Improvement of Comorbid Psoriasis in Patients With MS Treated With Natalizumab

ObjectiveTo present observations on administration of natalizumab to 18 patients with the comorbid MS and psoriasis, who represented a full subset of patients with such comorbidity within the patient records available.MethodsA retrospective analysis of patient records was performed. Patient histories were gathered and included date of diagnosis of MS and psoriasis, MS disease-modifying therapies (DMTs), Expanded Disability Status Scale (EDSS), reason for DMT switch, and effects on MS and psoriasis status.ResultsOn initiation of natalizumab, all 18 patients had a complete cessation of MS disease activity (within 2–8 months) with significant patient-reported improvement of psoriasis (within 1–5 months). This improvement was independent of previous MS therapy and led to 15 of 18 patients needing no additional treatment for MS and psoriasis (remaining 3 patients continued to use topical treatments for psoriasis).ConclusionsIn this cohort of 18 patients with comorbid MS and psoriasis, beneficial results on both diseases were observed after initiation of therapy with natalizumab.

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COVID-19 is associated with multiple sclerosis exacerbations that are prevented by disease modifying therapies

10.1101/2021.03.08.21253141 ◽

2021 ◽

Author(s):

Afagh Garjani ◽

Rodden M Middleton ◽

Rachael Hunter ◽

Katherine A Tuite-Dalton ◽

Alasdair Coles ◽

...

Keyword(s):

Multiple Sclerosis ◽

Cohort Study ◽

Expanded Disability Status Scale ◽

Community Based ◽

Web Based ◽

The United Kingdom ◽

Disease Modifying Therapies ◽

Disability Status ◽

Disease Modifying ◽

The Impact

ABSTRACTBackgroundInfections can trigger exacerbations of multiple sclerosis (MS). The effects of the coronavirus disease 2019 (COVID-19) on MS are not known. The aim of this study was to understand the impact of COVID-19 on new and pre-existing symptoms of MS.MethodsThe COVID-19 and MS study is an ongoing community-based, prospective cohort study conducted as part of the United Kingdom MS Register. People with MS and COVID-19 were invited by email to complete a questionnaire about their MS symptoms during the infection. An MS exacerbation was defined as developing new MS symptoms and/or worsening of pre-existing MS symptoms.ResultsFifty-seven percent (230/404) of participants had an MS exacerbation during their infection; 82 developed new MS symptoms, 207 experienced worsened pre-existing MS symptoms, and 59 reported both. Disease modifying therapies (DMTs) reduced the likelihood of developing new MS symptoms during the infection (OR 0.556, 95%CI 0.316-0.978). Participants with a higher pre-COVID-19 webEDSS (web-based Expanded Disability Status Scale) score (OR 1.251, 95%CI 1.060-1.478) and longer MS duration (OR 1.042, 95%CI 1.009-1.076) were more likely to experience worsening of their pre-existing MS symptoms during the infection.ConclusionCOVID-19 infection was associated with exacerbation of MS. DMTs reduced the chance of developing new MS symptoms during the infection.

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Treatment Discontinuation and Disease Progression with Injectable Disease-Modifying Therapies

International Journal of MS Care ◽

10.7224/1537-2073.2012-034 ◽

2013 ◽

Vol 15 (4) ◽

pp. 194-201 ◽

Cited By ~ 22

Author(s):

Robert J. Fox ◽

Amber R. Salter ◽

Tuula Tyry ◽

Jennifer Sun ◽

Xiaojun You ◽

...

Keyword(s):

