Results of treatment with alemtuzumab in a Spanish cohort of patients with multiple sclerosis in the real world: The RealMS study.

Background: Alemtuzumab (ALZ) is a humanized monoclonal antibody approved for the treatment of patients with highly active relapsing-remitting multiple sclerosis (RRMS) administered in two annual courses. The objective of this study was to describe the effectiveness and safety data of ALZ and to report the health resource utilization in patients receiving this treatment. Methods: In this retrospective, non-interventional study, information was retrieved from patients' medical charts at one center in Spain. Included patients were ≥18 years old, and ALZ treatment was initiated between 1 March 2015 and 31 March 2019, according to routine clinical practice and local labeling. Results: Of 123 patients, 78% were women. The mean (standard deviation, SD) age of patients at diagnosis was 40.3 (9.1) years, and the mean time since diagnosis was 13.8 (7.3) years. Patients were previously treated with a median (interquartile range; IQR) number of two (2.0-3.0) disease-modifying treatments (DMTs). Patients were treated with ALZ for a mean (SD) of 29.7 (13.8) months. ALZ reduced the annualized relapse rate (ARR) (1.5 before vs. 0.05 after; p < 0.001) and improved the median EDSS (4.63 before vs. 4.00 after; p < 0.001). Most (90.2%) patients were relapse-free while receiving ALZ. The mean number of gadolinium-enhancing [Gd+] T1 lesions was reduced (1.7 before vs. 0.1 after; p < 0.001), and the mean number of T2 hyperintense lesions was maintained (35.7 before vs. 35.4 after; p = 0.392). A total of 27 (21.9%) patients reported 29 autoimmune diseases: hyperthyroidism (12), hypothyroidism (11), idiopathic thrombocytopenic purpura (ITP) (3), alopecia areata (1), chronic urticaria (1), and vitiligo (1). The mean number of health resources (outpatient visits, emergency room visits, hospital admissions, and tests performed in the hospital) used while patients were treated with ALZ progressively decreased from year 1 to year 4, except for a slight increase at year 2 of outpatient visits. Conclusion: The ReaLMS study provides real-world evidence that ALZ can promote clinical and magnetic resonance imaging disease remission, as well as disability improvement in patients with MS, despite several prior DMT failures. The ALZ safety profile was consistent with data available from clinical trials and other real-world studies. Healthcare resource use was reduced throughout the treatment period.

Skin Autoimmunity Secondary to Alemtuzumab in a Tertiary Care Spanish Hospital.

Background and Objectives: The most common adverse events (AEs) after alemtuzumab (ALZ) include adverse infusion reactions, infections, and autoimmune disorders. Skin AEs are common during infusion, but there are few reported cases of long-term skin autoimmune disease. Methods: A retrospective case series of patients developing long-term autoimmune skin disorders after ALZ administration in a tertiary care hospital. Results: Of 133 patients treated with ALZ, 8 patients (6.02%) developed 9 autoimmune cutaneous AEs, including 4 events of alopecia areata, 2 of vitiligo, 2 of chronic urticaria, and 1 of inflammatory atrichia. Three of them occurred between the first and the second infusion. Discussion: The lesions described are secondary to autoimmune disorders, probably related to immune dysregulation because of a differential lymphocyte repopulation after ALZ. Autoimmune cutaneous AEs may be frequent, and it would be recommended to monitor its appearance to treat them.

Epidemiology of balance disorders in primary care. / Epidemiología de los trastornos del equilibrio en atención primaria.

BACKGROUND AND OBJECTIVE: In our country, there are no series of patients that have described the incidence of the different diseases which cause balance disorders (BD) in primary care. The objective of this study is to calculate the incidence of each disease to propose specific training measures. MATERIALS AND METHOD: Prospective cross-sectional study. Patient data of five primary care physicians in five different primary care centres in our hospital area were collected. All patients who attended consultations for any type of vertigo, imbalance or dizziness over one year as the main reason for consultation were recruited. Using a diagnostic-therapeutic algorithm, patients were diagnosed and treated in primary care or referred for study in hospital care. RESULTS: The population studied was 7,896 people. An annual incidence of BD of 2.2% was detected. Of the cases, 56.1% could be diagnosed and treated in primary care. Of the patients, 53.8% were diagnosed with some type of positional vertigo; the next three most frequent diagnoses were vestibular migraine, central nervous system ischaemia and medication side effects. These four groups accounted for 87.9% of the population. CONCLUSIONS: The incidence of BD in primary care requires an approach that includes training in the diagnosis and treatment of benign paroxysmal positional vertigo, headache, cardiovascular risk factors and pharmacology. It is not necessary to prescribe vestibular suppressants in most patients.

Predictors of clinically significant quality of life impairment in Parkinson's disease.

Quality of life (QOL) plays an important role in independent living in Parkinson's disease (PD) patients, being crucial to know what factors impact QoL throughout the course of the disease. Here we identified predictors of QoL impairment in PD patients from a Spanish cohort. PD patients recruited from 35 centers of Spain from the COPPADIS cohort from January 2016, to November 2017, were followed up during 2 years. Health-related QoL (HRQoL) and global QoL (GQoL) were assessed with the 39-item Parkinson's disease Questionnaire (PDQ-39) and the EUROHIS-QOL 8-item index (EUROHIS-QOL8), respectively, at baseline (V0) and at 24 months ± 1 month (V2). Clinically significant QoL impairment was defined as presenting an increase (PDQ-39SI) or decrement (EUROHIS-QOL8) at V2 ≥ 10% of the score at baseline (V0). A comparison with a control group was conducted for GQoL. GQoL did not change significantly in PD patients (N = 507; p = 0.686) or in the control group (N = 119; p = 0.192). The mean PDQ-39SI was significantly increased in PD patients (62.7 ± 8.5 years old; 58.8% males; N = 500) by 21.6% (from 16.7 ± 13 to 20.3 ± 16.4; p < 0.0001) at V2. Ninety-three patients (18.6%) presented a clinically significant HRQoL impairment at V2. To be younger (OR = 0.896; 95% CI 0.829-0.968; p = 0.006), to be a female (OR = 4.181; 95% CI 1.422-12.290; p = 0.009), and to have a greater increase in BDI-II (Beck Depression Inventory-II) (OR = 1.139; 95% CI 1.053-1.231; p = 0.001) and NMSS (Non-Motor Symptoms Scale) (OR = 1.052; 95% CI 1.027-1.113; p < 0.0001) total scores from V0 to V2 were associated with clinically significant HRQoL impairment at the 2-year follow-up (Hosmer-Lemeshow test, p = 0.665; R2 = 0.655). An increase in ≥5 and ≥10 points of BDI-II and NMSS total score at V2 multiplied the probability of presenting clinically significant HRQoL impairment by 5 (OR = 5.453; 95% CI 1.663-17.876; p = 0.005) and 8 (OR = 8.217; 95% CI, 2.975-22.696; p = 0.002), respectively. In conclusion, age, gender, mood, and non-motor impairment were associated with clinically significant HRQoL impairment after the 2-year follow-up in PD patients.