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1.
Mult Scler ; 30(10): 1350-1362, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-39240089

RESUMO

BACKGROUND: The impact of teleneurology on healthcare utilization (HCU) in MS is unknown. OBJECTIVE: Evaluate the association between teleneurology and HCU. METHODS: A retrospective longitudinal analysis of HCU among adult MS and clinically isolated syndrome (CIS) patients residing in the Cleveland/Akron area from July 2020 to July 2022. Negative binomial regression models evaluated the association between number of laboratory and MRI orders per visit and number of emergency visits per patient across patient groups with variable proportions of teleneurology visits. RESULTS: A total of 3208 patients completed 15,795 visits. Patients using teleneurology had more visits (rate ratio (RR) 1.707-1.719, p < 0.001). Teleneurology visits had fewer laboratory (RR 0.571) and MRI orders (RR 0.693, p < 0.001). There was no difference in emergency care utilization for teleneurology patients (p ⩾ 0.05). More emergency visits were observed in Black (RR 1.414) and Medicaid (RR 1.893) patients, regardless of visit type (p < 0.001). CONCLUSION: Teleneurology visits were associated with fewer orders, suggesting teleneurology may be incorporated into healthcare models without increasing utilization related to the visit. Teleneurology was also associated with increased visit volumes but no difference in emergency HCU. More studies are needed to clarify the ultimate impact of teleneurology on overall HCU. More emergency visits, regardless of visit type, were observed among at-risk populations, warranting further investigation.


Assuntos
Aceitação pelo Paciente de Cuidados de Saúde , Telemedicina , Humanos , Feminino , Masculino , Adulto , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Pessoa de Meia-Idade , Estudos Retrospectivos , Telemedicina/estatística & dados numéricos , Telemedicina/tendências , Estudos Longitudinais , Neurologia/tendências , Neurologia/estatística & dados numéricos
2.
Eur J Neurol ; 30(10): 3221-3227, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-37350150

RESUMO

BACKGROUND AND PURPOSE: Little is known about risk factors for developing neurological immunological adverse events (neuro-irAEs) from immune checkpoint inhibitors (ICIs). We report the incidence, predictors for development, impact on mortality of neuro-irAEs, and impact of ICIs on pre-existing neurological conditions in a large clinical cohort. METHODS: Patients who received ICIs between January 2011 and December 2018 were identified from a tertiary cancer center registry. Descriptive statistics were used to summarize patient, cancer, and treatment data. Odds ratios from univariable and multivariable logistic regression models were calculated to identify potential predictors for developing a neuro-irAE. Impact of neuro-irAEs on overall survival was estimated by Kaplan-Meier and Cox proportional hazard models. RESULTS: Overall frequency of neurological irAEs was 2.3%. Peripheral nervous system complications were most frequent (53.6%). Melanoma, younger age, prior chemotherapy, prior resection, CTLA-4 ICIs exposure, and combination PD-1 and CTLA-4 ICIs exposure had significantly higher odds for developing a neuro-irAE (p < 0.05) in univariate but not multivariate models. Those with a neuro-irAE were less likely to die at 3 years compared to those without a neuro-irAE (69% vs. 55%, p = 0.004) in univariate but not multivariate model. Flare of pre-existing neurological condition after exposure to ICIs was present (15.4%, 2 of 13 patients) but manageable. One patient was rechallenged with ICIs without recurrent flare. CONCLUSIONS: Neuro-irAEs are not associated with increase in overall mortality. Potential predictors for the development of neuro-irAEs are younger age, melanoma, prior chemotherapy and resection, CTLA-4, or combination ICIs exposure.


