SARS-CoV-2 vaccination and multiple sclerosis: a large multicentric study on relapse risk after the third booster dose

Background: COVID-19 vaccines have been recommended to people with multiple sclerosis (pwMS) and, to ensure durable immunity, a third booster dose has been administered in several countries. Data about potential risks associated with the third booster dose in pwMS, such as vaccine-triggered disease exacerbations, are still scarce. Objective: To investigate whether the administration of a third booster dose of mRNA COVID-19 vaccines was associated with an increased risk of short-term disease reactivation in a large cohort of pwMS. Methods: We retrospectively selected 1265 pwMS who received a third booster dose of an mRNA COVID-19 vaccine. Demographic and clinical data were collected, including the presence, number and characteristics of relapses in the 60 days prior to and after the third booster dose. Results: In the selected cohort, the relapse rate in the two months after administration of the third booster dose of mRNA COVID-19 vaccines did not increase when compared with the prior two months. Indeed, the percentage of pwMS experiencing relapses in the 60 days following the administration of the third booster dose was 2.1%, similar to the percentage recorded in 60 days prior to vaccination, which was 1.9%. Conclusions: The third booster dose of mRNA COVID-19 vaccines appeared to be safe for pwMS

Something about us : postgrau en Il·lustració creativa i tècniques de comunicació visual, postgrau en Il·lustració per a publicacions infantils i juvenils, 2020-2021

Durant aquest curs hem conviscut amb la incertesa, i hem mirat més que mai cap al nostre interior. Cadascú ha viscut la seva pròpia experiència, i per això busquem connectar amb els altres a través de les nostres diferents vivències i mirades. Be part of US. Be part of our collective explosion: “SOMETHING ABOUT US”. “SOMETHING ABOUT US” és el reflex de la realitat que ens ha tocat compartir. Ens parla de la singularitat i la mirada individual que cadascú ha aportat a aquest oment. És una exposició col·lectiva que mostra els treballs dels estudiants dels postgraus en Il·lustració creativa i tècniques de comunicació visual i en Il·lustració per a publicacions infantils i juvenils d’EINA realitzats durant el curs 2020-2021. A l’exposició es presenten projectes que funcionen també com a experiències individuals i col·lectives i que connecten amb el paper de l’il·lustrador en l’actualitat. Ens agradaria compartir amb tots vosaltres aquestes reflexions. Aquest catàleg aplega les diferents realitats i mirades de tots els estudiants de diferents indrets de món com Holanda, Itàlia, Iran, epública Dominicana, Uruguai, i múltiples llocs d’Espanya. Tal com comenten els participants: “Busquem la connexió entre les nostres diferents històries. Be part of us!”.y hemos mirado más que nunca hacia nuestro interior. Cada uno ha vivido su propia experiencia, y por ello buscamos conectar con los demás a través de nuestras diferentes vivencias y miradas. Be part of US. Be part of our collective explosion: “SOMETHING ABOUT US”. “SOMETHING ABOUT US” es el reflejo de la realidad que nos ha tocado compartir. Nos habla de la singularidad y la mirada individual que cada uno ha aportado a este momento. Es una exposición colectiva que muestra los trabajos de los estudiantes de los postgrados en Ilustración creativa y técnicas de comunicación visual y en Ilustración para publicaciones infantiles y juveniles de EINA realizados durante el curso 2020-2021. En la exposición se presentan proyectos que funcionan también como experiencias individuales y colectivas y que conectan con el papel del ilustrador en la actualidad. Nos gustaría compartir con todos vosotros estas reflexiones. Este catálogo reúne las diferentes realidades y iradas de todos los estudiantes de diferentes lugares de mundo como Holanda, Italia, Irán, República ominicana, Uruguay, y múltiples lugares de España. Tal y como comentan los participantes: Buscamos la conexión entre nuestras diferentes historias. Be part of us!”.During this course, we have lived with uncertainty, and we have looked inwards more than ever. Each of us has lived our own experience, and so we have sought to connect with others through our different experiences and perspectives. Be part of US. Be part of our collective explosion: SOMETHING ABOUT US”. “SOMETHING ABOUT US” reflects the reality we share. It tells us about the singularity and the individual look that each one of us has brought to this moment. It is a collective exhibition that shows the work of the students of the postgraduate courses in Creative Illustration and Visual Communication Techniques and in Illustration for Children’s and Teenagers’ Publications at EINA carried out during the academic year 2020-2021. The exhibition presents projects that also function as individual and collective experiences and that connect with the role of the illustrator today. We would like to share these reflections with all of you. This catalogue brings together the different realities and views of all the students from different parts of the world such as Holland, Italy, Iran, Dominican Republic, Uruguay, and many parts of Spain. As the participants comment: “We are looking for the connection between our different stories. Be part of us!”

