Latest News in Rheumatology
2/28/2003
Remicade (Infliximab) Recommended For European Approval
For Treating Ankylosing Spondylitis
Case Report: Anti-TNF Alpha Induced Systemic Lupus
Syndrome
Case Report: Association of Spondyloarthopathies With
Lumbar Synovial Cysts
Should We Blame Our Pain Threshold on Our Genes?
Doctors Urged to Admit Medical Errors
Caffeine May Hinder Rheumatoid Arthritis Drug
Kenilworth, NJ -- Schering-Plough Corporation announced that the European
Union's Committee for Proprietary Medicinal Products of the European Agency for
the Evaluation of Medicinal Products has issued a positive opinion recommending
approval of Remicade for the treatment of AS.
The positive opinion for Remicade as a treatment for AS is primarily based on
one-year results from a study showing that treatment with Remicade resulted in significant
improvements in disease signs and symptoms. 57% of patients in the study who
received Remicade achieved at least a 50% reduction in disease signs and
symptoms from the beginning of the study to the end of the study, compared with 9% of the patients
receiving a placebo. Improvement was observed by week two and was maintained
through week 54. Physical function and quality of life were similarly improved.
Remicade was also shown to be particularly effective in treating symptoms of the
disease related to axial (spinal and lumbosacral) points.
Commission approval for the treatment of AS would make Remicade the first and
only anti-TNF agent indicated for AS, which affects an estimated 1.5 million
Europeans. As is true in the U.S. at this time, Remicade is currently marketed in
Europe for rheumatoid arthritis and Crohn's disease.
Despite good clinical efficacy and tolerance, the possibility of drug-induced
autoimmune disorders remains a matter of concern for people taking anti-TNF alpha medications, like Remicade (Infliximab) and Enbrel (etanercept). Few cases
of induction of true lupus by Remicade without major organ involvement were
reported to be associated with the medication that resolved after
discontinuation of Remicade. Only four cases have been described with the use of
Enbrel.
There are now two new cases reported of Enbrel-induced lupus syndrome in
three patients with rheumatoid arthritis, and one new case of Remicade-induced
lupus syndrome.
Researcher M. Debrandt and colleagues from Paris, France published these
findings in a recent issue of the Clinical Rheumatology journal.
Intraspinal synovial cysts that cause lower back pain are well known but
rare. They are associated with facet joint arthropathy, general degenerative in
nature. Spinal synovial cysts have not been described in spondyloarthopathies (SpA),
but this publication reports a case of a 66-year-old man with chronic
undifferentiated SpA who reported severe weakness in both legs. Doctors found a
centrally located spinal cyst through a MRI, which led to the removal of the highly
inflammatory synovial cyst.
They say that this association may not be have happened by accident, and may
be related to inflammation of the facet joint in SpA.
Researchers A. Finckh and colleagues from the Centre Hospitalier Univer
Vaudois in Switzerland published this case report in a recent issue of the Clinical
Rheumatology journal.
Scientists have found one reason why people seem to be able to tolerate
physical and emotional pain differently -- how much you suffer is due at least
partly to a gene that helps regulate how many natural painkillers (called
endorphins) your body releases. University of Michigan neuroscientists emphasize
the need to customize pain treatment, and suggest that these results may help
doctors down the road predict which patients will respond to a certain kind of
medication. The COMT gene leads to the production of an enzyme in the body
involved in pain response, including part of the opioid system, the natural
painkilling mechanisms in the body. The study is published in the February issue
of Science.
Researcher Jon-Kar Zubieta, MD, and colleagues injected saline solutions into
the jaw muscle of 29 people to simulate a jaw condition known as
temporomandibular joint (TMJ) syndrome. At the same time, they exposed
participants to other physical and emotional stress.
They found that people with
a certain form of the COMT gene could withstand more pain in the jaw. These
people reported less pain and had fewer negative emotions as a result of the
pain. Participants who had another form of the COMT gene suffered the most from
the smallest saline injections and had far less natural painkiller action. There
were also people who fell in between the two groups based on a combination form
of the gene.
Zubieta estimates that a quarter of the U.S. population carries the more
"stoic" gene variation, while another quarter has the gene variant
that makes them super-sensitive to pain.
The researchers hope that by understanding what produces pain in the
body, doctors may one day have better treatment options for people with chronic
pain.
According to a recent study, when medical errors happen, what these patients
need from their doctors is much different from what they are likely to get. The
article appears in the February 26 issue of The Journal of the American
Medical Association.
52 patients and 46 doctors were divided into 13 focus groups (meeting
separately) to talk about what they would expect when a doctor tells a patient
that he or she was hurt because of a medical error. Doctors and patients then
met together to hear each other's point of view.
Patients reported that they want to know when medical errors happen, and they
want to know what the doctor is going to do to make sure it will not happen
again to them or somebody else. They want compassion and an apology.
Doctors reported that they were not sure how much patients wanted to know.
They did not want to look unprofessional by showing too much feeling, and they
were afraid an apology would lead to a malpractice suit.
