- |||||||||| Mavenclad (cladribine) / EMD Serono, Lemtrada (alemtuzumab) / Sanofi
Precision medicine in an unlikely future of multiple sclerosis treatment (Hall 12) - Jun 22, 2022 - Abstract #ECTRIMS2022ECTRIMS_93; We interpret our data to indicate that although DMTs differ quantitatively in their ability to suppress the focal inflammation that is the hallmark of early MS, few if any patients appear to be biologically non-responsive to any drug. This suggests that MS is largely pathogenetically homogenous and indicates that precision medicine may have limited prospects in the treatment of MS.
- |||||||||| Mavenclad (cladribine) / EMD Serono
Journal: Long term persistence of SARS-CoV-2 humoral response in multiple sclerosis subjects. (Pubmed Central) - Jun 15, 2022 This suggests that MS is largely pathogenetically homogenous and indicates that precision medicine may have limited prospects in the treatment of MS. The prominent decline in humoral response in MS subjects undergoing dimethyl fumarate-, interferon-β 1a- and glatiramer acetate-therapies should be considered when formulating booster regimens as these subjects would benefit of early booster vaccinations.
- |||||||||| teriflunomide / Generic mfg.
Teriflunomide associated alopecia areata - a case report (e-Poster Hall) - Jun 13, 2022 - Abstract #EADVSp2022EADV_Sp_350; In conclusion, the identification teriflunomide and leflunomide as potential triggers for AA, and their discontinuation may result in remission of the disease. On the other hand, although the association between AA and MS is not defined, due to their shared pathogenetic processes, close attention to MS signs and symptoms must be given in patients affected by AA.
- |||||||||| leflunomide / Generic mfg.
Journal: Leflunomide-Induced Liver Injury: Differences in Characteristics and Outcomes in Indian and US Registries. (Pubmed Central) - Jun 11, 2022 Leflunomide hepatotoxicity is more likely accompanied by SCAR, a short latency and a higher mortality in the Indian cohort, with a predominance of females, compared to US DILIN patients. The differences in skin involvement, immunoallergic features and outcomes among subjects from India vs. the USA suggest that genetic or environmental factors are important in the pathogenesis of liver injury.
- |||||||||| teriflunomide / Generic mfg.
Retrospective data, Journal, Real-world evidence: Evolution of teriflunomide use in multiple sclerosis: A real-world experience. (Pubmed Central) - Jun 9, 2022 The differences in skin involvement, immunoallergic features and outcomes among subjects from India vs. the USA suggest that genetic or environmental factors are important in the pathogenesis of liver injury. Our study confirms a major evolution in teriflunomide use in clinical settings, particularly for naïve patients and young women.
- |||||||||| Kesimpta (ofatumumab subcutaneous) / Novartis, Genmab, Mavenclad (cladribine) / EMD Serono, Lemtrada (alemtuzumab) / Sanofi
Timing Disease-Modifying Therapies with COVID-19 Vaccine in Multiple Sclerosis Patients: A Real-World Data (Gaylord National Resort & Convention Center - Prince George's Exhibit Hall) - May 9, 2022 - Abstract #CMSC2022CMSC_101; The majority of patients had the correct timing with respect to getting DMTs and their vaccines. However, patients on "Induction DMTs" have postponed BD, probably due to time and method of getting DMTs.
- |||||||||| Kesimpta (ofatumumab subcutaneous) / Novartis, Genmab
Ofatumumab Improves Neda-3 Likelihood in Hispanic/Latino Patients with Relapsing Multiple Sclerosis: Subgroup Analysis of the Asclepios Studies (Gaylord National Resort & Convention Center - Prince George's Exhibit Hall) - May 9, 2022 - Abstract #CMSC2022CMSC_79; Objectives: Report findings of a post hoc analysis assessing achievement of NEDA-3 with subcutaneous OMB vs oral teriflunomide (TER) in a subgroup of patients with RMS from the Phase 3 ASCLEPIOS I/II studies who identified as Hispanic/Latino... NEDA-3 efficacy data and the safety profile of OMB in the Hispanic/Latino subgroup are suggested to be consistent with the White subgroup in the ASCLEPIOS studies.
- |||||||||| Ponvory (ponesimod) / J&J
Analysis of Post-Treatment Relapse Activity in the Phase 3 Optimum Study of Ponesimod Compared with Teriflunomide (Gaylord National Resort & Convention Center - Prince George's Exhibit Hall) - May 9, 2022 - Abstract #CMSC2022CMSC_61; NEDA-3 achievement and the safety profile of OMB in the Black/African American subgroup are consistent with the White subgroup in the ASCLEPIOS studies. These prospectively obtained post-treatment observation data in patients who stopped ponesimod treatment in the OPTIMUM study, do not support increased early post-treatment relapse activity as compared to activity on treatment.
- |||||||||| Kesimpta (ofatumumab subcutaneous) / Novartis, Genmab
Injection-Related Reactions with Subcutaneous Administration of Ofatumumab in Relapsing Multiple Sclerosis: Data from Clinical Studies and Post Marketing Experience (Gaylord National Resort & Convention Center - Prince George's Exhibit Hall) - May 9, 2022 - Abstract #CMSC2022CMSC_56; Data from the core ASCLEPIOS I/II, APLIOS, APOLITOS trials and ALITHIOS study (overall, N=1969; patients who received continuous ofatumumab, N=1292; patients newly switched from teriflunomide to ofatumumab, N=677) and from the post-marketing setting (cut-off: 25 Sep 2021) were included in this analysis. Systemic and local-site IRRs reported upon first injection with ofatumumab in the core clinical studies and ALITHIOS trial, including in newly-switched patients and in the post-marketing setting were mostly mild-to-moderate in severity.
