Disease-modifying drugs for multiple sclerosis and infection risk: a cohort study

2018 ◽  
Vol 89 (10) ◽  
pp. 1050-1056 ◽  
Author(s):  
José Maria Andreas Wijnands ◽  
Feng Zhu ◽  
Elaine Kingwell ◽  
John David Fisk ◽  
Charity Evans ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
First Generation ◽  
Second Generation ◽  
Population Based ◽  
Infection Risk ◽  
Disease Modifying Drugs ◽  
Drug Classes ◽  
Increased Risk ◽  
Disease Modifying ◽  
Status Index

ObjectiveLittle is known about disease-modifying treatments (DMTs) for multiple sclerosis (MS) and infection risk in clinical practice. We examined the association between DMTs and infection-related medical encounters.MethodsUsing population-based administrative data from British Columbia, Canada, we identified MS cases and followed them from their first demyelinating event (1996–2013) until emigration, death or study end (December 2013). Associations between DMT exposure (by DMT generation or class) and infection-related physician or hospital claims were assessed using recurrent time-to-events models, adjusted for age, sex, socioeconomic status, index year and comorbidity count. Results were reported as adjusted HRs (aHRs).ResultsOf 6793 MS cases, followed for 8.5 years (mean), 1716 (25.3%) were DMT exposed. Relative to no DMT, exposure to any first-generation DMT (beta-interferon or glatiramer acetate) was not associated with infection-related physician claims (aHR: 0.96; 95% CI 0.89 to 1.02), nor was exposure to these drug classes when assessed separately. Exposure to any second-generation DMT (oral DMT or natalizumab) was associated with an increased hazard of an infection-related physician claim (aHR: 1.47; 95% CI 1.16 to 1.85); when assessed individually, the association was significant for natalizumab (aHR: 1.59; 95% CI 1.19 to 2.11) but not the oral DMTs (aHR: 1.17; 95% CI 0.88 to 1.56). While no DMTs were associated with infection-related hospital claims, these hospitalisations were also uncommon.ConclusionExposure to first-generation DMTs was not associated with an altered infection risk. However, exposure to the second-generation DMTs was, with natalizumab associated with a 59% increased risk of an infection-related physician claim. Continued pharmacovigilance is warranted, including an investigation of the DMT-associated infection burden on patient outcomes.

scholarly journals Disease-modifying drugs for multiple sclerosis and subsequent health service use

2021 ◽  
pp. 135245852110634
Author(s):  
Huah Shin Ng ◽  
Feng Zhu ◽  
Elaine Kingwell ◽  
Yinshan Zhao ◽  
Shenzhen Yao ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
First Generation ◽  
Service Use ◽  
Second Generation ◽  
Negative Binomial ◽  
Negative Binomial Regression ◽  
Population Based ◽  
Disease Modifying Drugs ◽  
Physician Visits ◽  
Disease Modifying

Objective: We assessed the relationship between the multiple sclerosis (MS) disease-modifying drugs (DMDs) and healthcare use. Methods: Persons with MS (aged ⩾18 years) were identified using linked population-based health administrative data in four Canadian provinces and were followed from the most recent of their first MS/demyelinating event or 1 January 1996 until the earliest of death, emigration, or study end (31 December 2017 or 31 March 2018). Prescription records captured DMD exposure, examined as any DMD, then by generation (first-generation (the injectables) or second-generation (orals/infusions)) and individual DMD. The associations with subsequent all-cause hospitalizations and physician visits were examined using proportional means model and negative binomial regression. Results: Of 35,894 MS cases (72% female), mean follow-up was 12.0 years, with person-years of DMD exposure for any, or any first- or second-generation DMD being 63,290, 54,605 and 8685, respectively. Any DMD or any first-generation DMD exposure (versus non-exposure) was associated with a 24% lower hazard of hospitalization (adjusted hazard ratio, aHR: 0.76; 95% confidence intervals (CIs): 0.71–0.82), rising to 29% for the second-generation DMDs (aHR: 0.71; 95% CI: 0.58–0.88). This ranged from 18% for teriflunomide (aHR: 0.82; 95% CI: 0.67–1.00) to 44% for fingolimod (aHR: 0.56; 95% CI: 0.36–0.87). In contrast, DMD exposure was generally not associated with substantial differences in physician visits. Conclusion: Findings provide real-world evidence of a beneficial relationship between DMD exposure and hospitalizations.

Perinatal outcomes in women with multiple sclerosis exposed to disease-modifying drugs

2011 ◽  
Vol 18 (4) ◽  
pp. 460-467 ◽  
Author(s):  
E Lu ◽  
L Dahlgren ◽  
AD Sadovnick ◽  
A Sayao ◽  
A Synnes ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Vaginal Delivery ◽  
Perinatal Outcomes ◽  
Population Based ◽  
Disease Modifying Drugs ◽  
Assisted Vaginal Delivery ◽  
Second Stage Of Labor ◽  
Relapsing Remitting ◽  
Exposure During Pregnancy ◽  
Disease Modifying

