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WINTER
MS LAB
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MS LAB SYSTEM
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About us
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PMA Pharma Marketing Advisors is a Bulgarian
company specialized in marketing and consultancy
analyses in the pharmaceutical industry. The
company is registered in 2008. PMAs team has
great experience at preparing marketing
strategies and studying the market for both local
and international clients.
Throughout the years, PMA has achieved
considerable professional and organizational
headway to organize and carry out laboratory
analysis of the MS patients NAB-status in
Bulgaria's leading MS center. We have developed
a specially designated web-based software
application set to provide operational management
and quality control.
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The problem
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• A potential problem with prolonged clinical use
  of recombinant human cytokines, including IFNb,
  is antibody induction.
• So far it is impossible on the basis of clinical
  data to identify who eventually develop binding
  and neutralizing antibodies.

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The most dramatic effect of antibodies is seen in
cases in wich the antibodies interfere whith the
effect of endogenous hormones. This has been
observed with the use of erythropoietin-alpha in
patients with chronic renal failure, where
several cases of pure red cell aplasia have been
reported1.
Recently, a case of a rare variant of malignant
melanoma was reported in a patient who had been
NAB-positive for several years, and it was
hypothesized that persistent NABs could be the
associated potential for adverse effect resulting
from the suppression of endogenous IFN-ß
activity2.

1. Casadevall et al. (2002) Pure red cell aplasia
   and antieruthropoietin antibodies in patients
   treated with recombinant erythropoietin. N Engl J
   Med 346 469-475.
2. Gibbs E. et al. (2008) Malignant melanoma in a
   multiple sclerosis patient with persistent
   neutralizing antibofies to interferon-beta. Eur J
   Neurol 15 e4.

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The solution
Beyond technical performance of laboratory
assays, the web-based software provides
operational, communicational and informational
environment for MS patients, health professionals
and laboratory staff.
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Results

• Determination of binding antibodies and
  neutralizing antibodies to human IFNb
• 250 MS patients
• 417 sera tests.

Fig. 2. Drugs distribution.
Fig. 1. Gender distribution.
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BAbs results
We use the BÜHLMANN anti-IFNß ELISA kit, which is
designated for direct and quantitative
determination of IgG antibodies to
therapeutically administered IFNb in human serum.
  Betaferon Extavia Rebif Avonex Total
n 92 20 89 49 250
negative 28 1 72 43 144
positive 64 19 17 6 106
positive/ n 70 95 19 12 42
Table 1. Prevalence of BAbs in IFNb-treated
patients.
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Buehlmann reference
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NAbs results
We use the Biomonitor iLiteTM anti-human IFN-beta
kit, which is designated for the
semi-quantitative determination of neutralizing
antibodies to human IFNb, using luciferase
generated bioluminescence.
  Betaferon Extavia Rebif Avonex Total
n 72 19 17 6 114
negative 48 16 14 5 83
positive 24 3 3 1 31
positive/ n 33 16 18 17 27
Table 2. Prevalence of NAbs in IFNb-treated
patients.
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Our vision
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WINTER
MS LAB for your MS patients
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Make your Software controlled Laboratory Assays
for BAbs and NAbs ...in our MS LAB!