- |||||||||| Utuxin (ublituximab) / TG Therap
Infusion-Related Reactions with Ublituximab in the Phase 3 Ultimate I and II Studies in Relapsing Multiple Sclerosis (Gaylord National Resort & Convention Center - Prince George's Exhibit Hall) - May 9, 2022 - Abstract #CMSC2022CMSC_46; In the ULTIMATE I and II studies in patients with relapsing multiple sclerosis (RMS), ublituximab met its primary endpoint of significantly reduced annualized relapse rate vs teriflunomide. IRRs were the prevailing adverse event with ublituximab in ULTIMATE I and II; the majority occurred at the first dose and had minimal impact on infusion completion.
- |||||||||| Kesimpta (ofatumumab subcutaneous) / Novartis, Genmab
Longer-Term Effects of Ofatumumab on Clinical and MRI Outcomes in Patients with Relapsing Multiple Sclerosis (Gaylord National Resort & Convention Center - Prince George's Exhibit Hall) - May 9, 2022 - Abstract #CMSC2022CMSC_43; IRRs were the prevailing adverse event with ublituximab in ULTIMATE I and II; the majority occurred at the first dose and had minimal impact on infusion completion. These analyses will provide further insights on the longer-term effects of continuous ofatumumab treatment for up to 4 years, and the effects of switching from teriflunomide to ofatumumab and providing further evidence to support the benefit/risk profile of ofatumumab.
- |||||||||| Utuxin (ublituximab) / TG Therap
Improved Cognitive Processing Speed with Ublituximab in Patients with Highly Active Relapsing Multiple Sclerosis (Gaylord National Resort & Convention Center - Prince George's Exhibit Hall) - May 9, 2022 - Abstract #CMSC2022CMSC_42; These analyses will provide further insights on the longer-term effects of continuous ofatumumab treatment for up to 4 years, and the effects of switching from teriflunomide to ofatumumab and providing further evidence to support the benefit/risk profile of ofatumumab. In patients with highly active RMS at baseline who had received prior DMT, ublituximab treatment provided clinically meaningful and statistically significant improvement in cognitive processing speed as measured by SDMT at 96 weeks vs teriflunomide in the ULTIMATE I and II studies.
- |||||||||| Mavenclad (cladribine) / EMD Serono
Patient Characteristics and Treatment Patterns Prior to Initiating Cladribine Tablets: A US Retrospective Commercial Claims Analysis (Gaylord National Resort & Convention Center - Prince George's Exhibit Hall) - May 9, 2022 - Abstract #CMSC2022CMSC_38; Of those on DMTs in the 1-year pre-index period, patients switched from ocrelizumab (12.1%), fingolimod (10.3%), dimethyl fumarate (11.3%), natalizumab (9.2%), glatiramer acetate (7.4%), teriflunomide (7.6%), and subcutaneous interferon-beta 1a (5.0%). These results provide a better understanding of real-world patient characteristics and treatment patterns among US commercially insured patients receiving CladT.
- |||||||||| Kesimpta (ofatumumab subcutaneous) / Novartis, Genmab
Longer-Term Safety of Ofatumumab in Patients with Relapsing Multiple Sclerosis (WOODROW WILSON D) - May 9, 2022 - Abstract #CMSC2022CMSC_4; Findings from ALITHIOS study for up to 3.5 years showed ofatumumab treatment to be well-tolerated with no new safety risks identified. This additional safety data up to 4 years will help to inform physicians on the longer-term safety profile of ofatumumab in RMS patients.
- |||||||||| teriflunomide / Generic mfg.
Pregestational maternal diabetes inhibits mitochondrial fusion through microRNA upregulation leading to congenital heart disease (Grand Hall C) - May 6, 2022 - Abstract #ASRI2022ASRI_126; Here we report that two mitochondrial fusion activators, Teriflunomide and Echinacoside, ameliorate pregestational maternal diabetes-induced and microRNA (miR)- induced CHDs by restoring the expression of mitofusin 1 and 2 (Mfn1 and Mfn2)...Either resorting Mfn1 or Mfn2 expression in the developing heart prevents compromised mitochondrial fusion and CHDs in diabetic pregnancy. Thus, the FoxO3a-miR-Mfn1/2 pathway plays a critical role in the pathogenesis of maternal diabetes-induced CHDs, and mitochondrial fusion activators may be effective preventives to non-genetic factorinduced CHDs.
- |||||||||| teriflunomide / Generic mfg.
Preclinical, Journal: Teriflunomide treatment exacerbates cardiac ischemia reperfusion injury in isolated rat hearts. (Pubmed Central) - May 1, 2022 Combining Molnupiravir with DHODH inhibitors may thus improve available therapy options for COVID-19. This study suggests that treatment with TERI leads to more negative outcomes following cardiac ischemia reperfusion, and administration of TERI to at-risk populations should receive special considerations.
- |||||||||| teriflunomide / Generic mfg.
Trial completion date, Trial primary completion date: An Observational Study on Teriflunomide-exposed Pregnancies (clinicaltrials.gov) - Apr 28, 2022 P=N/A, N=325, Recruiting, Thus, investing in adherence improvement is beneficial to improve outcomes in relapsing multiple sclerosis. Trial completion date: Jun 2023 --> Dec 2022 | Trial primary completion date: Jun 2023 --> Dec 2022
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