Utilization of Multiple Sclerosis Therapies in the Middle East Over a Decade: 2009–2018

Moradi, Nahid; Sharmin, Sifat; Malpas, Charles B; Özakbaş, Serkan; Shaygannejad, Vahid; Terzı, Murat; Boz, Cavit; Yamout, Bassem; Türkoğlu, Recai; Karabudak, Rana; Hamdy, Sherif; Soysal, Aysun; Altıntaş, Ayşe; Inshasi, Jihad; Al-Harbi, Talal; Alroughani, Raed; Kalinčík, Tomáš

doi:10.1007/s40263-021-00833-w

Cited by 8 publications

(12 citation statements)

References 40 publications

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“…Yet, a well-equipped MS care unit should be able to administer all DMTs and manage all side effects according to the ECTRIMS/EAN guideline [ 17 , 18 ]. Unlike in other countries, where not every DMT is available or funded by the health insurance, contributing to inequality [ 24 , 25 ], in Hungary all therapeutic options are funded by the NHIF, thus appropriate treatment of people with MS should be achievable, if adaptation to the latest guidelines came to fruition. The need for adaptation of the therapeutic guidelines was affirmed by other papers as well [ 26 , 27 ].…”

Section: Discussionmentioning

confidence: 99%

Do Hungarian multiple sclerosis care units fulfil international criteria?

et al. 2022

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A patients Because of the past 3 decades’ extensive research, several disease modifying therapies became available, thus a paradigm change is multiple sclerosis care was necessary. In 2018 a therapeutic guideline was created recommending that treatment of persons with multiple sclerosis should take place in specified care units where the entire spectrum of disease modifying therapies is available, patient monitoring is ensured, and therapy side effects are detected and treated promptly. In 2019 multiple sclerosis care unit criteria were developed, emphasizing personnel and instrumental requirements to provide most professional care. However, no survey was conducted assessing the real-world adaptation of these criteria. Objective To assess whether Hungarian care units fulfil international criteria. Methods A self-report questionnaire was assembled based on international guidelines and sent to Hungarian care units focusing on 3 main aspects: personnel and instrumental background, disease-modifying therapy use, number of people living with multiple sclerosis receiving care in care units. Data on number of persons with multiple sclerosis were compared to Hungarian prevalence estimates. Descriptive statistics were used to analyse data. Results Out of 27 respondent care units, 3 fulfilled minimum requirements and 7 fulfilled minimum and recommended requirements. The least prevalent neighbouring specialties were spasticity and pain specialist, and neuro-ophthalmologist and oto-neurologist. Only 15 centres used all available disease modifying therapies. A total number of 7213 people with multiple sclerosis received care in 27 respondent centres. Compared to prevalence estimates, 2500 persons with multiple sclerosis did not receive multiple sclerosis specific care in Hungary. Conclusion Less than half of Hungarian care units provided sufficient care for people living with multiple sclerosis. Care units employing fewer neighbouring specialties, might have difficulties diagnosing and providing appropriate care for persons with multiple sclerosis, especially for people with progressive disease course, contributing to the reported low number of persons living with multiple sclerosis.

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Section: Discussionmentioning

confidence: 99%

Do Hungarian multiple sclerosis care units fulfil international criteria?

et al. 2022

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“…Real-world clinical data have shown that initial use of highly effective DMTs (i.e., fingolimod, alemtuzumab, or natalizumab) significantly delayed the progression to secondary progressive MS compared with less effective agents (i.e., glatiramer acetate or interferon-β) [ 30 ]. The high use of these less effective DMTs in the KSA [ 10 ] suggests that the optimal treatment strategy is underutilized.…”

Section: Treatment Considerationsmentioning

confidence: 99%

“…Estimates indicate that approximately 74% of MS patients in the Middle East and 65–75% of MS patients in the KSA have RRMS [ 7 – 9 ]. In 2017–2018, the estimated annualized relapse rate (ARR) in the KSA was 0.70 [ 10 ].…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2022

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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.

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“…22 In the present study, we aimed to externally validate the original predictive model of DMT response ('Crystal Ball 1.2') 22 using a unique, non-overlapping Middle Eastern cohort from the MSBase. 23 The Middle Eastern cohort is geographically distinct from the cohort previously used in the development of this tool, with characteristics and treatment patterns that are different from a typical Western cohort. 23 Thus, this validation aims to establish the generalisability of the model to a new geographic area with differing clinical practices and different utilisation of DMTs.…”

Section: External Validation Of a Clinical Prediction Model In Multip...mentioning

confidence: 99%

“…23 The Middle Eastern cohort is geographically distinct from the cohort previously used in the development of this tool, with characteristics and treatment patterns that are different from a typical Western cohort. 23 Thus, this validation aims to establish the generalisability of the model to a new geographic area with differing clinical practices and different utilisation of DMTs.…”

Section: Introductionmentioning

confidence: 99%

External validation of a clinical prediction model in multiple sclerosis

et al. 2022

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Background: Timely initiation of disease modifying therapy is crucial for managing multiple sclerosis (MS). Objective: We aimed to validate a previously published predictive model of individual treatment response using a non-overlapping cohort from the Middle East. Methods: We interrogated the MSBase registry for patients who were not included in the initial model development. These patients had relapsing MS or clinically isolated syndrome, a recorded date of disease onset, disability and dates of disease modifying therapy, with sufficient follow-up pre- and post-baseline. Baseline was the visit at which a new disease modifying therapy was initiated, and which served as the start of the predicted period. The original models were used to translate clinical information into three principal components and to predict probability of relapses, disability worsening or improvement, conversion to secondary progressive MS and treatment discontinuation as well as changes in the area under disability-time curve (ΔAUC). Prediction accuracy was assessed using the criteria published previously. Results: The models performed well for predicting the risk of disability worsening and improvement (accuracy: 81%–96%) and performed moderately well for predicting the risk of relapses (accuracy: 73%–91%). The predictions for ΔAUC and risk of treatment discontinuation were suboptimal (accuracy < 44%). Accuracy for predicting the risk of conversion to secondary progressive MS ranged from 50% to 98%. Conclusion: The previously published models are generalisable to patients with a broad range of baseline characteristics in different geographic regions.

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Utilization of Multiple Sclerosis Therapies in the Middle East Over a Decade: 2009–2018

Cited by 8 publications

References 40 publications

Do Hungarian multiple sclerosis care units fulfil international criteria?

Do Hungarian multiple sclerosis care units fulfil international criteria?

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

External validation of a clinical prediction model in multiple sclerosis

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