Assuntos
Antineoplásicos Imunológicos , Melanoma , Neurologia , Humanos , Inibidores de Checkpoint Imunológico/efeitos adversos , Antígeno CTLA-4 , Antineoplásicos Imunológicos/efeitos adversos , Melanoma/tratamento farmacológico , Melanoma/induzido quimicamente , Estudos Retrospectivos
3.
Lancet ; 398(10306): 1184-1194, 2021 09 25.
Artigo em Inglês | MEDLINE | ID: mdl-34175020

RESUMO

The sphingosine 1-phosphate (S1P) signalling pathways have important and diverse functions. S1P receptors (S1PRs) have been proposed as a therapeutic target for various diseases due to their involvement in regulation of lymphocyte trafficking, brain and cardiac function, vascular permeability, and vascular and bronchial tone. S1PR modulators were first developed to prevent rejection by the immune system following renal transplantation, but the only currently approved indication is multiple sclerosis. The primary mechanism of action of S1PR modulators in multiple sclerosis is through binding S1PR subtype 1 on lymphocytes resulting in internalisation of the receptor and loss of responsiveness to the S1P gradient that drives lymphocyte egress from lymph nodes. The reduction in circulating lymphocytes presumably limits inflammatory cell migration into the CNS. Four S1PR modulators (fingolimod, siponimod, ozanimod, and ponesimod) have regulatory approval for multiple sclerosis. Preclinical evidence and ongoing and completed clinical trials support development of S1PR modulators for other therapeutic indications.


Assuntos
Ensaios Clínicos como Assunto , Esclerose Múltipla/tratamento farmacológico , Moduladores do Receptor de Esfingosina 1 Fosfato/farmacologia , Moduladores do Receptor de Esfingosina 1 Fosfato/uso terapêutico , Receptores de Esfingosina-1-Fosfato , Animais , Azetidinas/farmacologia , Azetidinas/uso terapêutico , Compostos de Benzil/farmacologia , Compostos de Benzil/uso terapêutico , Cloridrato de Fingolimode/farmacologia , Cloridrato de Fingolimode/uso terapêutico , Humanos , Doenças do Sistema Imunitário/tratamento farmacológico , Indanos/farmacologia , Indanos/uso terapêutico , Doenças do Sistema Nervoso/tratamento farmacológico , Oxidiazóis/farmacologia , Oxidiazóis/uso terapêutico , Transdução de Sinais/efeitos dos fármacos , Moduladores do Receptor de Esfingosina 1 Fosfato/classificação , Tiazóis/farmacologia , Tiazóis/uso terapêutico
4.
JAMA ; 325(8): 765-779, 2021 02 23.
Artigo em Inglês | MEDLINE | ID: mdl-33620411

RESUMO

Importance: Multiple sclerosis (MS) is an autoimmune-mediated neurodegenerative disease of the central nervous system characterized by inflammatory demyelination with axonal transection. MS affects an estimated 900 000 people in the US. MS typically presents in young adults (mean age of onset, 20-30 years) and can lead to physical disability, cognitive impairment, and decreased quality of life. This review summarizes current evidence regarding diagnosis and treatment of MS. Observations: MS typically presents in young adults aged 20 to 30 years with unilateral optic neuritis, partial myelitis, sensory disturbances, or brainstem syndromes such as internuclear ophthalmoplegia developing over several days. The prevalence of MS worldwide ranges from 5 to 300 per 100 000 people and increases at higher latitudes. Overall life expectancy is less than in the general population (75.9 vs 83.4 years), and MS more commonly affects women (female to male sex distribution of nearly 3:1). Diagnosis is made based on a combination of signs and symptoms, radiographic findings (eg, magnetic resonance imaging [MRI] T2 lesions), and laboratory findings (eg, cerebrospinal fluid-specific oligoclonal bands), which are components of the 2017 McDonald Criteria. Nine classes of disease-modifying therapies (DMTs), with varying mechanisms of action and routes of administration, are available for relapsing-remitting MS, defined as relapses at onset with stable neurologic disability between episodes, and secondary progressive MS with activity, defined as steadily increasing neurologic disability following a relapsing course with evidence of ongoing inflammatory activity. These drugs include interferons, glatiramer acetate, teriflunomide, sphingosine 1-phosphate receptor modulators, fumarates, cladribine, and 3 types of monoclonal antibodies. One additional DMT, ocrelizumab, is approved for primary progressive MS. These DMTs reduce clinical relapses and MRI lesions (new T2 lesions, gadolinium-enhancing lesions). Efficacy rates of current DMTs, defined by reduction in annualized relapse rates compared with placebo or active comparators, range from 29%-68%. Adverse effects include infections, bradycardia, heart blocks, macular edema, infusion reactions, injection-site reactions, and secondary autoimmune adverse effects, such as autoimmune thyroid disease. Conclusions and Relevance: MS is characterized by physical disability, cognitive impairment, and other symptoms that affect quality of life. Treatment with DMT can reduce the annual relapse rate by 29% to 68% compared with placebo or active comparator.


