Tumefactive demyelinating lesions: A literature review of recent findings.

Tumefactive demyelinating lesion is a variant of multiple sclerosis that is a diagnostic challenge. Tumefactive demyelinating lesion requires extensive work-up as its clinical and radiological features are often indistinguishable from other central nervous system lesions, such as tumors. Diagnosis is further complicated by the increasing recognition that tumefactive demyelinating lesions can occur alongside, evolve into, or develop from numerous conditions other than multiple sclerosis, pointing to a possible overlapping etiology. We review herein relevant studies from 2017 onwards to provide a current view on the pathogenesis, clinical and imaging findings, novel diagnostic techniques for differential diagnoses, and management of tumefactive demyelinating lesions.

Patterns of multiple sclerosis presentation to the emergency department.

Background: Multiple sclerosis (MS) patients are no strangers to the emergency department (ED) due to the relapsing and progressive nature of the disease and the associated complications. This study aimed to identify patterns of ED visits among patients diagnosed with MS, the underlying causes of these visits, and the factors associated with these visits. Methods: This was a single center retrospective cohort study which utilized a non-probability consecutive sampling technique to include all patients diagnosed with MS (471 patients) from March 2016 to October 2021 in King Abdulaziz Medical City, Jeddah, Saudi Arabia. ED visits were categorized as directly related to MS, indirectly related to MS, or unrelated to MS. Results: One in four people with MS visited the ED at least once with a total of 280 ED visits. Most ED visits were ones directly related to MS 43.6%, closely followed by unrelated to MS 41.1%, and then indirectly-related MS visits 15.4%. The most common presenting symptoms in directly-related MS visits were weakness 56.6% and numbness/tingling 56.6% followed by gait impairment 29.5%. Indirectly related to MS or unrelated to MS ED visits were commonly due to neurological 17.7% and gastrointestinal 17.1% causes. Using disease modifying therapy (DMT) was significantly associated with no ED visits (p < 0.001). The use of high-efficacy DMTs was significantly associated with no ED visits than using moderate efficacy DMT (p < 0.001). The use of B-cell depleting therapy (ocrelizumab and rituximab) was significantly associated with no visits to the ED than using any other DMT (p < 0.001). Evidence of brain atrophy on imaging was significantly associated with patients who presented to the ED ≥3 times (p = 0.006, UOR = 3.92). Conclusion: Due to the nature of the disease, many MS patients find themselves visiting the ED due to MS related and unrelated issues. These patients are not only required to be treated by neurologists but also by multiple disciplines. The use of high-efficacy DMTs and B-cell depleting therapy may reduce the total frequency of ED visits. Special attention should be paid to patients who have evidence of brain atrophy on imaging.

The clinical and radiological features and prevalence of Neuro-Behçet's Disease: A retrospective cohort multicenter study in Saudi Arabia.

BACKGROUND: Neuro-Behçet's disease (NBD) is defined as primary neurological involvement in patients with systemic symptoms of BD. The variety of clinical presentations seen in NBD and the long list of similar conditions make diagnosis challenging. This retrospective study aimed to estimate the prevalence and describe neurological involvement in patients with Behçet's disease who presented to King Abdulaziz Medical Cities in Jeddah and Riyadh, Saudi Arabia. METHODS: This was a retrospective, cohort study which utilized a non-probability consecutive sampling technique to include all patients diagnosed with NBD patients. All patients with BD (215) were screened for neurological symptoms. Thirty-five patients were found to be diagnosed with NBD. Outcomes were estimated using the modified Rankin scale (mRS). RESULTS: In our cohort, one in six patients with BD was diagnosed with NBD. A total of 35 patients were diagnosed with NBD (mean age 27.56 ± 10.36 years; [2.88:1; Male: Female]). The main clinical features of NBD were headaches, weakness, unsteadiness, and dysarthria. The most commonly involved sites on imaging were the brainstem, diencephalon, cerebellum and basal ganglia. Oligocolonal bands were negative in all patients. Maintenance therapy most commonly included oral corticosteroids, azathioprine, and/or infliximab. Most patients received pulse corticosteroids alone when presenting with acute relapse. Half of our cohort was asymptomatic and three in four had favorable outcomes. CONCLUSION: NBD is common among patients with BD in our population with most patients having favorable outcomes. Patients might have a wide array of symptoms which might make the diagnosis challenging.

