919 research outputs found
Long-term effectiveness in patients previously treated with cladribine tablets: a real-world analysis of the Italian multiple sclerosis registry (CLARINET-MS)
No full textBackground: The CLARINET-MS study assessed the long-term effectiveness of cladribine tablets by following patients with multiple sclerosis (MS) in Italy, using data from the Italian MS Registry.Methods: Real-world data (RWD) from Italian MS patients who participated in cladribine tablets randomised clinical trials (RCTs; CLARITY, CLARITY Extension, ONWARD or ORACLE-MS) across 17 MS centres were obtained from the Italian MS Registry. RWD were collected during a set observation period, spanning from the last dose of cladribine tablets during the RCT (defined as baseline) to the last visit date in the registry, treatment switch to other disease-modifying drugs, date of last Expanded Disability Status Scale recording or date of the last relapse (whichever occurred last). Time-to-event analysis was completed using the Kaplan-Meier (KM) method. Median duration and associated 95% confidence intervals (CI) were estimated from the model.Results: Time span under observation in the Italian MS Registry was 1-137 (median 80.3) months. In the total Italian patient population (n = 80), the KM estimates for the probability of being relapse-free at 12, 36 and 60 months after the last dose of cladribine tablets were 84.8%, 66.2% and 57.2%, respectively. The corresponding probability of being progression-free at 60 months after the last dose was 63.7%. The KM estimate for the probability of not initiating another disease-modifying treatment at 60 months after the last dose of cladribine tablets was 28.1%, and the median time-to-treatment change was 32.1 (95% CI 15.5-39.5) months.Conclusion: CLARINET-MS provides an indirect measure of the long-term effectiveness of cladribine tablets. Over half of MS patients analysed did not relapse or experience disability progression during 60 months of follow-up from the last dose, suggesting that cladribine tablets remain effective in years 3 and 4 after short courses at the beginning of years 1 and 2
First-line therapies in Late Onset Multiple Sclerosis: an Italian registry study
No full textBackground: The diagnosis of late onset (≥50 years) relapsing remitting multiple sclerosis (LORRMS) has been increasingly described in clinical practice, at the same time, data focusing on the specific therapeutic management of LORRMS are scarce.
Objective: To compare effectiveness of injectable and oral first line disease modifying therapies (DMTs) in a cohort of LORRMS patients with for time to first relapse, time to confirmed disability progression (CDP), and, additionally, for time to discontinuation.
Methods: This is a multicenter, observational, retrospectively acquired cohort study on LORRMS-naïve patients from the Italian MS Register who started either injectable or oral first line DMTs between January 1, 2013 and December 31, 2017. LORRMS were divided into two groups, namely the injectable group (IG) and oral group (OG). Cox models adjusted with inverse probability weighted propensity score were built for the investigated outcomes.
Results: Of a cohort of 3,989 patients, 302 were enrolled (203 in the IG and 99 in the OG). The two cohorts did not differ for baseline characteristics. Time to first relapse did not show any difference between the two groups (HR = 1.10; CI 95% 0.50-2.46, p=.797). Furthermore, no differences were found between the two groups with respect to the risk of CDP (HR = 1.04; CI 95% 0.35-3.06, p = .939), nor for the risk of DMT discontinuation (HR = 0.90; CI 95% 0.17-2.08, p =.425).
Conclusions: Real-world data from the Italian MS Register suggested that both injectables and oral first line DMTs controlled similarly the investigated outcomes in LORRMS
Breakthrough pain and its treatment: critical review and recommendations of IOPS (Italian Oncologic Pain Survey) expert group
No full textControversies exist about the definition and epidemiology of breakthrough cancer pain (BTcP), the pharmacological treatment options, drug dosing, and how to select the medications for BTcP among the new fentanyl products. Existing data were critically evaluated to provide recommendations by an expert group. An algorithm to diagnose BTcP should be used followed by a careful assessment. Fentanyl products provide efficacy and rapidity of action to counteract the temporal pattern of BTcP. The doses of opioids used for background pain should guide the choice of the doses of fentanyl products. The choice of fentanyl products should be based on individual clinical conditions
Multiple sclerosis in twins from continental Italy and Sardinia: a nationwide study
No full textKnowledge about the balance between heritable and nonheritable risk in multiple sclerosis (MS) is based on twin studies
in high-prevalence areas. In a study that avoided ascertainment limitations and directly compared continental Italy
(medium-prevalence) and Sardinia (high-prevalence), we ascertained 216 pairs from 34,549 patients. This gives a twinning
rate of 0.62% among MS patients, significantly less than that of the general population. In continental Italy,
probandwise concordance was 14.5% (95% confidence interval, 5.1–23.8) for monozygotic and 4.0% (95% confidence
interval, 0.8 –7.1) for dizygotic twins. Results in Sardinia resemble those in northern populations but in limited numbers.