Assuntos
Imunossupressores/uso terapêutico , Esclerose Múltipla/diagnóstico , Esclerose Múltipla/tratamento farmacológico , Sistema Nervoso Central/diagnóstico por imagem , Sistema Nervoso Central/patologia , Transtornos Cognitivos/etiologia , Progressão da Doença , Fadiga/etiologia , Feminino , Humanos , Imageamento por Ressonância Magnética , Esclerose Múltipla/complicações , Esclerose Múltipla/fisiopatologia , Gravidez , Qualidade de Vida
5.
Telemed J E Health ; 27(3): 323-329, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-32584654

RESUMO

Background: Teleneurology has been well described for acute stroke, but outpatient use has been limited. At home, virtual visits have the potential to improve access to neurological care. Introduction: This study reports on the use of a personal device videoconferencing platform for outpatient neurologic follow-up visits. Materials and Methods: This is a cross-sectional study that identified all virtual neurologic follow-up visits completed by patients ≥18 years at a single institution over 4 years. Virtual visits were conducted by personal smartphone or computer via videoconferencing with a provider. Patients were asked to rate their overall experience with the visit and provider (five-point scale). Travel distance from the institution was calculated using patient's home addresses. Results: Three thousand nine hundred thirteen patients completed 5,581 virtual visits during the study (mean age 49.4 ± 17.0 years, 58.7% female). Number of virtual visits increased from 30 in year 1 to 4,468 in year 4. Virtual visits were completed in all outpatient neurologic subspecialties. A total of 30.1% of patients were local (<50 miles), 25.9% were near regional (50-150 miles), 21.7% were far regional (151-270 miles), and 22.2% were remote (>270 miles). A distance of 1,327,128 miles of travel was prevented across the 5,581 visits. On average, patients rated their overall virtual visit experience 4.7/5 ± 0.89 and rated their provider 4.9/5 ± 0.48. Discussion: Virtual visits prevented a substantial amount of travel and resulted in high patient satisfaction. The sizable proportion of local patients may indicate that teleneurology provides important access for reasons beyond travel distance. Conclusion: This study demonstrates the feasibility of implementing outpatient teleneurology services.


Assuntos
Pacientes Ambulatoriais , Telemedicina , Adulto , Idoso , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados da Assistência ao Paciente , Satisfação do Paciente , Comunicação por Videoconferência
6.
Mult Scler ; 26(12): 1581-1589, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-31368401

RESUMO

BACKGROUND: Therapeutic research in multiple sclerosis (MS) has focused on the development of treatments with little investigation regarding the possibility of discontinuation of disease-modifying therapies (DMTs). OBJECTIVE: To understand the opinion of individuals with MS concerning stopping DMTs and the factors that influence the decision-making process. METHODS: A mixed method approach was used starting with three focus groups from which a survey was developed. This survey was sent to 1000 participants in the North American Research Committee on Multiple Sclerosis registry who met inclusion criteria (age ⩾45 years; on most recent DMT for ⩾5 years). Descriptive analysis and structural equation modeling were used. RESULTS: Of 1000 participants receiving the survey, 377 provided complete responses and met inclusion criteria. Only 11.9% of participants reported that if their disease was considered stable, they would consider coming off medications. A high level of external locus of control in influential others such as physicians significantly decreased the likelihood of considering discontinuation. CONCLUSIONS: Most individuals with MS report being unlikely to consider stopping MS therapy if their disease was considered "non-active." As the results of studies concerning DMT discontinuation are obtained, information from providers will be an important part of individuals' decision-making process.


