- |||||||||| dimethyl fumarate / Generic mfg., Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Real-life experience with sNFL in Multiple Sclerosis patients, as monitoring and treatment decision biomarker () - Sep 3, 2020 - Abstract #MSDC2020MSDC_1594;
sNFL were cross-sectionally evaluated in 830 relapsing remitting (RR), 53 primary progressive (PP) and 78 secondary progressive (SP) MS patients at different disease stages including diagnostic time, immediately before treatment, and during treatment with the main disease modifying treatments (DMTs): Interferon-beta, Glatiramer acetate, DimethylFumarate, Teriflunomide, Natalizumab, Alemtuzumab, Fingolimod, anti-CD20...Cut-off values specific for age decade were applied to discriminate patients samples in different contexts, showing correlation with disease subtype, clinical activity and DMTs efficacy. Our study shows that clinically applicable cut-offs can enable the implementation of sNFL in everyday clinical practice in individual patients, demonstrating its potential as monitoring and treatment decision biomarker.
- |||||||||| Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Multiple sclerosis during COVID-19 pandemic in Santiago, Chile () - Sep 3, 2020 - Abstract #MSDC2020MSDC_1525;
In relation with lymphodepleting drugs (e.g., alemtuzumab, ocrelizumab), the recommendations are less straightforward...19 pwMS receiving fingolimod, 11 interferons, 4 glatiramer acetate (GA) and 3 natalizumab continued their treatments without changes...Both patients on alemtuzumab had severe depletion of circulating T lymphocytes, but mild COVID-19 disease.Conclusions Lymphodepleting DMTs seem to be safe during the COVID-19 pandemic with self-limiting infections. The decision to start, continue or stop treatment with a given DMT should be strongly influenced by whether pwMS do follow recommendations or not to prevent exposure to the virus.
- |||||||||| dimethyl fumarate / Generic mfg., Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche, Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Comparison of Treatment Choices in a Single Center Pediatric Onset Multiple Sclerosis Registry () - Aug 25, 2020 - Abstract #MSDC2020MSDC_1484;
Three treatments are approved in Turkey: interferon-β, glatiramer acetate, fingolimod, other agents still being on off-label use.Objectives We aimed to evaluate POMS patients under new generation therapies (NGT) (teriflunomide, dimethyl fumarate, fingolimod, rituximab, ocrelizumab, natalizumab, alemtuzumab)...Only a few patients needed second-line treatments as a first-choice option in our POMS group. We did not observe any significant difference between clinical and MRI status among POMS patients under the first-line of newer drugs, although the latter was associated with a slightly lower EDSS score.
- |||||||||| Leustatin (cladribine) / J&J, fingolimod / Generic mfg., Novus Therap, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
[VIRTUAL] Risks associated with wash-out duration when switching from fingolimod to cell-depleting agents () - Aug 25, 2020 - Abstract #MSDC2020MSDC_1450;
It has been hypothesized that the therapeutic effects of subsequent cell-depleting agents may be compromised if lymphocyte recovery is still incomplete and that shorter wash-out periods do not affect the disease reactivation risk.Objectives To assess the risk of relapses following FTY discontinuation and the initiation of a B/T cell-depleting agent initiation in relation to the duration of wash-out between the drugs using data from the Italian MS Registry.Methods Patients who initiated alemtuzumab, rituximab, ocrelizumab or cladribine within six months of FTY discontinuation, and with a follow-up of at least six months, or until a relapse occurred, were included in the study. The multivariable Cox analysis showed that the time to a relapse was significantly influenced by the occurrence of relapses during FTY treatment (HR (95%CI): 1.4 (1.2-1.7); p/=18 weeks were associated with a higher risk of a relapse in comparison to wash-out durations shorter than 6 weeks (3.8 (1.1-13.2); p=0.037; 6.0 (1.7-21.9); p=0.006; 16.3 (4.8-56.3); p<0.001, respectively).Conclusions The risk of relapses during a cell-depleting therapy following a sequestering agent, namely FTY, increases progressively with the duration of wash-out, underlining the need of a short wash-out period also in this type of treatment sequence.
- |||||||||| [VIRTUAL] Multiple sclerosis and NMOSD testing and treatment availability in Latin America () - Aug 25, 2020 - Abstract #MSDC2020MSDC_1420;
Siponimod was not available in any conutry of the region...MS treatments was completely covered by the health care system in most of the surveyed countries.Conclusions the present study allows an understanding of the delivery of care for MS and NMOSD in the region. This information will allow us to make health care policies in affected patients that will improve the care in LATAM.
