Adherence to laboratory monitoring among people taking oral drugs for multiple sclerosis: A Canadian population-based study

2020 ◽  
pp. 135245852091050 ◽  
Author(s):  
Huah Shin Ng ◽  
Elaine Kingwell ◽  
Feng Zhu ◽  
Tingting Zhang ◽  
Ruth Ann Marrie ◽  
...  

Objective: To examine laboratory testing adherence by persons initiating an oral disease-modifying therapy (DMT) for multiple sclerosis (MS). Methods: Population-based health administrative and laboratory data were accessed in British Columbia, Canada, to identify everyone filling their first prescription for dimethyl fumarate (DMF), fingolimod or teriflunomide (2011–2015). The proportion of people adherent to each drug monograph’s recommended laboratory monitoring schedule, pre- and on-DMT, was estimated. The association between patient characteristics and adherence was examined using multivariable logistic regression. Results: A total of 1016 people were included (DMF 567, fingolimod 253 and teriflunomide 196). The proportions of people adherent to pre-DMT liver and lymphocyte tests ranged from 88% to 91% and 91% to 94%, respectively, while 77% adhered to pre-DMF urinalysis. Adherence to the first on-DMT liver test was 89% for DMF (within 6 months), 61% for fingolimod (within 3 months) and 40% for teriflunomide (within 1 month). Men were less likely than women to have pre-DMF urinalysis (adjusted odds ratio (aOR); 95% confidence interval (CI): 0.40–0.95) or on-DMF liver (aOR: 0.46; 95% CI: 0.23–0.95) or lymphocyte (aOR: 0.47; 95% CI: 0.22–0.98) tests. Conclusions: Adherence to recommended laboratory testing was high (>77%) before oral DMT initiation, but lower once on drug. There is a need to understand the long-term consequences of suboptimal laboratory monitoring and sex differences in the DMT-treated MS population.

2021 ◽  
pp. 135245852110053
Author(s):  
Emilio Portaccio ◽  
Mattia Fonderico ◽  
Bernhard Hemmer ◽  
Tobias Derfuss ◽  
Bruno Stankoff ◽  
...  

Background: The spread of Coronavirus disease-19 (COVID-19) poses unique challenges in the management of people with multiple sclerosis (PwMS). Objectives: To collect data about the impact of COVID-19 emergency on access to care for PwMS and on MS treatment practices. Methods: Between March and July 2020, the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) promoted an online survey covering patient access to care, management of relapses and visits, disease-modifying therapy (DMT) and experience with COVID-19. Results: Three-hundred and sixty neurologists from 52 countries (68% from Europe) completed the survey. 98% reported COVID-19-related restrictions. Telemedicine was adopted to overcome the limited access to care and was newly activated (73%) or widely implemented (17%). 70% reported changes in DMT management. Interferons and glatiramer were considered safe. Dimethyl fumarate, teriflunomide and fingolimod were considered safe except for patients developing lymphopenia. No modifications were considered for natalizumab in 64%, cladribine in 24%, anti-CD20 in 22% and alemtuzumab in 17%; 18% (for alemtuzumab and cladribine) and 43% (for anti-CD20) considered postponing treatment. Conclusion: The ECTRIMS survey highlighted the challenges in keeping standards of care in clinical practice. Telemedicine clearly needs to be implemented. Gathering data on DMT safety will remain crucial to inform treatment decisions.


2021 ◽  
pp. 135245852110196
Author(s):  
Jan Hillert ◽  
Jon A Tsai ◽  
Mona Nouhi ◽  
Anna Glaser ◽  
Tim Spelman

Background: Teriflunomide and dimethyl fumarate (DMF) are first-line disease-modifying treatments for multiple sclerosis with similar labels that are used in comparable populations. Objectives: The objective of this study was to compare the effectiveness and persistence of teriflunomide and DMF in a Swedish real-world setting. Methods: All relapsing-remitting multiple sclerosis (RRMS) patients in the Swedish MS registry initiating teriflunomide or DMF were included in the analysis. The primary endpoint was treatment persistence. Propensity score matching was used to adjust comparisons for baseline confounders. Results: A total of 353 teriflunomide patients were successfully matched to 353 DMF. There was no difference in the rate of overall treatment discontinuation by treatment group across the entire observation period (hazard ratio (HR) = 1.12; 95% confidence interval (CI) = 0.91–1.39; p = 0.277; reference = teriflunomide). Annualised relapse rate (ARR) was comparable ( p = 0.237) between DMF (0.07; 95% CI = 0.05–0.10) and teriflunomide (0.09; 95% CI = 0.07–0.12). There was no difference in time to first on-treatment relapse (HR = 0.78; 95% CI = 0.50–1.21), disability progression (HR = 0.55; 95% CI = 0.27–1.12) or confirmed improvement (HR = 1.17; 95% CI = 0.57–2.36). Conclusion: This population-based real-world study reports similarities in treatment persistence, clinical effectiveness and quality of life outcomes between teriflunomide and dimethyl fumarate.


