- Teriflunomide -- Benefit Assessment According to §35a Social Code Book V [BOOK]
- BOOKInstitute for Quality and Efficiency in Health Care (IQWiG): Cologne, Germany
- The aim of this report is to assess the added benefit of teriflunomide in comparison with the appropriate comparator therapy (ACT) in adult patients with relapsing remitting multiple sclerosis (RRMS)...
The aim of this report is to assess the added benefit of teriflunomide in comparison with the appropriate comparator therapy (ACT) in adult patients with relapsing remitting multiple sclerosis (RRMS). The Federal Joint Committee (G-BA) specified the ACT for the therapeutic indication of relapsing multiple sclerosis (RMS) as follows: beta interferons (1a or 1b) or glatiramer acetate, in each case under consideration of the approved therapeutic indication. Because RRMS is a subset of RMS, the G-BA’s specification also applies to the approved therapeutic indication of teriflunomide. The company chose interferon beta-1a (IFN-β1a) from the options specified by the G-BA, but limited itself to IFN-β1a 44μg subcutaneous (SC) 3 times a week (Rebif), one of the preparations from this drug group. A search targeted at the comparison with Rebif would not identify studies on the comparison with other preparations of this drug group. According to the G-BA’s specification however, all dosage forms, and thus all IFN-β1a preparations, are to be considered. Overall, the company’s limitation of the comparator therapy had no consequence for the present result of the assessment. The present benefit assessment was conducted in comparison with the ACT specified by the G-BA IFN-β1a. The assessment was based on patient-relevant outcomes.
- Fingolimod -- Benefit Assessment According to §35a Social Code Book V [BOOK]
- BOOKInstitute for Quality and Efficiency in Health Care (IQWiG): Cologne, Germany
- In the benefit assessment fingolimod was compared with: glatiramer acetate in patients with highly active relapsing-remitting multiple sclerosis (RRMS), who have failed to respond to a full and adequ...
In the benefit assessment fingolimod was compared with: glatiramer acetate in patients with highly active relapsing-remitting multiple sclerosis (RRMS), who have failed to respond to a full and adequate course (normally at least one year) of beta-interferon (IFN-β) (subsequently referred to as patients with highly active RRMS, full previous treatment with IFN-β), IFN-β 1a in patients with highly active RRMS, who have not yet received adequate treatment with IFN-β (subsequently referred to as patients with highly active RRMS, incomplete previous treatment with IFN-β) and IFN-β 1a in patients with rapidly evolving severe RRMS.
- Alemtuzumab improves quality-of-life outcomes compared with subcutaneous interferon beta-1a in patients with active relapsing-remitting multiple sclerosis. [Journal Article]
- MSMult Scler 2016 Nov 24
- CONCLUSIONS: Patients treated with alemtuzumab had improvements in physical, mental, and emotional QoL regardless of treatment history. Improvements were significantly greater with alemtuzumab versus subcutaneous interferon beta-1a on both disease-specific and general measures of QoL.
- Spontaneous regression of a parafalcine meningioma in a multiple sclerosis patient being treated with interferon beta-1a. [Journal Article]
- ANActa Neurochir (Wien) 2016 Nov 21
- Regression of meningioma after haemorrhage and the cessation of hormone treatment is well reported. However, spontaneous regression is very rarely observed. Here, we report the spontaneous regression...
Regression of meningioma after haemorrhage and the cessation of hormone treatment is well reported. However, spontaneous regression is very rarely observed. Here, we report the spontaneous regression of a parafalcine meningioma in a 56-year-old woman with multiple sclerosis, who was referred to our department after an incidental finding on magnetic resonance imaging. She was being treated with interferon beta-1a to manage the symptoms. To our knowledge, this is the first report of spontaneous regression of meningioma in a patient receiving interferon beta-1a therapy and just the second report of spontaneous regression in general.
