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drug 'slows osteoarthritis'
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Trimble Bracegirdle
May 9, 2012, 9:51:46 AM5/9/12
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Reporter JANET FRICKER IN BORDEAUX
French drugmaker Servier has presented late-stage data on Protelos,
which shows that the drug reduced structural progression of
osteoarthritis in knee joints by one-third.
The Phase III results, unveiled at the European Congress on Osteoporosis
and Osteoarthritis in Bordeaux, come from the first study ever to have
demonstrated a disease-modifying effect in OA. Furthermore,
investigators showed that Protelos (strontium ranelate), currently
licensed for osteoporosis, delivered beneficial effects on pain,
function, and mobility.
Cyrus Cooper, of the universities of Southampton and Oxford and the lead
investigator on the trial, said that "after years of labouring to manage
patients with blunt tools we finally have something that allows us to
alter the natural history of the disease". Until now, the only treatment
for OA, a condition estimated to affect one in six people, has been
life-style changes and symptomatic relief with analgesics.
In the Phase III study, 1,683 patients with knee osteoarthritis (mean
age 62.3 years) were randomised to receive Protelos 2g/day, 1g/day or
placebo. The primary endpoint was the measurement of narrowing of the
medial-tibio femoral compartment of the target joint.
At three years, results show that in comparison with placebo the space
between the joints was 33% wider (less narrow) for patients receiving
the 1g dose and 23% wider for those on 2g.
Both doses significantly decreased the number of patients reaching
>0.5mm loss of joint space, a threshold known to place people at a
fivefold increase in the risk of undergoing joint replacement surgery
over the next five years.
For the 1g dose, the risk of reaching this threshold was reduced by 34%,
and by 44% for the 2g dose.
Jean-Yves Reginster from the University of Liege, who presented the
study in the scientific session, noted that “such data suggests
that strontium ranelate could reduce the number of patients requiring
knee surgery". For every three years of treatment, he added, the
equivalent of a year of joint space would be saved.
Furthermore, Protelos 2g significantly reduced the WOMAC score (a global
score taking into consideration OA pain, function and mobility) in
comparison with placebo, while the 1g dose did not produce a
statistically significant effect.
Clearly, the 2g dose is needed to obtain the beneficial effects on pain
and stiffness,†added Prof Reginster.
Protelos costs less than £1 a day
The study has caused much excitement, not least because Protelos costs
less than £1 a day. Prof Cooper added that"for the first time, we
have a treatment that can slow the development of this debilitating
disease and could reduce or even eliminate the need for expensive and
painful joint replacement surgery".
Servier noted that in 2010, over 140,000 hip and knee replacements were
carried out in the UK, at a cost of over £1 billion to the National
Health Service.
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French drugmaker Servier has presented late-stage data on Protelos,
which shows that the drug reduced structural progression of
osteoarthritis in knee joints by one-third.
The Phase III results, unveiled at the European Congress on Osteoporosis
and Osteoarthritis in Bordeaux, come from the first study ever to have
demonstrated a disease-modifying effect in OA. Furthermore,
investigators showed that Protelos (strontium ranelate), currently
licensed for osteoporosis, delivered beneficial effects on pain,
function, and mobility.
Cyrus Cooper, of the universities of Southampton and Oxford and the lead
investigator on the trial, said that "after years of labouring to manage
patients with blunt tools we finally have something that allows us to
alter the natural history of the disease". Until now, the only treatment
for OA, a condition estimated to affect one in six people, has been
life-style changes and symptomatic relief with analgesics.
In the Phase III study, 1,683 patients with knee osteoarthritis (mean
age 62.3 years) were randomised to receive Protelos 2g/day, 1g/day or
placebo. The primary endpoint was the measurement of narrowing of the
medial-tibio femoral compartment of the target joint.
At three years, results show that in comparison with placebo the space
between the joints was 33% wider (less narrow) for patients receiving
the 1g dose and 23% wider for those on 2g.
Both doses significantly decreased the number of patients reaching
>0.5mm loss of joint space, a threshold known to place people at a
fivefold increase in the risk of undergoing joint replacement surgery
over the next five years.
For the 1g dose, the risk of reaching this threshold was reduced by 34%,
and by 44% for the 2g dose.
Jean-Yves Reginster from the University of Liege, who presented the
study in the scientific session, noted that “such data suggests
that strontium ranelate could reduce the number of patients requiring
knee surgery". For every three years of treatment, he added, the
equivalent of a year of joint space would be saved.
Furthermore, Protelos 2g significantly reduced the WOMAC score (a global
score taking into consideration OA pain, function and mobility) in
comparison with placebo, while the 1g dose did not produce a
statistically significant effect.
Clearly, the 2g dose is needed to obtain the beneficial effects on pain
and stiffness,†added Prof Reginster.
Protelos costs less than £1 a day
The study has caused much excitement, not least because Protelos costs
less than £1 a day. Prof Cooper added that"for the first time, we
have a treatment that can slow the development of this debilitating
disease and could reduce or even eliminate the need for expensive and
painful joint replacement surgery".
Servier noted that in 2010, over 140,000 hip and knee replacements were
carried out in the UK, at a cost of over £1 billion to the National
Health Service.
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