Assuntos
Esclerose Múltipla , Humanos , Esclerose Múltipla/tratamento farmacológico , Inquéritos e Questionários
7.
Mult Scler ; 26(10): 1163-1171, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32772807

RESUMO

BACKGROUND: People with multiple sclerosis (MS) may be at higher risk for complications from the 2019 coronavirus (COVID-19) pandemic due to use of immunomodulatory disease modifying therapies (DMTs) and greater need for medical services. OBJECTIVES: To evaluate risk factors for COVID-19 susceptibility and describe the pandemic's impact on healthcare delivery. METHODS: Surveys sent to MS patients at Cleveland Clinic, Johns Hopkins, and Vall d'Hebron-Centre d'Esclerosi Múltiple de Catalunya in April and May 2020 collected information about comorbidities, DMTs, exposures, COVID-19 testing/outcomes, health behaviors, and disruptions to MS care. RESULTS: There were 3028/10,816 responders. Suspected or confirmed COVID-19 cases were more likely to have a known COVID-19 contact (odds ratio (OR): 4.38; 95% confidence interval (CI): 1.04, 18.54). In multivariable-adjusted models, people who were younger, had to work on site, had a lower education level, and resided in socioeconomically disadvantaged areas were less likely to follow social distancing guidelines. 4.4% reported changes to therapy plans, primarily delays in infusions, and 15.5% a disruption to rehabilitative services. CONCLUSION: Younger people with lower socioeconomic status required to work on site may be at higher exposure risk and are potential targets for educational intervention and work restrictions to limit exposure. Providers should be mindful of potential infusion delays and MS care disruption.


Assuntos
Infecções por Coronavirus/epidemiologia , Emprego , Fatores Imunológicos/uso terapêutico , Esclerose Múltipla/terapia , Terapia Ocupacional , Modalidades de Fisioterapia , Pneumonia Viral/epidemiologia , Classe Social , Adulto , Fatores Etários , Betacoronavirus , COVID-19 , Comorbidade , Infecções por Coronavirus/prevenção & controle , Atenção à Saúde , Gerenciamento Clínico , Suscetibilidade a Doenças , Escolaridade , Feminino , Comportamentos Relacionados com a Saúde , Acessibilidade aos Serviços de Saúde , Terapia por Infusões no Domicílio , Humanos , Hipertensão/epidemiologia , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Obesidade/epidemiologia , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Fatores de Risco , SARS-CoV-2 , Espanha/epidemiologia , Estados Unidos/epidemiologia
8.
Epilepsia ; 61(8): e95-e100, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32697361

RESUMO

We describe the largest-to-date single-center implementation of tele-epilepsy. Beginning in 2017, all patients at a single tertiary care academic epilepsy center were offered the option to complete outpatient follow-up visits via video-conferencing using personal devices. A retrospective review of all patients who self-selected virtual visits over nearly 3 years showed 2140 patients completed 3698 tele-epilepsy visits, with 41% completing more than one visit during the study period. Based on the distance from the center to the home address, 26.7% of patients were local (≤50 miles), 30.5% were near regional (51-150 miles), 20.1% were far regional (151-270 miles), and 22.7% were remote (>270 miles), from 43 different states. An estimated 928 696 miles of travel was prevented, with a median travel distance saved of 124.5 miles (interquartile range = 45.0-253.0). The mean visit time was 15.7 (±10.4) minutes. More than 90% of patients gave the visit and provider experience the maximum rating, with a nearly 60% response rate on the post-visit survey. Virtual outpatient follow-up care provides a convenient way to connect with epilepsy specialists and reduce the burden of care by cutting travel time. Our experience demonstrates that outpatient tele-epilepsy is feasible, sustainable, and scalable.