2020 ◽  
Vol 6 (4) ◽  
pp. 205521732095981
Author(s):  
Carrie M Hersh ◽  
Haleigh Harris ◽  
Malissa Ayers ◽  
Devon Conway

Background Tobacco exposure is a modifiable risk factor for multiple sclerosis (MS). Studies evaluating the relationship between tobacco, disease activity, and disease modifying therapy (DMT) persistence yielded conflicting results. We sought to address this issue with data from clinical practice. Objective To compare 24-month disease outcomes in tobacco versus non-tobacco users treated with dimethyl fumarate (DMF) or fingolimod (FTY) in clinical practice. Methods We retrospectively identified 659 MS patients treated with DMF or FTY, stratified by patient-reported tobacco use. DMT discontinuation and measures of disease activity at 24 months were assessed using propensity score (PS) weighting. Outcome estimates were calculated as tobacco vs non-tobacco use. Results 164 tobacco users (DMF n = 101; FTY n = 63) and 495 non-tobacco users (DMF n = 294; FTY n = 201) were identified. Tobacco (39.4%) and non-tobacco (34.4%) users were equally likely to discontinue DMT (OR = 1.17, 95% CI 0.79, 1.75), but tobacco users discontinued therapy earlier (HR = 1.53, 95% CI 1.06, 2.43). There were no differences in ARR (rate ratio = 1.39, 95% CI 0.97, 1.96). However, tobacco users had decreased odds of NEDA-2 (OR = 0.61, 95% CI 0.44, 0.83). Conclusion Our findings suggest that tobacco is a negative risk factor for inflammatory disease activity and earlier DMF and FTY discontinuation.


Author(s):  
Amanbir Atwal ◽  
Alice Schabas ◽  
Jamie Head ◽  
Carolyn Taylor ◽  
Anthony Traboulsee ◽  
...  

ABSTRACT:Background: Advances in multiple sclerosis (MS) disease modifying therapy (DMT) have increased laboratory monitoring requirements. Our goal was to survey existing practices and perceptions of risk in laboratory monitoring throughout Canada and assess whether opportunities to improve patient care and safety exist. Methods: A web-based survey assessing prescriber demographics, current infrastructure, and concerns for lab monitoring was sent to the Canadian Network of MS Clinics (CNMSC) listserv, inviting MS clinicians across the country to participate. Results: Respondents included 32/65 CNMSC-affiliated neurologists (49%), 6 registered nurses (RN), 2 nurse practitioners (NP), and 2 non-neurologist physicians from 8/10 provinces. For some questions, analysis was limited to 34 DMT-prescribing clinicians only. Despite broad implementation of electronic medical records (25/34, 74%), many prescribers (15/34, 44%) still receive laboratory results in paper form. In terms of lab monitoring infrastructure, we noted regional variability in the employment of nursing to monitor patient compliance with required laboratory monitoring. There is also a gap in laboratory surveillance, as less than 5% of respondents reported regularly reviewing results on weekends. Providers’ length of practice and volume of MS patients were not associated with different perception of DMT laboratory monitoring risk. Conclusions: This nation-wide survey showed variability in infrastructure used in laboratory monitoring and regional variation in nursing involvement. Providers’ level of concern for laboratory monitoring for DMTs did not vary by years of experience or volume of MS patients followed, suggesting that improved systems, rather than education, could ameliorate perceptions of risk.


PLoS ONE ◽  
2019 ◽  
Vol 14 (6) ◽  
pp. e0218215 ◽  
Author(s):  
Ruth Ann Marrie ◽  
Julia O’Mahony ◽  
Colleen J. Maxwell ◽  
Vicki Ling ◽  
E. Ann Yeh ◽  
...  

2017 ◽  
Vol 74 (2) ◽  
pp. 219-226 ◽  
Author(s):  
Irene Eriksson ◽  
Thomas Cars ◽  
Fredrik Piehl ◽  
Rickard E. Malmström ◽  
Björn Wettermark ◽  
...  

2017 ◽  
Vol 23 (2) ◽  
pp. 297-299 ◽  
Author(s):  
Adam F Carpenter ◽  
Shikha J Goodwin ◽  
Peter F Bornstein ◽  
Andrew J Larson ◽  
Christine K Markus

Background: Fingolimod is an oral disease-modifying therapy for relapsing forms of multiple sclerosis, which acts by sequestering lymphocytes within lymph nodes. Objective: To describe a case of extrapulmonary cryptococcosis in a patient taking fingolimod. Methods: Case report. Results: A 47-year-old man developed a non-healing skin lesion approximately 16 months after starting treatment with fingolimod. Biopsy revealed cryptococcosis. Fingolimod was discontinued and the lesion resolved with antifungal therapy. Conclusion: Despite few reported opportunistic infections in the pivotal clinical trials and first few years post-marketing, there has been a recent increase in reported AIDS-defining illnesses in patients taking fingolimod. Neurologists should be alert for opportunistic infections in their patients using this medication.


2015 ◽  
Vol 22 (4) ◽  
pp. 520-532 ◽  
Author(s):  
Matthew Warrender-Sparkes ◽  
Tim Spelman ◽  
Guillermo Izquierdo ◽  
Maria Trojano ◽  
Alessandra Lugaresi ◽  
...  