Extending the Interval of Natalizumab Dosing: Is Efficacy Preserved?

Extending the natalizumab interval after the 24th administration could reduce the risk of progressive multifocal leukoencephalopathy (PML). The objective is to evaluate the noninferiority of the efficacy of an extended interval dosing (EID) compared with the standard interval dosing (SID) of natalizumab. It is an observational, multicenter (14 Italian centers), retrospective cohort study, starting from the 24th natalizumab infusion to the loss of follow-up or 2 years after baseline. Patients were grouped in 2 categories according to the mean number of weeks between doses: <\u20095 weeks, SID; 65\u20095 weeks, EID. Three hundred and sixty patients were enrolled. Median dose interval (MDI) following 24th infusion was 4.7 weeks, with a bimodal distribution (modes at 4 and 6 weeks). Two hundred and sixteen patients were in the SID group (MDI\u2009=\u20094.3 weeks) and 144 in the EID group (MDI 6.2 weeks). Annualized relapse rate was 0.060 (95% CI\u2009=\u20090.033-0.087) in the SID group and 0.039 (95% CI\u2009=\u20090.017-0.063) in the EID group. The non-inferiority of EID versus SID was satisfied. In conclusion, there is no evidence of a reduced efficacy of natalizumab in an EID setting. This observation confirms previous results and together with the emerging evidence of a reduced risk of PML associated to an EID, supports the need of a randomized study to assess the need to change the standard of the natalizumab dosing schedule

MRI activity and extended interval of Natalizumab dosing regimen: a multicentre Italian study

Background: To minimize the risk of Progressive Multifocal Leukoencephalopathy and rebound in JCV-positive multiple sclerosis (MS) patients after 24 natalizumab doses, it has been proposed to extend the administrations interval. The objective is to evaluate the EID efficacy on MRI activity compared with the standard interval dosing (SID).Methods: Observational, multicentre, retrospective cohort study, starting from the 24th natalizumab infusion to the loss of follow-up or 2 years after baseline. Three hundred and sixteen patients were enrolled. The median dose interval (MDI) following the 24th infusion was 5 weeks, with a bimodal distribution (modes at 4 and 6 weeks). Patients were grouped into 2 categories according to the mean number of weeks between doses: < 5 weeks, SID; >= 5 weeks, EID.Results: One hundred and eighty-seven patients were in the SID group (MDI = 4.5 weeks) and 129 in the EID group (MDI 6.1 weeks). The risk to develop active lesions on MRI is similar in SID and EID groups during the 6 and 12 months after the 24th natalizumab infusion, respectively 4.27% (95% CI:0.84-7.70) vs 4.71% (95% CI:0.16-9.25%) [p = 0.89] and 8.50% (95% CI:4.05-12.95) vs 6.55% (95% CI:2.11-11.00%) [p = 0.56]. The EID regimen does not appear to increase the occurrence of MRI activity during follow-up.Conclusion: There is no evidence of the reduced efficacy of natalizumab in an EID setting regarding the MRI activity. This observation supports the need for a bigger randomized study to assess the need to change the standard of the natalizumab dosing schedule, to better manage JCV-positive patients

A multicentRE observational analysiS of PErsistenCe to Treatment in the new multiple sclerosis era: the RESPECT study