Multiple Sclerosis ◽

Disease Progression ◽

Clinical Decision Making ◽

Medication Compliance ◽

Clinical Decision ◽

Research Committee ◽

The North ◽

Disease Modifying Therapies ◽

Patient Reported ◽

Disease Modifying

Injectable first-line disease-modifying therapies (DMTs) for multiple sclerosis (MS) are generally prescribed for continuous use. Accordingly, the various factors that influence patient persistence with treatment and that can lead some patients to switch medications or discontinue treatment may affect clinical outcomes. Using data from the North American Research Committee on Multiple Sclerosis (NARCOMS) database, this study evaluated participants' reasons for discontinuation of injectable DMTs as well as the relationship between staying on therapy and sustained patient-reported disease progression and annualized relapse rates. Participants selected their reason(s) for discontinuation from among 16 possible options covering the categories of efficacy, safety, tolerability, and burden, with multiple responses permitted. Both unadjusted data and data adjusted for baseline age, disease duration, disability, and sex were evaluated. Discontinuation profiles varied among DMTs. Participants on intramuscular interferon beta-1a (IM IFNβ-1a) and glatiramer acetate (GA) reported the fewest discontinuations based on safety concerns, although GA was associated with reports of higher burden and lower efficacy than other therapies. Difficulties with tolerability were more often reported as a reason for discontinuing subcutaneous (SC) IFNβ-1a than as a reason for discontinuing IM IFNβ-1a, GA, or SC IFNβ-1b. In the persistent therapy cohort, less patient-reported disability progression was reported with IM IFNβ-1a treatment than with SC IFNβ-1a, IFNβ-1b, or GA. These findings have relevance to clinical decision making and medication compliance in MS patient care.

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Tick-borne encephalitis vaccination in multiple sclerosis

Neurology Neuroimmunology & Neuroinflammation ◽

10.1212/nxi.0000000000000664 ◽

2020 ◽

Vol 7 (2) ◽

pp. e664

Author(s):

Alexander Winkelmann ◽

Christoph Metze ◽

Silvius Frimmel ◽

Emil C. Reisinger ◽

Uwe K. Zettl ◽

...

Keyword(s):

Multiple Sclerosis ◽

Disease Activity ◽

Geometric Mean ◽

Expanded Disability Status Scale ◽

Vaccine Response ◽

Link Type ◽

Tick Borne Encephalitis ◽

Disability Status ◽

Disease Modifying ◽

Relapse Rates

ObjectiveTo assess the changes in disease activity after tick-borne encephalitis (TBE) vaccination in patients with multiple sclerosis (MS) on a variety of disease-modifying drugs and to assess the immunogenicity, safety, and clinical tolerability of the vaccine in this patient group.MethodsWe conducted a prospective, multicenter, nonrandomized observational study. We enrolled 20 patients with MS receiving TBE vaccination who had been on disease-modifying treatment (DMT) for at least 6 months. Serum samples were obtained before and after 4 weeks of vaccination to determine the specific TBE antibody response. MS disease activity (Expanded Disability Status Scale and relapse rates) was evaluated for 1 year after immunization. Local and systemic adverse events were registered.ResultsIn 20 subjects with TBE vaccination, the annualized relapse rate decreased from 0.65 in the year before vaccination to 0.21 in the following year. Expanded Disability Status Scale remained stable during the 2-year period before vaccination and 1 year after vaccination (range: 1.50–1.97). The geometric mean titer (GMT) increased from 169 Vienna units per milliliter (VIEU/mL) to 719 VIEU/mL 4 weeks after vaccination (p = 0.001), and 77.8% had protective antibody titers after vaccination. In 9 patients treated with beta interferons, GMT increased from 181 VIEU/mL to 690 VIEU/mL (p = 0.018). Three subjects treated with glatiramer acetate developed a 2- to 9.6-fold increase. Patients treated with fingolimod developed the lowest increase in antibody titer.ConclusionTBE vaccination showed good tolerability and was safe in patients with MS. MS disease activity was not increased, and annualized relapse rates decreased after vaccination. Vaccine response differs according to the underlying DMT.Trial registrationClinicalTrials.gov, clinicaltrials.gov, Identifier: NCT02275741.

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An electronic, unsupervised patient-reported Expanded Disability Status Scale for multiple sclerosis

Multiple Sclerosis Journal ◽

10.1177/1352458520968814 ◽

2020 ◽

pp. 135245852096881

Author(s):

Andrew R Romeo ◽

William M Rowles ◽

Erica S Schleimer ◽

Patrick Barba ◽

Wan-Yu Hsu ◽

...

Keyword(s):