- Pharmacological treatment other than corticosteroids, intravenous immunoglobulin and plasma exchange for Guillain-Barré syndrome. [Review]
- CDCochrane Database Syst Rev 2016 Nov 15; 11:CD008630
- CONCLUSIONS: The quality of the evidence was very low. Three small RCTs, comparing interferon beta-1a or brain-derived neurotrophic factor with placebo, and cerebrospinal fluid filtration with plasma exchange, showed no significant benefit or harm for any of the interventions. A fourth small trial showed that the Chinese herbal medicine, tripterygium polyglycoside, hastened recovery in people with GBS to a greater extent than corticosteroids, but this result needs confirmation. We were unable to draw any useful conclusions from the few observational studies we identified.
- Peginterferon Beta-1a Shows Antitumor Activity as a Single Agent and Enhances Efficacy of Standard of Care Cancer Therapeutics in Human Melanoma, Breast, Renal, and Colon Xenograft Models. [Journal Article]
- JIJ Interferon Cytokine Res 2016 Nov 11
- Because of its tumor-suppressive effect, interferon-based therapy has been used for the treatment of melanoma. However, limited data are available regarding the antitumor effects of pegylated interfe...
Because of its tumor-suppressive effect, interferon-based therapy has been used for the treatment of melanoma. However, limited data are available regarding the antitumor effects of pegylated interferons, either alone or in combination with approved anticancer drugs. We report that treatment of human WM-266-4 melanoma cells with peginterferon beta-1a induced apoptotic markers. Additionally, peginterferon beta-1a significantly inhibited the growth of human SK-MEL-1, A-375, and WM-266-4 melanoma xenografts established in immunocompromised mice. Peginterferon beta-1a regressed large, established WM-266-4 xenografts in nude mice. Treatment of SK-MEL-1 tumor-bearing mice with a combination of peginterferon beta-1a and the MEK inhibitor PD325901 ((R)-N-(2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophenylamino)benzamide) significantly improved tumor growth inhibition compared with either agent alone. Examination of the antitumor activity of peginterferon beta-1a in combination with approved anticancer drugs in breast and renal carcinomas revealed improved antitumor activity in these preclinical xenograft models, as did the combination of peginterferon beta-1a and bevacizumab in a colon carcinoma xenograft model.
- The cross-reactivity of binding antibodies with different interferon beta formulations used as disease-modifying drugs in multiple sclerosis patients. [Journal Article]
- MMedicine (Baltimore) 2016; 95(45):e5337
- Interferon beta (IFNb) preparations are commonly used as first-line therapy in relapsing-remitting multiple sclerosis (RRMS). They are, however, characterized by limited efficacy, partly due to the f...
Interferon beta (IFNb) preparations are commonly used as first-line therapy in relapsing-remitting multiple sclerosis (RRMS). They are, however, characterized by limited efficacy, partly due to the formation of anti-IFNb antibodies in patients.In this pilot study, we assessed with the ELISA method the presence of the binding antibodies (BAbs) against interferon beta after 2 years of therapy with subcutaneous interferon beta 1a (Rebif) in 49 RRMS patients. Antibody levels were established again within 1 year after treatment withdrawal. We used 3 interferons that are commercially available for MS therapy, namely Avonex (Biogen Idec Limited), Rebif (Merck Serono), and Betaferon (Bayer Pharma AG), as antigens.BAbs reacting with Rebif were found in 24.4% to 55% of patients, depending on the units of their expression. The levels of anti-Rebif antibodies remained high in 8 patients and in 4 patients they dropped significantly. Strong correlations were obtained in all assays (anti-Rebif-anti-Avonex, anti-Rebif-anti-Betaferon, and anti-Betaferon-anti-Avonex) and the existence of cross-reactivity in the formation of antibodies against all the tested formulations of interferon beta was confirmed. The levels of BAbs remain significant in the clinical context, and their assessment is the first choice screening; however, methods of BAbs evaluation can be crucial for further decisions. More studies are needed to confirm our results; specifically it would be of interest to evaluate methods of neutralizing antibodies identification, as we only assessed the binding antibodies. Nevertheless, our results support the concept that in interferon nonresponders, that are positive for binding antibodies, switching the therapy to alternative disease-modifying agent (for example glatiramer acetate, fingolimod, or natalizumab) is justified, whereas the switch to another interferon formulation will probably be of no benefit.
