223 research outputs found
The importance of communication in the diagnosis of multiple sclerosis
The recent improvements in multiple sclerosis therapy have lead to consequent improvements in its prognosis: however, it still remains a chronic and unpredictable disease. The moment of the diagnosis is the starting point of a durable relationship between the physician and the patient, but, most of all, it is often referred to as the most traumatic experience in patients’ life. Patients’ compliance to prescribed therapies, so important in the course of every chronic condition, particularly hangs on the psychological approach used by the doctor in communicating and explaining the diagnosis for the first time, in addition to the patient’s personality. A brief overview on the main types of physicians’ and patients’ behaviours and communications styles is provided in this article
COVID-19 outbreak in Italy: an opportunity to evaluate extended interval dosing of ocrelizumab in MS patients
introduction during the COVID-19 pandemic, ocrelizumab (OCR) infusions for MS patients were often re-scheduled because of MS center's disruption and concerns regarding immunosuppression. The aim of the present study was to assess changes in OCR schedule during the first wave of pandemic in italy and to evaluate the effect of delayed infusion on clinical/radiological endpoints.methods data were extracted from the Italian MS register database. standard interval dosing was defined as an infusion interval <= 30 weeks, while extended interval dosing was defined as an infusion interval > 30 weeks at the time of the observation period. clinico-demographics variables were tested as potential predictors for treatment delay. time to first relapse and time to first MRI event were evaluated. Cumulative hazard curves were reported along their 95% confidence intervals. a final sample of one-thousand two patients with MS from 65 centers was included in the analysis: 599 pwMS were selected to evaluate the modification of OCR infusion intervals, while 717 pwRMS were selected to analyze the effect of infusion delay on clinical/MRI activity. results mean interval between two OCR infusions was 28.1 weeks before pandemic compared to 30.8 weeks during the observation period, with a mean delay of 2.74 weeks (p < 0.001). No clinico-demographic factors emerged as predictors of infusion postponement, except for location of MS centers in the north of italy. clinical relapses (4 in SID, 0 in EID) and 17 MRI activity reports (4 in SID, 13 in EID) were recorded during follow-up period. discussion despite the significant extension of OCR infusion interval during the first wave of pandemic in Italy, a very small incidence of clinical/radiological events was observed, thus suggesting durable efficacy of OCR, as well as the absence of rebound after its short-term suspension
Clinical effectiveness of different natalizumab interval dosing schedules in a large Italian population of patients with multiple sclerosis
Introduction Natalizumab (NTZ) is one of the most
effective treatment options for multiple sclerosis (MS)
treatment. Our study aimed to evaluate the effectiveness
of NTZ when administered according to the extended
dosing strategy compared with standard 4-weekly
administration in a large Italian MS population.
Materials and methods This retrospective multicentre
study included patients with relapsing-remitting
MS
(RR-MS)
who received NTZ administrations between the
1 June 2012 and the 15 May 2018 and were followed
by the ’Italian MS Register’. All patients with MS were
stratified into two groups based on NTZ administration
schedule: standard interval dosing (SID) patients who
received infusions on average from 28 to 32 days
(median 30) and extended interval dosing (EID) including
patients who have been infused with interval between
33 and 49 days (median 43). Clinical data were assessed
at baseline (before starting NTZ), after 12 (T1) and 24
months (T2) of treatment.
Results Out of 5231 patients with RR-MS
screened,
2092 (mean age 43.2±12.0, 60.6% women) were
enrolled. A total of 1254 (59.9%) received NTZ
according to SID, and 838 (40.1%) according to EID. At
12 and 24 months, no differences in terms of annualised
relapse rate and disability status were found between the
two groups. Progression index and confirmed disability
worsening were similar between the two groups.
Discussion The use of NTZ with an extended interval
schedule showed similar effectiveness compared with
SID. Unchanged clinical efficacy of EID schedule may
raise the question of a possible advantage in terms of
tolerability and safety
Definitive childlessness in women with multiple sclerosis: a multicenter study
The frequency of definitive childlessness in women with multiple sclerosis (MS) may be higher than in the general population. MS may also affect decisions on the delivery procedure and on breast-feeding issues. Aim of the study was to assess the frequency of childlessness and its possible causes, the proportion of cesarean deliveries (CD), and the frequency of breast-feeding in patients and controls who have reached the end of their reproductive period. Female MS patients (>43 years) and controls (>45 years) filled out a questionnaire. We enrolled 303 patients and 500 controls. MS was associated with a higher frequency of childlessness (22 vs 13%) and less patients were in a stable relationship (83 vs 89%). There was no difference in the reported rates of infertility and miscarriages, while elective abortions were more frequent in patients (20 vs 12%). MS did not significantly affect the frequency of CD or of breast-feeding. MS-related reasons for childlessness, reported by 16% of childless patients, included disability/fear of future disability, fear of genetically transmitting MS, fear of not starting/discontinuing treatments, and discouragement by physician. Definitive childlessness is more frequent in women with MS compared to controls. A portion of voluntary childlessness may be avoided through correct/tailored information to patients
Long-term disability trajectories in relapsing multiple sclerosis patients treated with early intensive or escalation treatment strategies
Background and aims: No consensus exists on how aggressively to treat relapsing-remitting multiple sclerosis (RRMS) nor on the timing of the treatment. The objective of this study was to evaluate disability trajectories in RRMS patients treated with an early intensive treatment (EIT) or with a moderate-efficacy treatment followed by escalation to higher-efficacy disease modifying therapy (ESC).
