Multiplexed Gene Expression as a Characterization of Bioactivity for Interferon Beta (IFN- β) Biosimilar Candidates: Impact of Innate Immune Response Modulating Impurities (IIRMIs)
AbstractRecombinant human interferon- β (rhIFN-β) therapy is the first-line treatment in relapsing-remitting forms of multiple sclerosis (MS). The mechanism of action underlying its therapeutic activity is only partially understood as IFN-βs induce the expression of over 1000 genes modifying multiple immune pathways. Currently, asses sment of potency for IFN-β products is based on their antiviral effect, which is not linked to its therapeutic effect. Here, we explore the use of a multiplexed gene expression system to more broadly characterize IFN-β bioactivity. We find that MM6 cells stimulated with US-licensed rhIFN-...
Source: The AAPS Journal - February 8, 2019 Category: Drugs & Pharmacology Source Type: research
Tolerability, treatment satisfaction and quality of life outcomes in stable multiple sclerosis patients switched from injectable therapies to auto injected intramuscular interferon beta 1a: the SFERA Study
ConclusionsWeekly intramuscular IFNB-1a may represent an alternative treatment option for clinically stable MS patients suffering from intolerable injection-related side effects under treatment with high frequency injectable DMTs. (Source: Multiple Sclerosis and Related Disorders)
Source: Multiple Sclerosis and Related Disorders - February 6, 2019 Category: Neurology Source Type: research
Modulating acute neuroinflammation in intracerebral hemorrhage: the potential promise of currently approved medications for multiple sclerosis.
Authors: Napier J, Rose L, Adeoye O, Hooker E, Walsh KB
Abstract
The secondary inflammatory injury following intracerebral hemorrhage (ICH) results in increased morbidity and mortality. White blood cells have been implicated as critical mediators of this inflammatory injury. Currently, no medications have been clinically proven to ameliorate or beneficially modulate inflammation, or to improve outcomes by any mechanism, following ICH. However, other neuroinflammatory conditions, such as multiple sclerosis, have approved pharmacologic therapies that modulate the inflammatory response and minimize the damage...
Source: Immunopharmacology and Immunotoxicology - February 2, 2019 Category: Allergy & Immunology Tags: Immunopharmacol Immunotoxicol Source Type: research
Intact Bioactivities and Improved Pharmacokinetic of the SL335-IFN- β-1a Fusion Protein that Created by Genetic Fusion of SL335, a Human Anti-serum Albumin Fab, and Human Interferon-β.
In conclusion, our results clearly demonstrated that SL335-IFN-β-1a is worthy of further development as an alternative long-acting IFN-β therapeutic.
PMID: 30684504 [PubMed - as supplied by publisher] (Source: Immunology Letters)
Source: Immunology Letters - January 23, 2019 Category: Allergy & Immunology Authors: Ji SI, Park JH, You HG, Chi HJ, Bang YW, Cha SH Tags: Immunol Lett Source Type: research
Systematic review and network meta-analysis comparing ocrelizumab with other treatments for relapsing multiple sclerosis
Conclusions: Results suggest that ocrelizumab has an efficacy superior to or comparable with all other currently approved DMTs across all endpoints analyzed, and a similar safety profile, indicating it offers a valuable package for the treatment of patients with RMS. (Source: Multiple Sclerosis and Related Disorders)
Source: Multiple Sclerosis and Related Disorders - January 3, 2019 Category: Neurology Source Type: research
Cost-utility analysis of alemtuzumab in comparison with interferon beta, fingolimod, and natalizumab treatment for relapsing-remitting multiple sclerosis in Austria.
CONCLUSION: The analysis shows that alemtuzumab is a cost-saving alternative to treat RRMS in pretreated and therapy naïve patients. From the patient perspective alemtuzumab improves quality of life.
PMID: 30522373 [PubMed - as supplied by publisher] (Source: Journal of Medical Economics)
Source: Journal of Medical Economics - December 15, 2018 Category: Health Management Tags: J Med Econ Source Type: research
A randomized double-blind trial of comparative efficacy and safety of Avonex and CinnoVex for treatment of relapsing-remitting multiple sclerosis
ConclusionAvonex and CinnoVex showed similar efficacy and safety outcome in patients with RRMS. (Source: Neurological Sciences)
Source: Neurological Sciences - December 1, 2018 Category: Neurology Source Type: research
Severe Coombs Positive Autoimmune Hemolytic Anemia after Alemtuzumab Infusion for Relapsing Remitting Multiple Sclerosis. What Can We Learn?
