Vaccination status and self-reported side effects after SARS-CoV-2 vaccination in relation to psychological and clinical variables in patients with multiple sclerosis.

The recent SARS-CoV-2 pandemic and the vaccination campaign posed a challenge to patients with autoimmune disease, such as multiple sclerosis (MS). We aimed for investigating whether psychological/sociodemographic/clinical characteristics of MS patients are associated with SARS-CoV-2 vaccination status and self-reported vaccination side effects (SEs). We have asked patients with MS about their willingness to receive recommended standard vaccinations pre-pandemically since June 2019. Between 10/2021 and 01/2022, we surveyed 193 of these MS patients about their current SARS-CoV-2 vaccination status, their perception of vaccination-related SEs, and reasons for and against SARS-CoV-2 vaccination. 75.6% of the patients declared their willingness to receive standard vaccinations before the pandemic. 84.5%, 78.2%, and 13.0% of the patients had received the first, second, and third SARS-CoV-2 vaccination, respectively, until the follow-up survey. The most common reason for not getting vaccinated against SARS-CoV-2 was concern about possible side effects (82.1%), followed by the belief that the vaccines had not been adequately tested (64.3%). Vaccination-related SEs were reported by 52.8% of the patients. Younger age, higher education, lower degree of disability, relapsing disease course, shorter disease duration, not receiving a disease-modifying therapy and higher anxiety and depression levels were associated with the occurrence of certain vaccination-related SEs. Concerns about novel vaccines are widespread among MS patients and necessitate targeted education of the patients, especially to those with more severe psychopathological symptoms (anxiety or depression) and those who are generally skeptical of vaccination.

Depression and Anxiety in Association with Polypharmacy in Patients with Multiple Sclerosis.

Polypharmacy (intake of ≥5 drugs) is an important issue for patients with chronic diseases such as multiple sclerosis (MS). We aimed to assess the prevalence of polypharmacy with regard to the severity of anxiety/depression and to comorbidities. Therefore, 374 MS patients from two German neurological sites were examined for drug burden, comorbidities, disability level and psychopathological measures capturing depression and anxiety using the Hospital Anxiety and Depression Scale (HADS-A and HADS-D). We found that patients with a higher HADS-D score take more medication (r = 0.217, p < 0.001). Furthermore, patients with higher depression severity were more likely to show polypharmacy (p < 0.001). These differences were not significant for anxiety. (p = 0.413). Regarding the frequency of ≥1 comorbidities, there were no significant differences between patients with different HADS-A (p = 0.375) or HADS-D (p = 0.860) severity levels, whereas the concrete number of comorbidities showed a significant positive linear correlation with HADS-A (r = 0.10, p = 0.045) and HADS-D scores (r = 0.19, p < 0.001). In conclusion, symptoms of depression pose a relevant issue for MS patients and are correlated with polypharmacy and comorbidities. Anxiety is not correlated with polypharmacy but with the frequency of several comorbidity groups in MS patients.

Therapy of women with multiple sclerosis: an analysis of the use of drugs that may have adverse effects on the unborn child in the event of (unplanned) pregnancy.

Background: Although effective contraception is strongly recommended during the therapy of women with multiple sclerosis (MS) with some immunomodulatory drugs, unplanned pregnancies still occur. Adequate medication management is essential to avoid foetal harm in the event of an unplanned pregnancy. Objective: The aim was to screen for medications used in women of childbearing age with MS that may pose a risk of side effects on foetal development. Methods: Sociodemographic, clinical and medication data were collected from 212 women with MS by structured interviews, clinical examinations and medical records. Using the databases from Embryotox, Reprotox, the Therapeutic Goods Administration and on the German summaries of product characteristics, we assessed whether the taken drugs were potentially harmful regarding the foetal development. Results: The majority of patients (93.4%) were taking one or more drugs for which a possible harmful effect on the foetus is indicated in at least one of the four databases used. This proportion was even higher in patients who used hormonal contraceptives (birth control pills or vaginal rings) (PwCo, n = 101), but it was also quite high in patients who did not use such contraceptives (Pw/oCo, n = 111) (98.0% and 89.2%, respectively). PwCo were significantly more likely to take five or more medications with potential foetal risk according to at least one database than Pw/oCo (31.7% versus 6.3%). PwCo were also more severely disabled (average Expanded Disability Status Scale score: 2.8 versus 2.3) and more frequently had comorbidities (68.3% versus 54.1%) than Pw/oCo. Conclusion: Data on the most commonly used drugs in MS therapy were gathered to study the risk of possible drug effects on foetal development in female MS patients of childbearing age. We found that the majority of drugs used by patients with MS are rated as having a potential risk of interfering with normal foetal development. More effective contraception and special pregnancy information programmes regarding the therapy management during pregnancy should be implemented to reduce potential risks to mother and child. Plain Language Summary: Use of drugs not recommended during pregnancy by women with multiple sclerosis Introduction: Patients with multiple sclerosis (MS) often have to take different drugs simultaneously. During the therapy with some immunomodulatory drugs, effective contraception is strongly recommended. Nevertheless, unplanned pregnancies occur regularly in women with MS.Methods: Here, we investigated whether the 212 patients included in this study were taking drugs with known possibility of harm to the development of an unborn child. This was done using four different drug databases.Results: A subset of 111 patients was not taking hormonal contraceptives (birth control pills or vaginal rings). Of those, 99 patients were taking at least one drug that is not recommended during pregnancy according to at least one of the four databases. Most of the medications taken have the potential to affect normal foetal development.Conclusion: To ensure safe use of medications, the patients should be reminded of the importance of effective contraception.

