):102-107

Yale University (EEL), New Haven, CT; Medical Partnership 4 MS (MP4MS) (DK), Coconut Creek, FL; Vanderbilt University (SP, MJB), Nashville, TN; University of Washington (GvG), Seattle; Washington University (SC, AHC, BJP), St. Louis, MO; MS Center of Tidewater (MR), Norfolk, VA; Nehme & Therese Tohme MS Center (SJK, BY, MZ), Beirut, Lebanon; RWJ Barnabas Health (SR-G, IK), West Orange, NJ; C/Fuentes Claras 1 (AC-R), Avila, Spain; MS Center of Northeastern NY (KE), Latham; Elliot Lewis Center for MS Care (EL), Wellesley, MA; Spectrum Health Medical Group (DV), Grand Rapids, MI; University of Alabama (WM), Birmingham; University of Southern California (RB), Los Angeles; and NYU Langone Health (LG, TEB, IK), New York, NY.

Background: Fingolimod is a daily oral medication used to treat relapsing multiple sclerosis (MS). Clinicians often adopt less frequent dosing for patients with profound drug-induced lymphopenia or other adverse events. Data on the effectiveness of alternate dose fingolimod are limited.

Methods: We conducted a multicenter, retrospective, observational study at 14 sites and identified 170 patients with MS taking alternate doses of fingolimod for ≥1 month. Clinical and radiologic outcomes were collected and compared during daily and alternate fingolimod dosing.

Results: Profound lymphopenia (77%), liver function abnormalities (9%), and infections (7%) were the most common reasons for patients to switch to alternate fingolimod dosing. The median follow-up was 12 months on daily dose and 14 months on alternate dose. Most patients (64%) took fingolimod every other day during alternate dosing. Disease activity was similar on alternate dose compared to daily dose: annualized relapse rate was 0.1 on daily dose vs 0.2 on alternate dose ( = 0.25); proportion of patients with contrast-enhancing MRI lesions was 7.6% on daily vs 9.4% on alternate ( = 0.55); proportion of patients with cumulative MS activity (clinical and radiologic disease) was 13.5% on daily vs 18.2% on alternate ( = 0.337). Patients who developed contrast-enhancing lesions while on daily dose were at higher risk for breakthrough disease while on alternate dose fingolimod (odds ratio 11.4, < 0.001).

Conclusions: These data support the clinical strategy of alternate dosing of fingolimod in patients with good disease control but profound lymphopenia or other adverse events while on daily dose.

Classification Of Evidence: This study provides Class IV evidence that for patients with MS on daily dose fingolimod with adverse events, alternate dose fingolimod is associated with disease activity similar to daily dose fingolimod.
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http://dx.doi.org/10.1212/CPJ.0000000000000434DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5914753PMC
April 2018

Rebound syndrome after teriflunomide cessation in a patient with multiple sclerosis.

J Neurol Sci 2017 Sep 9;380:79-81. Epub 2017 Jul 9.

Nehme and Therese Tohme Multiple Sclerosis Center, American University of Beirut Medical Center, Beirut, Lebanon.

We report a case of relapsing remitting multiple sclerosis (RRMS) with severe rebound syndrome 12weeks following discontinuation of teriflunomide therapy. The patient developed severe clinical relapses with significant increase in the number of brain and spine magnetic resonance imaging (MRI) lesions. She responded well to intravenous and oral steroids and was later maintained on rituximab.
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http://dx.doi.org/10.1016/j.jns.2017.07.014DOI Listing
September 2017

Letter to the editor.

Mult Scler 2018 03 27;24(3):363. Epub 2017 Jul 27.

Nehme and Therese Tohme Multiple Sclerosis Center, American University of Beirut Medical Center, Beirut, Lebanon.

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http://dx.doi.org/10.1177/1352458517717091DOI Listing
March 2018

Catastrophic relapses following initiation of dimethyl fumarate in two patients with neuromyelitis optica spectrum disorder.

Mult Scler 2017 Aug 10;23(9):1297-1300. Epub 2017 Apr 10.

Hammoud Hospital University Medical Center, Saida, Lebanon.

We report two cases of neuromyelitis optica spectrum disorder (NMOSD) who were misdiagnosed as multiple sclerosis (MS) and developed catastrophic relapses following initiation of dimethyl fumarate. Both patients developed a severe myelitis extending from the cervical cord to the medulla with significant cord swelling, resulting in complete quadriplegia and respiratory difficulties, in addition to severe bilateral visual loss in one patient. It is of note that both catastrophic relapses occurred 2 and 3 months following initiation of dimethyl fumarate.
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http://dx.doi.org/10.1177/1352458517694086DOI Listing
August 2017

Effect of Vitamin D Replacement on Cognition in Multiple Sclerosis Patients.

