- |||||||||| dimethyl fumarate / Generic mfg.
[VIRTUAL] Disease modifying therapies in patients with aggressive MS () - Aug 16, 2020 - Abstract #MSDC2020MSDC_405;
In agMS patients, Interferons (INFs) were the most frequently used DMDs with 34.8% followed by Glatiramer acetate (GLAT, 24.0%), Dimethyl fumarate (DMF, 15.8%), Teriflunomide (TRF, 7.6%), Natalizumab (NTZ, 5.4%), Fingolimod (FTY, 3.9%), Ocrelizumab (OCR, 3.2%), Steroids (STE, 1.8%), and others (3.5%)...The patients classified as agMS spent less time on the first DMD than non-agMS patients did. To investigate causal factors in the connection between DMD preference and resulting disease progression, Marginal Structural Models are required, adjusting for relevant time-varying confounders such as patient demography, clinical visit details, MRI, and relapse parameters.
- |||||||||| 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.
- |||||||||| teriflunomide / Generic mfg.
[VIRTUAL] Changes in immune blood cells in patients on teriflunomide treatment () - Aug 16, 2020 - Abstract #MSDC2020MSDC_398;
It was shown a decrease in leukocytes and lymphocytes in both groups and a moderate increase in monocytes in patients with NEDA that we did not find in ongoing disease activity patients. We did not find a statistically significant correlation between analytical values and response to treatment.
- |||||||||| dimethyl fumarate / Generic mfg.
[VIRTUAL] Baseline features in DISCOntinuation of disease modifying therapies in Multiple Sclerosis (DISCOMS) () - Aug 16, 2020 - Abstract #MSDC2020MSDC_391;
At enrollment, 42.6% were on an interferon, 30.3% on glatiramer acetate, 15.1% dimethyl fumarate, 6.4% fingolimod, 3.2% teriflunomide, 1.6% natalizumab, and 0.8% ocrelizumab...Enrolled participants represent a unique cohort of stable, older MS patients with relatively low disability. Upon completion, the study will increase our understanding of the utility of MS DMTs throughout the lifespan of MS.
- |||||||||| dimethyl fumarate / Generic mfg.
[VIRTUAL] Anti-CD20 therapy interferes with the immune response to the Hepatitis B virus vaccine in MS patients () - Aug 16, 2020 - Abstract #MSDC2020MSDC_382;
Onset of AntiCD20 also resulted in a significant decrease in the antibody titers (p<0.001) compared to those without AntiCD20. There was a dose-gradient effect in the achieved seroprotection with the number of vaccine doses administered before the onset of the anti-CD20 therapy (16.7%, 30%, 66.7% and 92.9% with one, two, three and four doses, respectively).Conclusions MS patients on anti-CD20 therapy mount deficient immune responses to VHB vaccination and therefore, vaccination should be completed in advance of treatment onset.
- |||||||||| [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.
- |||||||||| dimethyl fumarate / Generic mfg.
[VIRTUAL] Management of RIS () - Aug 16, 2020 - Abstract #MSDC2020MSDC_369;
Many experts groups in the USA, Europe, and South America have proposed guidelines to follow the RIS subjects. The recommendation is not to treat off label these subjects as 2 phases 3 studies are ongoing in the USA and Europe with dimethylfumarate and teriflunomide.
- |||||||||| dimethyl fumarate / Generic mfg., Ocrevus (ocrelizumab) / Roche, Biogen
[VIRTUAL] Ocrelizumab Phase IIIb efficacy from CASTING: 2-year NEDA (MRI re-baselined) subgroup rates in RRMS patients with a suboptimal response to prior DMTs () - Aug 16, 2020 - Abstract #MSDC2020MSDC_298;
P3
The NEDA rate did not vary by baseline age (≤40 years, 74.7%; >40 years, 75.0%). NEDA rates were higher in patients receiving one prior DMT (77.6%) versus two prior DMTs (70.3%) and remained generally high when stratified by the last prior DMT received before enrollment: interferons, 81.1%; glatiramer acetate, 73.9%; dimethyl fumarate, 73.8%; teriflunomide 69.8%; fingolimod, 68.9%.Conclusions The NEDA rate was high overall and across a wide range of disease-related and demographic subgroups, regardless of prior treatment background.