Immune checkpoint inhibition and targeted therapy for melanoma: A patient-oriented cross-sectional comparative multicentre study.

BACKGROUND: Choosing the adequate systemic treatment for melanoma is driven by clinical parameters and personal preferences. OBJECTIVE: Evaluation of the impact of disease and treatment on the daily life of patients receiving systemic therapy for melanoma. METHODS: A German-wide, cross-sectional comparative study was conducted at 13 specialized skin cancer centres from 08/2020 to 03/2021. A questionnaire was distributed to assess patients' perception of disease and symptoms, the impact of their current treatment on quality of life (QOL) and activities, adverse events (AEs), therapeutic visits, as well as believe in and satisfaction with their current systemic melanoma treatment. Patient-reported outcomes (PROs) were rated on a continuous numerical rating scale or selected from a given list. RESULTS: Four hundred and fourteen patients with systemic melanoma therapy were included. 359 (87%) received immune checkpoint inhibition (ICI) and 55 (13%) targeted therapy (TT). About 1/3 of patients were adjuvantly treated, the remaining because of unresectable/metastatic melanoma. In subgroup analyses, only in the adjuvant setting, TT patients reported a significant decrease in their treatment associated QOL compared to patients with ICI (p = 0.02). Patients with TT were 1.9 times more likely to report AEs than patients with ICI, a difference being significant just for the adjuvant setting (p = 0.01). ICI treatment intervals differed significantly between adjuvant and unresectable/metastatic setting (p = 0.04), though all patients, regardless of their specific ICI drug, evaluated their treatment frequency as adequate. TT patients with dabrafenib/trametinib (n = 37) or encorafenib/binimetinib (n = 15) did not differ regarding the strain of daily pill intake. Patients older than 63 years rated various PROs better than younger patients. CONCLUSIONS: Patients evaluated their treatment mainly positively. ICI might be preferred over TT regarding QOL and patient-reported AEs in the adjuvant setting. Older melanoma patients appeared to be less impacted by their disease and more satisfied with their treatment.

Vaccination willingness in association with personality traits in patients with multiple sclerosis in the course of SARS-CoV-2 pandemic.

Vaccination is a key strategy for controlling the SARS-CoV-2 pandemic. Acceptance of SARS-CoV-2 vaccines by chronically ill patients, such as multiple sclerosis (MS) patients, plays an important role in prevention of complicated disease course. This longitudinal, prospective, multi-centre-study of German MS-patients aimed to detect socio-demographic, clinical, or psychological determinants of attitudes towards standard vaccines, SARS-CoV-2 vaccines, and governmental measures before/during the pandemic. Exactly 404 MS-patients were investigated by standardized questionnaires and structured interviews on socio-demographic, clinical-neurological, and psychological characteristics, vaccination status, and vaccination from June 2019. Data on SARS-CoV-2 vaccination willingness were collected in two follow-up assessments (1st: June to July 2020, before SARS-CoV-2 vaccine availability, N = 200; 2nd: March to May 2021, after SARS-CoV-2 vaccine availability, N = 157). Age, sex, MS course type, depression, and personality characteristics (Extraversion, Novelty seeking, Self-directedness, and Cooperativeness) were significantly associated with vaccination willingness. Although the majority of MS-patients showed SARS-CoV-2 vaccination willingness at both follow-ups (1st: 60%, 2nd: 61%), a substantial proportion had concerns and were undecided or opposed to vaccination. Socio-demographic variables like age and sex, psychopathological status, and various personality characteristics might influence vaccination willingness and should be considered when discussing with MS-patients about SARS-CoV-2 vaccination.