Assuntos
Epilepsia/terapia , Neurologia , Preferência do Paciente , Satisfação do Paciente , Telemedicina/estatística & dados numéricos , Viagem/estatística & dados numéricos , Comunicação por Videoconferência , Centros Médicos Acadêmicos , Adolescente , Adulto , Assistência ao Convalescente , Assistência Ambulatorial , Criança , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Estudos Retrospectivos , Centros de Atenção Terciária , Fatores de Tempo , Adulto Jovem
9.
Telemed J E Health ; 26(12): 1537-1539, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-32552509

RESUMO

Background: The coronavirus disease of 2019 (COVID-19) pandemic and the need for social distancing have dramatically changed health care delivery. There is an urgent need to continue to deliver outpatient care for chronic neurological disease and teleneurology has the potential to fulfill this gap. Introduction: This study reports the implementation and utilization of teleneurology across all neurological subspecilities during the COVID-19 pandemic. Materials and Methods: This is a retrospective observational study that identified all in-person and teleneurology outpatient nonprocedural visits from January 5 to April 4, 2020, across neurological specialties at a single academic center. Visit volumes were assessed weekly and practice patterns were compared before and after March 15, 2020, as this was the date of a major statewide stay-at-home order in Ohio. Results: Before March 15 the mean in-person visit per week was 5129.4 and decreased to 866.7 after that date. The mean teleneurology visits per week increased from 209.1 to 2619.3 for the same time period. The overall teleneurology visit volume in the 3 weeks after March 15 increased by 533%. Discussion: In a relatively short time frame of 3 weeks, a single academic center was able to dramatically increase teleneurology visits to provide outpatient neurological care. Conclusions: This study demonostrates that teleneruology can be a solution for outpatient neurological care in the context of COVID-19. The increased utilization of teleneurology during this crisis has the potential to expand teleneurology and improve access to neurological care in the future outside the pandemic setting.


Assuntos
Assistência Ambulatorial/organização & administração , COVID-19/epidemiologia , Doenças do Sistema Nervoso/diagnóstico , Doenças do Sistema Nervoso/terapia , Pandemias , População Rural/estatística & dados numéricos , Telemedicina/métodos , Telemedicina/estatística & dados numéricos , Assistência Ambulatorial/estatística & dados numéricos , Humanos , Ohio/epidemiologia , Estudos Retrospectivos , SARS-CoV-2
15.
Neurology ; 102(2): e207916, 2024 Jan 23.
Artigo em Inglês | MEDLINE | ID: mdl-38165332

RESUMO

BACKGROUND AND OBJECTIVES: A shortage of neurology clinicians and healthcare disparities may hinder access to neurologic care. This study examined disparities in geographic access to neurologists and subspecialty multiple sclerosis (MS) care among various demographic segments of the United States. METHODS: Neurologist practice locations from 2022 CMS Care Compare physician data and MS Center locations as defined by the Consortium of Multiple Sclerosis Centers were used to compute spatial access for all U.S. census tracts. Census tract-level community characteristics (sex, age, race, ethnicity, education, income, insurance, % with computer, % without a vehicle, % with limited English, and % with hearing, vision, cognitive, and ambulatory difficulty) were obtained from 2020 American Community Survey 5-year estimates. Rural-urban status was obtained from 2010 rural-urban commuting area codes. Logistic and linear regression models were used to examine access to a neurologist or MS Center within 60 miles and 60-mile spatial access ratios. RESULTS: Of 70,858 census tracts, 388 had no neurologists within 60 miles and 17,837 had no MS centers within 60 miles. Geographic access to neurologists (spatial access ratio [99% CI]) was lower for rural (-80.49%; CI [-81.65 to -79.30]) and micropolitan (-60.50%; CI [-62.40 to -58.51]) areas compared with metropolitan areas. Tracts with 10% greater percentage of Hispanic individuals (-4.53%; CI [-5.23 to -3.83]), men (-6.76%; CI [-8.96 to -4.5]), uninsured (-7.99%; CI [-9.72 to -6.21]), individuals with hearing difficulty (-40.72%; CI [-44.62 to -36.54]), vision difficulty (-13.0%; [-18.72 to -6.89]), and ambulatory difficulty (-15.68%; CI [-19.25 to -11.95]) had lower access to neurologists. Census tracts with 10% greater Black individuals (3.50%; CI [2.93-10.71]), college degree holders (-7.49%; CI [6.67-8.32]), individuals with computers (16.57%, CI [13.82-19.40]), individuals without a vehicle (9.57%; CI [8.69-10.47]), individuals with cognitive difficulty (25.63%; CI [19.77-31.78]), and individuals with limited English (18.5%; CI [16.30-20.73]), and 10-year older individuals (8.85%; CI [7.03-10.71]) had higher spatial access to neurologists. Covariates for access followed similar patterns for MS centers. DISCUSSION: Geographic access to neurologists is decreased in rural areas, in areas with higher proportions of Hispanics, populations with disabilities, and those uninsured. Access is further limited for MS subspecialty care. This study highlights disparities in geographic access to neurologic care.