Role of C5 inhibitors in neuromyelitis optica spectrum disorders with seropositive anti-aquaporin-4 antibody: A systematic review and meta-analysis.

BACKGROUND: Neuromyelitis optica spectrum disorder (NMOSD) is an autoimmune disorder characterized by relapses of inflammation and demyelination primarily affecting the optic nerve and the spinal cord. C5 complement inhibition is an effective therapeutic approach in the treatment of NMOSD. In this systematic review and meta-analysis, we aimed to determine the role of C5 inhibitors in the treatment of patients with seropositive anti-aquaporin-4 antibody (AQP4+IgG) NMOSD. METHODS: This systematic review follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline. Relevant articles were systematically searched through Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science databases until October 6th, 2023. We included randomized clinical trials (RCTs) that investigated the treatment with C5 inhibitors compared to placebo in patients with seropositive NMOSD. The primary endpoint was the rates of first adjudicated relapse. Secondary endpoints included different disability and quality of life measures. The random-effects model was used for all statistical analyses. RESULTS: Two RCTs with a total of 201 patients were included. C5 inhibitors demonstrated significant reduction of first adjudicated relapse (risk ratio (RR) = 0.05, 95 % CI 0.01-0.15) and Hauser Ambulation Index (HAI) (mean difference (MD): -0.79, 95 % CI -1.27 to -0.31). There was no significant difference between the two groups in Expanded Disability Status Scale (EDSS) (MD -0.23, 95 % CI -0.54-0.08). C5 inhibitors significantly improved the mean change in EQ-5D index (MD 0.08, 95 % CI 0.01-0.14; P = 0.02); however, no significant difference was shown in the mean change in EQ-5D VAS (MD 3.79, 95 % CI -1.61 to 9.19; P = 0.17). Safety measures were comparable between C5 inhibitors and placebo. CONCLUSION: NMOSD Patients with AQP4+IgG receiving C5 inhibitors have lower rate of relapses and improved levels of disability and quality of life. Real-world studies are warranted to establish the long-term safety of C5 inhibitors.

The prevalence of major depression and generalized anxiety disorder in patients with multiple sclerosis in Saudi Arabia: a cross-sectional multicentered study.

Background: Multiple sclerosis (MS) is an autoimmune disease characterized by chronic, progressive neurodegeneration of the central nervous system (CNS), and it is the most common inflammatory neurological disease affecting young adults. Given the chronic, progressive nature of the disease, psychiatric disorders are more prevalent among these patients, as reported in the literature; however, data in Saudi Arabia are limited. This study aimed to estimate the prevalence of major depression and generalized anxiety disorder in patients with MS and their association with different patient demographics. Methods: This was a cross-sectional, multicentered study that included adult patients with MS from 30 June 2021 to 30 June 2022. Participants were interviewed in person and asked to complete a survey that included general demographics, the Patient Health Questionnaire-9 (PHQ-9), and the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Other variables related to the patients' conditions, such as MS type and Expanded Disability Status Scale (EDSS) score, were collected from the patient's electronic records. Descriptive statistics were performed, and associations were made using the chi-square, Fisher's exact, and analysis of variance tests, as appropriate. Results: A total of 192 participants were included in this study. Based on a cutoff score of >10 on the GAD-7 and PHQ-9 scales, the prevalence of generalized anxiety disorder was 26.1% (50), with the majority of participants having minimal anxiety (40%); meanwhile, the prevalence of major depression was 42.7% (n = 82), and most of them had mild depression (30%). Female participants scored significantly higher compared to men on the GAD-7 scale (p = 0.0376), but not on the PHQ-9 scale (p = 0.1134). In addition, no statistically significant association was detected between functional disability (EDSS score) and prevalence of anxiety and depression. Conclusion: This study demonstrated a high prevalence of generalized anxiety disorder and major depression among patients with MS compared with that in the general population, with women being more affected. As these comorbid disorders could negatively affect the disease course, screening is of paramount significance.