Screening for severe drug-drug interactions in patients with multiple sclerosis: A comparison of three drug interaction databases.

Background: Patients with multiple sclerosis (MS) often undergo complex treatment regimens, resulting in an increased risk of polypharmacy and potential drug-drug interactions (pDDIs). Drug interaction databases are useful for identifying pDDIs to support safer medication use. Objective: To compare three different screening tools regarding the detection and classification of pDDIs in a cohort of MS patients. Furthermore, we aimed at ascertaining sociodemographic and clinical factors that are associated with the occurrence of severe pDDIs. Methods: The databases Stockley's, Drugs.com and MediQ were used to identify pDDIs by screening the medication schedules of 627 patients. We determined the overlap of the identified pDDIs and the level of agreement in pDDI severity ratings between the three databases. Logistic regression analyses were conducted to determine patient risk factors of having a severe pDDI. Results: The most different pDDIs were identified using MediQ (n = 1,161), followed by Drugs.com (n = 923) and Stockley's (n = 706). The proportion of pDDIs classified as severe was much higher for Stockley's (37.4%) than for Drugs.com (14.4%) and MediQ (0.9%). Overall, 1,684 different pDDIs were identified by at least one database, of which 318 pDDIs (18.9%) were detected with all three databases. Only 55 pDDIs (3.3%) have been reported with the same severity level across all databases. A total of 336 pDDIs were classified as severe (271 pDDIs by one database, 59 by two databases and 6 by three databases). Stockley's and Drugs.com revealed 47 and 23 severe pDDIs, respectively, that were not included in the other databases. At least one severe pDDI was found for 35.2% of the patients. The most common severe pDDI was the combination of acetylsalicylic acid with enoxaparin, and citalopram was the drug most frequently involved in different severe pDDIs. The strongest predictors of having a severe pDDI were a greater number of drugs taken, an older age, living alone, a higher number of comorbidities and a lower educational level. Conclusions: The information on pDDIs are heterogeneous between the databases examined. More than one resource should be used in clinical practice to evaluate pDDIs. Regular medication reviews and exchange of information between treating physicians can help avoid severe pDDIs.

Associated factors of potential drug-drug interactions and drug-food interactions in patients with multiple sclerosis.

Background: Multiple sclerosis (MS) is the most common immune-mediated demyelinating disease in younger adults. Patients with MS (PwMS) are vulnerable to the presence of potential drug-drug interactions (pDDIs) and potential drug-food interactions (pDFIs) as they take numerous medications to treat MS, associated symptoms and comorbidities. Knowledge about pDDIs and pDFIs can increase treatment success and reduce side effects. Objective: We aimed at determining the frequency and severity of pDDIs and pDFIs in PwMS, with regard to polypharmacy. Methods: In the cross-sectional study, we analysed pDDIs and pDFIs of 627 PwMS aged ⩾18 years. Data collection was performed through patient record reviews, clinical examinations and structured patient interviews. pDDIs and pDFIs were identified using two DDI databases: Drugs.com Interactions Checker and Stockley's Interactions Checker. Results: We identified 2587 pDDIs (counted with repetitions). Of 627 PwMS, 408 (65.1%) had ⩾ 1 pDDI. Polypharmacy (concomitant use of ⩾ 5 drugs) was found for 334 patients (53.3%). Patients with polypharmacy (Pw/P) were found to have a 15-fold higher likelihood of having ⩾ 1 severe pDDI compared with patients without polypharmacy (Pw/oP) (OR: 14.920, p < 0.001). The most frequently recorded severe pDDI was between citalopram and fingolimod. Regarding pDFIs, ibuprofen and alcohol was the most frequent severe pDFI. Conclusion: Pw/P were particularly at risk of severe pDDIs. Age and educational level were found to be factors associated with the occurrence of pDDIs, independent of the number of medications taken. Screening for pDDIs/pDFIs should be routinely done by the clinical physician to increase drug safety and reduce side effects.