- |||||||||| [VIRTUAL] Telemedicine in/outside the pandemic: a survey about satisfaction of this tool in a cohort of multiple sclerosis patients and their neurologists () - Aug 25, 2020 - Abstract #MSDC2020MSDC_1412;
Treatments were almost equally distributed across first and second-line drugs (10% interferon, 10% glatiramer acetate, 14% teriflunomide, 22% dimethylfumarate, 23% fingolimod, 3% cladribine, 8% alemtuzumab, 10% ocrelizumab)...So far, we can conclude that telemedicine is a useful tool to overcome space-time limits, giving the best care to all patients in any condition. However, it cannot replace but only integrate traditional medicine.
- |||||||||| Leustatin (cladribine) / J&J
[VIRTUAL] Switches to immune-reconstitution therapies in Europe and the United States: Analyses from annual retrospective patient chart audits () - Aug 25, 2020 - Abstract #MSDC2020MSDC_1388;
Background There are currently two immune-reconstitution therapies (IRTs) licensed for relapsing multiple sclerosis (MS) - alemtuzumab (ALZ), an anti-CD52 monoclonal infusion, and cladribine (CdA), a short-course oral, T- and B-cell depletor.Objectives To review real world data of characteristics and disease-modifying treatment (DMT) history among EU and US patients switched to IRTs.Methods In 2019, 276 EU neurologists contributed online chart reviews for a retrospective audit of 1,266 MS patients who switched to a new DMT (ALZ: 77; CdA: 47) within the prior 3 months...In the US, glatiramer acetate more frequently preceded CdA (CdA: 38% vs. ALZ: 23%), while an anti-CD20 monoclonal antibody was more likely to have preceded ALZ (ALZ: 29% vs. CdA: 5%; p=0.030).Conclusions IRT treatment patterns in the EU and US are similar, with the exception of known differences in preceding injectable DMT use...ALZ is also more likely than CdA to be used among US patients diagnosed with, or at risk of transitioning to, progressive MS. Conversely, in the EU, the two IRTs are prescribed to very similar patient types.
- |||||||||| Campath (alemtuzumab) / Sanofi, Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Balo’s concentric sclerosis successfully treated with Alemtuzumab () - Aug 25, 2020 - Abstract #MSDC2020MSDC_1377;
Our patient has enjoyed a good outcome with resolution of symptoms, and a period of freedom from relapse and radiological activity. Alemtuzumab may be effective in the treatment of Balo’s concentric sclerosis if started early.
- |||||||||| Campath (alemtuzumab) / Sanofi, Lemtrada (alemtuzumab) / Sanofi
Clinical, Journal, Adverse events, Serious adverse event: Alemtuzumab: Rare serious adverse events of a high-efficacy drug. (Pubmed Central) - Aug 22, 2020
Alemtuzumab may be effective in the treatment of Balo’s concentric sclerosis if started early. No abstract available
- |||||||||| Tysabri (natalizumab) / Biogen, dimethyl fumarate / Generic mfg., Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Effects of natalizumab on patient-reported MS outcomes using prospective data from the Australian MS longitudinal study () - Aug 16, 2020 - Abstract #MSDC2020MSDC_1260;
We used marginal structural models to estimate causal effect of natalizumab versus other DMT comparators (any other DMT, classic injectables, oral therapies (teriflunomide and dimethyl fumarate), higher efficacy DMTs (fingolimod, alemtuzumab and mitoxantrone), fingolimod, and alemtuzumab), while adjusting for time-varying confounders and intermediates of treatment effects.Results The analysis included 2836 observations...The use of natalizumab was associated with a marginal decrease in self-reported progression in the previous 12 months while the use of injectable DMTs and fingolimod were associated with an increased self-reported progression. The use of natalizumab was associated with a reduction in work productivity loss due to absenteeism compared to a worsening for any other DMT, and similar trends were less pronounced for presenteeism and total work productivity loss.Conclusions Compared to other DMTs, the use of natalizumab was associated with superior effects over time for several MS symptoms and absenteeism.