- |||||||||| Kesimpta (ofatumumab subcutaneous) / Novartis, Genmab, Arzerra (ofatumumab) / Novartis, Genmab
[VIRTUAL] Long-term safety, compliance, and effectiveness of ofatumumab in patients with relapsing multiple sclerosis: ALITHIOS Phase 3b study () - Aug 16, 2020 - Abstract #MSDC2020MSDC_297;
Assessment of the long-term use of subcutaneous (s.c.) ofatumumab 20 mg is important to further understand its benefit-risk profile.Objectives To present the design of the ALITHIOS extension study of ofatumumab and evaluate treatment compliance, including treatment discontinuations, in patients transitioning to the ALITHIOS study.Methods ALITHIOS is an ongoing Phase 3b, open-label, umbrella extension study which has enrolled eligible patients (approximately 1700 patients) completing the Phase 3 ASCLEPIOS I/II, Phase 2 APOLITOS and APLIOS trials from >300 sites worldwide...The study is expected to complete in 2025. Study design details and compliance data will be presented at the congress.Conclusions The ALITHIOS study is designed to allow patients who participated in prior ofatumumab studies to continue with the treatment, and to further assess the benefit-risk profile of ofatumumab in RMS and tolerability in long-term use.
- |||||||||| fenebrutinib (GDC-0853) / Roche
[VIRTUAL] Examination of fenebrutinib, a highly selective BTKi, on disease progression of multiple sclerosis () - Aug 16, 2020 - Abstract #MSDC2020MSDC_290;
Study durations will be event driven, with the primary analysis occurring after a prespecified number of cCDP12 events (≥96 or ≥120 weeks in the RMS and PPMS trials, respectively).Conclusions Fenebrutinib will be investigated in RMS and PPMS and may offer a unique approach to slowing disease progression in MS. Furthermore, the use of the cCDP12 as a primary endpoint may provide a clearer, more complete picture of disability progression or improvement than the EDSS alone.
- |||||||||| Kesimpta (ofatumumab subcutaneous) / Novartis, Genmab, Arzerra (ofatumumab) / Novartis, Genmab
[VIRTUAL] Efficacy and safety of ofatumumab versus placebo in relapsing multiple sclerosis patients in Japan and Russia: Results from the Phase 2 APOLITOS study () - Aug 16, 2020 - Abstract #MSDC2020MSDC_288;
Background Ofatumumab, a fully human anti-CD20 monoclonal antibody, demonstrated superior efficacy versus teriflunomide with a favorable safety profile in the Phase 3 ASCLEPIOS I/II trials in relapsing multiple sclerosis (RMS) patients (Global, Ex-Japan)...Patients aged 18–55 years with confirmed MS diagnosis (2010 revised McDonald criteria), prior evidence of disease activity (≥1 relapse in the last 2 years AND MRI activity in the last year), and an EDSS score of 0–5.5 were randomized (2:1) to subcutaneous ofatumumab 20 mg or matching placebo (initial doses: Days 1, 7, 14, week 4; subsequent doses: every 4 weeks)...No deaths, opportunistic infections, or malignancies occurred during the study.Conclusions Ofatumumab demonstrated superior efficacy versus placebo in a RMS population with recent disease activity in Japanese and non-Japanese patients. No new safety signals were observed and the results were consistent with the Phase 3 ASCLEPIOS I/II trials.