Unmet Needs and Treatment of Relapsing-Remitting Multiple Sclerosis in Saudi Arabia: Focus on the Role of Ofatumumab.

Treatment-pattern data suggest that some patients with multiple sclerosis (MS) in the Kingdom of Saudi Arabia (KSA) may not be receiving optimal treatment. A virtual meeting of ten expert Saudi neurologists, held on October 23, 2020, discussed unmet needs in relapsing-remitting MS (RRMS), and the role of ofatumumab as a suitable treatment in the KSA. Multiple unmet needs were identified: poor quality of life, with high rates of depression and anxiety; a negative impact of MS on work ability; treatment choices that may compromise efficacy for safety or vice versa; inconvenient or complex dosage regimens; and limited access to patient education and support. Early use of highly effective disease-modifying treatments (DMTs) results in better patient outcomes than starting with less effective treatments and downstream escalation, but this strategy may be underutilized in the KSA. B cells are important in MS pathogenesis, and treatments targeting these may improve clinical outcomes. Ofatumumab differs from other B cell-depleting therapies, being a fully human monoclonal antibody that binds to CD20 at a completely separate site from the epitope bound by ocrelizumab, and being administered by subcutaneous injection. When compared with teriflunomide in two randomized, phase 3 clinical trials in patients with RRMS, ofatumumab was associated with significant reductions in annualized relapse rates, rates of confirmed disability worsening, and active lesions on magnetic resonance imaging. The incidence of adverse events, including serious infections, was similar with the two treatments. Ofatumumab is a valuable first- or second-line treatment option for RRMS in the KSA, particularly for patients who would benefit from highly effective DMTs early in the disease course, and for those who prefer the convenience of self-injection. Future research will clarify the position of ofatumumab in RRMS treatment, and comparative cost data may support the broad inclusion of ofatumumab in formularies across the KSA.

Saudi consensus recommendations on the management of multiple sclerosis: MS management in children and adolescents.

Multiple sclerosis (MS) most commonly presents in young adults, although 3-5% of patients develop MS prior to the age of 18 years. The new and comprehensive consensus for the management of MS in Saudi Arabia includes recommendations for the management of MS and other CNS inflammatory demyelinating disorders in pediatric and adolescent patients. This article summarizes the key recommendations for the diagnosis and management of these disorders in young patients. Pediatric and adult populations with MS differ in their presentation and clinical course. Careful differential diagnosis is important to exclude alternative diagnoses such as acute disseminated encephalomyelitis (ADEM) or neuromyelitis optica spectrum disorders (NMOSD). The diagnosis of MS in a pediatric/adolescent patient is based on the 2017 McDonald diagnostic criteria, as in adults, once the possibility of ADEM or NMOSD has been ruled out. Few data are available from randomized trials to support the use of a specific disease-modifying therapy (DMT) in this population. Interferons and glatiramer acetate are preferred initial choices for DMTs based on observational evidence, with the requirement of a switch to a more effective DMT if breakthrough MS activity occurs.

Saudi consensus recommendations on the management of Neuromyelitis Optica Spectrum Disorders (NMOSD).

This article focuses on the diagnosis and management of neuromyelitis optica spectrum disorder (NMOSD). NMOSD is an autoimmune, demyelinating condition characterized by inflammation of the optic nerve and/or the spinal cord, with symptoms that can range from mild impairment of movement to paralysis. The newly approved diagnostic criteria have improved the accuracy of NMOSD diagnosis. The management of NMOSD is under major revolution due to the many new therapeutic options. The role of the antibodies directed at aquaporin-4 (AQP4) has materialized as a biomarker for NMOSD. Several new treatments that target variable aspects in immunopathology such as IL-6, complement, or depletion of B cells are emerging. The management of AQP4-negative patients remains challenging.

Real-world effectiveness and safety profile of teriflunomide in the management of multiple sclerosis in the Gulf Cooperation Council countries: An expert consensus narrative review.

