Administration of subcutaneous interferon beta 1a in the evening: data from RELIEF study.

BACKGROUND: Subcutaneous recombinant interferon-beta 1a (IFN-ß1a SC) is indicated for treatment of relapsing multiple sclerosis (RMS); however, it is associated with development of flu-like syndrome (FLS) in 75% of patients. No recommendations are available on whether evening or morning administration could induce better or worse FLS. OBJECTIVE: Primary objective was to investigate whether morning administration of IFN-ß1a 44 µg (Rebif) would affect the severity of FLS versus evening administration, in patients with RMS. Secondary objectives were to investigate whether timing of administration could lead to a better quality of life. METHODS: Multicenter, open-label, 12-week, randomized, controlled, parallel-group, phase 4 study. RESULTS: Of 217 patients screened at 29 Italian sites, 200 were included in the study. Among these, 104 patients were randomized to IFN-ß1a SC administration in the morning and 96 in the evening. Morning administration resulted in higher FLS scores, as measured by the Multiple Sclerosis Treatment Concern Questionnaire, at week 4 (p = 0.0083) and week 8 (p = 0.0079); however, the difference was no longer significant at the end of 12 weeks. CONCLUSION: IFN-ß1a evening injections in the first 8 weeks of treatment led to an improvement in FLS; when continuing therapy, time of administration could be decided according to patient's lifestyle and preference.

Incidence of multiple sclerosis in the province of Catania. A geo-epidemiological study.

BACKGROUND: An increasing incidence of MS in the city of Catania was reported during 1975-2004, with a higher incidence along the south-eastern flank of the Mt.Etna. We evaluated the incidence of MS in the entire province of Catania during 2005-2015 and the spatial distribution of MS-cases using a cluster analysis. METHODS: Patients were considered as incident MS-cases if they fulfilled the revised McDonald criteria for MS during 2005-2015 and were residents in the province of Catania at the time of disease onset. Cluster analysis was performed using both LISA and Kulldorff's spatial scan statistic. Residence address at disease onset was considered for each case. Communalities were assessed considering the centroid of their inhabited area. RESULTS: A total of 973 MS-cases were identified. Mean annual incidence risk was 8.2/100,000 person-years (95%CI 7.7-8.7), significantly higher among women (10.5/100,000 versus 5.7/100,000). LISA identified a spatial aggregation of MS-cases in the eastern side of the province of Catania and Kulldorff's statistics confirmed the existence of a statistically significant spatial cluster in this area (SIR 1.23,95%CI 1.08-1.23, p-value 0.04). CONCLUSIONS: Our study confirms a high incidence of MS in the province of Catania and the presence of a spatial cluster along the eastern side of the province. This area is considered the most exposed to volcanogenic ashes due to the prevailing westerly to north-westerly trade winds. Even if such distribution could be related with a greater exposure to volcanogenic metals, further studies are needed to explore possible alternative hypotheses.

Multiple Sclerosis in the Mount Etna region: possible role of volcanogenic trace elements.

BACKGROUND: Trace elements have been hypothesised to be involved in the pathogenesis of Multiple Sclerosis and volcanic degassing is the major natural sources of trace elements. Both incidence of Multiple Sclerosis in Catania and volcanic activity of Mount Etna have been significantly increased during the last 30 years. Due to prevailing trade winds direction, volcanic gases from Etna summit craters are mostly blown towards the eastern and southern sectors of the volcano. OBJECTIVE: To evaluate the possible association between Multiple Sclerosis and exposure to volcanogenic trace elements. METHODS: We evaluated prevalence and incidence of Multiple Sclerosis in four communities (47,234 inhabitants) located in the eastern flank and in two communities (52,210 inhabitants) located in the western flank of Mount Etna, respectively the most and least exposed area to crater gas emissions. RESULTS: A higher prevalence was found in the population of the eastern flank compared to the population of the western one (137.6/100,000 versus 94.3/100,000; p-value 0.04). We found a borderline significantly higher incidence risk during the incidence study period (1980-2009) in the population of the eastern flank 4.6/100,000 (95% CI 3.1-5.9), compared with the western population 3.2/100,000 (95% CI 2.4-4.2) with a RR of 1.41 (95% CI 0.97-2.05; p-value 0.06). Incidence risks have increased over the time in both populations reaching a peak of 6.4/100,000 in the eastern flank and of 4.4/100.000 in the western flank during 2000-2009. CONCLUSION: We found a higher prevalence and incidence of Multiple Sclerosis among populations living in the eastern flank of Mount Etna. According to our data a possible role of TE cannot be ruled out as possible co-factor in the MS pathogenesis. However larger epidemiological study are needed to confirm this hypothesis.

Increasing frequency of multiple sclerosis in Catania, Sicily: a 30-year survey.

BACKGROUND AND OBJECTIVE: The objective of this study was to determine the prevalence and incidence of multiple sclerosis (MS) and its temporal profiles from 1975 to 2005 in the city of Catania. METHODS: The incidence of MS from 1975 to 31 December 1999 had been previously investigated by the same group. The frequency of MS in the community of Catania from 1 January 2000 to 31 December 2004 was studied in a population of 313,110 inhabitants (2001 census). All patients who satisfied Poser's criteria were considered as prevalent and incident cases. RESULTS: Three hundred and ninety-eight patients with MS who had experienced the clinical onset of the disease before 31 December 2004 were found in a population of 313,110 inhabitants. The prevalence rate was 127.1/100,000 [95% confidence interval (CI) 115.1-140.4]. From 2000 to 2004, 108 patients with MS had clinical onset of the disease. The mean annual incidence was 7.0/100,000 (95% CI 5.7-13.7) and was higher in women (8.4/100,000; 95% CI 6.4-10.5) than in men (5.3/100,000; 95% CI 3.7-7.2). The mean length of time between the date of clinical onset and the date of the diagnosis was 1.4 ± 1.7 years. During the last 30 years the incidence of MS in this population increased from 1.3/100,000 during the first quinquennium (1975-9) to 7.0/100,000 during 2000-4. CONCLUSIONS: Incidence rates have further increased in this population, suggesting that the risk of MS is still increasing.