- |||||||||| Campath (alemtuzumab) / Sanofi, Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Predictive biomarkers of the development of autoimmunity in patients treated with alemtuzumab () - Aug 16, 2020 - Abstract #MSDC2020MSDC_1155;
When explored total cell numbers, only plasmablast levels remained significant (p=0.02). A lower risk of autoimmune AEs after alemtuzumab was observed among patients with less than 7.6% of blood CD19+ B cells [odds ratio (OR) 16, confidence interval (CI) 3.86–58.95, p<0.0001] or less than 0.13% of plasmablast cells [OR 9.33, CI 2.17–42.65, p=0.002].Conclusions A low percentages of blood CD19+ B cells or plasmablasts before Alemtuzumab treatment predicted a lower risk of autoimmune AEs.
- |||||||||| [VIRTUAL] Real-world patient-level costs of administering infusion disease-modifying drugs: a US retrospective claims database analysis () - Aug 16, 2020 - Abstract #MSDC2020MSDC_1066;
Background There is limited research regarding the overall costs of administering infusion disease-modifying drugs (DMDs) in patients with multiple sclerosis (MS).Objectives The purpose of this study was to evaluate the real-world per-patient per-day costs of administering MS infusion DMDs.Methods Patients from the IQVIA™ RWD Adjudicated Claims–US database with a diagnosis of MS (ICD-9-CM/ICD-10-CM: 340.xx/G35) and ≥1 Healthcare Common Procedure Coding System (HCPCS) billed medical claims for an infusion DMD (natalizumab, alemtuzumab, or ocrelizumab) from 1/1/2017–9/30/2018 were identified...Costs billed on days other than the day of infusion administration were not included due to uncertainty regarding their relevance; therefore, cost estimates may be conservative.Conclusions Costs associated with administering infusion DMDs among patients with MS in the US should be considered in economic analyses. Challenges exist in setting rules for specificity and sensitivity (eg, time frame, code categorization, etc) for capturing appropriate costs.
- |||||||||| Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Quality of life (QoL) in treatment-refractory, disabled, multiple sclerosis (MS) during long-term repeated, alemtuzumab (ALE) as assessed by SF-36 () - Aug 16, 2020 - Abstract #MSDC2020MSDC_1062;
Shorter disease duration, lower EDSS, males, and receiving greater ALE courses report better emotional health than those with longer disease duration, higher EDSS, females, or patients with fewer treatments, respectively. Greater QoL in experienced patients may reflect long-term benefit and treatment response.
- |||||||||| [VIRTUAL] Impact of Natalizumab and Other High Efficacy Disease-Modifying Therapies on Productivity Loss in Multiple Sclerosis: A Systematic Literature Review. () - Aug 16, 2020 - Abstract #MSDC2020MSDC_1054;
Most studies were on natalizumab (k=13), followed by fingolimod (k=5), alemtuzumab (k=4), cladribine (k=1), and other DMTs (k=2)...A cohort study showed natalizumab led to significantly greater reduction in productivity loss than fingolimod, beta-interferons, and glatiramer acetate (k=1 cohort study)...However, a paucity of evidence and heterogeneity in study design limit comparisons to other hDMTs. Future research should evaluate the impact of specific hDMTs on attenuating productivity loss using methods reflecting real-world evidence, rather than modeling techniques, and productivity loss definitions already commonly used in the literature.
- |||||||||| Leustatin (cladribine) / J&J, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche, Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Brain volume loss is an important treatment attribute among RRMS patients: findings from a discrete choice experiment () - Aug 16, 2020 - Abstract #MSDC2020MSDC_1035;
Reducing the rate of BVL and risk of infection were approximately twice as important as reducing the 1-year relapse rate and risk of GI symptoms.Conclusions In addition to traditional measures of treatment benefit in RRMS, reducing the rate of BVL is a key outcome prioritized by patients for which they are willing to make tradeoffs. These findings suggest that reducing BVL should be considered when physicians engage in shared decision making with their patients.
- |||||||||| Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Real world evidence of progression independent of relapsing activity among MS patients treated with Alemtuzumab. () - Aug 16, 2020 - Abstract #MSDC2020MSDC_946;
The logistic regression analysis confirmed that older age at first ATZ course (OR 6.7, p=0.037) and being escalated to ATZ from previous DMTs (OR 1.1, p= 0.002) are factors significantly associated with higher risk of PIRA.Conclusions Conclusions We confirmed in the real-world setting that in a large proportion of patients the disability accumulation can occur despite effective therapeutic relapse suppression. Older patients receiving ATZ as escalation therapy are more likely to experience PIRA.
