Effects of immunomodulatory treatment with subcutaneous interferon beta-1a oncognitive decline in mildly disabled patients with relapsing-remitting multiple sclerosis

The objective of this study was to assess the effects of subcutaneous (sc) interferon beta-1a (IFNbeta-1a) on cognition in mildly disabled patients with relapsing-remitting multiple sclerosis (RRMS). Patients aged 18-50 years with RRMS (McDonald criteria; Expanded Disability Status Scale score <or=4.0) were assigned IFNbeta therapy at the physician's discretion and underwent standardized magnetic resonance imaging, neurological examination and neuropsychological testing at the baseline and regular intervals for up to three years. This analysis included 459 patients who received sc IFNbeta-1a (44 mcg: n = 236; 22 mcg: n = 223; three-year follow up was available for 318 patients). The hazard ratio for cognitive impairment over three years (44 mcg versus 22 mcg) was 0.68 (95% confidence interval [CI]: 0.480-0.972), suggesting a 32% lower risk with the higher dose treatment. At year 3, the proportion of patients who were cognitively impaired increased slightly from 23.5% at the baseline to 24.8% in the IFNbeta-1a 22 mcg treatment group, but remained stable at 15.2% in the IFNbeta-1a 44 mcg treatment group. The proportion of patients with cognitive impairment at year 3 was significantly higher in the 22 mcg group than in the 44 mcg group (P = 0.03), although a trend was also seen at the baseline (P = 0.058). Multivariate logistic regression (corrected for baseline cognitive deficits) indicated that treatment with the higher dose of IFNbeta-1a was predictive of lower cognitive impairment at three years (odds ratio: 0.51, 95% CI: 0.26-0.99) compared with the lower dose of IFNbeta-1a. These findings suggest that sc IFNbeta-1a may have dose-dependent cognitive benefits in mildly disabled patients with RRMS, and may support early initiation of high-dose IFNbeta-1a treatment

Quality of life, depression and fatigue in mildly disabled patients with relapsing-remitting multiple sclerosis receiving subcutaneous interferon beta-1a: 3-year results from the COGIMUS (COGnitive Impairment in MUltiple Sclerosis) study.

BACKGROUND: The precise relationships among quality of life, depression, fatigue and cognitive impairment in multiple sclerosis (MS) are complex and poorly understood. OBJECTIVE: To assess the effects of subcutaneous interferon beta-1a on quality of life, depression and fatigue over 3 years in the COGIMUS study, and to examine the relationship between these outcomes and baseline cognitive status. METHODS: COGIMUS was an observational 3-year trial assessing cognitive function in 459 patients with relapsing-remitting MS treated with subcutaneous interferon beta-1a. RESULTS: In total, 331 patients completed the study (168 received interferon beta-1a, 44 µg subcutaneously three times weekly, and 163 received interferon beta-1a, 22 µg subcutaneously three times weekly). Mean MS Quality of Life-54 (MSQoL-54) composite scores did not change over time. There were no significant differences between groups in MSQoL-54 composite scores when patients were grouped by treatment dose and baseline cognitive status. Mean (standard deviation) Hamilton Depression Rating Scale score decreased from 6.8 (4.9) at baseline to 5.8 (5.9) at year 3. Mean total Fatigue Impact Scale scores were low (<30) at all time points. CONCLUSION: Quality of life, depression and fatigue remained largely stable over 3 years; no effects of treatment dose or baseline cognitive status were found

The Italian multiple sclerosis register

The past decade has seen extraordinary increase in worldwide availability of and access to several large multiple sclerosis (MS) databases and registries. MS registries represent powerful tools to provide meaningful information on the burden, natural history, and long-term safety and effectiveness of treatments. Moreover, patients, physicians, industry, and policy makers have an active interest in real-world observational studies based on register data, as they have the potential to answer the questions that are most relevant to daily treatment decision-making. In 2014, the Italian MS Foundation, in collaboration with the Italian MS clinical centers, promoted and funded the creation of the Italian MS Register, a project in continuity with the existing Italian MS Database Network set up from 2001. Main objective of the Italian MS Register is to create an organized multicenter structure to collect data of all MS patients for better defining the disease epidemiology, improving quality of care, and promoting research projects in high-priority areas. The aim of this article is to present the current framework and network of the Italian MS register, including the methodology used to improve the quality of data collection and to facilitate the exchange of data and the collaboration among national and international groups