Conclusion: Severe coombs positive AIHA is a rare life-threatening complication that can occur after Alemtuzumab infusion for RRMS. It can be rapidly progressive, intravascular, severe (hemoglobin frequently reaching to <5gm/dl) and frequently refractory to steroids. It usually occurs between 3-15 months after the Alemtuzumab infusion and can be fatal (with 1 reported death so far). Higher level of awareness is needed by the consulting hematologists of such a rare serious adverse effect that can occur specifically few months after Alemtuzumab infusion and calls for a closer monitoring of patient's hematological status d...
Source: Blood - November 21, 2018 Category: Hematology Authors: Desai, P. A., Romere, C. M., Nguyen, L., Saksena, A., Abdullah, S. J., Diaz, A. E. Tags: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster II Source Type: research
Brain volume loss and no evidence of disease activity over 3 years in multiple sclerosis patients under interferon beta 1a subcutaneous treatment
The objective of our study was to evaluate the relationship of percentage of annualized brain volume loss (aBVL) and no evidence of disease activity (NEDA) in multiple sclerosis (MS) patients under interferon beta 1-a subcutaneous treatment (IFN-beta) during 3 years of follow up. Relapsing remitting MS (RRMS) patients, with less than three years from disease onset, expanded disability status scale (EDSS) ≤3 and in which IFN beta 1-a 44 mcg was indicated, were included. Demographic, clinical and structural parameters from the magnetic resonance (MR) during the 3 years of follow up were analyzed and compared between pa...
Source: Journal of Clinical Neuroscience - November 4, 2018 Category: Neuroscience Source Type: research
Inflammatory demyelinating diseases of the central nervous system in Niger.
CONCLUSION: Our case series suggests the rarity of inflammatory demyelinating diseases of CNS in Niger, and NMOSD seems to be more frequent than MS.
PMID: 30270137 [PubMed - as supplied by publisher] (Source: Revue Neurologique)
Source: Revue Neurologique - October 3, 2018 Category: Neurology Tags: Rev Neurol (Paris) Source Type: research
[PERSPECTIVES] Alemtuzumab as Treatment for Multiple Sclerosis
Alemtuzumab, the first monoclonal antibody to be used as a therapy and the first to be humanized, was introduced into the treatment of multiple sclerosis in 1991 after its successful use in hematology, oncology, and transplantation medicine. One phase 2 and two phase 3 trials of this lymphocyte-depleting agent have established alemtuzumab’s superior efficacy to interferon β-1a over the short term (2–3 years) with greater relapse rate reduction, reduced accumulation of disability, and more frequent sustained improvement in disability. Longer-term extension studies show durable effects on slowing cerebral at...
Source: Cold Spring Harbor perspectives in medicine - October 1, 2018 Category: Research Authors: Katsavos, S., Coles, A. Tags: Multiple Sclerosis PERSPECTIVES Source Type: research
Pediatric Multiple Sclerosis: an Update
AbstractPurpose of ReviewDiagnostic criteria for pediatric-onset multiple sclerosis (POMS) and related demyelinating disorders have been updated, neuroimaging studies have revealed new insights, biological assays identify patients with specific antibodies that influence both diagnosis and treatment, clinical trials are informing on treatment efficacy and safety, and longitudinal studies of neurological, cognitive and quality of life outcomes are informing on the impact of these diseases. We provide updates to assist providers caring for these children.Recent FindingsThe recent 2017 McDonald Criteria for MS provide a simpli...
Source: Current Neurology and Neuroscience Reports - September 18, 2018 Category: Neuroscience Source Type: research
Effect of interferon beta-1a subcutaneously three times weekly on clinical and radiological measures and no evidence of disease activity status in patients with relapsing –remitting multiple sclerosis at year 1
In the PRISMS study, interferon beta-1a subcutaneously (IFN β-1a SC) reduced clinical and radiological disease burden at 2 years in patients with relapsing–remitting multiple sclerosis. The study aimed to char... (Source: BMC Neurology)
Source: BMC Neurology - September 14, 2018 Category: Neurology Authors: Anthony Traboulsee, David K. B. Li, Mark Cascione, Juanzhi Fang, Fernando Dangond and Aaron Miller Tags: Research article Source Type: research
Trial of Fingolimod versus Interferon Beta-1a in Pediatric Multiple Sclerosis
New England Journal of Medicine,Volume 379, Issue 11, Page 1017-1027, September 2018. (Source: New England Journal of Medicine)
Source: New England Journal of Medicine - September 12, 2018 Category: Internal Medicine Authors: Tanuja Chitnis Douglas L. Arnold Brenda Banwell Wolfgang Br ück Angelo Ghezzi Gavin Giovannoni Benjamin Greenberg Lauren Krupp Kevin Rost ásy Marc Tardieu Emmanuelle Waubant Jerry S. Wolinsky Amit Bar-Or Tracy Stites Yu Chen Norman Putzki Martin Merschh Source Type: research
