China
Africa
Explore chapters and articles related to this topic
Digitally Augmenting Therapies: A DTx Opportunity for Pharma Portfolio Development
Published in Oleksandr Sverdlov, Joris van Dam, Digital Therapeutics, 2023
Benjamin D'hont, Romain Marmot
An example of this approach can be found in multiple sclerosis, where Bayer has developed BetaConnect,15 a digitally enhanced version of Betaseron (interferon beta-1b) to treat relapsing forms of MS. Betaseron combines the drug with a connected drug delivery system and an app-based platform. The connected pen delivers a better patient experience, including guidance on how to self-inject, automatic needle insertion and retraction, customizable injection speed, and depth. The app collects injection details, patient status, and symptoms. It connects the patient with a “BETA Nurse,” a care team member who can provide additional support to the patient whenever needed. The care team can access patients' data through a dedicated BetaConnect navigator and bring more visibility on the course of a treatment that is self-administered by patients at home.
Monographs of Topical Drugs that Have Caused Contact Allergy/Allergic Contact Dermatitis
Published in Anton C. de Groot, Monographs in Contact Allergy, 2021
A 36-year old woman was treated with subcutaneous injections of interferon beta-1b for multiple sclerosis. By the 14th of 22 injections, she noticed a transient erythema (appearing after 3–5 days), and after 5 non-consecutive injections (4 in the arm, 1 in the abdomen), she showed infiltrated, red, vesicular, itchy lesions at all 5 injection sites, which healed in 3–4 weeks. A patch test was negative to the commercial beta-interferon material. An intradermal test was negative after 20 minutes, but positive at D2 (2).
Intense Immunosuppression Followed by Autologous Stem Cell Transplantation in Severe Multiple Sclerosis Cases
Published in Richard K. Burt, Alberto M. Marmont, Stem Cell Therapy for Autoimmune Disease, 2019
G.L. Mancardi, R. Saccardi, A. Murialdo, F. Pagliai, F. Gualandi, A. Marmont, M. Inglese, P. Bruzzi, M.P. Sormani, M.G. Marrosu, G. Meucci, L. Massacesi, A. Bertolotto, A. Lugaresi, E. Merelli, M. Filippi
Sixteen cases have undergone ASCT with a median follow up of 24 months (range 4-42 months). Ten subjects were female and 6 male, with a median age of 34.5 years (range 26-52), median disease duration of 12 years (range 6-19) and a secondary progressive course for a median of 3 years (range 1-8). Relapses were superimposed in 7 of 16 cases. Ten subjects had been previously treated with interferon beta 1b, and 6 subjects with immunosuppressive therapies only (azathioprine, cyclophosphamide or mitoxantrone) or steroids, all without clinical response. At screening, the median EDSS was 6.5 (range 5.5-6.5) and the Scripps Neurological Rating Scale (SNRS) was 59 (range 41-66). At baseline, just before stem cell mobilization, the neurological condition had deteriorated in 6 cases (median EDSS was 6.5, range 5.5-8). Patient characteristics are reported in Table 1. The effect of ASCT was evaluated with serial monthly TD Gd-enhanced MRI for a pretreatment period of three months, and compared with serial monthly TD Gd-enhanced MRI imaging for the following 6 months. Subsequently, MR scans were obtained every three months until month 24 and then every 6 months. TD was utilized instead of a standard dose of Gd, since TD-enhanced MRI is much more sensitive in detecting disease activity.10 The MRI protocol was standardized in all Centers and was performed according to established criteria.9 All images were hard copied using a laser imager and stored on magnetic tapes. Images were sent to the Neuroimaging Research Unit, Scientific Institute and University, S. Raffaele Hospital, Milan, where they were examined and quantified by an experienced observer, blind to the period in which they were obtained, who counted the number of Gd-enhancing lesions and the number of new T2-weighted lesions. The images were then sequentially ordered, obtaining the number of Gd-enhancing and of T2-positive lesions before and after treatment.
Teriflunomide: an oral therapy for first-line treatment of children and adolescents living with relapsing-remitting multiple sclerosis
Published in Expert Review of Neurotherapeutics, 2023
Gloria Dalla Costa, Giancarlo Comi
International consensus highlights the significance of early treatment of MS to prevent disability, particularly in pediatric-onset MS due to its highly active nature [6]. Glatiramer acetate (GA) and beta interferons (IFNBs) have been found to be safe and effective in a variety of small studies, including retrospective studies and case studies. A study involving pediatric MS patients from seven countries showed that interferon beta-1b therapy had no unexpected or serious side effects [20]. The large-scale REPLAY study reported that children and adolescents treated with adult doses of subcutaneous IFNB-1a experienced overall good tolerability and no unexpected adverse drug reactions [21]. However, there is limited experience with glatiramer acetate, which is considered to be approximately as effective as IFNB [22].
The benefits and risks of escalation versus early highly effective treatment in patients with multiple sclerosis
Published in Expert Review of Neurotherapeutics, 2023
Annalisa Morgan, Emma Tallantyre, Daniel Ontaneda
Multiple sclerosis (MS) affects an estimated 2.8 million people worldwide and approximately 1 million in the U.S.A. alone. [1] MS is a chronic, demyelinating, inflammatory, and neurodegenerative disease of the central nervous system [2,3]. MS is more common in women and initially follows either a relapsing-remitting (RR) or primary progressive (PP) course [2,3]. Disease modifying therapies (DMTs) were first introduced in the 1990s with interferon beta-1b as the first treatment for MS [3]. Since that time, there have been considerable advances in the number, efficacy, and safety of therapeutics for MS, principally for RRMS [2–7]. There are now over two dozen US Food and Drug Administration (FDA)-approved therapies with more under development [2–7]. However, the increase in available DMTs has also led to increased debate in the MS field regarding the optimal first-line treatment approach in this patient population [2–14]. This debate partly arose from a need to make accessible treatment frameworks out of the abundant treatment options, and 2 main approaches have now arisen [2–14]. These approaches include a strategy of escalation (ESC) versus a strategy of early highly effective treatment (EHT) [2–14].
Analysis of completeness for spontaneous reporting of disease-modifying therapies in multiple sclerosis
Published in Expert Opinion on Drug Safety, 2021
Ariane G. S. Araujo, Rosa C. Lucchetta, Fernanda S. Tonin, Roberto Pontarolo, Helena H. L. Borba, Astrid Wiens
A priori, we did not identify causes that could explain the variability of completeness observed between the different DMTs. Our statistical analyses did not identify a significant association with the continent of origin of the reports, mainly because about 80% of the reports were provided by a single country (US), making it difficult to identify possible regional differences. The time of commercialization of DMTs or the route of administration does not seem to be related to the rate of completeness of the data. We found lower than expected completeness for interferon beta-1b, but not for interferon beta-1a (intramuscular or subcutaneous), although both had a similar time to market. The notoriety bias, in turn, may have influenced completeness. Natalizumab had a significantly higher proportion than expected well-documented reports, which may be related to greater attention to this drug in the postmarketing scenario, since it was withdrawn from the market due to uncertainties regarding its safety and reintroduced in 2006, under close monitoring [32].