G öttingen pigs as a potential model for natalizumab pharmacokinetics, pharmacodynamics, and immunogenicity evaluation
Biomed Pharmacother. 2022 Oct 26;156:113926. doi: 10.1016/j.biopha.2022.113926. Online ahead of print.ABSTRACTNatalizumab is a recombinant, humanized form of a monoclonal antibody that binds to CD49d. The presented study was conducted to explore the suitability of Göttingen pigs as a pharmacokinetic/pharmacodynamic model in the preclinical phase of biosimilar natalizumab development. The minipigs were treated with 1.286 or 3.0 mg of natalizumab (Tysabri®) per kg of body weight by a single 1-hour intravenous infusion. Six days before (baseline) and 30 days after administration of the single dose of natalizumab, blood samp...
Source: Biomedicine and pharmacotherapy = Biomedecine and pharmacotherapie - October 29, 2022 Category: Drugs & Pharmacology Authors: Tomasz Grabowski Rafa ł Derlacz Artur Burma ńczuk Source Type: research
G öttingen pigs as a potential model for natalizumab pharmacokinetics, pharmacodynamics, and immunogenicity evaluation
Biomed Pharmacother. 2022 Oct 26;156:113926. doi: 10.1016/j.biopha.2022.113926. Online ahead of print.ABSTRACTNatalizumab is a recombinant, humanized form of a monoclonal antibody that binds to CD49d. The presented study was conducted to explore the suitability of Göttingen pigs as a pharmacokinetic/pharmacodynamic model in the preclinical phase of biosimilar natalizumab development. The minipigs were treated with 1.286 or 3.0 mg of natalizumab (Tysabri®) per kg of body weight by a single 1-hour intravenous infusion. Six days before (baseline) and 30 days after administration of the single dose of natalizumab, blood samp...
Source: Biomedicine and pharmacotherapy = Biomedecine and pharmacotherapie - October 29, 2022 Category: Drugs & Pharmacology Authors: Tomasz Grabowski Rafa ł Derlacz Artur Burma ńczuk Source Type: research
A case of natalizumab ‐associated progressive multifocal leukoencephalopathy followed by immune reconstitution inflammatory syndrome with difficulty in the timing of immunotherapy
ConclusionsTreatment sequencing should be executed before the onset of NAT-PML. Changes in CSF cell count and IgG index may be useful for treatment decision; further research is needed. (Source: Clinical and Experimental Neuroimmunology)
Source: Clinical and Experimental Neuroimmunology - October 19, 2022 Category: Neurology Authors: Takamichi Sugimoto,
Shuichiro Neshige,
Shiro Aoki,
Kazuhide Ochi,
Ruoyi Ishikawa,
Megumi Nonaka,
Masahiro Nakamori,
Tomohisa Nezu,
Kazuo Nakamichi,
Yu Yamazaki,
Hirofumi Maruyama Tags: CASE REPORT Source Type: research
Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1) and Natalizumab Serum Concentration as Potential Biomarkers for Pharmacodynamics and Treatment Response of Patients with Multiple Sclerosis Receiving Natalizumab
ConclusionsSoluble vascular cell adhesion molecule 1 is a suitable pharmacodynamic marker during treatment with NTZ, which is significantly reduced already after the first dose, remains stable in individual patients even on extended interval dosing, and strongly correlates with NTZ SC. Because of the high inter-individual range, absolute levels of sVCAM-1 and NTZ SC are difficult to introduce as treatment monitoring biomarkers in order to predict disease activity in single patients. (Source: CNS Drugs)
Source: CNS Drugs - September 29, 2022 Category: Neurology Source Type: research
Persistence, Adherence, and Switching to Higher-Cost Therapy in Patients with Multiple Sclerosis Initiating Oral Disease-Modifying Therapies: A Retrospective Real-World Study
ConclusionPatients newly initiated on teriflunomide and fingolimod had better real-world persistence and adherence at 6 and 12 months, and longer time to switch to higher-cost therapies, than patients on dimethyl fumarate or diroximel fumarate. (Source: Neurology and Therapy)
Source: Neurology and Therapy - September 24, 2022 Category: Neurology Source Type: research
Superior effects of natalizumab versus other DMTs on patient-reported outcomes in people with multiple sclerosis
Conclusions
Natalizumab was associated with superior outcomes over time for many patient-reported health and employment outcomes when compared with other DMTs in this large prospective cohort study. These findings may influence treatment selection in clinical practice and future treatment cost-effectiveness analyses. (Source: Journal of Neurology, Neurosurgery and Psychiatry)
