ANNUAL REPORT 2012 - TiGenix

that the average cost of treatment of a patient with complex perianal fistula due to Crohn’s
disease is KEUR 34 per patient, of which KEUR 20.1 is destined to pharmacological treatment.
6.5.2.2. Cx611
The product Cx611 is finalizing clinical
development Phase IIa for the treatment
of rheumatoid arthritis. It is intended for
the treatment of RA and potentially other
inflammatory diseases.
Rheumatoid arthritis (“RA”) is one of the
most common autoimmune diseases. It is a
chronic systemic disorder characterized by
inflammation of the joint tissues, primarily
the synovium. The resultant inflammation
and build up of fluid in the joint leads to
stiffness, swelling, redness, and eventually
to debilitating pain. Inflammation of the
synovium may progress to degeneration of
the joint bone and cartilage as a result of
enzymatic actions of the cells involved in the
inflammatory process and the resultant joint
damage can lead to joint deformity.
RA represents the most common
inflammatory arthritis, affecting between
0.3 % to 1 % of the general population in
industrialized countries 19 .
The economic burden associated to the
treatment of RA is huge for any healthcare
system. For Europe alone, it has been
estimated that the combined annual
economic cost of this disease is as high as
EUR 45.5 billion (Lundkvis et al 2008). There
are considerable costs associated with
RA, such as informal care, non-medical
costs and lost production, which increase
with disease progression. Therefore, early
diagnosis and effective treatment leads to
considerable savings and improvements in
patients’ quality of life 20 . The direct medical
cost of treating RA has risen greatly over the
past ten years as a result of new biologics,
which can cost up to and above $12,000 a
year. In 1996, the average cost of treating RA
was roughly $6,000 a year. In 2005, for those
receiving biologic treatments, this number
was in the range of $15,000 to $17,000 21 ,
whereas in 2007 biologic therapies in the US
have been reported to cost between $13,000
and $20,000 per year per patient 22 .
The current pharmacological management
of rheumatoid arthritis involves early
intervention with synthetic disease modifying
anti-rheumatic drugs (“DMARDs”) either
singly or in combination. If inflammation
cannot be adequately suppressed by these
means, biologic DMARDs targeting the proinflammatory
cytokine TNF are employed.
In the event of inadequate response, dose
optimization (i.e. in the case of the anti-TNF
Infliximab), further anti-TNF , or alternatively,
biologics of a different mechanism of
action class can be used. Despite all these
treatments, RA remains as an insufficiently
unmet clinical need where several concerns
about long-term treatments based on
biologics are documented (Bongartz, 2009) :
- Lack of efficacy of biological treatments
in some patients, and non-tolerability or
recurrent secondary infections have been
factors which have contributed to the need
of developing new therapies.
- Adverse effects from current antirheumatic
medication occur, affecting various organ
systems and sometimes being serious.
19
WHO Report “The global burden of rheumatoid arthritis in the year 2000”. Deborah Symmons Colin Mathers, Bruce Pfleger.
20
Lundkvist J et al. Eur J Health Econ 8 (Suppl 2) :S49–S60.
21
Biotech in Autoimmune/Inflammatory Disease 2006 2 nd Edition Arrowhead Publishers.
22
Datamonitor, 2009.
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