Pharmacodynamic Comparison of Single Doses of IFN-beta 1a and IFN-beta 1b in Healthy Volunteers

Stürzebecher, S; Maibauer, R.; Heuner, Almut; Beckmann, Karola; B, Aufdembrinke

doi:10.1089/107999099312920

Cited by 72 publications

(38 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Nevertheless, because Avonex and Rebif are both forms of IFN␤-1a, they can be compared on a microgram for microgram basis. Also, the conversion of IFN␤-1a to IFN␤-1b doses can be calculated using published data, 36 with the result that 6 MIU Avonex (30 g) is equivalent to approximately 7-9 MIU Betaseron (220-280 g).…”

Section: Analysis Of the Evidence Immunomodulatory Treatments Intermentioning

confidence: 99%

“…By contrast, a different study 36 compared the effects of IFN␤-1a given SC and IM and IFN␤-1b given SC on neopterin, human Mx protein, and 2',5'-OAS in 75 healthy volunteer subjects. IFN␤-1a was administered at doses of 1, 3, 6, 9, and 12 MIU and IFN␤-1b at doses of 2, 4, 8, 12, and 16 MIU; each patient in the study received a single dose.…”

Section: Analysis Of the Evidence Immunomodulatory Treatments Intermentioning

confidence: 99%

See 1 more Smart Citation

Disease modifying therapies in multiple sclerosis: Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines [RETIRED]

et al. 2002

View full text Add to dashboard Cite

Overview. Clinical types of MS.MS is a chronic recurrent inflammatory disorder of the CNS. The disease results in injury to the myelin sheaths, the oligodendrocytes, and, to a lesser extent, the axons and nerve cells themselves. [1][2][3][4][5] The symptoms of MS vary, depending in part on the location of plaques within the CNS. Common symptoms include sensory disturbances in the limbs, optic nerve dysfunction, pyramidal tract dysfunction, bladder or bowel dysfunction, sexual dysfunction, ataxia, and diplopia. 5Four different clinical courses of MS have been defined. 6 The first, relapsing-remitting MS (RRMS), is characterized by self-limited attacks of neurologic dysfunction. These attacks develop acutely, evolving over days to weeks. Over the next several weeks to months, most patients experience a recovery of function that is often (but not always) complete. Between attacks the patient is neurologically and symptomatically stable. The second clinical course, secondary progressive MS (SPMS), begins as RRMS, but at some point the attack rate is reduced and the course becomes characterized by a steady deterioration in function unrelated to acute attacks. The third clinical type, primary progressive MS (PPMS), is characterized by a steady decline in function from the beginning without acute attacks. The fourth type, progressive-relapsing MS (PRMS), also begins with a progressive course although these patients also experience occasional attacks. Outcome measures in MS clinical trials.Evaluation of the relative effectiveness of different therapies requires consideration of which outcome measure or measures are relevant to the goals of therapy. Clearly, the most important therapeutic aim of any disease-modifying treatment of MS is to prevent or postpone long-term disability. However, long-term disability in MS often evolves slowly over many years.1-3 Clinical trials, by contrast, study patients for only short periods of time (2 or 3 years) and, therefore, use only short-term outcome measures to assess efficacy. As a result, it is important to validate any short-term measure by its correlation with the actual patient outcome many years later. For a discussion of these issues, interested readers should consult the full-length assessment on the Neurology Web site at www.neurology.org.Scope of this guideline. The purpose of this assessment is to consider the clinical utility of these disease-modifying agents including the anti-inflammatory, immunomodulatory, and immunosuppressive treatments that are currently available.

show abstract

Section: Analysis Of the Evidence Immunomodulatory Treatments Intermentioning

confidence: 99%

Section: Analysis Of the Evidence Immunomodulatory Treatments Intermentioning

confidence: 99%

Disease modifying therapies in multiple sclerosis: Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines [RETIRED]

et al. 2002

View full text Add to dashboard Cite

show abstract

“…In this regard, it is useful for readers to appreciate the complexity of this particular biologic system. [1][2][3][4][5][6][7][8][9] Thus, a brief overview of IFN biology is provided in the supplementary material to this as-sessment (available at www.neurology.org). The questions posed by this assessment are as follows: 1) Once NAb-positivity has developed in an individual patient, does this state persist?…”

mentioning

confidence: 99%

Neutralizing antibodies to interferon beta: Assessment of their clinical and radiographic impact: An evidence report: [RETIRED]