Background: The prevalence of multiple sclerosis (MS) is increasing in Gulf Cooperation Council (GCC) countries. Multiple sclerosis contributes to significant burden on patients and caregivers. The pharmacological treatment in MS involves treating acute exacerbations and preventing relapses and disability progression using disease-modifying therapies. Clinical evidence suggests that teriflunomide is one of the therapeutic choices for patients with relapsing-remitting MS (RRMS). However, genetic and cultural differences across different regions may contribute to variations in drug use. Therefore, it is necessary to consider real-world evidence for teriflunomide usage in GCC countries. Methods: An expert group for MS gathered from GCC countries in December 2020. The consensus highlighting role of teriflunomide in MS management has been developed using clinical experiences and evidence-based approach. Results: The expert-recommended patient profile for teriflunomide usage includes individuals aged 18 years and above, both men and women (on effective contraceptives) with clinically isolated syndrome or RRMS. The factors considered were cost-effectiveness of the drug, patient preference, adherence, monitoring, established safety profile, and coronavirus disease 2019 status. Conclusion: Expert recommendations based on their clinical experience will be more helpful to clinicians in clinical settings regarding the usage of teriflunomide and provide valuable insights applicable in day-to-day practice.

Prevalence of Pediatric Onset Multiple Sclerosis in Saudi Arabia.

BACKGROUND: The prevalence of multiple sclerosis (MS) appears to be increasing worldwide. However, data on the pediatric onset of MS is lacking, particularly in developing countries. OBJECTIVE: This study is aimed at reporting the current burden of the pediatric onset of MS in the five regions of Saudi Arabia. METHODS: This study used relevant data from the National Saudi MS Registry that was operational between 2015 and 2018. The data on patients with pediatric onset MS from all the hospitals included in the registry was retrospectively analyzed using the age of diagnosis. Patients who were 1-18 years old when diagnosed were included in the analysis. RESULTS: The registry included 287 patients with pediatric onset MS, with a mean age of diagnosis at 15.7 (SD: 2.06). 74.2% of the participants were females. For the included hospitals, the estimated prevalence of pediatric MS was at 2.73/100,000 pediatric Saudi population. The prevalence of pediatric MS in the remaining nonparticipant hospitals was then projected taking into account both the size of pediatric population in the Kingdom per region and the number of facilities treating and managing MS in each of the corresponding regions. The overall projected prevalence was found to be 14.33/100,000 Saudi pediatric population. CONCLUSION: To the best of our knowledge, this study reported the latest epidemiological data of pediatric onset of MS in Saudi Arabia. The current prevalence of MS among the pediatric Saudi population was found to be 2.73/100,000, and the overall projected prevalence was estimated at 14.33/100,000. Our findings were similar to those in other pediatric MS cohorts. Further studies are needed to understand the long-term prognosis, response to treatment, and disease course.

Economic Evaluation of Cladribine Tablets in Patients With High Disease Activity-Relapsing-Remitting Multiple Sclerosis in the Kingdom of Saudi Arabia.

OBJECTIVE: Cladribine tablets are the first short-course oral treatment approved for high disease activity relapsing-remitting multiple sclerosis (HDA-RRMS) across various countries. This analysis assessed the cost-effectiveness of introducing cladribine tablets as a treatment option for patients with high disease activity compared with other HDA-RRMS therapies in the Kingdom of Saudi Arabia (KSA). METHODS: The cost-effectiveness model was adapted from the KSA payer's perspective. Data for the model's adaptation were retrieved from the literature and validated by key opinion leaders. The comparators considered in the model were alemtuzumab, dimethyl fumarate, fingolimod, interferon beta-1a (subcutaneous and intramuscular) and beta-1b, natalizumab, and teriflunomide. A sensitivity analysis was also performed to assess the robustness of the analysis. RESULTS: The cost-effectiveness results showed cladribine tablets as the dominant strategy (ie, less costly and more effective) versus all the comparators. The incremental cost and quality-adjusted life-years gained were largely driven by drug acquisition cost and delayed expanded disability status scale progression, respectively. Cladribine tablets showed an 81% to 100% probability of being cost-effective at a threshold of Saudi Riyal 225 326 per quality-adjusted life-years gained against different comparators. CONCLUSIONS: Cladribine tablets are a dominant treatment option for patients with HDA-RRMS from the payer perspective in the KSA.