Source: Journal of Neurology, Neurosurgery and Psychiatry - September 14, 2022 Category: Neurosurgery Authors: Chen, J., Diouf, I., Taylor, B. V., Kalincik, T., van der Mei, I. Tags: Multiple sclerosis Source Type: research
Improvements in Cognitive Processing Speed, Disability, and Patient-Reported Outcomes in Patients with Early Relapsing-Remitting Multiple Sclerosis Treated with Natalizumab: Results of a 4-year, Real-World, Open-Label Study
ConclusionThese results further extend our knowledge of the effectiveness, specifically regarding improvements in cognitive processing speed, disability and PROs, of long-term natalizumab treatment in early RRMS patients.Clinicaltrials.govNCT01485003 (5 December 2011) (Source: CNS Drugs)
Source: CNS Drugs - September 5, 2022 Category: Neurology Source Type: research
Pharmacological Management of Inflammatory Bowel Disease: a Century of Expert Opinions in Cecil Textbook of Medicine
Conclusions:
The pharmacological management of IBD has been the focus of intense research and development in the past 60 years. The pillars of drug treatment have been 5-aminosalicylates and corticosteroids. Recent pharmacological innovations (immunomodulators and biologicals) constitute an encouraging paradigm shift in the treatment of UC and Crohn disease. (Source: American Journal of Therapeutics)
Source: American Journal of Therapeutics - September 1, 2022 Category: Drugs & Pharmacology Tags: Original Investigation Source Type: research
Monoclonal antibody treatment during pregnancy and lactation in women with multiple sclerosis or neuromyelitis optica spectrum disorder
AbstractMultiple sclerosis (MS) and neuromyelitis optica (NMOSD) are more prevalent in women and mainly affecting young women, the majority of whom are of childbearing age. In addition, recent treatment algorithms suggest that patients who have poor prognostic factors are treated with highly effective disease-modifying drugs from the beginning. Monoclonal antibodies for MS or NMOSD are basically highly effective disease-modifying drugs. Therefore, young women with MS or NMOSD will have more opportunities to receive monoclonal antibody treatment than ever before. Currently, five monoclonal antibodies for MS or NMOSD are ava...
Source: Clinical and Experimental Neuroimmunology - August 30, 2022 Category: Neurology Authors: Chiyoko Nohara Tags: INVITED REVIEW Source Type: research
Updated Results of the COVID-19 in MS Global Data Sharing Initiative: Anti-CD20 and Other Risk Factors Associated With COVID-19 Severity
Discussion
Analyzing the largest international real-world data set of people with MS with suspected/confirmed COVID-19 confirms that the use of anti-CD20 medication (both ocrelizumab and rituximab), as well as male sex, older age, progressive MS, and higher disability are associated with more severe course of COVID-19. (Source: Neurology Neuroimmunology and Neuroinflammation)
Source: Neurology Neuroimmunology and Neuroinflammation - August 29, 2022 Category: Neurology Authors: Simpson-Yap, S., Pirmani, A., Kalincik, T., De Brouwer, E., Geys, L., Parciak, T., Helme, A., Rijke, N., Hillert, J. A., Moreau, Y., Edan, G., Sharmin, S., Spelman, T., McBurney, R., Schmidt, H., Bergmann, A. B., Braune, S., Stahmann, A., Middleton, R. M. Tags: COVID-19, Multiple sclerosis, All epidemiology, Risk factors in epidemiology Research Article Source Type: research
Anti ‐monoclonal antibody treatment during pregnancy and lactation in women with multiple sclerosis or neuromyelitis optica spectrum disorder
AbstractMultiple sclerosis (MS) and neuromyelitis optica (NMOSD) are more prevalent in women and mainly affecting young women, the majority of whom are of childbearing age. In addition, recent treatment algorithms suggest that patients who have poor prognostic factors are treated with highly effective disease-modifying drugs from the beginning. Anti-monoclonal antibodies for MS or NMOSD are basically highly effective disease-modifying drugs. Therefore, young women with MS or NMOSD will have more opportunities to receive anti-monoclonal antibody treatment than ever before. Currently, five anti-monoclonal antibodies for MS o...