Methods: RRMS patients with â©ľ5-year follow-up and â©ľ3 visits after disease modifying therapy (DMT) start were selected from the Italian MS Registry. EIT group included patients who received as first DMT fingolimod, natalizumab, mitoxantrone, alemtuzumab, ocrelizumab, cladribine. ESC group patients received the high efficacy DMT after â©ľ1 year of glatiramer acetate, interferons, azathioprine, teriflunomide or dimethylfumarate treatment. Patients were 1:1 propensity score (PS) matched for characteristics at the first DMT. The disability trajectories were evaluated by applying a longitudinal model for repeated measures. The effect of early versus late start of high-efficacy DMT was assessed by the mean annual Expanded Disability Status Scale (EDSS) changes compared with baseline values (delta-EDSS) in EIT and ESC groups.
Results: The study cohort included 2702 RRMS patients. The PS matching procedure produced 363 pairs, followed for a median (interquartile range) of 8.5 (6.5-11.7) years. Mean annual delta-EDSS values were all significantly (p < 0.02) higher in the ESC group compared with the EIT group. In particular, the mean delta-EDSS differences between the two groups tended to increase from 0.1 (0.01-0.19, p = 0.03) at 1 year to 0.30 (0.07-0.53, p = 0.009) at 5 years and to 0.67 (0.31-1.03, p = 0.0003) at 10 years.
Conclusion: Our results indicate that EIT strategy is more effective than ESC strategy in controlling disability progression over time
Risk of Getting COVID-19 in People With Multiple Sclerosis
Background and Objectives
Several studies have assessed risk factors associated with the severity of COVID-19 outcomes in
people with multiple sclerosis (PwMS). The potential role of disease-modifying therapies
(DMTs) and demographic and clinical factors on the risk of acquiring SARS-CoV-2 infection
has not been evaluated so far. The objective of this study was to assess risk factors of contracting
SARS-CoV-2 infection in PwMS by using data collected in the Italian MS Register (IMSR).
Methods
Acase-control (1:2) studywas set up. Cases included PwMSwith a confirmed diagnosis ofCOVID-19,
and controls included PwMS without a confirmed diagnosis of COVID-19. Both groups were propensity
score–matched by the date of COVID-19 diagnosis, the date of last visit, and the region of
residence. No healthy controls were included in this study. COVID-19 risk was estimated by multivariable
logistic regression models including demographic and clinical covariates. The impact of DMTs
was assessed in 3 independent logistic regression models including one of the following covariates: last
administeredDMT, previousDMTsequences, or the place where the last treatment was administered.
Results
A total of 779 PwMS with confirmed COVID-19 (cases) were matched to 1,558 PwMS without
COVID-19 (controls). In all 3 models, comorbidities, female sex, and a younger age were significantly
associated (p < 0.02)with a higher risk of contractingCOVID-19. Patients receiving natalizumab as last
DMT(OR[95%CI]: 2.38 [1.66–3.42], p < 0.0001) and those who underwent an escalation treatment
strategy (1.57 [1.16–2.13], p = 0.003) were at significantly higher COVID-19 risk. Moreover, PwMS receiving their last DMT requiring
hospital access (1.65 [1.34–2.04], p < 0.0001) showed a significant higher risk than those taking self-administered DMTs at home.
Discussion
This case-control study embedded in the IMSR showed that PwMS at higher COVID-19 risk are younger, more frequently
female individuals, and with comorbidities. Long-lasting escalation approach and last therapies that expose patients to the
hospital environment seem to significantly increase the risk of SARS-CoV2 infection in PwMS.
