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- Coles, AJ, et al.
(author)
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Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data
- 2022
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In: Multiple sclerosis (Houndmills, Basingstoke, England). - : SAGE Publications. - 1477-0970 .- 1352-4585. ; 28:5, s. 842-846
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Journal article (peer-reviewed)abstract
- Does preexisting or treatment-emergent autoimmunity increase the risk of subsequent autoimmune disease in individuals with relapsing-remitting multiple sclerosis (MS) after alemtuzumab? In the extended phase 2/3 trials, 34/96 (35.4%) patients with and 395/1120 (35.3%) without preexisting autoimmunity developed non-MS autoimmunity. Thyroid autoimmunity after alemtuzumab courses 1 or 2 did not increase subsequent non-thyroid autoimmune adverse events. Therefore, autoimmune disease before or after alemtuzumab treatment does not predict autoimmunity after further courses, so should not preclude adequate alemtuzumab dosing to control MS. Finally, post-marketing safety data contribute toward a full record of the alemtuzumab benefit/risk profile for the MS field.
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- Kobelt, G, et al.
(author)
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Real-Life Outcome in Multiple Sclerosis in the Czech Republic
- 2019
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In: Multiple sclerosis international. - : Hindawi Limited. - 2090-2654 .- 2090-2662. ; 2019, s. 7290285-
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Journal article (peer-reviewed)abstract
- Background. Cohort studies and registries provide opportunities to estimate long-term outcome in multiple sclerosis. Objectives. To describe changes in disability (EDSS), relapse activity, and health care consumption over the period 2008-2015 by combining two Czech cost-of-illness studies with disease data from the MS Center in Prague. Methods. The combined dataset included 426 patients with a mean observation time of 8.3 years. A Cox proportional hazards model with time-varying covariates for treatment, disease course, and EDSS was applied to estimate the effect of treatment on the risk of progression to EDSS 4 and the risk of relapses. The use of health care resources (hospitalization, consultation, and tests) was compared between the two cross-sectional studies. Results. Total health care costs appeared stable between 2008 and 2015, despite more intense use of disease-modifying treatments in 2015 (52% of patients versus 31% in 2008). 39% of patients starting treatment at EDSS 0-3 in 2008 progressed to EDSS 4 or higher by 2015, while 65% of patients starting at EDSS 0-2 remained stable. The number of relapses was associated with a higher risk of progression. In a marginal structural Cox model of the relapse risk, treatment with natalizumab or fingolimod was associated with a lower risk of relapse (hazard ratio 0.68, p<0.01). Treatment with natalizumab or fingolimod was associated with a lower risk of progression to EDSS 4. Conclusion. Our results link relapses to progression and indicate that the newer treatments have a better effectiveness, despite difficulties caused by small a sample size, administrative rules guiding treatment, and absence of a random comparator group.
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