Objective: We aimed to analyse the effect of the introduction of fingolimod, the first oral disease-modifying therapy, on treatment utilisation and persistence in an international cohort of patients with multiple sclerosis (MS). Methods: MSBASIS, a prospective, observational sub-study of the MSBase registry, collects demographic, clinical and paraclinical data on patients followed from MS onset ( n=4718). We conducted a multivariable conditional risk set survival analysis to identify predictors of treatment discontinuation, and to assess if the introduction of fingolimod has altered treatment persistence. Results: A total of 2640 patients commenced immunomodulatory therapy. Following the introduction of fingolimod, patients were more likely to discontinue all other treatments (hazard ratio 1.64, p<0.001) while more patients switched to fingolimod than any other therapy (42.3% of switches). Patients switched to fingolimod due to convenience. Patients treated with fingolimod were less likely to discontinue treatment compared with other therapies ( p<0.001). Female sex, country of residence, younger age, a high Expanded Disability Status Scale score and relapse activity were all independently associated with higher rates of treatment discontinuation. Conclusion: Following the availability of fingolimod, patients were more likely to discontinue injectable treatments. Those who switched to fingolimod were more likely to do so for convenience. Persistence was improved on fingolimod compared to other medications.


2017 ◽  
Vol 24 (7) ◽  
pp. 942-950 ◽  
Author(s):  
Kyle Smoot ◽  
Kateri J Spinelli ◽  
Tamela Stuchiner ◽  
Lindsay Lucas ◽  
Chiayi Chen ◽  
...  

Background: Following approval of dimethyl fumarate (DMF), we established a registry of relapsing multiple sclerosis (RMS) patients taking DMF at our community MS center. Objective: To track DMF patients’ tolerability, disease progression, and lymphopenia. Methods: Patients prescribed DMF for RMS from March 2013 to March 2016 were prospectively enrolled ( N = 412). Baseline data, clinical relapses, magnetic resonance imaging (MRI) activity, discontinuation, and lymphocyte counts were captured through chart review. Results: The mean age of patients starting DMF was 49.4 ± 12.0 years and 70% transitioned from a previous disease-modifying therapy (DMT). Of the patients, 38% discontinued DMF, 76% of whom discontinued due to side effects. Clinical relapse and MRI activity were low. Comparing patients who transitioned from interferon-β (IFN), glatiramer acetate (GA), or natalizumab (NTZ), patients previously on NTZ had higher rates of relapse than those previously on GA (annualized relapse rate p = 0.039, percent relapse p = 0.021). Grade III lymphopenia developed in 11% of patients. Lymphopenia was associated with older age ( p < 0.001) and longer disease duration ( p < 0.001). Conclusion: Given the high rates of lymphopenia and discontinuation, it has become our clinical practice to more closely scrutinize older patients and those with a longer disease duration who are potential candidates for initiating DMF therapy.


2018 ◽  
Vol 8 (4) ◽  
pp. 292-301 ◽  
Author(s):  
Brandi Vollmer ◽  
Daniel Ontaneda ◽  
Anasua Bandyopadhyay ◽  
Sam Cohn ◽  
Kavita Nair ◽  
...  

BackgroundDimethyl fumarate (DMF) and fingolimod (FTY) are approved oral disease-modifying therapies for relapsing multiple sclerosis (MS). Observational studies are valuable when randomized clinical trials cannot be done due to ethical or practical reasons. Two-site studies allow investigators to further ascertain external validity of previously examined treatment effect differences. Limited head-to-head 2-site studies exist comparing DMF and FTY.MethodsPatients prescribed DMF (n = 737) and FTY (n = 535) from 2 academic multiple sclerosis (MS) centers (Cleveland Clinic and University of Colorado) were identified. Discontinuation and disease activity endpoints were assessed using propensity score (PS) weighting. Covariates used in the PS model included demographics and clinical and MRI characteristics.ResultsPS weighting demonstrated excellent covariate balance. Discontinuation was more common in DMF (44.2%) compared to FTY (34.8%) over 24 months (odds ratio [OR] 1.55, 95% confidence interval [CI] 1.21–1.99, p < 0.001). The leading cause for discontinuation was intolerability for both DMF (56.1% of DMF discontinuations) and FTY (46.2% of FTY discontinuations) (OR 1.65, 95% CI 1.21–2.25, p = 0.002). The proportion of patients with clinical relapses was low for both medications (DMF, 15.1%; FTY, 13.1%). There was no difference in the proportion of patients with relapses (OR 1.27, 95% CI 0.90–1.80, p = 0.174), gadolinium-enhancing lesions (OR 1.42, 95% CI 0.92–2.20, p = 0.114), or new T2 lesions on brain MRI (OR 1.13, 95% CI 0.83–1.55, p = 0.433).ConclusionsThis combined analysis suggests DMF and FTY have similar effectiveness in a large, 2-site clinical population over 24 months. Discontinuation of both DMTs was common and occurred more frequently with DMF, largely driven by intolerability.


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