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ARTHRITIS
FOUNDATION OF VICTORIA
www.arthritisvic.org.au ... (Copy
reviewed 2005)
NEW MEDICATIONS
This page contains basic information about new treatments that are announced from
time to time. Some of this information is provided by the Arthritis Victoria
Centre for Rheumatic Diseases.
Synvisc / Bone Marrow
Transplantation / Enbrel / Arthrotec
/ Celebrex
Synvisc is classified as a medical device, because it acts physically, rather than
chemically or pharmacological. The technical term for its action is
viscosupplementation..
Synvisc is a temporary replacement and supplementation for synovial fluid (which exists
within a joint and provides lubrication and protection to the cartilage, as well as shock
absorption) of the knee joint. It has not been clinically trialed on other joints of the
body.
It is claimed that, because it improves the effect of existing synovial fluid in the
affected knee joint, Synvisc significantly decreases pain in the knee, allowing people to
move and exercise more.
It makes no claim for cure.
Synvisc is only intended for intra-articular (injection into the joint) use to treat
pain associated with osteoarthritis of the knee.
Three injections of Synvisc are administered directly into the affected knee joint by a
doctor at one-weekly intervals.
Optimal pain relief and restoration of joint mobility can be experienced for up to 6
months. Repeat courses are available.
Contraindications (When not suitable or safe to use):
- If there is poor venous or lymphatic circulation in the affected leg.
- If the joint to be treated is very swollen, infected or severely inflamed.
Availability
The doctor can order it directly from the distributor or you can arrange direct
delivery to your doctor from the distributor, Clifford Hallam Pharmaceuticals Pty Ltd.
Tel: 1800 355 929.
Synvisc costs $444.50 per course of three injections.
Arthritis Victoria strongly advises that any person
considering this treatment should first consult with their doctor or rheumatologist to
determine if it is appropriate for them, and seek further information about the product by
ringing The Bayer Synvisc Information Line on 1800 222 937 or www.synvisc.bayer.com.au
It is important to make a number of points
regarding the recent publicity. The first is that this is an experimental form of therapy,
which is to be studied intensively in controlled clinical trials. A trial is about to take
place in a number of centres around Australia including the Royal Melbourne Hospital, St.
Vincent’s Hospital in Sydney, Royal Perth Hospital and the Mater Hospital in
Brisbane. Initially, only a small number of patients will be entered into the study (10 at
each site) and we expect that these patients will be drawn from those already attending
outpatient clinics attached to the rheumatology departments of each of these hospitals.
Therefore, we are not seeking to recruit any extra patients for the study at this stage.
The results of the study will take some time to gather and patients will need to be
observed carefully for many months before any conclusions can be drawn. If the initial
studies look promising, further trials will probably proceed and these may involve larger
numbers of patients. Until then, this is not a treatment that will be generally available
to patients with severe rheumatoid arthritis.
Secondly, it is important for you to keep in close contact with your
treating rheumatologist. He or she is aware of these clinical trials and is the best
person to give you further advice. Most patients with rheumatoid arthritis can be
adequately managed by the treating rheumatologist using treatment that we already have
available. The purpose of this study is to explore the safety and efficacy of a new type
of treatment for those patients with severe rheumatoid arthritis who have failed standard
treatment. This is a relatively small group of people and because the new treatment is
experimental, it needs to be done in carefully controlled clinical trials.
Finally, it is important for you to remain positive and optimistic in
the face of the difficulties you undoubtedly have from your rheumatoid arthritis. Please
remember that the press tend to highlight the most dramatic elements of a story.
Even in the patients who do not respond to our standard types of
treatment, rheumatologists are increasingly able to deal with complications of rheumatoid
arthritis and the outlook for all patients continues to improve.
