RESUMO
BACKGROUND: cladribine tablets is a highly effective option for the treatment of relapsing-remitting multiple sclerosis (RRMS). OBJECTIVE: to evaluate the effectiveness of cladribine in a real-world setting. METHODS: this prospective real-world study consecutively screened all RRMS patients from seven different MS centers in Sicily (Italy), who completed the 2-year treatment course of cladribine tablets in the period between 11th March 2019 and 31st October 2021. Data about Expanded Disability Status Scale (EDSS), relapses, previous treatments, adverse events (AEs) and magnetic resonance imaging (MRI) were collected. Patients who were previously treated with other DMTs were further stratified in moderately active treatment (MAT) and highly active treatment (HAT) patients. RESULTS: a total of 217 patients, (70% women, with mean age of 38.4 ± 11.3 years), were enrolled. Fifty patients (23.0%) were naïve to treatment and 167 (77%) switched from another disease modifying therapies. After the second year of treatment, about 80% of were EDSS progression free, 88% remained relapse-free at T24, and 48% of patients were MRI activity-free. Kaplan Meier analyses showed significant differences between MT and HAT in terms of time to first clinical relapse (HR: 2.43, IC 1.02 - 5.76; p=0.04), time to the first new T1-gadolinium enhancing lesion (HR: 3.43, IC 1.35 - 8.70; p= 0.009) and time to MRI worsening (HR: 2.42, IC 1.15 - 5.09; p= 0.02). CONCLUSION: this study confirmed that cladribine is an effective treatment for MS, in particular in naïve patients and in those who have switched from MATs.
RESUMO
STUDY OBJECTIVES: Few studies have analyzed the prevalence of isolated rapid eye movement sleep behavior disorder (RBD) giving different estimates. Aim of the study was to estimate the prevalence of isolated RBD in the city of Catania. METHODS: A 3-stage design was adopted. Participants attending the offices of general practitioners in the city of Catania were screened with the RBD Single Question Screen questionnaire (Stage I). Positive participants were interviewed by phone and, if suspected of RBD, were invited for clinical examination by a movement disorders specialist and a sleep specialist (Stage II). After the clinical examination, patients diagnosed as probable isolated RBD (pRBD) were invited to undergo a video polysomnography (Stage III) to confirm the diagnosis of definite RBD. RESULTS: A total of 1,524 participants were screened. Of these, 220 (14.4%) screened positive. One hundred forty-three of them were further screened by phone, of whom 75 were suspected RBD. Thirty-six patients were diagnosed as pRBD, giving a prevalence of 2.36% (95% confidence interval, 1.71-3.25). Twelve pRBD agreed to a video polysomnography and, of these, 4 were diagnosed as definite RBD, giving a prevalence of 0.26% (95% confidence interval, 0.07-0.67). Prevalence adjusted by nonparticipants was 3.48% (95% confidence interval, 2.67-4.52) and 1.18% (95% confidence interval, 0.45-1.37) for pRBD and definite RBD, respectively. CONCLUSIONS: Prevalence of both pRBD and definite RBD in Italy is comparable to the estimates reported in literature, confirming that isolated RBD has a low prevalence in the general population. CITATION: Cicero CE, Giuliano L, Sgroi R, et al. Prevalence of isolated RBD in the city of Catania, Italy: a population-based study. J Clin Sleep Med. 2021;17(11):2241-2248.