Vaccination Coverage against Tetanus, Diphtheria, Pertussis and Poliomyelitis and Validity of Self-Reported Vaccination Status in Patients with Multiple Sclerosis.

Multiple sclerosis (MS) is a chronic immune-mediated disease with a neurodegenerative component of the central nervous system. Immunomodulatory therapy can increase the risk of infection, which is a particular risk for MS patients. Therefore, a complete vaccination status is of utmost importance as protection against vaccine-preventable infectious diseases. Our aim was to investigate the vaccination status, vaccination card knowledge and the vaccination behavior of MS patients with regard to vaccinations against tetanus, diphtheria, pertussis and poliomyelitis. Three hundred twenty-seven patients with MS were evaluated by anamnesis, clinical examination, structured interview and vaccination card control in this two-center study. Based on the recommendations of the Robert Koch Institute, we assessed the completeness of the vaccination status of the examined vaccinations. Furthermore, a comparative analysis of patients with complete/incomplete or correctly/wrongly self-reported vaccination status was performed. In the cohort analyzed, the vaccination coverage was 79.5% for tetanus, 79.2% for diphtheria, 74.8% for pertussis and 84.8% for poliomyelitis. The assumed vaccination status was higher for tetanus (86.5%) and lower for diphtheria (69.4%), pertussis (61.2%) and poliomyelitis (75.9%). Patients who were unvaccinated or only partially vaccinated against tetanus had received vaccination advice from a physician less often in the past year (13.4 vs. 36.9%, p < 0.001) and had no one to check the vaccination card more often (35.8 vs. 12.3%, p < 0.001). High sensitivity (93.7%) and low specificity (30.3%) were determined regarding the validity of self-reported tetanus vaccination status. Patients with a correctly reported tetanus vaccination status were more likely to have their vaccination card checked by a physician than those who overestimated or underestimated their vaccination status (76.7 vs. 63.0/43.8%, p = 0.002). Similar findings were seen with regard to diphtheria, pertussis and poliomyelitis vaccination. Patients without a regular vaccination card control (17.1%) were more likely to be male (44.6 vs. 29.4%, p = 0.037), had fewer siblings on average (1.1 vs. 1.6, p = 0.016), dealt less frequently with the issue of vaccination in the past year (32.1 vs. 69.3%, p < 0.001) and more frequently had the wish to receive vaccination advice (48.2 vs. 34.4%, p = 0.030) than patients in whom the vaccination card was checked regularly by a physician. To minimize the risk of infection in MS patients, treating physicians should provide regular vaccination counseling and perform vaccination card controls, as these factors are associated with a higher vaccination coverage and a higher validity of self-reported vaccination statuses.

General vaccination willingness and current vaccination status in relation to clinical and psychological variables in patients with multiple sclerosis.

BACKGROUND: Infections can have a significant impact on morbidity and mortality in multiple sclerosis (MS) patients. Therefore, vaccinations are of immense importance. If vaccination willingness is to be increased, possible influencing factors should be identified. The aim of the present study was to investigate the status of active immunisation in MS patients in association with sociodemographic, clinical-neurological, psychopathological and personality variables using the NEO-Five Factor Inventory, the Temperament and Character Inventory-Revised and the Hospital Anxiety and Depression Scale. METHOD: Four hundred and four MS patients from two German neurological hospitals were examined for their vaccination attitudes, in detail, the general willingness to vaccinate and the current vaccination status of mumps, measles and rubella (MMR) as well as tetanus and influenza. We also looked at the current level of disability in relation to the current vaccination status, as well as possible associated personality and psychopathological variables. RESULTS: Patients with a complete MMR vaccination status were significantly younger and those with a complete influenza vaccination status were significantly older than those with related incomplete vaccination status. Tetanus vaccination status completeness did not differ depending on age and did not show substantial association with personality scores. However, influenza vaccination completeness was associated with differences in personality and psychopathological variables; extraversion, openness, novelty seeking, harm avoidance and anxiety. A reported general vaccination willingness was significantly correlated with the current completeness of tetanus and influenza vaccinations. Novelty seeking, persistence, extraversion, agreeableness, conscientiousness and neuroticism were found associated with an increased vaccination willingness. Anxiety and depression were not related to general vaccination willingness. CONCLUSIONS: No specific personality trait could be defined on its own in relation to general vaccination willingness or complete vaccination status. Younger patients should be made more aware of influenza vaccination. Reasons for rather low vaccination rates need to be further investigated.