Multiple Sclerosis ◽

Clinical Care ◽

Expanded Disability Status Scale ◽

Clinical Assessments ◽

Patient Reported ◽

Disability Status ◽

Two Measures ◽

Highly Correlated ◽

Participation In Research ◽

Good Agreement

Background: In persons with multiple sclerosis (MS), the Expanded Disability Status Scale (EDSS) is the criterion standard for assessing disability, but its in-person nature constrains patient participation in research and clinical assessments. Objective: The aim of this study was to develop and validate a scalable, electronic, unsupervised patient-reported EDSS (ePR-EDSS) that would capture MS-related disability across the spectrum of severity. Methods: We enrolled 136 adult MS patients, split into a preliminary testing Cohort 1 ( n = 50), and a validation Cohort 2 ( n = 86), which was evenly distributed across EDSS groups. Each patient completed an ePR-EDSS either immediately before or after a MS clinician’s Neurostatus EDSS evaluation. Results: In Cohort 2, mean age was 50.6 years (range = 26–80) and median EDSS was 3.5 (interquartile range (IQR) = [1.5, 5.5]). The ePR-EDSS and EDSS agreed within 1-point for 86% of examinations; kappa for agreement within 1-point was 0.85 ( p < 0.001). The correlation coefficient between the two measures was 0.91 (<0.001). Discussion: The ePR-EDSS was highly correlated with EDSS, with good agreement even at lower EDSS levels. For clinical care, the ePR-EDSS could enable the longitudinal monitoring of a patient’s disability. For research, it provides a valid and rapid measure across the entire spectrum of disability and permits broader participation with fewer in-person assessments.

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Determinants of non-adherence to disease-modifying therapies in multiple sclerosis: A cross-Canada prospective study

Multiple Sclerosis Journal ◽

10.1177/1352458516657440 ◽

2016 ◽

Vol 23 (4) ◽

pp. 588-596 ◽

Cited By ~ 12

Author(s):

Kyla A McKay ◽

Helen Tremlett ◽

Scott B Patten ◽

John D Fisk ◽

Charity Evans ◽

...

Keyword(s):

Multiple Sclerosis ◽

Alcohol Dependence ◽

Disease Duration ◽

Poor Adherence ◽

Time Points ◽

Cognitive Difficulties ◽

Disease Modifying Therapies ◽

Disability Status ◽

Mild Disability ◽

Disease Modifying

Background: Poor adherence to the disease-modifying therapies (DMTs) for multiple sclerosis (MS) may attenuate clinical benefit. A better understanding of characteristics associated with non-adherence could improve outcomes. Objective: To evaluate characteristics associated with non-adherence to injectable DMTs. Methods: Consecutive patients from four Canadian MS Clinics were assessed at three time points over two years. Clinical and demographic information included self-reported DMT use, missed doses in the previous 30 days, health behaviors, and comorbidities. Non-adherence was defined as <80% of expected doses taken. We employed generalized estimating equations to examine characteristics associated with non-adherence at all time points with findings reported as adjusted odds ratios (OR). Results: In all, 485 participants reported use of an injectable DMT, of whom 107 (22.1%) were non-adherent over the study period. Non-adherence was associated with a lower Expanded Disability Status Scale score (0–2.5 vs 3.0–5.5, OR: 1.80; 95% confidence interval (CI): 1.06–3.04), disease duration (⩽5 vs <5 years, OR: 2.23; 95% CI: 1.10–4.52), alcohol dependence (OR: 2.14; 95% CI: 1.23–3.75), and self-reported cognitive difficulties, measured by the Health Utilities Index-3 (OR: 1.55; 95% CI: 1.08–2.22). Conclusions: Nearly one-quarter of participants were non-adherent during the study. Alcohol dependence, perceived cognitive difficulties, longer disease duration, and mild disability status were associated with non-adherence. These characteristics may help healthcare professionals identify patients at greatest risk of poor adherence.

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THUR 193 Alemtuzumab improves disability across functional systems

Journal of Neurology Neurosurgery & Psychiatry ◽

10.1136/jnnp-2018-abn.96 ◽

2018 ◽

Vol 89 (10) ◽

pp. A28.1-A28

Author(s):

Sharrack Basil ◽

Hunter Samuel ◽

Aburashed Rany ◽

Alroughani Raed ◽

Dive Dominique ◽

...

Keyword(s):

