Department of Molecular Biosciences and LaMontagne Center for Infectious Diseases, The University of Texas at Austin, Austin, Texas, USA payne@utexas.edu.
Microbiology Division, ICMR-Regional Medical Research Centre, Chandrasekharpur, Bhubaneswar, 751023, Orissa, India. Electronic address: bbpal_rmrc@yahoo.co.in.
Microbiology Division, ICMR-Regional Medical Research Centre, Chandrasekharpur, Bhubaneswar, 751023, Orissa, India. Electronic address: smruti2007rkl@gmail.com.
Molecular Genetics Laboratory, Centre for Human Microbial Ecology, Translational Health Science and Technology Institute, NCR Biotech Science Cluster, Faridabad 121001, India; School of Life Sciences, Manipal Academy of Higher Education, Manipal 576104, Karnataka, India. Electronic address: bhabatosh@thsti.res.in.
Division of Infectious Diseases, Brigham and Women's Hospital, Boston, MA, USA; Department of Microbiology, Harvard Medical School, Boston, MA, USA; Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, MA, USA; Howard Hughes Medical Institute, Bethesda, MD, USA. Electronic address: mwaldor@research.bwh.harvard.edu.
Biosimilars provide an opportunity for a more sustainable and cost-effective treatment for multiple sclerosis (MS). This study evaluated the potential financial impact of implementing a formulary chan...
The budget impact of transitioning to biosimilar NTZ for the treatment of relapsing-remitting MS (RRMS) was estimated over a 3-year time horizon based on real-world dosing. Additional scenario analyse...
The target population was estimated from a 1-million-member hypothetical commercial health plan. Model inputs were drug acquisition costs and treatment-related and patient coinsurance costs. Budget im...
Over 3 years, 255 patients were estimated to be treated with high-efficacy disease-modifying therapies for RRMS. The inclusion of biosimilar NTZ onto a formulary would result in cumulative cost saving...
Adoption of biosimilar NTZ can yield considerable cost savings to US health plans that could result in increased treatment access for patients with RRMS....
Natalizumab is a high-efficacy therapy for recurrent multiple sclerosis (RMS) with a four-week administration interval. Controlled trials have shown that extending this interval to six weeks led to be...
This monocentric retrospective self-controlled study included adult patients with RMS treated with natalizumab with a four-week interval between infusions for a minimum of six months, before switching...
Fifty-seven patients were included in the analysis. The mean (95%CI) annualized relapse rate (AAR) before natalizumab introduction was 1.03 (0.52; 1.55). During the four-week interval dosing period, n...
We did not observe more relapses or signs of MRI activity when extending the interval between natalizumab infusions from four to six weeks....
Natalizumab via subcutaneous administration was recently approved for patients with multiple sclerosis....
In light of personalized extended dosing, in which treatment intervals are prolonged to a concentration cut-off, it would be preferable to measure natalizumab drug concentrations in capillary blood....
In this cross-sectional study in patients treated with intravenous (IV) natalizumab, capillary blood samples by fingerprick and venous blood samples were collected in 30 participants prior to IV admin...
Natalizumab concentrations were similar with a mean bias of -0.36 μg/mL (95% CI: 1.3 to -2 μg/mL)....
This study shows that physicians can monitor natalizumab drug concentrations by a fingerprick, which could be used for personalized extended dosing....
Natalizumab is a humanized monoclonal antibody used for treatment of highly active relapsing-remitting multiple sclerosis (MS). With more than 15 years of post-marketing experience with natalizumab in...
A group of neurologists from various MS clinics across Canada met in September 2021 to update the 2015 Canadian practice recommendations for the use of natalizumab in persons with MS (PwMS)....
The recommendations focused on the long-term efficacy and safety data from real-world studies, patient selection according to JCV index criteria, risk management strategies for PML (including extended...
The recommendations of clinical neurologists seek to optimize the management of PwMS who may benefit from treatment with natalizumab....
Cognitive impairment occurs in 40%-70% of persons with multiple sclerosis (MS)....
To examine the effectiveness of natalizumab compared with other disease-modifying treatments (DMTs) on improving cognition as measured by the Symbol Digit Modalities Test (SDMT)....
Data were collected as part of Swedish nationwide phase IV surveillance studies (2007-2020). An increase in SDMT score by ⩾10% of the difference between maximum score possible (110) and the baseline v...
We included 2100 persons with relapsing-remitting MS treated with natalizumab and 2622 persons treated with other DMTs. At 6 months, 45% reached improvement. The natalizumab group showed largest odds ...
Treatment with natalizumab or other monoclonal antibodies is associated with a significantly faster likelihood of cognitive improvement than platform or oral DMTs....
Natalizumab is a well-established disease-modifying therapy used in active multiple sclerosis (MS). The most serious adverse event is progressive multifocal leukoencephalopathy. For safety reasons, ho...
The impact of early versus later high-efficacy disease-modifying therapy (DMT) in patients with multiple sclerosis (MS) is uncertain. This study reported the association of early versus later natalizu...
The study included 661 participants diagnosed with MS in 1994 or later from 7 US centers participating in the MS Partners Advancing Technology for Health Solutions (MS PATHS) network. Time to natalizu...
TTNT varied from 0.1 to 19.8 years (median [interquartile range] 4.2 [1.8, 9.0] years). A significant association between later natalizumab use and worse outcomes was demonstrated for walking speed (p...
Later initiation of natalizumab was associated with worse clinical and radiologic imaging outcomes. Thus, high-efficacy DMT may have greater benefit when started earlier in MS patients. These results ...
Natalizumab (NTZ) is an established treatment for highly active, relapsing-remitting multiple sclerosis. In the context of rare progressive multifocal leukoencephalopathy and extended interval dosing ...
In a retrospective study at the Medical University of Innsbruck, Austria, we identified patients treated with NTZ and chose samples longitudinally collected during routine follow-ups for the measureme...
One hundred and thirty-seven patients were included. We found a strong negative correlation between NTZ SC and sVCAM-1. Both showed significant associations with body mass index, infusion interval, sa...
Soluble 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 pati...
Natalizumab is a biologic drug for relapsing-remitting multiple sclerosis that may induce the generation of anti-drug antibodies in some patients. Anti-natalizumab antibodies (ANA) increase the risk o...
Retrospective observational study including MS patients treated with natalizumab that experienced infusion-related events (IRE) or disease exacerbations (DE). ANA were tested by Elisa including a scre...
A total of 1251 MS patients were included and 153 (12.3%) had ANA with at least one single point determination, which were more frequent among patients with IRE compared to those with DE (21,6% vs.10....
Real-world evidence shows that the presence of ANA is behind an important percentage of patients treated with natalizumab that experience IRE, as well as DE but in a lower degree. These findings suppo...
The humanized anti-α4 integrin blocking antibody natalizumab (NTZ) is an effective treatment for relapsing-remitting multiple sclerosis (RRMS) that is associated with the risk of progressive multifoca...
Here we aimed to identify the minimal NTZ concentration required to inhibit the arrest of human effector/memory CD4...
Making use of three different human in vitro BBB models and in vitro live-cell imaging we observed that NTZ mediated inhibition of α4-integrins failed to abrogate T cell arrest to the inflamed BBB und...
Taken together, our in vitro observations show that high levels of endothelial ICAM-1 abrogate NTZ mediated inhibition of T cell interaction with the BBB. EID of NTZ in MS patients may thus require co...