- The cost-effectiveness of disease-modifying therapies for the treatment of relapsing-remitting multiple sclerosis. [Journal Article]
- JMJ Med Econ 2016 Nov 21; :1-6
- CONCLUSIONS: Several simplifying assumptions were made that may represent potential limitations of this analysis (e.g. a constant treatment effect over time was assumed).The results from this analysis suggest that the NTZ, DMF, and PEG are cost-effective DMT choices compared to FIN, GA, and IFN, respectively. The actual impact on a particular plan will vary based on drug pricing and other factors affecting drug cost accrual.
- Peginterferon beta-1a versus other self-injectable disease-modifying therapies in the treatment of relapsing-remitting multiple sclerosis in Scotland: a cost-effectiveness analysis. [Journal Article]
- JMJ Med Econ 2016 Nov 4; :1-11
- CONCLUSIONS: The impact of improved adherence with peginterferon beta-1a on clinical and economic outcomes and the impact of subsequent DMTs after treatment discontinuation were not considered. Oral and infused DMTs were not included as comparators. Conclusion Long-term treatment with peginterferon beta-1a improves clinical outcomes, while its cost profile makes it either dominant or cost-effective compared with other self-injectable DMTs for the treatment of RRMS in Scotland.
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- Occurrence of Anti-Drug Antibodies against Interferon-Beta and Natalizumab in Multiple Sclerosis: A Collaborative Cohort Analysis. [Journal Article]
- PlosPLoS One 2016; 11(11):e0162752
- Immunogenicity of biopharmaceutical products in multiple sclerosis is a frequent side effect which has a multifactorial etiology. Here we study associations between anti-drug antibody (ADA) occurrenc...
Immunogenicity of biopharmaceutical products in multiple sclerosis is a frequent side effect which has a multifactorial etiology. Here we study associations between anti-drug antibody (ADA) occurrence and demographic and clinical factors. Retrospective data from routine ADA test laboratories in Sweden, Denmark, Austria and Germany (Dusseldorf group) and from one research study in Germany (Munich group) were gathered to build a collaborative multi-cohort dataset within the framework of the ABIRISK project. A subset of 5638 interferon-beta (IFNβ)-treated and 3440 natalizumab-treated patients having data on at least the first two years of treatment were eligible for interval-censored time-to-event analysis. In multivariate Cox regression, IFNβ-1a subcutaneous and IFNβ-1b subcutaneous treated patients were at higher risk of ADA occurrence compared to IFNβ-1a intramuscular-treated patients (pooled HR = 6.4, 95% CI 4.9-8.4 and pooled HR = 8.7, 95% CI 6.6-11.4 respectively). Patients older than 50 years at start of IFNβ therapy developed ADA more frequently than adult patients younger than 30 (pooled HR = 1.8, 95% CI 1.4-2.3). Men developed ADA more frequently than women (pooled HR = 1.3, 95% CI 1.1-1.6). Interestingly we observed that in Sweden and Germany, patients who started IFNβ in April were at higher risk of developing ADA (HR = 1.6, 95% CI 1.1-2.4 and HR = 2.4, 95% CI 1.5-3.9 respectively). This result is not confirmed in the other cohorts and warrants further investigations. Concerning natalizumab, patients older than 45 years had a higher ADA rate (pooled HR = 1.4, 95% CI 1.0-1.8) and women developed ADA more frequently than men (pooled HR = 1.4, 95% CI 1.0-2.0). We confirmed previously reported differences in immunogenicity of the different types of IFNβ. Differences in ADA occurrence by sex and age are reported here for the first time. These findings should be further investigated taking into account other exposures and biomarkers.