Source: Clinical and Experimental Neuroimmunology - August 23, 2022 Category: Neurology Authors: Chiyoko Nohara Tags: INVITED REVIEW Source Type: research
116 Evaluating the introduction of subcutaneous natalizumab to a cohort of patients with multiple sclerosis
Conclusion
Subcutaneous natalizumab is a well-tolerated alternative to the intravenous infusion. In this cohort of patients, the majority were satisfied with switching, finding the SC injection more convenient, although some patients reported more pain especially when delivered in the arm. A major benefit to patients and staff is reduced delivery time, improving access to valuable infusion space. Monitoring will be reduced further to 15 minutes, once patients have received 6 injections. (Source: Journal of Neurology, Neurosurgery and Psychiatry)
Source: Journal of Neurology, Neurosurgery and Psychiatry - August 12, 2022 Category: Neurosurgery Authors: Edwards, M., Pearson, O., Ingram, G. Tags: Poster presentations Source Type: research
120 UK multiple sclerosis registries project: disease modifying treatment durability
Conclusion
This multi-centre study has revealed highly variable durability between DMTs over time, which may impact real-world effectiveness. These results may inform DMT clinical decision-making and improve outcomes for pwMS. (Source: Journal of Neurology, Neurosurgery and Psychiatry)
Source: Journal of Neurology, Neurosurgery and Psychiatry - August 12, 2022 Category: Neurosurgery Authors: Froud, J., John, F. S., Willis, M., Anderson, V., Uzochukwu, E., Thomas, R. W.-, Harding, K., Tallantyre, E., Robertson, N., et al Tags: Poster presentations Source Type: research
131 Understanding the administration and monitoring time burden of several disease-modifying therapies for relapsing multiple sclerosis
Conclusions
While active HCP time varies across sites, infusion DMTs are projected to require the greatest amount of HCP time associated with administration and monitoring over 4 years versus oral DMTs. (Source: Journal of Neurology, Neurosurgery and Psychiatry)
Source: Journal of Neurology, Neurosurgery and Psychiatry - August 12, 2022 Category: Neurosurgery Authors: Rog, D., Brownlee, W., Carod-Artal, F. J., Kalra, S., Cock, E. D., Leclerc, S., Amin, A., Ashton, L., Evans, H. Tags: Poster presentations Source Type: research
135 The UK MS pregnancy register: baseline data from the first fifty enrolled patients
Conclusions
These results show that a patient-facing pregnancy MS registry is feasible and can collect previous adverse pregnancy outcomes. Future results will inform clinicians and women about the safety of DMT and adjunctive medication during pregnancy and postpartum. (Source: Journal of Neurology, Neurosurgery and Psychiatry)
Source: Journal of Neurology, Neurosurgery and Psychiatry - August 12, 2022 Category: Neurosurgery Authors: Iyer, P., Craig, E., Brex, P., Ford, H., Hughes, S., Middleton, R., Murray, K., Pearson, O., Rog, D., Dobson, R. Tags: Poster presentations Source Type: research
