scholarly journals Current requirements for studies of drugs for the pathogenetic treatment of multiple sclerosis

2019 ◽  
Vol 11 (4) ◽  
pp. 166-171
Author(s):  
A. N. Boyko ◽  
N. N. Spirin ◽  
Ya. V. Vlasov ◽  
M. N. Zakharova
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trials ◽  
High Efficiency ◽  
New Drugs ◽  
Extensive Experience ◽  
Number Of Patients ◽  
Long Term Follow Up ◽  
Based Medicine

More than 10 multiple sclerosis-modifying drugs (MSMDs) are widely used now. Novel MSMDs should be investigated in strict accordance with the evidence-based medicine principles governing clinical trials (of both original drugs and their analogues) that prove the high efficiency, safety, and tolerability of new drugs versus the already existing ones. Russia has gained extensive experience in conducting such studies using the well-known drugs as a comparison group. The efficiency and safety of new therapy should be evaluated according to the international criteria on the basis of a sufficient number of patients during a long-term follow-up. When combining the drugs, their efficiency and the risk of adverse effects can vary. The published results of a small study of the combined drug Leucovir (Belarus) do not meet these requirements, and the possibility of using this drug to treat multiple sclerosis can be discussed only after adequate phases II and III clinical trials.

scholarly journals Disability improvement as a clinically relevant outcome in clinical trials of relapsing forms of multiple sclerosis

2021 ◽  
pp. 135245852110002
Author(s):  
Bruce AC Cree ◽  
Jeffrey A Cohen ◽  
Anthony T Reder ◽  
Davorka Tomic ◽  
Diego Silva ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trials ◽  
Therapeutic Benefit ◽  
Disease Modifying Therapies ◽  
Long Term Follow Up ◽  
Post Hoc ◽  
Switch Group ◽  
Relevant Outcome

Background: Disease-modifying therapies (DMTs) can reduce the risk of disability worsening in patients with relapsing forms of multiple sclerosis (RMS). High-efficacy DMTs can lead to confirmed or sustained disability improvement (CDI and SDI). Objective and Methods: Post hoc analyses of data from the TRANSFORMS, FREEDOMS, and FREEDOMS II trials and their extensions assessed the effects of fingolimod (0.5–1.25 mg/day) on stabilizing or improving disability over ⩽8 years in participants with RMS. CDI and SDI rates were compared between participants initially randomized to fingolimod, interferon (IFNβ-1a), or placebo. Results: At 8 years’ follow-up in TRANSFORMS, 35.1% (95% confidence interval [CI], 28.2%–43.1%) of assessed participants in the IFNβ-1a–fingolimod switch group and 41.9% (36.6%–47.6%) on continuous fingolimod experienced CDI; disability did not worsen in approximately 70%. Similar results were seen in the combined FREEDOMS population. Proportionally fewer TRANSFORMS participants achieved SDI in the IFNβ-1a–fingolimod switch group than on continuous fingolimod (5.4% [3.0%–9.5%] vs 14.2% [10.8%–18.4%], p = 0.01). Conclusion: CDI and SDI are outcomes of interest for clinical trials and for long-term follow-up of participants with RMS. Monitoring CDI and SDI in addition to disability worsening may facilitate understanding of the therapeutic benefit of RMS treatments.

scholarly journals Improved Biochemical Parameters in Patients Who Undergo Early Resection in Isolated Ileocaecal Crohn’s Disease

2017 ◽  
Vol 2017 ◽  
pp. 1-5
Author(s):  
Mirzafaraz Saeed ◽  
Hari Hullur ◽  
Amro Salem ◽  
Abbas Ali ◽  
Yousif Sahib ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Surgical Resection ◽  
Complete Blood Count ◽  
Long Term Results ◽  
Number Of Patients ◽  
Long Term Follow Up ◽  
One Year

Introduction. The aim of this study is to evaluate the outcome of introduction of early surgery in the course of isolated ileocecal Crohn’s disease, where there is no absolute indication of surgery. Methods. Observational study involving patients with isolated ileocecal Crohn’s disease who underwent early surgical resection (within one year of the presentation of the hospital). A complete blood count, ESR, and CRP were done and compared between the preoperative value, 1st postoperative visit (3-4 weeks), and last follow-up visit. Statistical analysis was done using Analysis of Variance (ANOVA) to compare the different figures. Results. There was a statistically significant increase in the hemoglobin levels between preoperative, postoperative, and long-term follow-up and a significant decrease in leukocyte count between the pre- and postoperative values (F=19.8, p<0.001 and F=8.9, p=0.002, resp.). Similarly, the ESR and CRP values were decreased significantly at long-term follow-up (F=8.5, p=0.019 and F=8.3, p=0.013, resp.). Conclusion. Early surgical resection in isolated ileocaecal Crohn’s disease achieved significant biochemical improvements. These successful results in this small number of patients indicate that early surgical intervention may provide better outcomes. These initial results encourage larger and comparative studies of long-term results versus long-term use of biological agents.

Long-term follow-up for multiple sclerosis patients initially treated with interferon-beta and glatiramer acetate

2018 ◽  
Vol 394 ◽  
pp. 127-131 ◽  
Author(s):  
Brian C. Healy ◽  
Bonnie I. Glanz ◽  
Jonathan D. Zurawski ◽  
Maria Mazzola ◽  
Tanuja Chitnis ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Glatiramer Acetate ◽  
Interferon Beta ◽  
Long Term Follow Up ◽  
Multiple Sclerosis Patients
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