The Italian multiple sclerosis register

The past decade has seen extraordinary increase in worldwide availability of and access to several large multiple sclerosis (MS) databases and registries. MS registries represent powerful tools to provide meaningful information on the burden, natural history, and long-term safety and effectiveness of treatments. Moreover, patients, physicians, industry, and policy makers have an active interest in real-world observational studies based on register data, as they have the potential to answer the questions that are most relevant to daily treatment decision-making. In 2014, the Italian MS Foundation, in collaboration with the Italian MS clinical centers, promoted and funded the creation of the Italian MS Register, a project in continuity with the existing Italian MS Database Network set up from 2001. Main objective of the Italian MS Register is to create an organized multicenter structure to collect data of all MS patients for better defining the disease epidemiology, improving quality of care, and promoting research projects in high-priority areas. The aim of this article is to present the current framework and network of the Italian MS register, including the methodology used to improve the quality of data collection and to facilitate the exchange of data and the collaboration among national and international groups

Concomitant rheumatoid arthritis and amyotrophic lateral sclerosis: report of two new cases and review of literature

To describe a rare association between rheumatoid arthritis (RA) and amyotrophic lateral sclerosis (ALS). Two new cases of patients with RA who developed amyotrophic lateral sclerosis (ALS), one receiving anti-TNFα agents, were reported. Only other five cases of this rare association have been previously described in literature. The simultaneous presence of the two diseases represents a difficult diagnostic challenge because RA may mimic some musculoskeletal symptoms of ALS. There is no evidence in favor of a common pathophysiologic mechanism, and thus the possibility of a fortuitous association must be raised. A neurotoxic side effect of various drugs for RA treatment could be considered. Casual or causal association remains a difficult choice. The possibility of a coincidental association must be raised but neurologic side effects of TNFα blockers lead to discussion

Systemic lupus erythematosus related recurrent transverse myelitis in a patient with myasthenia gravis and multiple sclerosis

The authors report the clinical history of a patient with myasthenia gravis and multiple sclerosis who subsequently developed systemic lupus erythematosus related recurrent transverse myelitis

A reappraisal of incidence and prevalence of multiple sclerosis in the province of Ferrara, 1994-1999

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Environmental risk factors and multiple sclerosis: a community-based, case-control study in the province of Ferrara, Italy.

The frequency of multiple sclerosis (MS) in Italy and in other areas of the world seems to have increased over time, suggesting that some environmental factors operate in its etiology. We performed a retrospective, community-based case-control study on MS in order to verify the etiologic role of selected environmental factors. We found an association between MS and higher educational level, employment in public administration, past history of allergies, and infection at an early age with measles, rubella and whooping cough. Our data seem to confirm that exogenous factors play a role in the etiology of MS although some confounding variables could have accounted for the associations

Baseline Patient and Caregiver Characteristics From a Prospective, Noninterventional, Real-World Study (REALITY) on the Effect of Alemtuzumab on Fatigue and Other Patient- and Caregiver-Reported Quality-of-Life Outcomes in Patients With RRMS

Objective: Assess the burden of MS on patient and caregiver quality of life (QoL) at baseline before starting alemtuzumab. Background: Alemtuzumab significantly improved clinical, MRI, and QoL outcomes versus subcutaneous interferon beta-1a in patients with RRMS in clinical trials. Little is known about real-world QoL in alemtuzumab-treated patients and their caregivers. Design/Methods: REALITY is a 3-year prospective, multicenter, noninterventional, observational, real-world study of alemtuzumab-treated RRMS patients conducted in Denmark, Italy, and Norway. Included patients had a baseline Fatigue Scale for Motor and Cognitive Functions (FSMC) total score ≥43. Patient QoL was assessed using FSMC and Multiple Sclerosis Impact Scale (MSIS)-29, and caregiver QoL using 36-Item Short-Form (SF-36) Health Survey physical component summary (PCS) and mental component summary (MCS). Results: Baseline characteristics were available for 87 (100%) patients and 55 caregivers. Patients were 81% female, mean (SD) age 36.4 (8.4) years, MS duration 7.8 (6.1) years, EDSS score 3.1 (1.6), and number of previous MS therapies 2.9 (1.5). Caregivers were 62% male, mean age 44.8 (11.7) years; 85% had been a caregiver for &gt;1 year, 64% were employed full-time, and 75% had children living at home. Before alemtuzumab initiation, mean patient-reported FSMC total score (n=67) was 66.4 (15.6). Patients’ MSIS-29 physical and psychological impact scores at baseline (n=46) were 42.3 (24.6) and 51.7 (28.7), respectively, whereas matched caregivers’ estimates (blinded to patients’ responses) were 36.5 (22.2) and 49.8 (25.9). Caregivers reported mean baseline SF-36 PCS and MCS scores of 48.5 (10.6) and 44.3 (9.9), respectively (lower than general population norm-based score of 50 [10]). Conclusions: Before alemtuzumab initiation, caregivers’ perceptions of patient QoL trended better than patients’ own QoL evaluations and caregivers experienced lower QoL versus the general population on SF-36. The ongoing REALITY study will assess the effect of alemtuzumab treatment on these measures