Expanded Disability Status Scale ◽

Functional Systems ◽

Link Type ◽

Disease Modifying Therapy ◽

Disability Status ◽

Bayer Healthcare ◽

Core Study ◽

Study Support ◽

Disease Modifying ◽

Edss Score

The effect of alemtuzumab on functional systems (FS) scores of the Expanded Disability Status Scale (EDSS) was assessed in CARE-MS II patients over 6 years (y) (CARE-MS II, NCT00548405; extension, NCT00930553). Patients received alemtuzumab (12 mg/day; 2 courses: baseline, 5 days; 12 months later, 3 days), and as-needed alemtuzumab retreatment for relapse/MRI activity in the extension or another disease-modifying therapy per investigator discretion. Assessments: Proportion of patients achieving stable/improved EDSS score (versus core study baseline), FS scores, and 6 month confirmed disability improvement (CDI). In patients who achieved CDI over 6 y (n=126), assessments at 6 months post-CDI onset: EDSS score (<4; ≥4), number of improved FS per patient, and percentage with stable/improved FS scores. At Y6, 77% of patients showed stable/improved EDSS scores; 75%–85% showed stability/improvement in each FS. Through Y6, 43% achieved 6 month CDI. At 6 months post-CDI onset, 96% of CDI patients had an EDSS score <4, and 70% achieved improvements in >1 FS. Improvements were observed in each FS, most frequently Sensory (48%), Pyramidal (44%), and Cerebellar (44%) systems; 21%–25% showed improvements in the Brainstem, Cerebral, Visual, and Bowel/Bladder FS. These findings indicate a broad treatment effect of alemtuzumab on multiple aspects of disability improvements. STUDY SUPPORT: Sanofi and Bayer HealthCare Pharmaceuticals.

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The Value of Self-Reported Cognitive Performance in low, medium and high EDSS

10.1101/2021.02.02.21250685 ◽

2021 ◽

Author(s):

Delphine Van Laethem ◽

Alexander De Cock ◽

Jeroen Van Schependom ◽

Ralph HB Benedict ◽

Guy Nagels ◽

...

Keyword(s):

Cognitive Performance ◽

Physical Disability ◽

Screening Tool ◽

Cognitive Tests ◽

Expanded Disability Status Scale ◽

Patient Report ◽

Patient Reported ◽

Disability Status ◽

Degree Of Disability ◽

Positive Correlations

AbstractBackgroundThe inconsistent association of patient-reported Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) scores with performance-based cognitive tests in MS could be related to the degree of disability, due to certain MSNQ-questions assuming some self-dependence and intact instrumental ADLs.ObjectivesTo test whether the relation between subjective and objective cognitive performance could be moderated by physical disability as measured by the Expanded Disability Status Scale (EDSS), we assessed the correlation between MSNQ and Symbol Digit Modalities Test (SDMT) scores in different EDSS groups.MethodsFrom 288 MS patients who completed the patient-report MSNQ and a two‐question screening tool for depression, we also collected SDMT and EDSS scores. We analysed correlations in the total group and three EDSS subgroups: Low 0.0 – 3.0, Medium 3.5 – 6.0 and High 6.5 – 9.5.ResultsWe found a significant and negative correlation between patient-reported MSNQ scores and SDMT scores in the low EDSS (r = -.225, p = .044), but not in the medium and high EDSS groups, and significant positive correlations between MSNQ and depression in all subgroups.ConclusionsOur data suggest that the patient-report MSNQ has potential as a measure of cognition in patients with low EDSS-scores but not in the medium and high EDSS ranges.

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THUR 177 Efficacy of alemtuzumab retreatment after 2 initial courses

Journal of Neurology Neurosurgery & Psychiatry ◽

10.1136/jnnp-2018-abn.82 ◽

2018 ◽

Vol 89 (10) ◽

pp. A23.2-A23

Author(s):

Sharrack Basil ◽

Singer Barry ◽

Boster Aaron ◽

Bass Ann ◽

Berkovich Regina ◽

...

Keyword(s):

Rate Ratio ◽

Expanded Disability Status Scale ◽

Link Type ◽

Disease Modifying Therapy ◽

Disability Status ◽

Bayer Healthcare ◽

Core Study ◽

Study Support ◽

Disease Modifying ◽

Edss Score

Efficacy of alemtuzumab retreatment (course [C] 3) after the initial 2 courses were evaluated (CARE-MS II, NCT00548405; extension, NCT00930553). Patients received alemtuzumab retreatment (12 mg/day, 3 consecutive days;≥12 months apart) as needed for relapse and/or MRI activity or another disease-modifying therapy (DMT) per investigator’s discretion. Assessments 12 months before C3 and up to 3 years after C3: annualised relapse rate (ARR); improved/stable Expanded Disability Status Scale (EDSS) score (versus core study baseline); 6 month confirmed disability improvement (CDI). Patients receiving another DMT were excluded. Analyses included patients who received C3 or more, with data censored at the time of C4 if a fourth course was received. Through Year 6, 88% of patients entering the extension remained on study, with 45% receiving ≥1 retreatment. ARR decreased from 0.85 (12 months before C3) to 0.20 (12 months after C3; rate ratio [95% CI], 0.24 [0.17–0.34]; p<0.0001), and remained low (0.27) 3 years after C3. 68% of patients maintained stable/improved EDSS 12 months after C3. The percentage with CDI increased from 4% (12 months before C3) to 14% (12 months after C3; p=0.0126). These findings demonstrate the efficacy of alemtuzumab C3 in patients with disease activity after the initial 2 courses.Study support: Sanofi and Bayer HealthCare Pharmaceuticals.

