Analysis of seroconversion following COVID-19 vaccination among multiple sclerosis patients treated with disease-modifying therapies in Poland.

CLINICAL RATIONALE FOR THE STUDY: The rapid spread of SARS-CoV-2 throughout the world has highlighted the importance of vaccinations to control the pandemic and to protect people at risk for severe disease courses. Disease-modifying therapies (DMT) in multiple sclerosis (MS), whether immunomodulatory or immunosuppressive, may affect the immune response. Therefore, the question arose as to whether these vaccinations would be effective. AIM OF THE STUDY: We planned a study to assess the immune response to SARS-CoV-2 vaccines by type of therapy. MATERIAL AND METHODS: Participants were recruited from 14 Polish MS centres. The data was obtained by neurologists using a questionnaire. We collected data on 353 MS patients (269 females, 84 males) who received complete primary SARS-CoV-2 vaccination. All persons with MS (PwMS) were treated with disease-modifying therapies. RESULTS: 305 out of 353 PwMS (86.4%) were positive for IgG Abs against SARS-CoV-2 S domain S1 Ag after vaccination. A strong immune response was noted in 129 PwMS (36.5%). The rate of seroconversion after SARS-CoV-2 vaccination in PwMS who received immunomodulatory DMTs (interferon beta, glatiramer acetate, teriflunomide, dimethyl fumarate, natalizumab) was 91.5%, in PwMS receiving immune reconstruction therapy (alemtuzumab, cladribine) was 92%, and in immunosuppressive DMTs (fingolimod, ocrelizumab), the seroconversion rate was 59%. CONCLUSIONS AND CLINICAL IMPLICATIONS: Our study shows that, in PwMS receiving immunomodulatory therapy, the immune response to vaccination is generally excellent. Even in immunosuppressive patients, seroconversion is satisfactory.

Long-term cenobamate retention, efficacy, and safety: outcomes from Expanded Access Programme.

AIM OF THE STUDY: To evaluate the long-term retention rate, efficacy, and tolerability of adjunctive cenobamate (CNB) in patients with drug-resistant epilepsy within the Polish Expanded Access Programme (EAP). CLINICAL RATIONALE FOR THE STUDY: Long-term retention rate is a useful measure of effectiveness including efficacy, safety, and tolerability of antiseizure medications. MATERIAL AND METHODS: We conducted a multicentre retrospective analysis of consecutive patients with focal epilepsy treated with CNB in the EAP between January 2020 and May 2023. All patients who completed the open-label extension phases of the YKP3089C013 and YKP3089C017 trials were offered the opportunity to continue CNB treatment within the EAP. We analysed cenobamate retention, seizure outcomes, and adverse events. RESULTS: 38 patients (18 females; 47.3%) continued CNB treatment within the Expanded Access Programme for 41 months. The mean baseline age of patients was 39.3 years (range: 18-57). All patients were on polytherapy, with the most commonly used antiseizure medications being valproate, levetiracetam, and carbamazepine. Adjunctive CNB treatment resulted in a reduced mean seizure frequency from 8.1 seizures (range: 4-20) per month to 3 seizures (range: 0-8) per month. At the final follow-up, the median CNB dose was 200 mg/day (range: 50-350). Among the patients, 24 (63.1%) achieved ≥ 50% seizure reduction, and eight (21%) remained seizure-free for at least 12 months. One in three patients experienced adverse events, which resolved in half of the subjects. The most frequent adverse events were dizziness, somnolence, and headache. The retention rate after completing the open-label extension phase was 100%. CONCLUSIONS AND CLINICAL IMPLICATIONS: Long-term effectiveness, including ≥ 50% seizure reduction and a 100% retention rate, was sustained over 41 months of CNB treatment within the Expanded Access Programme. No new safety issues were identified. These results provide support for the potential long-term clinical benefits of cenobamate.

Body Composition in Multiple Sclerosis Patients and Its Relationship to the Disability Level, Disease Duration and Glucocorticoid Therapy.

Background: Patients with multiple sclerosis (MS) have many potential factors (spasticity, immobilization, glucocorticoids use) for the deterioration of body composition. Aim: To assess the nutritional status (by classical anthropometry and by bioelectrical impedance analysis (BIA)) in MS patients and to correlate it with clinical state, MS duration time and the presence of glucocorticoid therapy in anamnesis (ever used). Methods: Anthropometrical (BMI and waist and hip circumferences, waist-to-height ratio (W/HtR), and waist-to-hip ratio (WHR)) and body composition (BIA) data were evaluated in 176 patients with MS. Fat mass (FM), and fat-free mass (FFM) were expressed as kilograms (kg), percentage (%) and indexes (FMI: fat mass index, FFMI: fat-free mass index) expressed in kg/m2. The median Expanded Disability Status Scale score was 4.5. Patients were then divided according to EDSS score as mild (EDSS 1.0−4.0) or moderate (EDSS 4.5−6.5) disability subgroup. Results: Waist c., WHtR, WHR, and FM% were significantly higher in the moderate MS group (p < 0.01; p < 0.001; p < 0.001; and p < 0.05, respectively). Whilst, FFM% was significantly lower (p < 0.05). BMI did not correlate significantly with any disability status score and MS time. Significant correlations were observed between EDSS, ΔEDSS and MS time and Waist c., WHtR, WHR, FM% and FFM%. WHtR had the strongest significance (p < 0.0001 vs. EDSS; p < 0.0001 vs. ΔEDSS; and p < 0.01 vs. MS time, respectively). After the adjustment to the MS time, only FM% was no longer significantly related to both EDSS and ΔEDSS. MS duration time, EDSS, ΔEDSS, WHtR, FM(kg), FM%, and FMI were significantly higher in the patients with a positive history of glucocorticoid therapy (all p < 0.05). Whilst, FFM% was significantly lower in MS patients treated with glucocorticoids (p < 0.01). Conclusions: Greater disability in MS patients is strongly related to lower fat-free mass and higher fat mass, especially with the abdominal distribution, irrespective of the duration time of the disease. Oral glucocorticoid therapy seems to have a negative impact on the body composition of MS patients. However, further prospective multifactorial studies in this field have to be done. For the proper assessment of nutritional status in MS patients, Waist c., WHtR, WHR, or body composition parameters seem to be of greater use than BMI.