Beta-interferon For Multiple Sclerosis Research Articles

Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities.

Subcutaneous delivery of biotherapeutics has become a valuable alternative to intravenous administration across many disease areas. Although the pharmacokinetic profiles of subcutaneous and intravenous formulations differ, subcutaneous administration has proven effective, safe, well-tolerated, generally preferred by patients and healthcare providers and to result in reduced drug delivery-related healthcare costs and resource use. The aim of this article is to discuss the differences between subcutaneous and intravenous dosing from both health-economic and scientific perspectives. The article covers different indications, treatment settings, administration volumes, and injection devices. We focus on biotherapeutics in rheumatoid arthritis (RA), immunoglobulin-replacement therapy in primary immunodeficiency (PI), beta interferons in multiple sclerosis (MS), and monoclonal antibodies (mAbs) in oncology. While most subcutaneous biotherapeutics in RA, PI, and MS are self-administered at home, mAbs for oncology are still only approved for administration in a healthcare setting. Beside concerns around the safety of biotherapeutics in oncology, a key challenge for self-administration in this area is that doses and dosing volumes can be comparatively large; however, this difficulty has recently been overcome to some extent by the development of high-concentration solutions, the use of infusion pumps, and the coadministration of the dispersion enhancer hyaluronidase. Furthermore, given the increasing number of biotherapeutics being considered for combination therapy and the high dosing complexity associated with these, especially when administered intravenously, subcutaneous delivery of fixed-dose combinations might be an alternative that will diminish these burdens on healthcare systems.

Beta-interferons in multiple sclerosis: A single center experience in India

Background:Indian-Asian multiple sclerosis behaves somewhat differently from Western disease. It is not known if the response to β-interferon is also different.Aim:To demonstrate the decrease in relapses with β-interferon in Indian patients with multiple sclerosis.Patients and Methods:Patients with relapsing–remitting or secondary progressive multiple sclerosis with at least two relapses were started on β-interferon.Results:Sixteen patients were followed up for a period of 1–3 years. Fifteen had relapsing–remitting multiple sclerosis (MS). The mean number of relapses in these patients before interferons were started was 3.4. The mean yearly relapse rate was 1.3. The mean Kurtzke Expanded Disability Status Scale (EDSS) at the start of β-interferon therapy in relapsing–remitting MS was 1.7. Ten of these patients were on Avonex® (interferon β1a) and six (including the patient with secondary progressive MS) were on Betaferon® (interferon β1b). On follow-up, three patients (two on Avonex® and one on Betaferon® ) had relapses. The respective β-interferon being received by these patients was continued, with no further relapses. The remaining patients had no relapse or clinical or MRI progression after starting the drug. The side effect profile of the drug in these patients was favorable; although nearly all developed fever on the first day of the injection, only 50% of the patients continued to have fever after 3 months. Two patients developed psychiatric symptoms, requiring discontinuation of the drug.Conclusion:Our prospective follow-up study shows that β-interferons are safe and effective in Indian patients with relapsing–remitting or secondary progressive MS.

Beta-interferons in multiple sclerosis

Beta-interferons in multiple sclerosis

Chronic myeloid leukaemia in two multiple sclerosis patients on interferon beta-1a

Haematological problems are commonly associated with use of beta-interferon in multiple sclerosis (MS) patients. However these problems are usually benign and are reversible when the drug is stopped. We describe two patients, with the diagnosis of MS, who developed leucocytosis. Cytogenetic studies showed the presence of the Philadelphia chromosome in all the cells analysed, confirming the diagnosis of chronic myeloid leukaemia (CML). The first patient currently on imatimib mesylate and interferon beta-1a is asymptomatic. For the second patient, interferon beta-1a was withdrawn after suspicion of CML.

Regulation of p53 expression in PBMC by beta Interferon in Multiple Sclerosis (94.21)

Abstract Background: Beta Interferon (IFN) is a first line treatment in Multiple Sclerosis (MS); however its mechanism of action remains unclear. P53 is a key player in regulating apoptosis through the transcriptional activation of target genes. Previous studies showed an integration of beta IFN signaling with stabilization of p53 in murine cells. We examined the activation and stabilization of p53 in PBMC following in vitro culture with beta IFN, and in patients receiving beta IFN treatment. Methods: PBMC were isolated from 6 heath controls (HC) and 6 MS patients and then cultured with beta IFN. We also examined p53 expression in 7 MS patients receiving beta IFN-1b treatment. P53 expression in vitro and in vivo experiments was determined by real time RT-PCR, Western blotting and flow cytometry. Results: P53 expression increased in a dose and time dependant manner following culture with beta IFN. Flow cytometry studies showed increased stabilization of p53 in CD3+ T cells and monocytes. PBMC isolated from MS patients receiving beta IFN in vivo also showed the increase in p53 stabilization. However, the stabilization varied between patients receiving beta IFN: two patients showed no increase in p53; in the remaining five patients, the kinetics of p53 induction varied. Conclusion: Our studies show that p53 is vigorously induced in PBMC in vitro and following injection of drug in vivo. P53 expression induced was variable between patients receiving beta IFN. We suggest that p53 can potentially regulate the expansion of autoreactive cells that might contribute to the development and progression of MS. The study was supported by funds from Serono Inc

Rapid and responsive health technology assessment: the development and evaluation process in the South and West region of England

The Development and Evaluation Committee (DEC) provides local guidance on the value of new and existing health care technologies, including drugs, devices, procedures and health care settings. The system is made up of two components: i) literature review and cost‐effectiveness estimation of the proposed and current technologies, and ii) consideration by the Development and Evaluation Committee which arbitrates, makes recommendations and disseminates results across the South and West region. Sixty‐three reviews have been undertaken to date, including, for example, beta interferon for multiple sclerosis, pulsed dye laser in the treatment of port‐wine stains, and paclitaxel in ovarian cancer. The outcomes of this service are guides to purchasing which are both carefully researched and scrutinized.

Therapeutic advances: beta-interferon for multiple sclerosis.

Multiple sclerosis (MS) is a very distressing condition for which there is no effective treatment. Two randomized double-blind placebo-controlled trials of beta-interferon in mildly disabled patients with relapsing remitting MS have been published. Although promising, beta-interferon is not a cure for MS and the clinical significance of the small effect of beta-interferon on disease progression is not known. The high cost of beta-interferon, the distressing nature of MS and the small benefit demonstrated in clinical trials mean that purchasers and clinicians will face hard decisions in managing the introduction of these drugs.

Double blind study of intrathecal beta-interferon in multiple sclerosis: clinical and laboratory results.

Sixteen patients with clinically definite MS admitted to a double blind randomised controlled trial of intrathecal natural beta-IFN were followed for a mean of 22 months including the six month treatment period. Clinical response, evaluated in terms of relapse frequency and of progression rate, showed an increase in relapse rate in treated patients during the six month treatment period and, overall, no benefit in treated versus placebo patients. Serial evaluations were made of cerebrospinal fluid (CSF) cells, IgG, myelin basic protein and CSF and blood T-cell subsets. A rise in CSF IgG Index, MBP and DR+ cells in IFN-treated patients suggested an activation of intrathecal immune response in treated patients.