- |||||||||| Kesimpta (ofatumumab subcutaneous) / Novartis, Genmab, Mavenclad (cladribine) / EMD Serono, Lemtrada (alemtuzumab) / Sanofi
Review, Journal: B cells in multiple sclerosis - from targeted depletion to immune reconstitution therapies. (Pubmed Central) - Jan 18, 2022 We also review the immunological effects - with a focus on the effects on B cell subsets - of several successful therapeutic approaches in MS, including agents that selectively deplete B cells (rituximab, ocrelizumab and ofatumumab), agents that less specifically deplete lymphocytes (alemtuzumab and cladribine) and autologous haematopoietic stem cell transplantation, in which the immune system is unselectively ablated and reconstituted. We consider the insights that these effects on B cell populations provide and their potential to further our understanding and targeting of B cells in MS.
- |||||||||| Ocrevus (ocrelizumab) / Roche, Biogen, Lemtrada (alemtuzumab) / Sanofi
Review, Journal: Product review on MAbs (alemtuzumab and ocrelizumab) for the treatment of multiple sclerosis. (Pubmed Central) - Jan 15, 2022 In this product review, we will discuss the first DMT that acts as IRT, an anti-CD52 monoclonal antibody alemtuzumab and an anti CD20 monoclonal antibody, ocrelizumab that has the potential to act as an IRT, but is administered continuously. Special emphasis will be given on safety in the context of COVID-19 pandemics and vaccination strategies.
- |||||||||| Lemtrada (alemtuzumab) / Sanofi
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: LEMTRADA Pregnancy Registry in Multiple Sclerosis (clinicaltrials.gov) - Jan 11, 2022 P=N/A, N=42, Terminated, aHSCT suppresses inflammatory activity more effectively than alemtuzumab and might enable improvement of overall disability and cognition in MS. N=204 --> 42 | Trial completion date: Nov 2026 --> Nov 2021 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2026 --> Nov 2021; The sponsor stopped the study due to low recruitment with no safety concerns
- |||||||||| Mavenclad (cladribine) / EMD Serono, Lemtrada (alemtuzumab) / Sanofi
‘’Emerging Role of Autologous Hematopoietic Stem Cell Transplantation in the Management of Multiple Sclerosis: A Systematic Review of the Literature.’’ (Salt Palace Convention Center Hall A) - Jan 9, 2022 - Abstract #TCTASTCTCIBMTR2022TCT_ASTCT_CIBMTR_1185; The indication for treatment is age less than 45 years, short duration (less than 10 years),Expanded Disability Status Scale(EDSS) >5.5 not very disabled, highly active RRMS, malignant and in progressive MS.. By comparing AHSCT to DMD’s , it seems relatively cost-effective as compared to MS therapy with DMDs for one year like AHSCT costs an average of 80,000 to 120,000$ but one year DMD’s costs ranges from 50,000$ to 70,000$.It considers a mean cost of 60,000$ per year for treatment with DMDs because of expensive drugs and monoclonal antibodies.
- |||||||||| Comirnaty (tozinameran) / Pfizer, Fosun Pharma, BioNTech, Lemtrada (alemtuzumab) / Sanofi
Clinical, Journal: Effect of Different Disease-Modifying Therapies on Humoral Response to BNT162b2 Vaccine in Sardinian Multiple Sclerosis Patients. (Pubmed Central) - Jan 7, 2022 We did not observe a statistically significant difference in response between patients treated with the other drugs (dimethyl fumarate, interferon, alemtuzumab and glatiramer acetate) and untreated patients...Humoral response to BNT162b2 is significantly influenced by the specific DMTs followed by patients, as well as by other factors such as previous SARS-CoV-2 infection, age, sex, and smoking status. These results are important to inform targeted strategies to prevent clinically relevant COVID-19 in MS patients.
