Safety concerns and risk management of multiple sclerosis therapies

2016 ◽  
Vol 136 (3) ◽  
pp. 168-186 ◽  
Author(s):  
P. Soelberg Sorensen
Keyword(s):  
Multiple Sclerosis ◽  
Risk Management ◽  
Safety Concerns

Biological and nonbiological complex drugs for multiple sclerosis in Latin America: regulations and risk management

2015 ◽  
Vol 15 (6) ◽  
pp. 597-600 ◽  
Author(s):  
Adriana Carrá ◽  
Miguel Angel Macías Islas ◽  
Adriana Tarulla ◽  
Denis Bernardi Bichuetti ◽  
Alessandro Finkelsztejn ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Risk Management ◽  
Latin America

scholarly journals An ID-Associated Application to Facilitate Patient-Tailored Management of Multiple Sclerosis

2021 ◽  
Vol 11 (8) ◽  
pp. 1061
Author(s):  
Michael Lang ◽  
Daniela Rau ◽  
Lukas Cepek ◽  
Fia Cürten ◽  
Stefan Ringbauer ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Risk Management ◽  
Health Data ◽  
Mobile App ◽  
Patient Communication ◽  
Software Application ◽  
Promising Tool ◽  
Physician Patient Communication ◽  
Management Plans ◽  
Physician Patient

Despite improvements in diagnosis and treatment, multiple sclerosis (MS) is the leading neurological cause of disability in young adults. As a chronic disease, MS requires complex and challenging management. In this context, eHealth has gained an increasing relevance. Here, we aim to summarize beneficial features of a mobile app recently implemented in clinical MS routine as well as beyond MS. PatientConcept is a CE-certified, ID-associated multilingual software application allowing patients to record relevant health data without disclosing any identifying data. Patients can voluntarily share their health data with selected physicians. Since its implementation in 2018, about 3000 MS patients have used PatientConcept. Initially developed as a physician–patient communication platform, the app maps risk management plans of all current disease modifying therapies and thereby facilitates adherence to specified monitoring appointments. It also allows continuous monitoring of various PROs (PatientReportedOutcomes), enabling a broad overview of the disease course. In addition, various studies/projects currently assess monitoring, follow-up, diagnostics and telemetric evaluations of patients with other diseases beyond MS. Altogether, PatientConcept offers a broad range of possibilities to support physician–patient communication, implementation of risk management plans and assessment of PROs. It is a promising tool to facilitate patient-tailored management of MS and other chronic diseases.

scholarly journals Interdisciplinary Risk Management in the Treatment of Multiple Sclerosis

2016 ◽  
Author(s):  
Joachim Havla ◽  
Clemens Warnke ◽  
Tobias Derfuss ◽  
Ludwig Kappos ◽  
Hans-Peter Hartung ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Risk Management

scholarly journals Real-world study of efficacy, risk management and reasons for discontinuation of natalizumab for treatment of multiple sclerosis in Russia

PLoS ONE ◽  
2019 ◽  
Vol 14 (5) ◽  
pp. e0217303 ◽  
Author(s):  
Evgeniy Evdoshenko ◽  
Alexandra Stepanova ◽  
Maria Shumilina ◽  
Maria Davydovskaya ◽  
Natalia Khachanova ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Risk Management ◽  
Real World

scholarly journals Tolerability and Safety of Switching from Rituximab to Ocrelizumab: Evaluating Factors Associated with Infusion Related Reactions

2022 ◽  
Vol 8 (1) ◽  
pp. 205521732110693
Author(s):  
Enrique Alvarez ◽  
Kavita V. Nair ◽  
Stefan Sillau ◽  
Ian Shelton ◽  
Rebecca Seale ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
B Cells ◽  
Prospective Study ◽  
Factors Associated ◽  
Safety Concerns ◽  
Comparator Group ◽  
Antidrug Antibodies ◽  
Switch Group

Background Ocrelizumab and rituximab are frequently used treatments for multiple sclerosis (MS). Data on switching from rituximab to ocrelizumab is limited. Objectives To assess the frequency, severity, and factors of infusion related reactions (IRRs) in patients with MS who switch from rituximab to ocrelizumab, compared to those who stay on rituximab. Methods Prospective study on MS patients aged 18–65, on rituximab for at least 2 cycles, who either switched to ocrelizumab (switch group) or stayed on rituximab (comparator group) (n = 100 each). Participants were followed for IRRs, safety, and tolerability over 12 months. Results The proportion of IRRs in patients who continue on rituximab (14%) were similar to those who switched to ocrelizumab on Day 1 (14%; p = 1.000) and Week 24 (12%; p = 0.647) but higher than at Day 15 (4%; 0.005). The risk of IRRs for the switch group was associated with the presence of B cells (CD19 and/or CD20 counts ≥1%) increasing by 5.01 (1.49, 16.82) times on Day 1 (p = 0.007). Antidrug antibodies to ocrelizumab were not associated with IRRs. No other safety concerns were identified in switching to ocrelizumab. Conclusion IRRs are similar between both groups, which suggests that it is safe to switch from rituximab to ocrelizumab.

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