Assuntos
Esclerose Múltipla , Neurologia , Médicos , Masculino , Humanos , Neurologistas , Limitação da Mobilidade , Esclerose Múltipla/epidemiologia , Esclerose Múltipla/terapia
16.
Telemed Rep ; 5(1): 247-255, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-39184874

RESUMO

Background: During the COVID-19 pandemic, use of telemedicine (TM) increased dramatically, but it is unclear how use varies by characteristics of people with Alzheimer's disease (AD), multiple sclerosis (MS), or Parkinson's disease (PD). Methods: This cross-sectional study used US PharMetrics Plus commercial claims data from January 1, 2019, to December 31, 2021. TM use (≥1 Current Procedural Terminology code) was assessed in each study year (2019, 2020, and 2021) among people with ≥1 inpatient or ≥2 outpatient diagnosis codes ≥30 days apart for AD, MS, or PD. Any TM use and disease-related visits (AD, MS, or PD diagnosis code within TM claim) were summarized, and characteristics of TM users versus nonusers during the pandemic (2020 and 2021) were described. Results: Among people with AD, MS, or PD, 0.9% used TM in 2019 versus 58.0% in 2020 and 42.5% in 2021. Among TM users in 2020 and 2021, the majority had TM visits related to their neurological disorder (73.2% and 64.6%, respectively). During the pandemic, approximately 25% of total TM visits (n = 296,434) were provided by a neurologist. Mean (SD) age of TM users was similar to nonusers (60.5 [15.1] and 61.5 [15.3] years), but TM users were more likely to be female (62% vs 60%), enrolled in Medicare (33% vs 30%), and reside in western (64.2% vs 35.8%) or eastern (61.0% vs 39.0%) regions versus nonusers. Conclusions: Although results indicate expanded use of and access to TM among people with AD, MS, or PD, differences in patient and health care provider characteristics for TM use were notable.

17.
Ther Adv Neurol Disord ; 17: 17562864241237856, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38855023

RESUMO

Background: Several oral disease-modifying therapies (DMTs) have been approved by the Food and Drug Administration for the treatment of relapsing-remitting multiple sclerosis (RRMS). In the absence of head-to-head randomized data, matching-adjusted indirect comparisons (MAICs) can evaluate the comparative effectiveness and safety of ozanimod versus other oral DMTs in RRMS. Objectives: To synthesize results from the published MAICs of ozanimod and other oral DMTs for 2-year outcomes in RRMS. Methods: Published MAICs involving ozanimod for the treatment of RRMS were identified. Extracted data elements included efficacy [annualized relapse rate (ARR), confirmed disability progression (CDP), and brain volume loss] and safety [adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation, and infection] outcomes. Results: The four MAIC studies identified compared ozanimod with fingolimod, teriflunomide, dimethyl fumarate (DMF), and ponesimod. All comparisons were adjusted for differences in age, sex, relapses within the previous year, Expanded Disability Status Scale score, and percentage of patients with prior DMTs. Outcomes at 2 years were analyzed based on comparisons that lacked a common comparator arm. Ozanimod was associated with significantly lower ARR versus teriflunomide [ARR ratio (95% CI) 0.73 (0.62, 0.84) and DMF 0.80 (0.67, 0.97)], with no significant difference versus fingolimod or ponesimod. The proportions of patients treated with ozanimod or fingolimod had similar 3- and 6-month CDP. Compared with teriflunomide and DMF, ozanimod was associated with a significantly lower risk of 3-month CDP; 6-month CDP was comparable. Ozanimod was associated with significantly lower rates of any AE and AEs leading to discontinuation compared with the other oral DMTs evaluated. Ozanimod also had significantly lower rates of SAEs versus teriflunomide and DMF and lower rates of reported infection outcomes versus fingolimod and ponesimod. Conclusion: Compared with the other oral DMTs evaluated in MAICs, ozanimod was associated with a favorable safety profile and improved or comparable efficacy outcomes.