Prevalence and Severity of Potential Drug-Drug Interactions in Patients with Multiple Sclerosis with and without Polypharmacy.

Polypharmacy (PP) is a common problem in modern medicine, especially known to affect patients with chronic diseases such as multiple sclerosis (MS). With an increasing number of drugs taken, the risk of potential drug-drug interactions (pDDIs) is rising. This study aims to assess the prevalence and clinical relevance of polypharmacy and pDDIs in patients with MS. Pharmacological data of 627 patients with MS were entered into two drug-drug-interaction databases to determine the number and severity of pDDIs for each patient. The patients were divided into those with and without PP (total PP and prescription medication PP (Rx PP)). Of the 627 patients included, 53.3% and 38.6% had total PP and Rx PP, respectively. On average, every patient took 5.3 drugs. Of all patients, 63.8% had at least one pDDI with a mean of 4.6 pDDIs per patient. Less than 4% of all pDDIs were moderately severe or severe. Medication schedules should be checked for inappropriate medication and for possible interacting drugs to prevent pDDIs. Physicians as well as pharmacists should be more sensitive towards the relevance of pDDIs and know how they can be detected and avoided.

Vaccination Setting of Patients with Autoimmune Diseases in Times of Severe Acute Respiratory Syndrome Coronavirus Type 2 Pandemic Using the Example of Multiple Sclerosis Patients: A Longitudinal Multicenter Study.

BACKGROUND: Severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) infection represents a serious health risk, especially in chronically ill people. Multiple sclerosis (MS) is the most common chronic immune-mediated neurological disease. Vaccinations play an important role in the therapeutic MS management. This study aimed at determining MS patients' attitudes toward vaccinations and governmental measures before and during the SARS-CoV-2 pandemic, including associations with sociodemographic and clinical variables. METHODS: In a longitudinal, multicenter study, 200 MS patients were investigated regarding their vaccination attitudes before and after the first wave of the SARS-CoV-2 pandemic. Data on vaccination status and burden (physical, psychological, and social) experienced as caused by the pandemic and related governmental safety measures were registered. RESULTS: Patients with progressive MS felt significantly more pandemic-burdened than patients with relapsing-onset MS (p < 0.001). Older patients were more frequently willing to get vaccinated against SARS-CoV-2 than younger patients (p < 0.001). After the first pandemic wave, patients with pre-pandemic willingness to comply with vaccination recommendations were more likely to accept recommended standard vaccinations (60% vs. 36%) and a possible SARS-CoV-2 vaccination than pre-pandemic nonwilling patients (66.7% vs. 42.0%). CONCLUSIONS: The vaccination topic was not immediately present in many patients before the pandemic. MS patients need comprehensive and understandable education meeting their concerns using evidence-based and convincing arguments on the subject of vaccination, particularly younger patients. Older patients are already more often willing to become vaccinated. Complete vaccination status is necessary to avoid multiple infections.

The risk of polypharmacy, comorbidities and drug-drug interactions in women of childbearing age with multiple sclerosis.

BACKGROUND AND AIMS: Multiple sclerosis (MS) is the most common neuroimmunological disease of the central nervous system in young adults. Despite recommended contraception, unplanned pregnancies can occur in women of childbearing age with MS. MS- and comorbidities-related multimedication in these patients represents a potential risk. We aimed to raise awareness regarding the frequency of polypharmacy and drug-drug interactions (DDIs) in female MS patients of childbearing age. METHODS: Sociodemographic, clinical and pharmaceutical data were collected through patient records, clinical investigations and structured patient interviews of 131 women with MS. The clinical decision support software MediQ was used to identify potential DDIs. A medication and DDI profile of the study population was created by statistical analysis of the recorded data. RESULTS: Of the 131 female MS patients, 41.2% were affected by polypharmacy (concurrent use of ⩾5 drugs). Polypharmacy was associated with higher age, higher degree of disability, chronic progressive MS disease course and comorbidities. With an average intake of 4.2 drugs per patient, a total of 1033 potential DDIs were identified. Clinically relevant DDIs were significantly more frequent in patients with polypharmacy than in patients without polypharmacy (31.5% versus 5.2%; Fisher's exact test: p < 0.001). CONCLUSION: For the first time, a comprehensive range of potential DDIs in women of childbearing age with MS is presented. Polypharmacy is associated with the occurrence of clinically relevant DDIs. This shows the need for effective and regular screening for such interactions in order to prevent avoidable adverse effects.