- |||||||||| Lemtrada (alemtuzumab) / Sanofi
Journal: Multiple sclerosis: structural and functional integrity of the visual system following alemtuzumab therapy. (Pubmed Central) - Jan 4, 2022 We found evidence of partial lesion remyelination after alemtuzumab therapy, indicating either natural restoration in the context of a 'permissive' local milieu; or potentially an independent, pro-reparative mechanism of action. The visual system presents a unique opportunity to study function-structure specific effects of therapy and inform the design of future phase 2 MS remyelination trials.
- |||||||||| Lemtrada (alemtuzumab) / Sanofi
Biomarker, Clinical, Retrospective data, Journal: IgG4-related autoimmune manifestations in Alemtuzumab-treated multiple sclerosis patients. (Pubmed Central) - Jan 4, 2022 Compared to baseline, total IgG-levels showed a trend towards reduced levels following two-courses of Alemtuzumab, but no significant change of C3 and/or C4-levels was observed. In conclusion, monitoring of IgG4-levels can serve as a marker for secondary autoimmunity risk in multiple sclerosis patients treated with Alemtuzumab.
- |||||||||| Mavenclad (cladribine) / EMD Serono, Lemtrada (alemtuzumab) / Sanofi
Clinical, Journal: Assessing and mitigating risk of infection in patients with multiple sclerosis on disease modifying treatment. (Pubmed Central) - Dec 30, 2021 MS-specialist neurologist has to face new challenges regarding the management of immunosuppression-related infectious complications. The implementation of patient-centered management focus on preventive and mitigating strategies with a multidisciplinary approach should be seen in the future as a marker of excellence of MS management.
- |||||||||| Lemtrada (alemtuzumab) / Sanofi
Journal, HEOR: Modeling the Cost-Utility of Treatment Sequences for Multiple Sclerosis. (Pubmed Central) - Dec 30, 2021 This microsimulation model overcomes the limitation of previous models by modeling treatment sequences. Because it better reflects clinical reality, it facilitates incorporating cost-utility information in clinical guidelines.
- |||||||||| Campath (alemtuzumab) / Sanofi, Lemtrada (alemtuzumab) / Sanofi
Journal: CD52-targeted depletion by Alemtuzumab ameliorates allergic airway hyperreactivity and lung inflammation. (Pubmed Central) - Dec 29, 2021 Our results demonstrate that CD52 depletion is a viable therapeutic option for reduction of pulmonary inflammation, abrogation of eosinophilia, improvement of lung function, and thus treatment of allergic AHR. Taken together, our data suggest that anti-CD52 depleting monoclonal antibodies, such as Alemtuzumab, can serve as viable therapeutic drugs for amelioration of T2- and ILC2-dependent AHR.
- |||||||||| Lemtrada (alemtuzumab) / Sanofi
Biomarker, Journal: Immune Regulatory Cell Bias Following Alemtuzumab Treatment in Relapsing-Remitting Multiple Sclerosis. (Pubmed Central) - Dec 25, 2021 P=N/A Here, we showed for the first time that functionally competent regulatory B cells re-appear with similar kinetics to that of regulatory T-cells, whereas the change in anti-inflammatory bias of monocytes does not occur until after the second treatment course. These findings justify future studies of all regulatory cell types following alemtuzumab treatment to reveal further insights into mechanisms of drug action, and to identify key immunological predictors of durable clinical efficacy in alemtuzumab-treated patients.
- |||||||||| Lemtrada (alemtuzumab) / Sanofi
Clinical, Journal, HEOR, Real-world evidence: Newly approved agents for relapsing remitting multiple sclerosis: how real-world evidence compares with randomized clinical trials? (Pubmed Central) - Dec 16, 2021 These include fingolimod, teriflunomide, dimethyl fumarate, alemtuzumab and ocrelizumab...From the safety point of view, observational studies revealed new adverse events, mostly in the area of bacterial and opportunistic infections, not seen in the relative registration programme. This is a very important gain because it allows to elaborate appropriate strategies to prevent and handle the risks.