Classification of Evidence
This study provides Class III evidence that among patients with MS, younger age, being female individuals, having more
comorbidities, receiving natalizumab, undergoing an escalating treatment strategy, or receiving treatment at a hospital were
associated with being infected with COVID-19. Among patients with MS who were infected with COVID-19, a severe course
was associated with increasing age and having a progressive form of MS, whereas not being on treatment or receiving an
interferon beta agent was protective
Conversion to secondary progressive multiple sclerosis: patient awareness and needs. results from an online survey in Italy and Germany
Background: Few studies have investigated the experiences of patients around the conversion to secondary progressive multiple sclerosis (SPMS). ManTra is a mixed-method, co-production research project conducted in Italy and Germany to develop an intervention for newly-diagnosed SPMS patients. In previous project actions, we identified the needs and experiences of patients converting to SPMS via literature review and qualitative research which involved key stakeholders.Aims: The online patient survey aimed to assess, on a larger and independent sample of recently-diagnosed SPMS patients: (a) the characteristics associated to patient awareness of SPMS conversion; (b) the experience of conversion; (c) importance and prioritization of the needs previously identified.Methods: Participants were consenting adults with SPMS since <= 5 years. The survey consisted of three sections: on general and clinical characteristics; on experience of SPMS diagnosis disclosure (aware participants only); and on importance and prioritization of 33 pre-specified needs.Results: Of 215 participants, those aware of their SPMS diagnosis were 57% in Italy vs. 77% in Germany (p = 0.004). In both countries, over 80% of aware participants received a SPMS diagnosis from the neurologist; satisfaction with SPMS disclosure was moderate to high. Nevertheless, 28-35% obtained second opinions, and 48-56% reported they did not receive any information on SPMS. Participants actively seeking further information were 63% in Germany vs. 31% in Italy (p < 0.001).Variables independently associated to patient awareness were geographic area (odds ratio, OR 0.32, 95% CI 0.13-0.78 for Central Italy; OR 0.21, 95% CI 0.08-0.58 for Southern Italy [vs. Germany]) and activity limitations (OR 7.80, 95% CI 1.47-41.37 for dependent vs. autonomous patients).All pre-specified needs were scored a lot or extremely important, and two prioritized needs were shared by Italian and German patients: "physiotherapy" and "active patient care involvement." The other two differed across countries: "an individualized health care plan" and "information on social rights and policies" in Italy, and "psychological support" and "cognitive rehabilitation" in Germany.Conclusions: Around 40% of SPMS patients were not aware of their disease form indicating a need to improve patient-physician communication. Physiotherapy and active patient care involvement were prioritized in both countries
Natalizumab, Fingolimod and Dimethyl Fumarate Use and Pregnancy-Related Relapse and Disability in Women With Multiple Sclerosis
To investigate pregnancy-related disease activity in a contemporary multiple sclerosis (MS) cohort
Disease-Modifying Therapies and Coronavirus Disease 2019 Severity in Multiple Sclerosis
Objective: This study was undertaken to assess the impact of immunosuppressive and immunomodulatory therapies on the severity of coronavirus disease 2019 (COVID-19) in people with multiple sclerosis (PwMS).
Methods: We retrospectively collected data of PwMS with suspected or confirmed COVID-19. All the patients had complete follow-up to death or recovery. Severe COVID-19 was defined by a 3-level variable: mild disease not requiring hospitalization versus pneumonia or hospitalization versus intensive care unit (ICU) admission or death. We evaluated baseline characteristics and MS therapies associated with severe COVID-19 by multivariate and propensity score (PS)-weighted ordinal logistic models. Sensitivity analyses were run to confirm the results.
Results: Of 844 PwMS with suspected (n = 565) or confirmed (n = 279) COVID-19, 13 (1.54%) died; 11 of them were in a progressive MS phase, and 8 were without any therapy. Thirty-eight (4.5%) were admitted to an ICU; 99 (11.7%) had radiologically documented pneumonia; 96 (11.4%) were hospitalized. After adjusting for region, age, sex, progressive MS course, Expanded Disability Status Scale, disease duration, body mass index, comorbidities, and recent methylprednisolone use, therapy with an anti-CD20 agent (ocrelizumab or rituximab) was significantly associated (odds ratio [OR] = 2.37, 95% confidence interval [CI] = 1.18-4.74, p = 0.015) with increased risk of severe COVID-19. Recent use (<1 month) of methylprednisolone was also associated with a worse outcome (OR = 5.24, 95% CI = 2.20-12.53, p = 0.001). Results were confirmed by the PS-weighted analysis and by all the sensitivity analyses.
Interpretation: This study showed an acceptable level of safety of therapies with a broad array of mechanisms of action. However, some specific elements of risk emerged. These will need to be considered while the COVID-19 pandemic persists
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