When the patients and doctors met together to discuss their thoughts,
patients learned that the doctors are often afraid to talk about the terrible
anguish they feel over medical errors, and doctors learned that patients
correlate the amount of information a doctor reveals with the level of trust
they can place upon the doctor.
Researcher Victoria J. Fraser, MD, Professor of Medicine at Washington
University, St. Louis (where the study took place) said that patients and
doctors should understand that they are all human beings and should act to each
other "more like the humans they are." She believes that medical error
is not the result of being bad, but of being human. "What patients need is
the most important thing. By communicating more effectively and supportively,
doctors make things better and not worse. The more open and honest, caring and
compassionate a doctor is...that will always be better than not being able to
communicate and show concern and offer support. The relationship between a
doctor and a patient is very important. It is not a machine. It is two people,
both trying to do their best and trying to get the best outcome. If we can get
healthcare back to being more personal, the way it used to be, healthcare will
be better."
Patients were surprised to hear how much medical errors affected the doctors
who took part in the study. Some doctors who had committed medical errors
described the following responses to their errors: an inability to sleep, loss
of appetite, depression, feeling they were failures, feeling like quitting,
feeling like they couldn't go on. Fraser suggested that doctors have the
potential to harm someone every day, which she believes is a very powerful
burden -- "Every mistake a doctor makes affects a person's
life."
But doctors in turn need to learn to deal with these issues. John D. Banja,
PhD, clinical ethicist at the Emory University Center for Ethics in Public
Policy and the Professions, says, "When you've made a medical error, you
have to answer the patient's questions as best you know, you have to swallow
your pride, you have to try to get over your own psychological defense
mechanisms. The doctor is struggling with intense feelings of embarrassment, of
incompetence, of humiliation, and of fear of being sued. When a human is in such
personal turmoil, you are trying to ward off these nasty feelings. That's why it
is not unusual that doctors will blame one another [or the patient], in order to
rationalize the error. This is a natural response for any human being. So we
have to be aware of how our psychological defenses are going to impact our
ability to communicate medical error." Banja believes that doctors need to
apologize because "it is amazing how therapeutic the apology is."
Yet saying "I'm sorry" scares many doctors more than anything
because they feel it sets them up for a lawsuit. Oftentimes, medical schools and
hospital legal staffs warn doctors against apologies, but J. Scott Kramer, a
medical malpractice attorney and member of the medical malpractice task force of
the Philadelphia Court of Common Pleas, says that a simple apology could avoid a
trip from the patient to a lawyer in the first place. He says that plaintiffs'
lawyers make a big show of doctors being uncaring in cases where they have less
than forthcoming with information about a medical error, and so providing
information and offering empathy "is very appropriate and not an indication
of liability or a guilty conscience."
The researchers believe that we need to build systems to give doctors
emotional support, education, and training about how to communicate more
effectively. Furthermore, they suggest that this could help patients see the
compassion in their doctors again.
New York (Reuters Health) - A recent study shows that caffeine
provided by less than two cups of coffee a day might be enough to dull the
effects of methotrexate, a drug that some doctors prescribe to people with
spondylitis or rheumatoid arthritis. Results appear in the February issue of the
Journal of Arthritis & Rheumatism.
The investigators, led by Dr. Gideon Nesher of Shaare-Zedek Medical Center in
Jerusalem, studied 39 adults with rheumatoid arthritis. All of the study
participants were recently diagnosed with rheumatoid arthritis and were started
on 7.5 milligrams of methotrexate a week. Their symptoms and daily diets
were followed for three months, and patients were analyzed in three groups based
on their caffeine intake.
Nesher's team found that by the end of the study, participants with the
highest caffeine consumption showed less improvement in morning stiffness and
joint pain compared with the lowest-intake group. Those with the highest
caffeine intake--comparable to about one-and-a-half cups of coffee or more per
day--showed a weaker response to methotrexate than did patients with the lowest
caffeine intake.
According to the researchers, caffeine may interfere with methotrexate's
ability to fight rheumatoid arthritis because caffeine acts on cell receptors
called adenosine receptors. It's not yet clear why methotrexate helps rheumatoid
arthritis, but one theory is that it increases adenosine production, which in
turn reduces the inflammation that marks rheumatoid arthritis.
"I think the findings are intriguing," Dr. John Klippel, medical
director of the Atlanta-based Arthritis Foundation, told Reuters Health. He
notes that one should be cautious in interpreting the results of such a small
study, and that it is highly difficult to make specific dietary recommendations
based on these findings. However, he noted, rheumatoid arthritis patients on
methotrexate who want to watch their caffeine intake might try limiting
themselves to one cup of coffee a day. Earlier research in animals had suggested
a caffeine-methotrexate connection, and this latest study has "taken the
next step" by finding a relationship in people with rheumatoid arthritis.
According to the researchers, their findings suggest that a daily intake of
more than 180 mg of caffeine dulls the effects of methotrexate compared with
caffeine doses of less than 120 mg per day. A typical cup of brewed coffee
contains around 120 mg of caffeine.
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