Background: The incidence of disease-modifying drug (DMD) exposure during pregnancy in multiple sclerosis (MS) is unknown and limited data exists regarding the potential harm of DMD exposure during pregnancy. Objective: To investigate the incidence and effect of in utero DMD exposure on perinatal outcomes. Methods: We conducted a retrospective analysis by linking two provincial, population-based databases, the British Columbia (BC) MS database with the BC Perinatal Database Registry. Delivery (duration of the second stage of labor, assisted vaginal delivery and Cesarean section) and neonatal (birth weight, gestational age, 5-minute Apgar score and congenital anomalies) outcomes were compared between women exposed and unexposed to a DMD within 1 month prior to conception and/or during pregnancy. Findings were reported as odds ratios (ORs) with 95% confidence intervals (CIs). Results: In all, 311 women with relapsing–remitting MS delivered 418 singleton babies between April 1998 and March 2009. 21/101 (21%) of births to MS women treated with DMD prior to pregnancy were exposed to a DMD. In all cases, exposure was documented as unintentional and DMD treatment was stopped within 2 months of gestation. The overall incidence of exposure was 21/418 (5%). DMD exposure was associated with a trend towards a greater risk of assisted vaginal delivery compared to the DMD naïve groups (OR = 3.0; 95% CI: 1.0–9.2). All other comparisons of perinatal outcomes were unremarkable. Conclusion: The incidence of DMD exposure was relatively low and no cases were intentional. Further studies are needed to ascertain the safety of DMD exposure during pregnancy in MS.

Disease progression among multiple sclerosis patients before and during a disease-modifying drug program: a longitudinal population-based evaluation

2009 ◽  
Vol 15 (11) ◽  
pp. 1286-1294 ◽  
Author(s):  
PJ Veugelers ◽  
JD Fisk ◽  
MG Brown ◽  
K. Stadnyk ◽  
IS Sketris ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Disease Progression ◽  
Program Effectiveness ◽  
Population Based ◽  
Eligibility Criteria ◽  
Disease Modifying Drugs ◽  
Regression Methods ◽  
Disease Modifying ◽  
Multiple Sclerosis Patients ◽  
Relapsing Remitting Multiple Sclerosis

Randomized controlled trials have demonstrated the efficacy of disease-modifying drugs (DMDs) in persons with relapsing—remitting multiple sclerosis (MS) and secondary progressive MS with superimposed relapses. However, these brief studies of selected patients have focused mainly on reducing attacks and must be complemented by evaluations in ‘realworld’ clinical settings to establish the effectiveness of DMD programs in slowing disease progression and to inform health policy and program decision-making. We assessed the effectiveness of DMDs as administered in a comprehensive publicly funded drug insurance program that provides DMDs to a geographically defined population of MS patients who meet specific eligibility criteria. Data from 1752 MS patients (10,312 assessments) seen between 1980 and 2004 at a regional MS Clinic serving the entire population of Nova Scotia, Canada were analysed. Using survival methods we observed a statistically significant reduction in disease progression to specific Expanded Disability Status Scale endpoints following the introduction of this program. Subgroup analyses of patients eligible for treatment using hierarchical linear regression methods also suggested that disease progression was slowed in patients treated with the first DMD prescribed. These findings provide evidence supporting DMD program effectiveness that can be used to inform the broader implementation of such programs.

scholarly journals PND45 USE OF DISEASE-MODIFYING DRUGS IN MULTIPLE SCLEROSIS: A POPULATION BASED STUDY

2008 ◽  
Vol 11 (3) ◽  
pp. A150-A151
Author(s):  
K Noyes ◽  
A Bajorska ◽  
S Schwid ◽  
R Holloway ◽  
A Dick
Keyword(s):  
Multiple Sclerosis ◽  
Population Based ◽  
Population Based Study ◽  
Disease Modifying Drugs ◽  
Disease Modifying

Vaccinations in patients with multiple sclerosis: A Delphi consensus statement

2020 ◽  
pp. 135245852095231 ◽  
Author(s):  
Agostino Riva ◽  
Valeria Barcella ◽  
Simone V Benatti ◽  
Marco Capobianco ◽  
Ruggero Capra ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Seasonal Influenza ◽  
Careful Consideration ◽  
Delphi Consensus ◽  
Consensus Process ◽  
Disease Modifying Drugs ◽  
Risks And Benefits ◽  
Modified Delphi ◽  
Increased Risk ◽  
Evidence Based Decision Making

Background: Patients with multiple sclerosis (MS) are at increased risk of infection. Vaccination can mitigate these risks but only if safe and effective in MS patients, including those taking disease-modifying drugs. Methods: A modified Delphi consensus process (October 2017–June 2018) was used to develop clinically relevant recommendations for making decisions about vaccinations in patients with MS. A series of statements and recommendations regarding the efficacy, safety and timing of vaccine administration in patients with MS were generated in April 2018 by a panel of experts based on a review of the published literature performed in October 2017. Results: Recommendations include the need for an ‘infectious diseases card’ of each patient’s infectious and immunisation history at diagnosis in order to exclude and eventually treat latent infections. We suggest the implementation of the locally recommended vaccinations, if possible at MS diagnosis, otherwise with vaccination timing tailored to the planned/current MS treatment, and yearly administration of the seasonal influenza vaccine regardless of the treatment received. Conclusion: Patients with MS should be vaccinated with careful consideration of risks and benefits. However, there is an urgent need for more research into vaccinations in patients with MS to guide evidence-based decision making.

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