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Urinary neopterin and nitric oxide metabolites as markers of interferon beta-1a activity in primary progressive multiple sclerosis.

AbstractBACKGROUND:
Interferon beta has not been demonstrated to be effective in exploratory phase 2 clinical trials in primary progressive multiple sclerosis. However, using more sensitive indicators of a treatment response, such as biomarkers, might help to identify sub-groups of patients who may benefit from therapy.
OBJECTIVE:
To assess the utility of measuring urinary neopterin and nitric oxide metabolite excretion for monitoring interferon beta-1a (IFNbeta-1a) treatment in patients with primary progressive multiple sclerosis.
METHODS:
Fifty patients from a phase II trial of IFNbeta-1a (Placebo n = 20; Avonex 1 x 30 microg/week (IFN-30), n = 15; Avonex 1 x 60 microg/week (IFN-60), n = 15), were enrolled. Patients were assessed using the Expanded Disability Status Scale. Urine samples were collected on each visit, 3 months apart, for a period of 24 months. Nitric oxide metabolites, nitrite/nitrate (NOx), were measured by colorimetric assay and neopterin and creatinine (Cr) were assayed using a high-performance liquid chromatography technique. NOx/creatinine ratio (NOxCR) and urinary neopterin/creatinine ratio (UNCR) quotients were calculated.
RESULTS:
There was no significant difference between pre-dose, baseline levels of UNCR or NOxCR between the study groups. On the intention-to-treat analysis, there was a significant difference in UNCR levels between the placebo compared with IFN-30 (p = 0.03) or IFN-60 (p = 0.002) groups. The IFN-30 and IFN-60 groups did not differ. Within IFNbeta-1a-treated patients with primary progressive multiple sclerosis, median UNCR values were significantly higher in clinically stable (no Expanded Disability Status Scale change) compared with progressive patients (p = 0.002). IFNbeta-1a treatment did not significantly influence NOx excretion in patients with primary progressive multiple sclerosis.
CONCLUSIONS:
Urinary neopterin is a potential biomarker to monitor the in vivo effects of IFNbeta-1a in primary progressive multiple sclerosis and other multiple sclerosis sub-types.
AuthorsK Rejdak, S M Leary, A Petzold, A J Thompson, D H Miller, G Giovannoni
JournalMultiple sclerosis (Houndmills, Basingstoke, England) (Mult Scler) Vol. 16 Issue 9 Pg. 1066-72 (Sep 2010) ISSN: 1477-0970 [Electronic] England
PMID20639271 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Biomarkers
  • Immunologic Factors
  • Nitrates
  • Nitrites
  • Nitric Oxide
  • Neopterin
  • Interferon-beta
  • Creatinine
  • Interferon beta-1a
Topics
  • Adult
  • Biomarkers (urine)
  • Chromatography, High Pressure Liquid
  • Colorimetry
  • Creatinine (urine)
  • Disability Evaluation
  • Drug Monitoring (methods)
  • Female
  • Humans
  • Immunologic Factors (therapeutic use)
  • Interferon beta-1a
  • Interferon-beta (therapeutic use)
  • Male
  • Middle Aged
  • Multiple Sclerosis, Chronic Progressive (diagnosis, drug therapy, urine)
  • Neopterin (urine)
  • Nitrates (urine)
  • Nitric Oxide (urine)
  • Nitrites (urine)
  • Poland
  • Predictive Value of Tests
  • Time Factors
  • Treatment Outcome
  • Up-Regulation

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