et al. 2007

View full text Add to dashboard Cite

Abstract-The clinical and radiologic impact of developing neutralizing antibodies (NAbs) to interferon beta (IFN␤) while on this therapy for multiple sclerosis (MS) is assessed. On the basis of Class II and III evidence, it is concluded that treatment of patients with MS with IFN␤ (Avonex, Betaseron, or Rebif) is associated with the production of NAbs (Level A). NAbs in the serum are probably associated with a reduction in the radiographic and clinical effectiveness of IFN␤ treatment (Level B). In addition, the rate of NAb production is probably less with IFN␤-1a treatment than with IFN␤-1b treatment, although the magnitude and persistence of this difference is difficult to determine (Level B). Finally, it is probable that there is a difference in seroprevalence due to variability in the dose of IFN␤ injected or in the frequency or route of its administration (Level B). Regardless of the explanation, it seems clear that IFN␤-1a (as it is currently formulated for IM injection) is less immunogenic than the current IFN␤ preparations (either IFN␤-1a or IFN␤-1b) given multiple times per week subcutaneously (Level A). However, because NAbs disappear in some patients even with continued IFN␤ treatment (especially in patients with low titers), the persistence of this difference is difficult to determine (Level B). Although the finding of sustained high-titer NAbs (Ͼ100 to 200 NU/mL) is associated with a reduction in the therapeutic effects of IFN␤ on radiographic and clinical measures of MS disease activity, there is insufficient information on the utilization of NAb testing to provide specific recommendations regarding when to test, which test to use, how many tests are necessary, or which cutoff titer to apply (Level U).

show abstract

“…Diversi studi hanno confrontato l'attività biologica delle preparazioni di INF-β utilizzando marcatori indiretti della sua azione farmacodinamica [20][21][22][23][24]. Si tratta tuttavia di studi che, avendo utilizzato differenti approcci metodologici e standard di riferimento, risultano non sempre comparabili.…”

Section: Discussioneunclassified

“…Lo studio non ha evidenziato differenze significative sia degli incrementi massimi dei tre marcatori nei due gruppi a confronto, sia della durata complessiva dell'effetto. Inoltre, la somministrazione di INF-β1a (i.e., di Avonex ® ) per via sottocutanea è risultata equivalente alla via intramuscolare [20].…”

Section: Discussioneunclassified

Analisi Costo Minimizzazione delle preparazioni di Interferon Beta per il trattamento della Sclerosi Multipla

Macchia¹,

Russo²,

Caprino³

2004

View full text Add to dashboard Cite

SIFEIT, Società italiana per studi di economia ed etica sul farmaco e sugli interventi terapeutici INTRODUZIONELa Sclerosi Multipla (SM) è una patologia neurologica cronico-degenerativa che si caratterizza per la presenza di una progressiva demielinizzazione della sostanza bianca del sistema nervoso centrale [1]. La SM presenta frequentemente un esordio in età giovanile (tra i 20 e i 45 anni), con una maggiore prevalenza tra le donne (2:1) e può assumere diverse modalità di decorso: la forma più comune è quella detta Relasping-Remitting, nella quale a periodi di recrudescenza della malattia (con comparsa di sintomi di deficit neurologico) seguono periodi di totale remissione; tale decorso è presente nel 70% dei pazienti all'esordio della malattia. In circa il 50% dei casi, al decorso relasping-remitting ne segue uno secondariamente progressivo, che si caratterizza per lo sviluppo nel tempo di un progressivo danno neurologico associato a crescenti livelli di ABSTRACTThe multiple sclerosis (MS) is a neurologic disease that is characterized by a progressive demielinization of the white matter of the central nervous system. In the lasts decades, several therapies have been introduced after randomized, double-blind, placebo controlled trials. These trials supported the efficacy of Interferon-beta (INF-β) in reducing relapsing frequency and slowing the progressive disability, mainly in cases affected by relapsing-remitting MS course. In Italy four different preparations of INF-β are available for MS treatment having different INF-β types (i.e., INF-β1a e INF-β1b), different administration schemes, different INF-β doses and ways of administration. Recently, the biological activity of these preparations have been compared using the same assay system against the same INF-β standard. The aim of this study was to carry out a cost-minimization analysis, on the MS treatments in Italy comparing of the available preparations in terms of cost per microgram standardized by the level of biological activity. The economic evaluation has been conducted adopting the hospital perspective. Health resources have been valued considering euro currency during 2004. According to registered treatment protocol, the results showed that the micrograms per week of INF-β standardized by the level of biological activity ranged from 30µg of Avonex ® to 132µg of Rebif44 ® . Under the same levels of biological activity, Rebif44® resulted the INF-β preparation with the lower cost per micrograms (1.95 euro), followed by Rebif ® 22 and Betaferon ® that had a similar cost (2.90 e 2.97 respectively). Avonex ® resulted the INF-β preparation with the highest cost per micrograms (6,37 euro), about three times higher than that of the preparation with the lowest cost. ANALISI ECONOMICAdisabilità. Inoltre in circa il 10% dei casi, soprattutto quando l'esordio avviene in età più avanzata, la malattia può assumere un decorso primariamente progressivo. Solo in una residua percentuale di casi, infine, la malattia può assumere un decorso benigno, che si caratterizz...

show abstract

Pharmacodynamic Comparison of Single Doses of IFN-beta 1a and IFN-beta 1b in Healthy Volunteers

Cited by 72 publications

References 15 publications

Disease modifying therapies in multiple sclerosis: Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines [RETIRED]

Disease modifying therapies in multiple sclerosis: Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines [RETIRED]

Neutralizing antibodies to interferon beta: Assessment of their clinical and radiographic impact: An evidence report: [RETIRED]

Analisi Costo Minimizzazione delle preparazioni di Interferon Beta per il trattamento della Sclerosi Multipla

Contact Info

Product

Resources

About