- |||||||||| Mavenclad (cladribine) / EMD Serono, Lemtrada (alemtuzumab) / Sanofi
Journal: Associations of Disease-Modifying Therapies With COVID-19 Severity in Multiple Sclerosis. (Pubmed Central) - Dec 16, 2021 Using the largest cohort of people with MS and COVID-19 available, we demonstrated consistent associations of rituximab with increased risk of hospitalisation, ICU admission, and requiring artificial ventilation, and ocrelizumab with hospitalisation and ICU admission. Despite the study's cross-sectional design, the internal and external consistency of these results with prior studies suggests rituximab/ocrelizumab use may be a risk factor for more severe COVID-19.
- |||||||||| Mavenclad (cladribine) / EMD Serono, Lemtrada (alemtuzumab) / Sanofi
Retrospective data, Review, Journal: Impact of disease-modifying therapies on MRI and neurocognitive outcomes in relapsing-remitting multiple sclerosis: a protocol for a systematic review and network meta-analysis. (Pubmed Central) - Dec 16, 2021 We will include parallel group randomised controlled trials of DMTs including interferon beta-1a intramuscular, interferon beta-1a subcutaneous, interferon beta-1b, peginterferon beta-1a, glatiramer acetate, natalizumab, ocrelizumab, alemtuzumab, dimethyl fumarate, teriflunomide, fingolimod, cladribine, ozanimod, mitoxantrone and rituximab, either head-to-head or against placebo in adults with RRMS...Results will be disseminated in a peer-reviewed academic journal. CRD42021239630.
- |||||||||| Mavenclad (cladribine) / EMD Serono, Lemtrada (alemtuzumab) / Sanofi
Journal: Pregnancy and multiple sclerosis: an update. (Pubmed Central) - Oct 28, 2021 We present a case of Graves' disease with active, moderate-to-severe Graves' ophthalmopathy in a patient with pre-existing AFTN presenting with a coexisting, rare case of Marine-Lenhart syndrome associated with immune reconstitution after alemtuzumab treatment. The evidence of potential fetotoxicities and adverse pregnancy outcomes associated with DMTs is increasing, although more research is needed to evaluate the safety of drugs and to track long-term health outcomes for the mother and the child.
- |||||||||| Lemtrada (alemtuzumab) / Sanofi
Review, Journal: Alemtuzumab: A Review in Relapsing Remitting Multiple Sclerosis. (Pubmed Central) - Oct 27, 2021 Alemtuzumab has an acceptable tolerability profile, with infusion-associated reactions, infections and autoimmunity being the main safety and tolerability issues. Current evidence indicates that alemtuzumab is an effective treatment option for adults with highly active RRMS, with an acceptable safety and tolerability profile and convenient treatment regimen.
- |||||||||| Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Psoriasis in Multiple Sclerosis Patients Treated with Disease Modifying Therapies () - Oct 8, 2021 - Abstract #CMSC2021CMSC_624; This observation is in line with reports from rheumatology and other medical fields where either de-novo psoriasis or exacerbation of known psoriasis have been observed in association with B cell depletion. Further research is needed to identify an actual excess risk and unravel the underlying immunopathologic mechanisms.
- |||||||||| Ocrevus (ocrelizumab) / Roche, Biogen, Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Number-Needed-to-Harm (NNH) in Alemtuzumab and Ocrelizumab Pivotal Clinical Trials in Relapsing MS () - Oct 8, 2021 - Abstract #CMSC2021CMSC_601; P3 Overall the safety profile of OCR is better than that of ALE, although alemtuzumab holds an advantage over ocrelizumab in terms of AEs leading to study drug discontinuation. NNH itself is limited by clinical trial differences, and there is an increasing need to develop novel techniques to compare the safety and tolerability of MS DMTs across clinical trials.
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