Initial high-efficacy disease-modifying therapy in multiple sclerosis

Neurology ◽  
2020 ◽  
Vol 95 (8) ◽  
pp. e1041-e1051 ◽  
Author(s):  
Mathias Due Buron ◽  
Thor Ameri Chalmer ◽  
Finn Sellebjerg ◽  
Ismael Barzinji ◽  
Jeppe Romme Christensen ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Lower Probability ◽  
Matched Sample ◽  
Class Iii ◽  
High Efficacy ◽  
Disease Modifying Therapies ◽  
Baseline Activity ◽  
First Relapse ◽  
Disease Modifying ◽  
Edss Score

ObjectiveTo determine the effectiveness of high-efficacy disease-modifying therapies (heDMTs) vs medium-efficacy disease-modifying therapies (meDMT) as the first treatment choice in treatment-naive patients with multiple sclerosis (MS) on disability worsening and relapses. We assessed this using a nationwide population-based MS registry.MethodsWe identified all patients starting a heDMT as first-time treatment from the Danish Multiple Sclerosis Registry and compared treatment outcomes with a propensity score matched sample of patients starting meDMT.ResultsWe included 388 patients in the study: 194 starting initial therapy with heDMT matched to 194 patients starting meDMT. At 4 years of follow-up, the probabilities of a 6-month confirmed Expanded Disability Status Scale (EDSS) score worsening were 16.7% (95% confidence interval [CI] 10.4%–23.0%) and 30.1% (95% CI 23.1%–37.1%) for heDMT and meDMT initiators, respectively (hazard ratio [HR] 0.53, 95% CI 0.33–0.83, p = 0.006). Patients initiating heDMT also had a lower probability of a first relapse (HR 0.50, 95% CI 0.37–0.67). Results were similar after pairwise censoring and in subgroups with high baseline activity, diagnosis after 2006, or information on baseline T2 lesion load.ConclusionWe found a lower probability of 6-month confirmed EDSS score worsening and lower probability of a first relapse in patients starting a heDMT as first therapy, compared to a matched sample starting meDMT.Classification of evidenceThis study provides Class III evidence that for patients with MS, starting heDMT lowers the risk of EDSS worsening and relapses compared to starting meDMT.

scholarly journals Use of Disease-Modifying Therapies in Pediatric Relapsing-Remitting Multiple Sclerosis in the United Kingdom

2021 ◽  
Vol 8 (4) ◽  
pp. e1008
Author(s):  
Omar A. Abdel-mannan ◽  
Celeste Manchoon ◽  
Thomas Rossor ◽  
Justine-Clair Southin ◽  
Carmen Tur ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Disease Modifying Therapies ◽  
Increased Risk ◽  
Relapsing Remitting ◽  
Relapse Time ◽  
Disease Modifying ◽  
Edss Score ◽  
Remitting Multiple Sclerosis ◽  
Time To Relapse ◽  
Relapsing Remitting Multiple Sclerosis

ObjectivesTo compare the real-world effectiveness of newer disease-modifying therapies (DMTs) vs injectables in children with relapsing-remitting multiple sclerosis (RRMS).MethodsIn this retrospective, multicenter study, from the UK Childhood Inflammatory Demyelination Network, we identified children with RRMS receiving DMTs from January 2012 to December 2018. Clinical and paraclinical data were retrieved from the medical records. Annualized relapse rates (ARRs) before and on treatment, time to relapse, time to new MRI lesions, and change in Expanded Disability Status Scale (EDSS) score were calculated.ResultsOf 103 children treated with DMTs, followed up for 3.8 years, relapses on treatment were recorded in 53/89 (59.5%) on injectables vs 8/54 (15%) on newer DMTs. The ARR was reduced from 1.9 to 1.1 on injectables (p < 0.001) vs 1.6 to 0.3 on newer DMTs (p = 0.002). New MRI lesions occurred in 77/89 (86.5%) of patients on injectables vs 26/54 (47%) on newer DMTs (p = 0.0001). Children on newer DMTs showed longer time to relapse, time to switch treatment, and time to new radiologic activity than patients on injectables (log-rank p < 0.01). After adjustment for potential confounders, multivariable analysis showed that injectables were associated with 12-fold increased risk of clinical relapse (adjusted hazard ratio [HR] = 12.12, 95% CI = 1.64–89.87, p = 0.015) and a 2-fold increased risk of new radiologic activity (adjusted HR = 2.78, 95% CI = 1.08–7.13, p = 0.034) compared with newer DMTs. At 2 years from treatment initiation, 38/103 (37%) patients had MRI activity in the absence of clinical relapses. The EDSS score did not change during the follow-up, and only 2 patients had cognitive impairment.ConclusionNewer DMTs were associated with a lower risk of clinical and radiologic relapses in patients compared with injectables. Our study adds weight to the argument for an imminent shift in practice toward the use of newer, more efficacious DMTs in the first instance.Classification of EvidenceThis study provides Class IV evidence that newer DMTs (oral or infusions) are superior to injectables (interferon beta/glatiramer acetate) in reducing both clinical relapses and radiologic activity in children with RRMS.

scholarly journals Sequencing of high-efficacy disease-modifying therapies in multiple sclerosis: perspectives and approaches

2018 ◽  
Vol 13 (11) ◽  
pp. 1871 ◽  
Author(s):  
Francois Grand′Maison ◽  
Michael Yeung ◽  
SarahA Morrow ◽  
Liesly Lee ◽  
Francois Emond ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
High Efficacy ◽  
Disease Modifying Therapies ◽  
Disease Modifying

Identification of patients with relapsing multiple sclerosis eligible for high-efficacy therapies