An indirect comparison of ozanimod vs other oral treatments in relapsing-remitting multiple sclerosis The many treatment options available for relapsing-remitting multiple sclerosis (RRMS) make treatment decisions difficult. While direct head-to-head treatment comparisons provide useful information, these studies are not available for every pair of treatments. Indirect comparisons of published study results can help fill that evidence gap. A technique called matching-adjusted indirect comparison (MAIC) offers a statistically robust way to compare safety/efficacy outcomes from different studies by accounting for important differences across the studies. We collected data from four MAIC studies that compared 2-year treatment outcomes in patients treated with ozanimod versus those treated with fingolimod, teriflunomide, dimethyl fumarate (DMF), or ponesimod. Each study accounted for differences in age, sex, relapses within the previous year, disability status, and previous therapy use. We found ozanimod was either better than or similar to other treatments based on the outcomes measured. The annual rate of RRMS relapse was lower for patients treated with ozanimod than for patients treated with teriflunomide or DMF and similar for patients treated with ponesimod or fingolimod. Ozanimod-treated patients saw their RRMS progress at rates similar to those treated with fingolimod at 3 and 6 months and teriflunomide and DMF at 6 months; RRMS was more likely to progress at 3 months in patients treated with teriflunomide and DMF versus those treated with ozanimod. Our analyses also found that patients treated with ozanimod had lower rates of side effects, including those serious enough to cause treatment discontinuation, compared with patients receiving other treatments. By comparing findings from existing MAIC studies, we found that patients with RRMS treated with ozanimod had fewer side effects and better or similar efficacy outcomes compared with patients who received other treatments for RRMS. These findings can potentially inform treatment decisions for patients with RRMS.

18.
Neurodegener Dis Manag ; 14(2): 21-33, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38623894

RESUMO

Aim: To assess time to improvement in Quality of Life in Neurological Disorders (Neuro-QoL) domains for patients treated with natalizumab versus ocrelizumab. Methods: Patients enrolled in the MS PATHS network who initiated treatment with either natalizumab or ocrelizumab rated the Neuro-QoL domains of physical function, symptoms, emotional health, cognitive function and social ability. Results: Time to clinically meaningful improvement was significantly shorter with natalizumab versus ocrelizumab for cognitive function (event time ratio [95% CI]: 0.37 [0.24-0.57]; p < 0.001), sleep disturbance (0.45 [0.28-0.72]; p = 0.001), social role participation (0.37 [0.21-0.66]; p = 0.001) and social role satisfaction (0.5 [0.31-0.8]; p = 0.004). Conclusion: Natalizumab had shorter time to clinically meaningful improvement in cognitive, sleep, and social role Neuro-QoL domains versus ocrelizumab.


Knowledge of treatment-related benefits associated with medication choices, including improvement of quality of life (QoL), are strong influential factors for patients to start and continue their therapies. Little is known about patient-reported time to onset of functional improvement upon the initiation of medications for multiple sclerosis (MS). The Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS) network, a repository of collaborative international data on routine MS management, includes patient-reported information on the health-related QoL using the Quality of Life in Neurological Disorders (Neuro-QoL) measure. This study included data from 883 eligible patients enrolled in MS PATHS, with the aim of assessing and comparing the time to improvement in physical, mental and social health for patients treated with natalizumab versus ocrelizumab using Neuro-QoL. Natalizumab and ocrelizumab are both high-efficacy treatment options for relapsing forms of MS. The results demonstrated that, compared with ocrelizumab, natalizumab treatment led to faster effect on mental and social health, as well as quicker improvements in physical functioning in the arms and hands. Overall, it took shorter time for natalizumab-treated patients to achieve better QoL compared with ocrelizumab. These findings highlight the importance of QoL in disease management and provide a patient perspective for healthcare providers when making decisions about high-efficacy treatments for their patients with MS.