- |||||||||| Leustatin (cladribine) / J&J, Ocrevus (ocrelizumab) / Roche, Biogen
[VIRTUAL] Ocrelizumab as an immune reconstitution therapy? A case report. () - Aug 16, 2020 - Abstract #MSDC2020MSDC_937;
Caution is recommended in extrapolation from a single case, however investigation of ocrelizumab as an immune reconstitution therapy is warranted. Limited duration ocrelizumab treatment could have substantial benefits in terms of side effects, cost and patient convenience whilst maintaining efficacy.
- |||||||||| dimethyl fumarate / Generic mfg., Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche, Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Safety Outcomes after Treatment with Alemtuzumab or Autologous Hematopoietic Stem Cell Transplantation in Multiple Sclerosis Patients () - Aug 16, 2020 - Abstract #MSDC2020MSDC_560;
Alemtuzumab, AHSCT, and a matched reference group of non-induction therapies (natalizumab, dimethyl fumarate, rituximab, fingolimod) were included if started between 2008 and 2017...Other adverse events were rare. Overall mortality was slightly higher in the alemtuzumab group, but only one of the four deaths was clearly linked to the treatment.
- |||||||||| [VIRTUAL] Comorbid Anxiety, Depression, and Fatigue Symptoms by Disease Modifying Therapy: A National Multiple Sclerosis Cohort () - Aug 16, 2020 - Abstract #MSDC2020MSDC_519;
DMTs were classified in LED (interferon beta-1a, interferon beta-1b, peginterferon beta-1a, glatiramer acetate), MED (teriflunomide, fingolimod, siponimod, dimethyl fumarate), and HED (alemtuzumab, ocrelizumab, rituximab, natalizumab, cladribine)...LED-treated patients had lower fatigue and depression scores compared to those on HED. Indication biases may have influenced our results; longitudinal studies taking into account prior DMT history and indicators for specific DMTs should evaluate whether certain DMT classes affect future depression, anxiety, or fatigue levels.
- |||||||||| [VIRTUAL] A real-world analysis of ocrelizumab treatment patterns among multiple sclerosis patients in Saskatchewan, Canada () - Aug 16, 2020 - Abstract #MSDC2020MSDC_501;
22 patients (19%) switched from dimethyl fumarate; followed by 11 patients (9.5%) from glatiramer acetate, 9 patients (7.8%) from teriflunomide, 6 patients (5.2%) from interferon-beta 1a, 5 patients (4.3%) from natalizumab, 4 patients (3.4%) from alemtuzumab, 3 patients (2.6%) from fingolimod and 2 patients (1.7%) from interferon-beta 1b...Twenty four patients had a comorbid diagnosis of depression.Conclusions The majority of patients who started on ocrelizumab had RRMS. The most common reason to switch to ocrelizumab was due to adverse events or persistence of relapses.
- |||||||||| Ocrevus (ocrelizumab) / Roche, Biogen, Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Switching to Ocrelizumab from other second line treatments in relapsing-remitting Multiple Sclerosis: a single Center cohort () - Aug 16, 2020 - Abstract #MSDC2020MSDC_479;
MRI follow-up showed new/enlarging T2 lesions in 4 patients (3 switching from FTY and 1 from NTZ), on average 7 months after starting OCR, and a T1 Gd+ lesion in one patient switching from FTY (3 months after starting OCR). All other patients did not show clinical or radiological disease activity.Conclusions In our single Center cohort, switching to OCR from other second line treatments appears to be safe and in most patient effective.
- |||||||||| Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Management of infectious risk in multiple sclerosis: implication for screening, prophylaxis and therapies () - Aug 16, 2020 - Abstract #MSDC2020MSDC_439;
Hepatitis B virus (HBV) reactivation may be harmful mainly for ocrelizumab and alemtuzumab treated patients.Objectives Aim of the study was to define the infectious risk in DMTs-treated MS patients with approaches tailored to individual patients.Methods At the Neuroinfectious Unit of Policlinico Umberto I (Rome), before starting or switching to DMTs, MS patients were evaluated for infectious risk...Beside preventing TB reactivation, TB prophylaxis based on two active molecules, allows an earlier starting of DMTs. Moreover, TB screening may contribute to reduce the transmission, morbidity, and mortality of active disease in global population.