In this independent, multicenter, retrospective study, we investigated the short-term persistence to treatment with first-line self-injectable or oral disease-modifying treatments (DMTs) in patients with relapsing-remitting multiple sclerosis. Data of patients regularly attending 21 Italian MS Centres who started a self-injectable or an oral DMT in 2015 were collected to: (1) estimate the proportion of patients discontinuing the treatment; (3) explore reasons for discontinuation; (3) identify baseline predictors of treatment discontinuation over a follow-up period of 12 months. We analyzed data of 1832 consecutive patients (1289 women, 543 men); 374 (20.4%) of them discontinued the prescribed DMT after a median time of 6 months (range 3 days to 11.5 months) due to poor tolerability (n\u2009=\u2009163; 43.6%), disease activity (n\u2009=\u200995; 25.4%), adverse events (n\u2009=\u200964; 17.1%), convenience (i.e. availability of new drug formulations) and pregnancy planning (n\u2009=\u200921; 1.1%). Although the proportion of discontinuers was higher with self-injectable (n\u2009=\u2009107; 22.9%) than with oral DMT (n\u2009=\u2009215; 16.4%), the Cox regression model revealed no significant between-group difference (p\u2009=\u20090.12). Female sex [hazard ratio (HR)\u2009=\u20091.39, p\u2009=\u20090.01] and previous exposure to\u2009 65\u20093 DMTs (HR\u2009=\u20091.71, p\u2009=\u20090.009) were two independent risk factors for treatment discontinuation, regardless of prescribed DMTs. Our study confirms that persistence to treatment represents a clinical challenge, irrespective of the route of administration

mRNA COVID-19 vaccines do not increase the short-term risk of clinical relapses in multiple sclerosis

[no abstract available

A real-world study of alemtuzumab in a cohort of Italian patients

Background and purpose: Real-world data on alemtuzumab are limited and do not provide evidence of its effectiveness after various disease-modifying therapies (DMTs). Our aim was to provide real-world data on the impact of clinical variables and previous DMTs on clinical response to alemtuzumab. Methods: Sixteen Italian multiple sclerosis centers retrospectively included patients who started alemtuzumab from January 2015 to December 2018, and recorded demographics, previous therapies, washout duration, relapses, Expanded Disability Status Scale (EDSS) score, and magnetic resonance imaging data. Negative binomial regression models were used to assess the effect of factors on annualized relapse (ARR) after alemtuzumab initiation. Results: We studied 322 patients (mean age 36.8 years, median EDSS score 3, median follow-up 1.94 years). Previous treatments were: fingolimod (106), natalizumab (80), first-line oral agents (56), first-line injectables (interferon/glatiramer acetate; 30), and other drugs (15). Thirty-five patients were treatment-naïve. The pre-alemtuzumab ARR was 0.99 and decreased to 0.13 during alemtuzumab treatment (p < 0.001). The number of previous-year relapses was associated with alemtuzumab ARR (adjusted risk ratio [RR] 1.38, p = 0.009). Progression-free survival was 94.5% after 1 year, and 89.2% after 2 years of alemtuzumab treatment. EDSS score improvement occurred in 13.5% after 1 year, and 20.6% after 2 years. Re-baselining patients after 6 months of alemtuzumab treatment, led to no evidence of disease activity status in 71.6% after 1 year and 58.9% after 2 years. Conclusions: Alemtuzumab decreases ARR independent of previous therapy, including patients with disease activity during natalizumab treatment. Overall, 90% of patients showed no disease progression, and 20% an improvement after 2 years of alemtuzumab

Assessing association of comorbidities with treatment choice and persistence in MS: A real-life multicenter study

OBJECTIVE: To assess whether the presence of concomitant diseases at multiple sclerosis (MS) diagnosis is associated with the choice and the treatment persistence in an Italian MS cohort.METHODS: We included newly diagnosed patients (2010-2016) followed in 20 MS centers and collected demographic and clinical data. We evaluated baseline factors related to the presence of comorbidities and the association between comorbidities and the clinical course of MS and the time to the first treatment switch.RESULTS: The study cohort included 2,076 patients. Data on comorbidities were available for 1,877/2,076 patients (90.4%). A total of 449/1,877 (23.9%) patients had at least 1 comorbidity at MS diagnosis. Age at diagnosis (odds ratio 1.05, 95% confidence interval [CI] 1.04-1.06; p &lt; 0.001) was the only baseline factor independently related to the presence of comorbidities. Comorbidities were not significantly associated with the choice of the first disease-modifying treatment, but were significantly associated with higher risk to switch from the first treatment due to intolerance (hazard ratio 1.42, CI 1.07-1.87; p = 0.014). Association of comorbidities with risk of switching for intolerance was significantly heterogeneous among treatments (interferon \uce\ub2, glatiramer acetate, natalizumab, or fingolimod; interaction test, p = 0.04).CONCLUSIONS: Comorbidities at diagnosis should be taken into account at the first treatment choice because they are associated with lower persistence on treatment