- |||||||||| teriflunomide / Generic mfg., ponesimod (ACT-128800) / J&J
[VIRTUAL] Effect on disability measures and MSFC in patients with relapsing multiple sclerosis from the phase 3 ponesimod versus teriflunomide optimum study () - Aug 16, 2020 - Abstract #MSDC2020MSDC_283;
The PON vs TER worsening events up to EOS were, respectively: confirmed 20% worsening in T25FW, 9.2% vs 13.1% (hazard ratio [HR]:0.70; p=0.045); 4-point worsening in SDMT, 22.1% vs 26.4% (HR:0.82; p=0.12)], composite EDSS/SDMT, 26.3% vs 32.7% (HR:0.80; p=0.045)]; composite EDSS/9HPT/T25FW, 18.2% vs 24.0% (HR:0.76; p=0.035); numerical differences in favour of PON in time to confirmed worsening in 9HPT and SDMT assessed individually were not statistically significant.Conclusions Measures of worsening of impairment and disability in this exploratory analysis indicated benefits for PON vs TER. Composite endpoints provide more power to statistical assessments owing to greater number of events analyzed, making them particularly useful in RMS trials.
- |||||||||| ponesimod (ACT-128800) / J&J
[VIRTUAL] Cardiac Safety of Ponesimod in Relapsing Multiple Sclerosis in the Randomized, Active-Controlled, Double-Blind, Parallel-Group Phase 3 OPTIMUM Study () - Aug 16, 2020 - Abstract #MSDC2020MSDC_273;
P3
The up-titration was not associated with clinically significant bradyarrhythmia events; none were serious or leading to discontinuation of treatment, no 2nd degree or higher AV blocks were reported.Conclusions In the 2-year OPTIMUM study, PON treatment was not associated with an increased risk for major CV events such as MI, stroke, or CV death compared to TER. The up-titration regimen successfully mitigates 1st-dose effects and supports removing the requirement for 1st-dose cardiac monitoring in patients without risk factors of symptomatic bradycardia.
- |||||||||| Kesimpta (ofatumumab subcutaneous) / Novartis, Genmab, Arzerra (ofatumumab) / Novartis, Genmab
[VIRTUAL] Benefit-risk of ofatumumab in treatment-naïve early relapsing multiple sclerosis patients () - Aug 16, 2020 - Abstract #MSDC2020MSDC_271;
Compliance of all patients with ofatumumab was high (98.8%).Conclusions Ofatumumab is the first high efficacy DMT that can be self-administered at home, as demonstrated in Phase 3 ASCLEPIOS I/II trials. Ofatumumab showed superior efficacy vs teriflunomide in newly diagnosed, treatment-naïve patients with low absolute relapse rates, very low MRI lesion activity and prolonged time to disability worsening, consistent with the overall study population.
- |||||||||| dimethyl fumarate / Generic mfg., Mavenclad (cladribine) / EMD Serono
[VIRTUAL] Real World Experience of Oral Immune Reconstitution therapy (Cladribine) in the treatment of multiple sclerosis in the United Arab Emirates () - Aug 16, 2020 - Abstract #MSDC2020MSDC_220;
37% were naïve, 29% were switched from Fingolimod, 12% from Natalizumab, 10.4 % from Teriflunomide, 10% from dimethyl fumarate and 3% from interferons...I patient had to stop therapy as she became pregnant after 6 months of first year course. No patient had progression in EDSS scoreConclusions Oral Cladribine (MAVENCLAD) is a safe effective and well tolerated medication for the treatment of Multiple sclerosis especially for those who have had an inadequate response to, or are unable to tolerate, one or more therapies for relapsing remitting Multiple Sclerosis .
- |||||||||| dimethyl fumarate / Generic mfg.
[VIRTUAL] Oral therapies for treatment of relapsing-remitting multiple sclerosis in Austria () - Aug 16, 2020 - Abstract #MSDC2020MSDC_207;
Background Studies matching the clinical efficacy between fingolimod (FTY), dimethylfumarate (DMF) and teriflunomide (TERI) provided conflicting results...Patients treated with DMF showed less sustained disability progression for 12 weeks than FTY treated patients. However, FTY and DMF treatment was associated with more likely EDSS regression for 12 and 24 weeks and a lowerprobability for treatment interruptionas compared to TERI treated patients.