- |||||||||| dimethyl fumarate / Generic mfg., Mavenclad (cladribine) / EMD Serono, Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Cladribine tablets in patients with RRMS and active SPMS after suboptimal response to prior DMD (MASTER-2 and CLICK-MS): initial baseline demographics () - Aug 16, 2020 - Abstract #MSDC2020MSDC_400;
Most recent DMDs used included teriflunomide (23.1%), dimethyl fumarate (23.1%), fingolimod (19.2%), ocrelizumab (13.5%), natalizumab (9.6%) and alemtuzumab (1.9%)...Thirty-six treatment emergent AEs (2 serious, but unrelated) were seen in 12 pts in 9.97 pt-yrs to date. Additional MASTER-2 and CLICK-MS pt baseline data will be shown in the presentation.Conclusions These studies will report real-world effectiveness and safety data of cladribine tablets in pts with RRMS and active SPMS with suboptimal response to prior oral, infusion, or injectable DMDs.
- |||||||||| omeprazole / Generic mfg., Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Cardiovascular monitoring during alemtuzumab infusion in Multiple Sclerosis patients () - Aug 16, 2020 - Abstract #MSDC2020MSDC_397;
Nevertheless, bradycardia was frequently recorded even though usually asymptomatic. Careful monitoring should be continued for the whole protocol of AL infusion since CV events can be observed independently from the expected early infusion-related reactions likely associated to cytokine release.
- |||||||||| Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Alemtuzumab induces changes in the innate immune system in patients with relapsing-remitting multiple sclerosis () - Aug 16, 2020 - Abstract #MSDC2020MSDC_379;
Furthermore, CD163+ monocytes, showing phagocytic activity were increased 6 months post-treatment and were still slightly elevated after 12 months, while phagocytosing B-cells showed an increase 12 months post alemtuzumab treatment Conclusions Alemtuzumab treatment goes along with complex alterations of the immune system including innate immunity mechanisms. In the peripheral blood compartment, PBMC display an increase in phagocytotic activity.
- |||||||||| [VIRTUAL] Comparison of disability trajectories in relapsing Multiple Sclerosis patients treated with early intensive or escalation treatment strategies () - Aug 16, 2020 - Abstract #MSDC2020MSDC_370;
ESC group included those who received the high efficacy DMT after ≥1 year of glatiramer acetate, interferons, azathioprine, teriflunomide or dimethylfumarate treatment...In particular, the mean delta-EDSS differences between the two groups tend 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. Conclusions Our results indicate that EIT strategy is more effective than ESC strategy in controlling disability progression and the effect tends to increase over time despite patients in the ESC group escalated to a higher-efficacy DMT.
- |||||||||| Campath (alemtuzumab) / Sanofi, Tysabri (natalizumab) / Biogen, Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Alemtuzumab following natalizumab: a multicentric Italian real-world experience () - Aug 16, 2020 - Abstract #MSDC2020MSDC_365;
No patient developed PML.Conclusions Alemtuzumab started shortly after natalizumab interruption was highly efficacious in controlling disease course, as 87% of patients showed no evidence of clinical and radiological activity one year after treatment starting. The choice of alemtuzumab use in JCV seropositive patients must take in consideration the necessity to treat a very severe disease and the safety profile of the drug to which switching.
- |||||||||| Campath (alemtuzumab) / Sanofi, dimethyl fumarate / Generic mfg., Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] A Case of Drug Induced Myocarditis Associated With the Administration of Alemtuzumab () - Aug 16, 2020 - Abstract #MSDC2020MSDC_350;
At four month follow up, repeat cardiac MRI showed improved EF to 54% with resolution of myocardial edema. Conclusions To our knowledge this is the first report of alemtuzumab induced myocarditis and while an isolated event, prescribers should be aware of this potential adverse effect.
- |||||||||| Ocrevus (ocrelizumab) / Roche, Biogen, Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Autologous Stem Cell Transplantation versus Alemtuzumab or Ocrelizumab in Relapsing Remitting Multiple Sclerosis (StarMS) () - Aug 16, 2020 - Abstract #MSDC2020MSDC_270;
The primary endpoint, no evidence of disease activity (NEDA) rate, will be assessed throughout the 2-year follow-up period.Results Results are expected to be available in approximately 4 years’ time. Results will be published in peer-reviewed academic journals, presented at relevant conferences, and disseminated via patient groups as applicable.Conclusions The StarMS trial has the potential to provide definitive data on the comparative efficacy of aHSCT vs highly efficacious DMTs, help improve patient outcomes, and impact national and international guidelines.
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