Monozygotic concordance was 22.2% (95% confidence interval, 0–49.3) probandwise, but no concordant dizygotic pairs
were identified. A questionnaire on 80 items possibly related to disease cause was administered to 70 twin pairs, 135
sporadic patients, and 135 healthy volunteers. Variables positively (7) or negatively (2) associated with predisposition
and concordance in twins largely overlapped and were mainly linked to infection. If compared with previous studies, our
data demonstrate that penetrance in twins appears to correlate with MS prevalence. They highlight the relevance of
nonheritable variables in Mediterranean areas. The apparent underrepresentation of MS among Italian twins draws
attention to protective factors, shared by twins, that may influence susceptibility
Multiple sclerosis in twins from continental Italy and Sardinia: a nationwide study
No full textKnowledge about the balance between heritable and nonheritable risk in multiple sclerosis (MS) is based on twin studies
in high-prevalence areas. In a study that avoided ascertainment limitations and directly compared continental Italy
(medium-prevalence) and Sardinia (high-prevalence), we ascertained 216 pairs from 34,549 patients. This gives a twinning
rate of 0.62% among MS patients, significantly less than that of the general population. In continental Italy,
probandwise concordance was 14.5% (95% confidence interval, 5.1–23.8) for monozygotic and 4.0% (95% confidence
interval, 0.8 –7.1) for dizygotic twins. Results in Sardinia resemble those in northern populations but in limited numbers.
Monozygotic concordance was 22.2% (95% confidence interval, 0–49.3) probandwise, but no concordant dizygotic pairs
were identified. A questionnaire on 80 items possibly related to disease cause was administered to 70 twin pairs, 135
sporadic patients, and 135 healthy volunteers. Variables positively (7) or negatively (2) associated with predisposition
and concordance in twins largely overlapped and were mainly linked to infection. If compared with previous studies, our
data demonstrate that penetrance in twins appears to correlate with MS prevalence. They highlight the relevance of
nonheritable variables in Mediterranean areas. The apparent underrepresentation of MS among Italian twins draws
attention to protective factors, shared by twins, that may influence susceptibility
Natalizumab in pediatric multiple sclerosis: results of a cohort of 55 cases.
No full textBACKGROUND: Limited information is available on the use of natalizumab (NA) in pediatric multiple sclerosis (ped-MS) patients.
OBJECTIVE: The purpose of this study was to describe the long-term effects of NA in a large cohort of active ped-MS patients.
METHODS: Patients with definite ped-MS were treated with NA if in the previous year they had experienced at least two relapses or a severe relapse with incomplete recovery while on immunomodulating treatment, or at least two relapses and new magnetic resonance imaging (MRI) lesions regardless of any prior treatment.
RESULTS: The study included 55 patients (mean age: 14.4 years, mean number of relapses: 4.4, pre-treatment mean disease duration: 25.5 months). They received a median number of 26 infusions. Three relapses occurred during the follow-up, one female patient continued to deteriorate in cognitive functioning. Mean Expanded Disability Status Scale (EDSS) scores decreased from 2.7 to 1.9 at the last visit (p<0.001). During the follow-up the majority of patients remained free from MRI activity. Transient and mild clinical adverse events occurred in 20 patients. Mild hematological abnormalities occurred in seven patients. Anti-JCV antibodies were detected in 20/51 tested patients.