- |||||||||| dimethyl fumarate / Generic mfg., Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
[VIRTUAL] Evaluation of diagnosis and treatment practices in patients with Multiple Sclerosis by Brazilian neurologists’ experts in demyelinating disorders. () - Aug 16, 2020 - Abstract #MSDC2020MSDC_156;
In PPMS case, almost all respondents agreed to start treatment with ocrelizumab or rituximab...Furthermore, almost all specialists check levels of vitamin D and prescribe supplements for low levels.Conclusions This study allowed the identification of areas of agreement among Brazilian neurologists on different scenarios related to patients with MS. These results can be used to promote debate among Brazilian experts, with the goal of helping update future protocols and improve patient management.
- |||||||||| ponesimod (ACT-128800) / J&J
[VIRTUAL] Effect of oral ponesimod on clinical disease activity and MRI-based outcomes in patients with relapsing multiple sclerosis: Phase 3 OPTIMUM study () - Aug 16, 2020 - Abstract #MSDC2020MSDC_151;
P3
At week 108, 28.2% (159/564) PON vs 18.3% (102/558) TER patients (OR: 1.70, 95% CLs: 1.27;2.28, p=0.0004) achieved NEDA-3; 15.0% (79/526) PON vs 8.5% (45/532) TER patients (OR: 1.85, 95% CLs: 1.24;2.76, p=0.0026) achieved NEDA-4. The most common reason for not achieving NEDA-3 or NEDA-4 status was presence of new/enlarging T2 lesions.Conclusions PON showed benefit vs TER for all MRI outcomes including brain volume loss and a significantly higher proportion of patients achieved NEDA-3 and NEDA-4 status, supporting the effects observed on clinical endpoints.
- |||||||||| [VIRTUAL] Comparative Efficacy of Relapsing Multiple Sclerosis Therapies: A Model-Based Meta-Analysis for Annual Relapse Rate () - Aug 16, 2020 - Abstract #MSDC2020MSDC_129;
Results suggested that ponesimod had numerically superior ARR benefits compared to interferon β-1a (subcutaneous), peginterferon β-1a, glatiramer acetate, and dimethyl fumarate (RR range: 0.68–0.94). Ponesimod had similar ARR benefits to S1P receptor modulators ozanimod, fingolimod, cladribine, and daclizumab (RR range: 1.00–1.04).Conclusions Ponesimod reduced ARR in patients with RMS, and was statistically superior as compared with placebo and a range of other DMTs.
- |||||||||| [VIRTUAL] Comparative Efficacy of Relapsing Multiple Sclerosis Therapies: A Longitudinal Model-Based Meta-Analysis for Confirmed Disability Accumulation () - Aug 16, 2020 - Abstract #MSDC2020MSDC_128;
Results favored ponesimod in comparison to placebo (HR: 0.61; 95% CI: 0.44–0.83), glatiramer acetate (0.65; 0.44–0.94), and interferon β-1b (0.51; 0.33–0.77) in delaying 12-week CDA. Ponesimod was estimated to have numerical improvement to S1P receptor modulators fingolimod, ozanimod, laquinimod, as well as teriflunomide, interferon β-1a (intramuscular and subcutaneous), peginterferon β-1a, cladribine, daclizumab, and dimethyl fumarate (HR range: 0.77–0.94).Conclusions Ponesimod was statistically superior compared to placebo and a range of other DMTs suggesting robust efficacy in the treatment of MS.
- |||||||||| Zeposia (ozanimod) / BMS, teriflunomide / Generic mfg.