Professor Ian Wicks
Head, Rheumatology Unit, RMH
Director, Arthritis Victoria Centre for Rheumatic Diseases
(added 23/12/98)
Etanercept (ENBREL) for Rheumatoid Arthritis
The U.S. Food and Drug Administration today (2nd of November, 1998) licensed a new
genetically engineered protein called ENBREL (Etanercept) that helps reduce the symptoms
of moderate to severe, active rheumatoid arthritis (RA) in patients who have not responded
well to other treatments. It can also be used in combination with methotrexate if patients
do not benefit enough from use of methotrexate alone. Enbrel binds to tumor necrosis
factor (TNF), a naturally occurring protein in the body, and inhibits its action. TNF,
which promotes inflammation in the body, is found at elevated levels in the fluid
surrounding the affected joints of RA patients.
The dosage of ENBREL for adult patients with RA is 25 mg given twice weekly as a
subcutaneous injection.
ENBREL has been studied in more than 1,000 people with RA. At 3 months, Phase III study
results in 234 patients demonstrated that 62 percent of the patients receiving a 25 mg
dose of ENBREL reached the primary endpoint of 20 percent improvement by ACR criteria
– a composite score of select measurements of RA symptoms including joint pain, joint
swelling, and patient and physician global assessment – compared to 23 percent of the
patients in the placebo group. In this study, responses were rapid, often appearing within
one to two weeks after initiation of therapy, and nearly always occurred within months. At
6 months, the secondary endpoints of this study demonstrated a 69% median improvement in
pain (vs. 2% for placebo), a 71% median improvement in tender joint counts (vs. 6% for
placebo), a 51% median improvement in swollen joint counts (vs. 2% for placebo), and an
88% median reduction in duration of morning stiffness (vs. 4% for placebo).
More than 100 patients have been treated with ENBREL for at least 15 months, and more
than 80 percent of them experienced relief of their symptoms, which was sustained.
Clinical studies showed that patients have responded to ENBREL even after other therapies
failed and that ENBREL can be given in combination with methotrexate, without increasing
side effects. Longer term studies with ENBREL are ongoing and will continue to expand the
ENBREL database.
Less than 1 percent of patients experienced an allergic reaction when Enbrel was given,
but no severe reactions were seen.
Although it is theoretically possible that Enbrel may affect the body's defenses
against infections and malignancies, clinical studies to date have not shown an increase
in serious infections or malignancies. However, the company is conducting further studies
to look at the long-term safety of the product.
Enbrel has also been studied in 54 children aged 4 to 17 years old with moderate to
severe juvenile RA with results similar to those of the adult studies. It is recommended
that if possible, children be up-to-date with current vaccine immunization guidelines
before starting therapy with Enbrel because it is not known whether immunization responses
will be affected by treatment.
Enbrel will be co-marketed by the Immunex Corporation, Seattle, Wash. and Wyeth-Ayerst
Laboratories,
Philadelphia, Pennsylvania, under the trade-name Enbrel.
At this stage it is not known when Enbrel will become available in Australia.
Arthrotec is a combination of diclofenac (VOLTAREN) and
misoprostal (CYTOTEC). As you may be aware the coadministration of these two drugs has
been shown to reduce the incidence of gastric ulcers and possibly decrease gastric
symptoms. Misoprostal is a prostaglandin analogue that is involved in the protection
of the stomach lining - it is secreted by the lining layer cells and found in the mucus
layer. NSAIDs like diclofenac deplete this prostaglandin from the mucus and increase the
vulnerability of the stomach to acid - and therefore to an ulcer.
Misoprostal has been available on its own for several years now for people who have had
previous ulcers and need NSAIDs.
Arthrotec is combining the NSAID and misoprostal in one tablet rather than two. It does
reduce the risk of ulcers but it is not a PBS item and therefore costs $60-80/ month
The anti-inflammatory component is NO different
Celebrex, real name Celecoxib, is one of the new Cyclooxygenase 2
inhibitors. It is the most advanced in trials and certainly looks promising. In trials so
far it has far less gastrointestinal toxicity than standard NSAIDs
Its efficacy is the same as other NSAIDs
The Centre for Rheumatic Diseases will be conducting a trial using this drug - called
SUCCESS-1 in early 1999.
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