CONCLUSIONS: NA was well tolerated in all patients. A strong suppression of disease activity was observed in the majority of patients during the follow-up
Management of oxygen saturation monitoring in preterm newborns in the NICU: the Italian picture
No full textBACKGROUND: Although many studies emphasize the importance of using oxygen saturation (SpO2) targets in the NICUs, there is a wide variability in used saturation ranges among centers. Primary aim was to draw a representative picture on how the management of oxygen monitoring is performed in the Italian NICUs. Second aim was to identify healthcare-professionals related factors associated with oxygen targeting in the preterm population. METHODS: Cross-sectional study with data collection via an electronic survey form. A questionnaire containing pre-piloted and open questions on monitoring and management of the SpO2 was administered to neonatologists across the network of the Italian Society of Neonatology. The questions focused on: the infrastructure, specific training, healthcare professionals and patients-related factors. The results of the survey were anonymously collected, summarized and analyzed. RESULTS: Out of 378 questionnaires, 93 were correctly filled. Thirty-six different SpO2 ranges were observed. Centers using written standard operating procedures on oxygen management and SpO2 monitoring maintained a correct average range of SpO2 90-95%, avoided hyperoxia and reconsidered saturation targets in relation to comorbidities. 39.8% of responders disabled alarms during neonatal care. One center used biomarkers for complete monitoring of neonatal oxygenation status. CONCLUSIONS: There is considerable variation in SpO2 targets for preterm infants in the Italian NICUs. Standard operating procedures and specific training for health care personnel are the main factors playing a role for the correct maintenance of the recommended oxygen targets in preterms
Long-term follow-up (up to 11 years) of an Italian pediatric MS cohort treated with Natalizumab: a multicenter, observational study
No full textBackground Natalizumab (NAT) has a strong impact on disease activity of aggressive pediatric multiple sclerosis (MS), with no difference in safety profile compared to adult MS. However, available data are limited by short follow-up. Our aim was to report long-term follow-up data (up to 11 years) of a large Italian pediatric MS cohort treated with NAT. Materials and methods We retrospectively collected data of pediatric MS patients treated with NAT included in a previous study and prospectively followed in Italian MS centers. We compared disease activity pre, during, and post-NAT and we performed survival analyses of time to evidence of disease activity (EDA) during NAT, time to reach EDA post-NAT, and time to NAT discontinuation. Results Ninety-two patients were included from 19 MS centers in Italy. At NAT initiation, cohort's characteristics were as follows: 55 females; 14.7 +/- 2.4 (mean +/- SD) years of age; 34 naive to disease modifying therapies; 1-year pre-NAT annualized relapse rate (ARR): 2.2 +/- 1.2; EDSS (median [IQR]): 2.5 [2.0-3.0]; gadolinium-enhancing lesions: 2 [1-5]; 41 JCV positives. During NAT treatment (61.9 +/- 35.2 mean infusions), ARR lowered to 0.08 +/- 0.23 (p < 0.001), EDSS score to 1.5 [1.0-2.5] at last infusion (p < 0.001), and 51% patients had EDA (21% after 6 months of rebaseline). No serious adverse events were reported. Forty-nine patients discontinued NAT, mainly due to PML concern; the majority (29/49) had disease reactivation in the subsequent 12 months, of which three with a clinical rebound. Conclusion NAT treatment maintains its high efficacy for a long time in pediatric MS patients, with no new safety issues
Breastfeeding is not related to postpartum relapses in multiple sclerosis.
No full textObjective: To assess the relationship between breastfeeding and risk of puerperal relapses in a large cohort of patients with multiple sclerosis (MS).
Methods: We prospectively followed-up pregnancies occurring between 2002 and 2008 in women with MS, recruited from 21 Italian MS centers, and gathered data on breastfeeding through a standardized interview. The risk of relapses after delivery was assessed using the Cox regression analysis.
Results: A total of 302 out of 423 pregnancies in 298 women resulted in full-term deliveries. Patients were followed up for at least 1 year after delivery. The time-dependent profile of the relapse rate before, during, and after pregnancy did not differ between patients who breastfed and patients who did not. In the multivariate analysis, adjusting for age at onset, age at pregnancy, disease duration, disability level, and relapses in the year prior to pregnancy and during pregnancy, treatment with disease-modifying drugs (DMDs), and exposure to toxics, the only significant predictors of postpartum relapses were relapses in the year before pregnancy (hazard ratio [HR] = 1.5; 95% confidence interval [CI] 1.3-1.9; p < 0.001) and during pregnancy (HR = 2.2; 95% CI 1.5-3.3; p < 0.001).
Conclusions: In our sample, postpartum relapses were predicted only by relapses before and during pregnancy. Therefore, the reported association between breastfeeding and a lower risk of postpartum relapses may simply reflect different patient behavior, biased by the disease activity. Our results can assist neurologists facing the breastfeeding issue in mother counseling and shared decision-making. Especially, among patients with high risk of postpartum relapses, breastfeeding may not be feasible and early postpartum treatment should be an option. Neurology(R) 2011;77:145-15
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