Comparative injection-site pain and tolerability of subcutaneous serum-free formulation of interferonβ-1a versus subcutaneous interferonβ-1b: results of the randomized, multicenter, Phase IIIb REFORMS studyReportar como inadecuado




Comparative injection-site pain and tolerability of subcutaneous serum-free formulation of interferonβ-1a versus subcutaneous interferonβ-1b: results of the randomized, multicenter, Phase IIIb REFORMS study - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

BMC Neurology

, 12:154

Demyelinating diseases

Abstract

BackgroundIn patients with relapsing–remitting multiple sclerosis RRMS, subcutaneous sc interferon IFNβ-1a and IFNβ-1b have been shown to reduce relapse rates. A formulation of IFNβ-1a has been produced without fetal bovine serum and without human serum albumin as an excipient not currently approved for use in the US. The objectives of this study were to evaluate tolerability, injection-site redness, subject-reported satisfaction with therapy, and clinical safety and efficacy of the serum-free formulation of IFNβ-1a versus IFNβ-1b in IFNβ-treatment-naïve patients with RRMS. The objectives of the extension phase were to evaluate long-term safety and tolerability of IFNβ-1a.

MethodsThis randomized, parallel-group, open-label study was conducted at 27 clinical sites in the US. Eligible patients aged 18–60 years were randomized to receive either IFNβ-1a, titrated to 44 μg sc three times weekly tiw n = 65, or IFNβ-1b, titrated to 250 μg sc every other day n = 64 over 12 weeks. Following this, all patients received IFNβ-1a 44 μg tiw for 82–112 weeks. Primary endpoint was mean change in patient-reported pain, as assessed by visual analog scale VAS diary pain score from 0 mm no pain to 100 mm worst possible pain at the injection site, from pre-injection to 30 min post-injection over the first 21 full-dose injections. Secondary assessments included proportion of patients pain-free as recorded by VAS diary and the Short-Form McGill Pain questionnaire VAS.

ResultsA total of 129 patients were included in the intent-to-treat analysis. Mean standard deviation change in VAS diary pain score was not significantly different between groups, although numerically lower with IFNβ-1a versus IFNβ-1b from pre-injection to immediately post-injection 1.46 2.93 vs. 4.63 10.57 mm, 10 min post-injection 0.70 1.89 vs. 1.89 5.75 mm, and 30 min post-injection 0.67 2.32 vs. 1.14 4.94 mm. Proportion of patients pain-free at all time periods post-injection was also not significantly different between groups. Adverse events were consistent with the known safety profiles of these treatments.

ConclusionsIn IFNβ-treatment-naïve patients with RRMS, both the serum-free formulation of IFNβ-1a and IFNβ-1b treatments were generally accompanied by low-level injection-site pain and were well tolerated.

Trial registrationClinicalTrials.gov NCT00428584

KeywordsRandomized controlled trial Interferonβ-1a Interferonβ-1b Relapsing–remitting multiple sclerosis Subcutaneous injections Injection-site pain Pain measurement Electronic supplementary materialThe online version of this article doi:10.1186-1471-2377-12-154 contains supplementary material, which is available to authorized users.

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Autor: Barry Singer - Daniel Bandari - Mark Cascione - Christopher LaGanke - John Huddlestone - Randy Bennett - Fernando Dangond -

Fuente: https://link.springer.com/







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