Sci Rep 2017 04 4;7:45926. Epub 2017 Apr 4.

American University of Beirut Medical Center, Nehme and Therese Tohme Multiple Sclerosis Center, Beirut, Lebanon.

Multiple Sclerosis is associated with deficient serum 25 hydroxyvitamin D (25 (OH)D) level and cognitive impairment. The aim of this study is to evaluate cognitive performance in MS patients with deficient 25 (OH)D (<25 ng/ml) compared to patients with sufficient levels (>35 ng/ml), then to evaluate the change in cognitive performance after 3 months of vitamin D3 oral replacement. Eighty-eight MS patients with relapsing remitting and clinically isolated type of MS, older than 18 years treated with interferon beta were enrolled. Cognitive testing was performed at baseline and at 3 months using the Montreal Cognitive Assessment (MoCA), Stroop, Symbol Digit Modalities (SDMT) and Brief Visuospatial Memory Test (BVMT-R). Serum 25 (OH)D was measured at baseline and at the end of the study. Vitamin D3 replacement improved the MS patients' cognitive performance after 3 months on the MoCA and BVMT-Delayed Recall (DR). Sufficient serum 25 (OH)D level predicted better cognitive performance on the BVMT-DR at baseline (β: 1.74, p: <0.008) and 3 months (β: 1.93, p: <0.01) after adjusting for all measured confounding variables. Vitamin D replacement could improve cognitive performance in MS patients and make a significant difference in the patient's quality of life.
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http://dx.doi.org/10.1038/srep45926DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5379671PMC
April 2017

Pregnancy and the Use of Disease-Modifying Therapies in Patients with Multiple Sclerosis: Benefits versus Risks.

Mult Scler Int 2016 18;2016:1034912. Epub 2016 Dec 18.

Department of Neurosciences, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.

The burden of multiple sclerosis (MS) in women of childbearing potential is increasing, with peak incidence around the age of 30 years, increasing incidence and prevalence, and growing female : male ratio. Guidelines recommend early use of disease-modifying therapies (DMTs), which are contraindicated or recommended with considerable caution, during pregnancy/breastfeeding. Many physicians are reluctant to prescribe them for a woman who is/is planning to be pregnant. Interferons are not absolutely contraindicated during pregnancy, since interferon- appears to lack serious adverse effects in pregnancy, despite a warning in its labelling concerning risk of spontaneous abortion. Glatiramer acetate, natalizumab, and alemtuzumab also may not induce adverse pregnancy outcomes, although natalizumab may induce haematologic abnormalities in newborns. An accelerated elimination procedure is needed for teriflunomide if pregnancy occurs on treatment or if pregnancy is planned. Current evidence supports the contraindication for fingolimod during pregnancy; data on other DMTs remains limited. Increased relapse rates following withdrawal of some DMTs in pregnancy are concerning and require further research. The postpartum period brings increased risk of disease reactivation that needs to be carefully addressed through effective communication between treating physicians and mothers intending to breastfeed. We address the potential for use of the first- and second-line DMTs in pregnancy and lactation.
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http://dx.doi.org/10.1155/2016/1034912DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5203912PMC
December 2016

Three cases of herpes zoster radiculitis in MS patients treated with natalizumab.

Mult Scler Relat Disord 2016 Sep 25;9:122-4. Epub 2016 Jul 25.

Nehme and Therese Tohme Multiple Sclerosis Center, Department of Neurology, American University of Beirut Medical Center, Beirut, Lebanon. Electronic address:

Natalizumab was the first FDA-approved monoclonal antibody for the treatment of multiple sclerosis (MS). We report on 3 natalizumab-treated patients who developed herpes zoster infections. In addition to progressive multifocal leukoencephelopathy, other opportunistic infections have been rarely reported during Natalizumab treatment. We believe that clinicians need heightened awareness of these infections in view of the risks of serious complications.
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http://dx.doi.org/10.1016/j.msard.2016.07.012DOI Listing
September 2016

Vitamin D receptor biochemical and genetic profiling and HLA-class II genotyping among Lebanese with multiple sclerosis - A pilot study.

J Neuroimmunol 2016 Apr 15;293:59-64. Epub 2016 Feb 15.

Department of Pathology and Laboratory Medicine, American University of Beirut Medical Center, Lebanon. Electronic address:

Background: Multiple sclerosis (MS) is an autoimmune demyelinating disease affecting mostly young adult females with multifactorial etiology. Recent studies suggested that adequate vitamin D levels may lower the risk of developing MS.