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P.051 Patient-reported adverse events on Multiple Sclerosis disease-modifying therapies in an urban tertiary MS clinic

Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques ◽

10.1017/cjn.2016.155 ◽

2016 ◽

Vol 43 (S2) ◽

pp. S33-S33

Author(s):

ZJ Liao ◽

L Lee ◽

K Carr

Keyword(s):

Multiple Sclerosis ◽

Adverse Events ◽

Real Life ◽

Retrospective Chart Review ◽

First Line ◽

Disease Modifying Therapies ◽

Multiple Sclerosis Disease ◽

Patient Reported ◽

Disease Modifying ◽

The Impact

Background: Disease-modifying therapies (DMT) have been shown to reduce relapses and delay disability in individuals with relapsing-remitting multiple sclerosis (MS). However, these medications can cause adverse events (AE) leading to poor adherence. To better understand their clinical utility, this study examined real-life experiences with DMT in a tertiary MS clinic. Methods: A retrospective chart review (1999-2015) was conducted to evaluate the prevalence of AE and discontinuation rates of Health Canada approved DMT. Results: 445 MS patients who have used at least one DMT in their lifetime were reviewed. Among first-line injectable therapies, interferon beta (IFNβ) 1-α IM users (49.6%) were most likely to report an AE. Flu-like reactions and injection site reactions were the most commonly reported AE. Among first-line oral therapies, BG-12 users (58.5%) were most likely to report an AE. The most common AE were flushing and gastrointestinal upset. DMT that were most frequently discontinued as a result of AE were IFNβ 1-α SC (39.3%), IFNβ 1-α IM (36.8%) and BG-12 (34.6%). Conclusions: The prevalence of AE and discontinuation rate were congruent. In comparison with recent literature, this study demonstrated lower prevalence of AE but equivocal or higher discontinuation rates. This discrepancy could represent a more realistic depiction of the impact that DMT AE have on patients.

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P.027 Efficacy of a fourth alemtuzumab course in RRMS patients from CARE-MS II who experienced disease activity after three prior courses

Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques ◽

10.1017/cjn.2018.129 ◽

2018 ◽

Vol 45 (s2) ◽

pp. S23-S23

Author(s):

A Traboulsee ◽

R Alroughani ◽

A Boster ◽

AD Bass ◽

R Berkovich ◽

...

Keyword(s):

Disease Activity ◽

Inadequate Response ◽

Expanded Disability Status Scale ◽

Inclusion Criteria ◽

Prior Therapy ◽

Disease Modifying Therapy ◽

Improved Outcomes ◽

Disability Status ◽

Disease Modifying ◽

Edss Score

Background: In RRMS patients with inadequate response to prior therapy, 2 alemtuzumab courses (12 mg/day; baseline: 5 days; 12 months later: 3 days) significantly improved outcomes versus SC IFNB-1a over 2 years (CARE-MS II [NCT00548405]). Efficacy remained durable in a 4-year extension (NCT00930553); patients could receive as-needed alemtuzumab retreatment (≥12 months apart) for disease activity, or another disease-modifying therapy (DMT). Through Year 6, 88% remained on study; 50% received neither alemtuzumab retreatment nor another DMT; 16% received ≥4 courses; 3% received ≥5 courses. We evaluated Course 4 (C4) efficacy in patients receiving ≥4 courses. Methods: Annualized relapse rate (ARR); improved/stable Expanded Disability Status Scale (EDSS) score (versus baseline); 6-month confirmed disability improvement (CDI). 11% of patients met inclusion criteria: ≥4 courses within 60 months of baseline; no DMT. Those receiving C5 were censored at that time. Results: ARR decreased after C4 (12 months pre-C4 [-12M]: 0.75; 12 months post-C4 [+12M]: 0.19; P<0.0001), remaining low (0.23) at Year 3 post-C4. More patients had stable/improved EDSS scores +12M (67.5%) versus at C4 administration (53.5%). Percentage with CDI increased post-C4 (-12M: 10.0%; +12M: 26.7%). Conclusions: C4 reduced relapses and stabilized/improved disability in patients with disease activity after initial treatment (C1, C2) plus one additional course (C3).

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