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CerebroSpinal Fluid Abnormalities
In A Phase III Trial Of Avonex (IFN-ß-1a)
For Relapsing Multiple Sclerosis



The Multiple Sclerosis Collaborative Research Group

Rudick RA, Cookfair DL, Simonian NA, Ransohoff RM, Richert JR, Jacobs LD, Herndon RM, Salazar AM, Fischer JS, Granger CV, Goodkin DE, Simon JH, Bartoszak DM, Bourdette DN, Braiman J, Brownscheidle CM, Coats ME, Cohan SL, Dougherty DS, Kinkel RP, Mass MK, Munchsauer FE, O'Reilly K, Priore RL, Whitham RH, et al
J NeuroImmunol 1999 Jan 1;93(1-2):8-14
The Cleveland Clinic Foundation, Mellen Center For Multiple Sclerosis Treatment and Research, Dept of Neurology, OH 44106, USA
rudickr@cesmpt.ccf.org
PMID# 10378864; UI# 99305209
Abstract

Background And Objective
This report provides results of CSF analyzes done in a subset of Relapsing/Remitting MS patients participating in a placebo-controlled, double-blind, Phase III Clinical trial of IFN-ß-Studies supported by the National Multiple Sclerosis Society (grants RG2019, RG2827), and (Avonex, Biogen).

The clinical trial demonstrated that IFN-ß 1a treatment resulted in significantly reduced disability progression, annual relapse rate, and new Brain lesions visualized by Cranial Magnetic Resonance Imaging.

    The objectives of the current study were to determine:
  • Whether CSF abnormalities in MS patients correlated with disease or MRI characteristics, and
  • Effects of IFN-ß-1a therapy on these CSF abnormalities.

Methods
CSF was analyzed from 262 (87%) of the 301 study subjects at entry into the clinical trial, and a second CSF sample was analyzed from 137 of these 262 subjects after 2 years of therapy.

CSF cell counts, OligoClonal Bands (OCB), IgG index, and free kappa light chains were measured using standard assays. Baseline CSF results were compared with Demographic, Disease, and MRI parameters.

Differences in on-study relapse rate, Gadolinium enhancement, and EDSS change according to baseline CSF status was used to determine the predictive value of CSF for subsequent clinical and MRI disease activity.

Change in CSF parameters after 104 weeks were used to determine the effects of treatment.

Results

  1. At study baseline, 37% of the subjects had abnormal CSF WBC counts, 61% had abnormal levels of CSF free kappa light chains, 84% had abnormal IgG index values, and 90% were positive for OCB.

  2. Baseline IgG index, kappa light chains, and OCB showed weakly positive, statistically significant correlations with Gd-enhanced lesion volume and T2 lesion volume.

  3. WBC showed a statistically significant correlation with Gd-enhancing lesion volume but was uncorrelated with T2 lesion volume.

  4. There was an associated between baseline CSF WBC counts and on-study clinical and MRI disease activity in placebo recipients.

  5. IFN-ß-1a treatment resulted in significantly reduced CSF WBC counts, but there was no treatment related change in CSF IgG index, kappa light chains, or OCB, which remained relatively stable over time in both patient groups.

Conclusions
The current study documents significant reductions in CSF WBC counts in patients treated with IFN-ß-1a for 104 weeks.

This finding is considered relevant to the therapeutic response, since CSF WBC counts were found to be positively correlated with subsequent clinical and MRI disease activity in Placebo-treated Relapsing MS patients.



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