[VIRTUAL] Comparative Efficacy and Safety of Ozanimod Versus Teriflunomide for Relapsing-Remitting Multiple Sclerosis: a Matching-Adjusted Indirect Comparison () - Aug 16, 2020 - Abstract #MSDC2020MSDC_127;
The following outcomes of interest were assessed: annualized relapse rate (ARR), proportion of patients relapsed, confirmed disability progression (CDP) sustained for 12 and 24 weeks, overall adverse events (AEs), serious AEs (SAEs), and discontinuations due to AEs.Results After matching, baseline patient characteristics were balanced between ozanimod and TEF. Compared with TEF, ozanimod demonstrated improvements in ARR (rate ratio [RR]: 0.73; 95% CI: 0.62–0.84), proportion of patients relapsed (odds ratio [OR]: 0.56; 95% CI: 0.44–0.70), overall AEs (OR: 0.35; 95% CI: 0.29–0.43), SAEs (OR: 0.53; 95% CI: 0.37–0.77), and discontinuations due to AEs (OR: 0.14; 95% CI: 0.09–0.21) and similar CDP at 12 (RR: 0.80; 95% CI: 0.61–1.05) and 24 (RR: 0.80; 95% CI: 0.59–1.08) weeks.Conclusions Ozanimod was associated with improved relapse outcomes and lower risks of AEs over 1–2 years of follow-up compared with TEF, with no differences in CDP.
- |||||||||| teriflunomide / Generic mfg., Arzerra (ofatumumab) / Novartis, Genmab
[VIRTUAL] Baseline serum neurofilament light levels have prognostic value for on-study MRI activity: Results from ASCLEPIOS trials () - Aug 16, 2020 - Abstract #MSDC2020MSDC_113;
The relative treatment effect of ofatumumab versus teriflunomide was similar across all measures in both the high and low sNfL groups.Conclusions Baseline sNfL levels were prognostic for on-study lesion formation and BVL for at least 2 years, in all patients and in the subgroup of newly diagnosed, treatment-naïve patients. sNfL levels can supplement clinical assessments and help identify patients at high risk for future disease activity.
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen
Journal: New Arrival of Disease Modifying Drugs Initiates New Era in Multiple Sclerosis Treatment in Japan (Pubmed Central) - Aug 13, 2020
Ofatumumab and siponimod will be approved probably in 2021...A clinical trial revealed that the efficacy of ofatumumab is clearly superior to teriflunomide that has comparable efficacy to dimethyl fumarate...On the other hand, initiation of high efficacy drugs may be reasonable to prevent from disease progression. Even if either is acceptable, early induction of DMD with sufficient efficacy is mandatory for MS treatment.
- |||||||||| Clinical, Reimbursement, Journal, Medicaid: Expenditure, Utilization, and Cost of Specialty Drugs for Multiple Sclerosis in the US Medicaid Population, 2008-2018. (Pubmed Central) - Jul 30, 2020
The specialty drugs considered in our analysis included dimethyl fumarate, fingolimod, teriflunomide, cladribine, siponimod, alemtuzumab, natalizumab, ocrelizumab, daclizumab, glatiramer acetate, peginterferon beta-1a, interferon beta-1a, and interferon beta-1b...The growing utilization and spending trends for specialty MS medications are significant and sizable in the US Medicaid programs. Medicaid cost-containment strategy is warranted to control the economic burden of state budgets across the country.
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen, Rituxan (rituximab) / Roche, Biogen, Zenyaku Kogyo, Lemtrada (alemtuzumab) / Sanofi
Journal: Blood neurofilament light levels segregate treatment effects in multiple sclerosis. (Pubmed Central) - Jul 22, 2020
This shows that even if there is evidence of teratogenic effects in animals, an 8-week exposure to teraflunomide >0.02 mg/L did not have effects on the newborn. Choice of DMT in RRMS is significantly associated with degree of reduction in pNfL, which supports a role for pNfL as a drug response marker.
- |||||||||| teriflunomide / Generic mfg.
Clinical, Journal: The peripheral blood immune cell profile in a teriflunomide-treated multiple sclerosis patient with COVID-19 pneumonia. (Pubmed Central) - Jul 21, 2020
At the infection time point, no differences in the percentages of immune activation and immunesenescence of CD4+ and CD8+ T-cells were observed compared to the pre-infection time point. Our evaluation seems to confirm that teriflunomide controls T-cells immune activation and immunosenescence suggesting that teriflunomide should not be discontinued in MS patients with an active COVID-19 pneumonia.
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