Managing multiple sclerosis in the Covid19 era: a review of the literature and consensus report from a panel of experts in Saudi Arabia.

Disease-modifying therapies (DMT) for relapsing-remitting MS (RRMS) act on the immune system, suggesting a need for caution during the SARS-CoV2/Covid-19 pandemic. A group of experts in MS care from Saudi Arabia convened to consider the impact of Covid-19 on MS care in that country, and to develop consensus recommendations on the current application of DMT therapy. Covid-19 has led to disruption to the care of MS in Saudi Arabia as elsewhere. The Expert Panel considered a DMT's overall tolerability/safety profile to be the most important consideration on whether or not to prescribe at this time. Treatment can be started or continued with interferon beta, teriflunomide, dimethyl fumarate, or natalizumab, as these DMTs are not associated with increased risk of infection (there was no consensus on the initiation of other DMTs). A consensus also supported continuing treatment regimens with fingolimod (or siponimod) and cladribine tablets for a patient without active Covid-19. No DMT should be imitated in a patient with active Covid-19, and (only) interferon beta could be continued in the case of Covid-19 infection. Vaccination against Covid-19 is a therapeutic priority for people with MS. New treatment should be delayed for 2-4 weeks for vaccination. Where treatment is already ongoing, vaccination against Covid-19 should be administered immediately without disruption of treatment (first-line DMTs, natalizumab, fingolimod), when lymphocytes have recovered sufficiently (cladribine tablets, alemtuzumab) or 4 months after the last dose (ocrelizumab). These recommendations will need to be refined and updated as new clinical evidence in this area emerges.

Social Anxiety and Obsessive-Compulsive Disorder Are Common Among Persons With Multiple Sclerosis at King Abdulaziz Medical City, Riyadh.

Background Multiple sclerosis (MS) is associated with a physical disability and disturbed psychosocial functioning in young people. Many psychological and psychiatric comorbidities have been reported in MS. Objective To determine the frequency of social anxiety disorder (SAD) and obsessive-compulsive disorder (OCD) among MS patients and their relation to MS severity. Methods A cross-sectional survey was conducted in an adult MS cohort. Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) and Social Phobia Inventory (SPIN) were used to determine the presence and severity of OCD and SAD. The Statistical Package for the Social Sciences (SPSS) version 22 (IBM Corp., Armonk, NY) was used for statistical analysis. The Mann-Whitney U test and logistic regression were used to assess the association of the two diseases with the severity of MS. Results A total of 145 persons with MS (pwMS) were studied. The mean age was 33.5 (±8.5) years; the mean duration of MS was 7.2 (± 5.1) years. The majority (74.1%) were women; 57.3% were married; 63% had a college education; 50% belonged to the higher middle-class socioeconomic strata. Relapsing-remitting multiple sclerosis was the most common type of MS (92.2%). The mean Expanded Disability Status Scale (EDSS) score was 2.24 (±2.19). SAD was reported by 26.9%, and OCD was reported by 31% of the cohort. PwMS with walking difficulty but not wheelchair-bound had a statistically significant increased risk of SAD (p = 0.036). There was no direct association between MS-related disability and OCD. However, pwMS with SAD were more likely to have concomitant OCD (t=4.68, p-value <0.001, 95% CI: 0.47-1.16). Increasing disability was associated with higher chances of developing social anxiety and, in turn, OCD (t=3.39, p-value <0.001, 95% CI: 0.66-2.52). Conclusions Social anxiety and obsessive-compulsive disorders were present in nearly one-third of pwMS. Impaired walking but not wheelchair dependence was associated with social anxiety. PwMS with SAD were more likely to have obsessive-compulsive disorder.

Family Planning for People with Multiple Sclerosis in Saudi Arabia: an Expert Consensus.