2021 ◽  
Author(s):  
José Meca-Lallana ◽  
Juan Antonio García-Merino ◽  
Sergio Martínez-Yélamos ◽  
Angela Vidal-Jordana ◽  
Lucienne Costa ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Decision Making ◽  
Expert Opinion ◽  
Second Line ◽  
High Efficacy ◽  
Clinical Evolution ◽  
Disease Modifying Therapies ◽  
Disease Modifying ◽  
Relapsing Multiple Sclerosis ◽  
Selection Of

Relapsing multiple sclerosis (RMS) presents a highly variable clinical evolution among patients, and its management should be personalized. Although there is no cure at present, effective disease-modifying therapies (DMTs) are available. Selection of the most appropriate DMT for each patient is influenced by several clinical, radiological and demographic aspects as well as personal preferences that, at times, are not covered in the regulatory criteria. This may be a source of difficulty, especially in certain situations where so-called ‘high-efficacy DMTs’ (usually considered second-line) could be of greater benefit to the patient. In this narrative review, we discuss evidence and experience, and propose a pragmatic guidance on decision-making with respect to the indication and management of high-efficacy DMT in adult patients with RMS based on expert opinion.

scholarly journals The Impact of Adherence to Disease-Modifying Therapies on Functional Outcomes in Veterans with Multiple Sclerosis

2021 ◽  
Vol 13 ◽  
pp. 117957352110287
Author(s):  
Meheroz H Rabadi ◽  
Kimberly Just ◽  
Chao Xu
Keyword(s):  
Multiple Sclerosis ◽  
Functional Outcomes ◽  
Adherence Rate ◽  
Disability Progression ◽  
Disease Modifying Therapies ◽  
The Mean ◽  
Disease Modifying ◽  
Edss Score ◽  
The Impact ◽  
Adherence Group

Background: Patients who adhere to their DMTs have lower rate of MS-related relapses and disability. Objective: We sought to determine the adherence rate to disease-modifying therapies (DMTs) and its impact on functional outcome(s) in veterans with multiple sclerosis (MS). Method: We reviewed the electronic records of 279 veterans with MS who were periodically followed in our MS clinic. We compared 3 groups of patients, defined according to their adherence to DMTs (non-adherent; poorly adherent; adherent) on their effect on disability progression and time to sustained EDSS score of 6. Results: There were 148 (53%) veterans with MS who were non-adherent to any DMT medication(s) while of the 131 (47%) veterans who were taking medications, 118 (42%) had a good- and 13 (5%) had poor-adherence. The mean age at MS onset was 36.6 (± 11.2) and mean duration of MS for the sample was 24 ± 13.5 years. The mean initial EDSS and TFIM scores were 4.09 ± 2.9 SD and 104 ± 25.7 for the study sample. The change in MMSE, TFIM scores, and time to sustained EDSS score of 6 significantly favored the good- compared to the non-adherence group ( P < .01). Conclusion: This study suggests that veterans with MS who adhered to their DMTs had less decline in their MS-related cognition, disease severity and disability compared to non- and poorly-adherent groups even after adjusting for age, gender, MS duration, and type. Time to EDSS score of 6 was significantly prolonged in the good-adherence group.

scholarly journals Humoral immune response to COVID-19 mRNA vaccine in patients with multiple sclerosis treated with high-efficacy disease-modifying therapies

2021 ◽  
Vol 14 ◽  
pp. 175628642110128
Author(s):  
Anat Achiron ◽  
Mathilda Mandel ◽  
Sapir Dreyer-Alster ◽  
Gil Harari ◽  
David Magalashvili ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Immune Response ◽  
Humoral Immunity ◽  
Lymphocyte Count ◽  
Healthy Subjects ◽  
Vaccine Dose ◽  
Humoral Response ◽  
High Efficacy ◽  
Disease Modifying Therapies ◽  
Disease Modifying

Background and Aims: The National Multiple Sclerosis Society and other expert organizations recommended that all patients with multiple sclerosis (MS) should be vaccinated against COVID-19. However, the effect of disease-modifying therapies (DMTs) on the efficacy to mount an appropriate immune response is unknown. We aimed to characterize humoral immunity in mRNA-COVID-19 MS vaccinees treated with high-efficacy DMTs. Methods: We measured SARS-CoV-2 IgG response using anti-spike protein-based serology (EUROIMMUN) in 125 MS patients vaccinated with BNT162b2-COVID-19 vaccine 1 month after the second dose. Patients were either untreated or under treatment with fingolimod, cladribine, or ocrelizumab. A group of healthy subjects similarly vaccinated served as control. The percent of subjects that developed protective antibodies, the titer, and the time from the last dosing were evaluated. Results: Protective humoral immunity of 97.9%, 100%, 100%, 22.7%, and 3.8%, was observed in COVID-19 vaccinated healthy subjects ( N = 47), untreated MS patients ( N = 32), and MS patients treated with cladribine ( N = 23), ocrelizumab ( N = 44), and fingolimod ( N = 26), respectively. SARS-CoV-2 IgG antibody titer was high in healthy subjects, untreated MS patients, and MS patients under cladribine treatment, within 29.5–55 days after the second vaccine dose. Only 22.7% of patients treated with ocrelizumab developed humoral IgG response irrespective to normal absolute lymphocyte count. Most fingolimod-treated MS patients had very low lymphocyte count and failed to develop SARS-COV-2 antibodies. Age, disease duration, and time from the last dosing did not affect humoral response to COVID-19 vaccination. Conclusions: Cladribine treatment does not impair humoral response to COVID-19 vaccination. We recommend postponing ocrelizumab treatment in MS patients willing to be vaccinated as a protective humoral response can be expected only in some. We do not recommend vaccinating MS patients treated with fingolimod as a protective humoral response is not expected.

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