Objectives: Our aim was to explore the relationship between vitamin D receptor (VDR) polymorphism, HLA-DR locus genotype, and serum vitamins D and A levels in the Lebanese population.

Methods: Fifty MS patients were recruited for this study. The control group consisted of 48 healthy and 51 patients with other neurological disorders (non-MS). Biochemical analysis included serum 25 hydroxyvitamin D (25OHD) and vitamin A. Molecular analysis targeted VDR genotypes (ApaI, TaqI and BsmI) and low resolution HLA typing for DRB1 locus.

Results: Healthy and non-MS groups had comparable parameters and were combined into one control group. No significant differences were found between MS and control groups for VDR genotypes. The frequency of HLA-DRB1*15 was significantly higher in MS patients (22%) compared to controls (8%) (p=0.018). Odds ratio for MS in the presence of DRB1*15 allele was 3.21 (p=0.018). Cosegregation with A (ApaI) and b (BsmI) alleles did not influence the risk for MS. 25OHD levels were significantly higher in MS patients compared to controls (p=0.002), due to more frequent oral supplementation (p=0.005). Vitamin A levels were comparable between the two groups. When all parameters were included in a logistic regression model adjusted for supplementation, only HLA-DRB1*15 (OR=3.42; p=0.027) contributed significantly to MS risk.

Conclusion: There was no association between serum vitamin D or A or VDR genotypes and MS. HLA-DRB1*15 was the major factor imposing more than 3 folds greater risk for developing MS among Lebanese.
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http://dx.doi.org/10.1016/j.jneuroim.2016.02.008DOI Listing
April 2016

JC virus seroprevalence and seroconversion in multiple sclerosis cohort: A Middle-Eastern study.

J Neurol Sci 2016 Jan 24;360:61-5. Epub 2015 Nov 24.

Nehme and Therese Tohme MS Center, American University of Beirut Medical Center, Beirut, Lebanon.

Objectives: To estimate JCV seroprevalence and risk of seroconversion against JCV among MS patients in the Middle East.

Methods: This multicenter study was conducted by implementing a cross-sectional design to assess JCV seroprevalence, and a longitudinal design to assess the risk of JCV seroconversion. Multivariable logistic and Poisson regression analyses were used to assess the relationship between clinical variables and JCV seropositivity and risk of seroconversion.

Results: Of 581 MS patients, 64.9% patients were females. Mean age and mean disease duration were 33.9 and 8.4years respectively. JCV seroprevalence was 48.7%. Male gender (p=0.002), age at onset (p=0.001) and disease duration of 20 or more years (p=0.007) were significantly associated with JCV seropositivity. Among patients (n=125), followed longitudinally, the risk of JCV seroconversion was 17.6% (95% CI: 11.4%-25.4%) during a median follow-up of 18months. The proportion of seroreverted and pseudoconverted patients was 4% and 3.2% respectively.

Conclusions: JCV seroprevalence among MS patients in the Middle East was lower than international figures. Male gender, age at onset and disease duration were significantly associated with JCV seropositivity. Risk of JCV seroconversion was higher than previously reported figures. Observed JCV sero-reversion or pseudo-conversion entail watchful period before embarking on a clinical decision.
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http://dx.doi.org/10.1016/j.jns.2015.11.044DOI Listing
January 2016

Safety and efficacy of fingolimod in clinical practice: The experience of an academic center in the Middle East.

J Neuroimmunol 2015 Dec 26;289:93-7. Epub 2015 Oct 26.

Nehme and Therese Tohme Multiple Sclerosis Center, Department of Neurology, American University of Beirut Medical Center, Beirut, Lebanon. Electronic address:

Background: Few published studies addressed real-world clinical experience with fingolimod especially in the Middle East region.

Objective: To review our clinical experience with fingolimod at a specialized academic MS center in Lebanon.

Methods: All patients treated with fingolimod at the MS Center between October 2011 and January 2015 were retrospectively identified.

Results: A total of 122 patients were included. The first dose observation was uneventful in 98.8% of patients. Annualized relapse rate decreased from 1.16 pre-treatment to 0.29 post-treatment representing a relative risk reduction of 75% (p<0.0001). The proportion of patients with no new T2 or enhancing lesions was 66.3%. Seventy-six (62.3%) patients experienced adverse events with lymphopenia, increase liver enzymes, urinary tract infections and fatigue being the most common.

Conclusion: Our cohort confirms the effectiveness and safety of fingolimod in a real world setting.
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http://dx.doi.org/10.1016/j.jneuroim.2015.10.015DOI Listing
December 2015