More than half of all patients with multiple sclerosis (MS) in the Kingdom of Saudi Arabia (KSA) are women of childbearing age. Raising a family is an important life goal for women in our region of the world. However, fears and misconceptions about the clinical course of relapsing-remitting MS (RRMS) and the effects of disease-modifying drugs (DMDs) on the foetus have led many women to reduce their expectations of raising a family, sometimes even to the point of avoiding pregnancy altogether. The increase in the number of DMDs available to manage RRMS and recent studies on their effects in pregnancy have broadened management options for these women. Interferon beta now has an indication in Europe for use during pregnancy (according to clinical need) and can be used during breastfeeding. Glatiramer acetate is a further possible option for women with lower levels of RRMS disease activity who are, or about to become, pregnant; natalizumab may be used up to 30 weeks in patients with higher levels of disease activity. Where possible, physicians need to support and encourage women to pursue their dream of a fulfilling family life, supported where necessary by active interventions for RRMS that are increasingly evidence based.

Acute Brucellosis with a Guillain-Barre Syndrome-Like Presentation: A Case Report and Literature Review.

INTRODUCTION: Brucellosis is a zoonotic disease that can affect the central and peripheral nervous system and it has variable neurological manifestation. However, brucellosis infection that presents with acute peripheral neuropathy mimicking Guillain-Barre syndrome (GBS) is rarely reported in the literature. OBJECTIVE AND METHOD: We report a 56-year-old man who was initially diagnosed with GBS, and then he was confirmed to have acute Brucella infection. We also did a systematic literature review to study the natural history and management of previously reported cases of brucellosis that presented with manifestations consistent with GBS. RESULTS: We found 19 (including our patient) cases of brucellosis that presented with GBS-like manifestations. The age range was 9-62 years. Eight (42.1%) patients had a history of fever. Seven (36.8%) patients had no constitutional symptoms. Five (26.3%) patients had splenomegaly. Brucella serological tests were positive in all patients, while blood Brucella culture was positive in three (37.5%) out of eight patients. Albuminocytological dissociation was present in nine (64.3%) out of 14 patients. Nerve conduction studies and electromyography were consistent with demyelination polyneuropathy in eight (42.1%) patients, with axonal polyneuropathy in six (31.6) patients, and with mixed axonal and demyelinating polyneuropathy in one (5.3%) patient. Spine MRI showed root enhancement in three (42.9%) patients. CONCLUSION: In regions endemic with brucellosis, acute peripheral neuropathy presentation may warrant investigations for Brucella infection.

Patterns and Outcomes of Complementary and Alternative Medicine Use Among Adult Patients With Multiple Sclerosis.

Multiple sclerosis (MS) is a chronic autoimmune disease that causes demyelination of the central nervous system. No treatment has been shown to be curative; thus, we assume that the tendency for patients with MS to use unconventional therapies, such as complementary and alternative medicine (CAM), might increase. The aim of this study was to explore the pattern of CAM use among patients with MS at a tertiary health care center in Saudi Arabia (SA). This was a questionnaire-based observational cross-sectional study that targeted adult patients diagnosed with MS at King Abdulaziz Medical City in Riyadh, SA, from 2018 to 2019. The sample size included 176 patients, and a consecutive non-probability sampling technique was used to engage them during their appointments. An Arabic questionnaire was used to evaluate patients' use of CAM. The mean age of participants was 34.6 ± 10.9 years, females represented the majority 125 (71%) of participants, and 89% of the participants reported using CAM at least once, with one or more modalities being used. Prayer, Salat, was the most frequent modality (60%) followed by supplication, Dua'a (59%), Ruqia, reciting Holy Quran (52%), and vitamins (44%). Symptomatic improvement was reported by 49 (27.8%) of dietary supplement users and 81 (46%) of non-dietary supplement medicine users. The study found a high prevalence of CAM utilization among Saudi adult patients with MS, which exceeded internationally reported rates. Although some patients described some improvement in their symptoms, further research is needed to evaluate the effectiveness of CAM.

Familial aggregation of multiple sclerosis: Results from the national registry of the disease in Saudi Arabia.