Assuntos
Anticorpos Monoclonais Humanizados , Fatores Imunológicos , Natalizumab , Qualidade de Vida , Humanos , Masculino , Feminino , Anticorpos Monoclonais Humanizados/uso terapêutico , Natalizumab/uso terapêutico , Adulto , Pessoa de Meia-Idade , Fatores Imunológicos/uso terapêutico , Resultado do Tratamento , Fatores de Tempo , Esclerose Múltipla/tratamento farmacológico , Esclerose Múltipla/psicologia , Doenças do Sistema Nervoso/tratamento farmacológico
19.
Contemp Clin Trials ; 142: 107544, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38657731

RESUMO

BACKGROUND: Multiple sclerosis (MS) affects nearly 1 million people and is estimated to cost $85.4 billion in the United States annually. People with MS have significant barriers to receiving care and telemedicine could substantially improve access to specialized, comprehensive care. In cross-sectional analyses, telemedicine has been shown to be feasible, have high patient and clinician satisfaction, reduce patient costs and burden, and enable a reasonable assessment of disability. However, no studies exist evaluating the longitudinal impact of telemedicine care for MS. Here we describe the study protocol for VIRtual versus UsuAL In-office care for Multiple Sclerosis (VIRTUAL-MS). The main objective of the study is to evaluate the impact of telemedicine for MS care on: patient clinical outcomes, economic costs, patient, and clinician experience. METHODS: This two-site randomized clinical trial will enroll 120 adults with a recent diagnosis of MS and randomize 1:1 to receive in-clinic vs. telemedicine care for 24 months. The primary outcome of the study is worsening in any one of the four Multiple Sclerosis Functional Composite 4 (MSFC4) measures at 24 months. Other study outcomes include patient and clinician satisfaction, major healthcare costs, Expanded Disability Status Scale, treatment adherence, and digital outcomes. CONCLUSION: The results of this study will directly address the key gaps in knowledge about longitudinal telemedicine-enabled care in an MS population. It will inform clinical care implementation as well as design of trials in MS and other chronic conditions. TRIAL REGISTRATION: NCT05660187.


Assuntos
Esclerose Múltipla , Satisfação do Paciente , Telemedicina , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Custos de Cuidados de Saúde , Esclerose Múltipla/terapia , Esclerose Múltipla/economia , Telemedicina/organização & administração , Estados Unidos
20.
Lancet Reg Health Am ; 18: 100415, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36844018

RESUMO

Background: Appalachia is rural and socioeconomically deprived with a heavy burden of neurological disorders and poor access to healthcare providers. Rates of neurological disorders are increasing over time without equal increases in providers, indicating that Appalachian disparities are likely to worsen. Spatial access to neurological care has not been robustly explored for U.S. areas, so we aimed to examine disparities in the vulnerable Appalachian region. Methods: Using 2022 CMS Care Compare physician data, we conducted a cross-sectional health services analysis, where we computed spatial accessibility of neurologists for all census tracts in the 13 states with Appalachian counties. We stratified access ratios by state, area deprivation, and rural-urban commuting area (RUCA) codes then utilized Welch two-sample t-tests to compare Appalachian tracts with non-Appalachian tracts. Using stratified results, we identified Appalachian areas where interventions would have the largest impact. Findings: Appalachian tracts (n = 6169) had neurologist spatial access ratios between 25% and 35% lower than non-Appalachian tracts (n = 18,441; p < 0.001). When stratified by rurality and deprivation, three-step floating catchment area spatial access ratios for Appalachian tracts remained significantly lower in the most urban (RUCA = 1 [p < 0.0001) and most rural tracts (RUCA = 9 [p = 0.0093]; RUCA = 10 [p = 0.0227]). We identified 937 Appalachian census tracts where interventions can be targeted. Interpretation: After stratifying by rural status and deprivation, significant disparities in spatial access to neurologists remained for Appalachian areas, indicating both poorer access in Appalachia and that neurologist accessibility cannot be determined solely by remoteness and socioeconomic status. These findings and our identified disparity areas have broad implications for policymaking and intervention targeting in Appalachia. Funding: R.B.B. was supported by NIH Award Number T32CA094186. M.P.M. was supported by NIH-NCATS Award Number KL2TR002547.

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