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[Alemtuzumab therapy 2017]
Tamás Biernacki1, Krisztina Bencsik1, Dániel Sandi1
1Szegedi Tudományegyetem, Általános Orvostudományi Kar, Szent-Györgyi Albert Klinikai Központ, Neurológiai Klinika, Szeged.
Abstract:
Multiple sclerosis (MS) is a chronic, immune-mediated disease of the central nervous system comprising of inflammation, demyelinisation and neurodegeneration. The natural history of MS is heterogenous. Owing to the vast range and severity of the symptoms MS can cause the effect of the disease on one's cognitive and physical status is unpredictable. According to the new, phenotype based classification two subgroups can be distinguished; relapsing-remitting (RR) and progressive MS. Relapsing-remitting MS can be further divided into active and inactive disease. The activity of the disease can be proven either clinically and/or by radiological means. A patient's disease is considered inactive, if it fulfills the criteriae set in the "no evidence of disease activity-3" (NEDA-3) concept, meaning that no progression can be seen on the MRI scans, the patient is relapse free and there is no worsening on any disability scale. Nowadays a paradigm shift can be seen in the treatment of MS. The aim of this shift is to provide each and every patient with the most potent medication best suiting his/her illness as soon as possible. Alemtuzumab offers a great option as either a first line treatment or as escalation therapy for patients with a highly active disease. The efficacy of alemtuzumab was proven in two phase III trials (CARE-MS I, II), where it was compared to subcutaneous interferon b-1a, administered three times weekly. In both studies alemtuzumab was superior to subcutaneous interferon b-1a in terms of relapse rate reduction, in all scouted MRI parameters. In the CARE-MS II trial it was found superior in terms of progression slowing. In the studies' first 2 years 32% and 39% of the alemtuzumab treated patients managed to achieve the NEDA-3 state (data from CARE-MS II and I respectively). At the end of the 4 year extension of both studies these numbers have increased to 60% and 55% respectively. The aim of our synopsis is to suggest neurologists an evidence based guideline, a therapeutic algorithm to be used when they give their MS patients the very best, personalised treatment, and also to appoint the recently introduced alemtuzumab to its proper place in the algorithm.
Insights
Alemtuzumab is effective for treating active relapsing-remitting multiple sclerosis (MS), significantly reducing relapses and disease progression. Many patients achieve no evidence of disease activity (NEDA-3) with this treatment.
Area of Science:
- Neurology
- Immunology
Background:
- Multiple sclerosis (MS) is a chronic, unpredictable central nervous system disease characterized by inflammation, demyelination, and neurodegeneration.
- MS presents with heterogeneous symptoms and is classified into relapsing-remitting (RRMS) and progressive forms, with RRMS further divided into active and inactive disease states.
- Achieving 'no evidence of disease activity-3' (NEDA-3) signifies a lack of clinical relapses, radiological progression, and disability worsening.
Purpose of the Study:
- To provide neurologists with an evidence-based guideline for personalized multiple sclerosis treatment.
- To establish a therapeutic algorithm that incorporates alemtuzumab for optimal patient management.
- To define the appropriate role of alemtuzumab in the treatment algorithm for highly active MS.
Main Methods:
- Review of two Phase III clinical trials (CARE-MS I and II) comparing alemtuzumab to subcutaneous interferon beta-1a.
- Analysis of efficacy data regarding relapse rate reduction, MRI parameters, and disease progression.
- Evaluation of NEDA-3 achievement rates in alemtuzumab-treated patients over 4 years.
Main Results:
- Alemtuzumab demonstrated superiority over interferon beta-1a in reducing relapse rates and improving MRI outcomes in both trials.
- CARE-MS II showed alemtuzumab was superior in slowing disease progression.
- Significant percentages of patients achieved NEDA-3: 32-39% within 2 years, increasing to 55-60% by year 4.
Conclusions:
- Alemtuzumab is a highly effective treatment option for active relapsing-remitting multiple sclerosis, suitable for first-line or escalation therapy.
- The data supports the use of alemtuzumab in achieving sustained disease control and NEDA-3 status in MS patients.
- A proposed therapeutic algorithm should guide neurologists in integrating alemtuzumab for personalized MS management.
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