BACKGROUND: Multiple Sclerosis (MS) is a chronic CNS inflammatory disease commonly affecting young adults. Both genetics and environmental factors have been reported to have a role in pathophysiology of the disease. OBJECTIVE: This article aims to report familial nature and aspects of MS in Saudi Arabia. METHOD: The study utilized data collected by the National Saudi MS Registry between 2015 and 2018; especially data relevant to the familial history of MS. SPSS 22 was used for all analysis and reporting. Statistical significance was set at p-value < 0.05. RESULTS: The registry included 20 hospitals and a total of 2516 patients from the different regions of Saudi Arabia with median age 32.00 (Range: 11-63) and 66.5% being female. About 12.8% of all registered patients reported a family history of MS (95%CI: 11.2-13.9). Reported parental consanguinity was significantly higher among patients with family history (FMS) (56.3%) compared to non-FMS patients (27.9%). 42.53% of FMS patients reported having siblings affected with MS (95%CI: 37.01-48.21), with more female siblings affected than males (63.4% vs 36.6% respectively). CONCLUSION: Our Findings suggested that FMS was less prevalent than what was reported previously; however, parental consanguinity was significantly more prevalent among FMS patients than non-FMS. Our findings were in line with those reported in recent studies in the region, but lower than those reported by western countries indicating that increasing prevalence of MS in Saudi Arabia could be multifactorial and other environmental factors should be considered for understanding this recent rise in the prevalence of MS in Saudi Arabia.

Long-term efficacy and safety of alemtuzumab in patients with RRMS: 12-year follow-up of CAMMS223.

BACKGROUND: In the phase 2 CAMMS223 trial (NCT00050778), alemtuzumab significantly improved clinical and MRI outcomes versus subcutaneous interferon beta-1a over 3 years in treatment-naive patients with relapsing-remitting MS. Here, we assess efficacy and safety of alemtuzumab over 12 years in CAMMS223 patients who enrolled in the CAMMS03409 extension (NCT00930553), with available follow-up through the subsequent TOPAZ extension (NCT02255656). METHODS: In CAMMS223, patients received 2 alemtuzumab courses (12 mg/day; baseline: 5 days; 12 months later: 3 days); 22% received a third course. In the open-label, nonrandomized extensions, patients could receive as-needed additional alemtuzumab or other disease-modifying therapies. RESULTS: Of 108 alemtuzumab-treated patients in CAMMS223, 60 entered the CAMMS03409 extension; 33% received a total of 2 alemtuzumab courses, and 73% received no more than 3 courses through Year 12. Over 12 years, annualized relapse rate was 0.09, 71% of patients had stable or improved Expanded Disability Status Scale scores, and 69% were free of 6-month confirmed disability worsening. In Year 12, 73% of patients were free of MRI disease activity. Cumulatively throughout the extensions (Years 7-12), 34% of patients had no evidence of disease activity. Adverse event (AE) incidence declined through Year 12. Infusion-associated reactions peaked at first course and declined thereafter. Cumulative thyroid AE incidence was 50%; one immune thrombocytopenia event occurred, and there were no autoimmune nephropathy cases. CONCLUSIONS: Alemtuzumab efficacy was maintained over 12 years in CAMMS223 patients, with 73% receiving no more than three courses. The safety profile in this cohort was consistent with other alemtuzumab clinical trials.

Alemtuzumab-induced simultaneous onset of autoimmune haemolytic anaemia, alveolar haemorrhage, nephropathy, and stroke: A case report.

BACKGROUND: Alemtuzumab is a humanized anti-CD 52 monoclonal antibody approved as a disease-modifying therapy for active relapsing-remitting Multiple Sclerosis (MS). Alemtuzumab has been associated with several adverse effects, including infusion-associated reactions, infections, acquired autoimmune diseases, and malignancies. CASE PRESENTATION: We report a case of Alemtuzumab-induced simultaneous onset of autoimmune haemolytic anaemia, alveolar haemorrhage, nephropathy and stroke in a 52-year-old man that occurred 8 months after initiation of alemtuzumab. The laboratory testing was consistent with autoimmune haemolytic anaemia. Computed tomography of the chest and bronchoscopy revealed an alveolar haemorrhage. Stroke workup revealed acute infarcts in bilateral occipital territories. CONCLUSION: This is the first case report of a simultaneous onset of autoimmune haemolytic anaemia, alveolar haemorrhage, nephropathy, and ischaemic stroke after the first alemtuzumab course in relapsing-remitting MS patient. This case highlights the potential for the co-occurrence of unexpected and potentially life-threatening complications of alemtuzumab therapy necessitating rigorous monitoring once prescribed.