Latest News in Rheumatology
2/14/2003
Monoclonal
Antibody May Control Crohn's Disease in Children
FDA
Approves First Ceramic Hip Implant
Hospital
Care of Osteoporosis-Related Vertebral Fractures
Gender,
Ethnic Differences in Fear, Anxiety May Affect Surgical Intervention and
Recovery
Paperwork Irks Patients Most
Physicians
To Get New Online Generic Drug Resource
Philadelpha, PA -- Crohn's disease (CD) affects more than 100,000
children in the U.S., some of which have symptoms of spondylitis. A recent study
published in the January 2003 issue of the American Journal of
Gastroenterology shows promising results in treating CD in children with
infliximab (Remicade®). Remicade® was recently approved for use in adults who
have spondylitis associated with CD but this study shows that the medication is
effective and safe in treating children with the disease.
The study looked at 82 patients who received Remicade® treatment at the
Children's Hospital of Philadelphia. It was the largest cohort of pediatric
patients who received this treatment for CD. Few complications or problems were
reported in the study.
19 of the 33 patients being treated with corticosteroid at the start of the
Remicade® treatments were able to discontinue corticosteroid usage. Current
treatments with corticosteroids and drugs affecting the immune system can
produce the following side effects: acne, weight gain, impaired growth,
osteoporosis, the risk of hepatitis, and bone marrow suppression. But Remicade®
showed the potential to significantly reduce the need for steroids in these
children.
"Monoclonal antibodies and other biological agents are a technology that
we're going to see much more from in the future," said Robert Baldassano,
M.D., director of the Center for Inflammatory Bowel Disease at The Children's
Hospital of Philadelphia and primary investigator of the study. He believes that
"they will revolutionize care in many fields of medicine."
Tumor necrosis factor alpha (TNF-a), a protein produced by the immune system,
is among the causes of inflammation in CD and spondylitis. Monoclonal antibodies
are naturally occurring human antibodies that are genetically altered in a lab,
cloned in large numbers, and introduced into the patient to target disease
sites. Remicade® is a genetically engineered monoclonal antibody that acts
against TNF-a.
The FDA has approved the first ceramic-on-ceramic hip implant to be used in
total hip replacement procedures. According to the manufacturer, Trident Ceramic
Acetabular Insert can absorb more wear and tear and lasts longer than
traditional polyethylene-on-metal and metal-on-metal conventional hip
replacement systems.
This new implant includes a titanium sleeve that encases the
ceramic-on-ceramic bearing surfaces. Researchers say that it is designed for
younger and more active patients who require a hip transplant.
A clinical trial involving more than 1,100 patients found that the Trident
implant is safe, and it extended the long-term performance of artificial hip
joints when compared to traditional implants.
According to the manufacturer, the Trident implant will become available in
early 2003.
There has been little documented information on resource implications of
hospitalization for osteoporosis-related vertebral fracture, so this study used
data from a national sample of hospitalized patients to help identify
characteristics of patients who are hospitalized with vertebral fracture. Their
patterns of using resources were compared with patterns observed for hip
fracture and hospitalizations.
Data from the Nationwide Inpatient Sample for 1997 were used to identify men
and woman age 45 years and above who had a primary diagnosis of vertebral
fracture. They then used 68,901 patients hospitalized for vertebral fracture in
this study. 77% were women, most were white, 75 years and older, and had
multiple comorbid diagnoses.
- Total charges averaged $8,000-$10,000 per hospitalization and were higher
in men.
- The average length of stay was just under 6 days.
- More than 50% of discharged patients required some form of continuing
care.
- Hospitalizations for vertebral fracture occurred at only one-fourth the
rate of those for hip fracture, and created only half the hospital charges
per admission.
- Vertebral fracture accounted for over 400,000 total hospital days and
generated charges in excess of $500 million. This impact is considerably
higher than has been described in previous studies.
Orthopaedic surgeons studying gender and ethnic differences among patients
undergoing joint replacement find that fear and anxiety may play a large role in
delaying surgery, which could result in increased pain and poorer preoperative
functional status. Therefore, timing for surgical intervention is significantly
linked to fear and anxiety, and differs highly among genders and various
ethnicities. This is based on a compilation of studies commissioned by the
Orthopaedic Research and Education Foundation, as presented at the American
Academy of Orthopaedic Surgeons' 70th Annual Meeting in New Orleans, LA.
Study Participants:
- 331 patients
- 66.5% females, 33.5% males
- 12.7% African-American
- 28.7% Caucasian
- 55.3% Hispanic
- 3.3% "multiculture"
- 37.2% underwent Primary Total Hip Replacement
- 35.6% underwent Primary Total Knee Replacement
- 15.1% underwent Revision Total Hip Replacement
- 8.8% underwent Revision Total Knee Replacement
Overall, the findings suggest that intervention to alleviate fear and anxiety
before surgery would encourage females and African-Americans to pursue
arthroplasty surgery sooner, leading to lower preoperative pain levels and
higher functionality scores, which would result in better outcomes.
"Pursuing arthroplasty surgery during the precise window of opportunity
for best surgical outcomes requires the identification and alleviation of the
fear and anxiety that patients experience, which may affect their surgical
outcomes," according to principal study investigator, Carlos Lavernia, MD,
orthopaedic surgeon in Miami, FL.
They also found that female patients pursue surgical intervention with a
statistically lower quality of life and physical function than males do. When
evaluating preoperative physical function, females averaged a score of 10 and
males averaged a score of 20 (a much higher level of functionality). Women
demonstrated higher scores in escape and avoidance behavior, too.
Results indicated that African-American arthroplasty patients often have
poorer preoperative functional status than do nonminority patients because they
tend to wait longer to surgically correct the problem. Pain and anxiety scores
are higher in African-Americans than in Caucasian patients.
A recent study in Milbank Quarterly concluded that paperwork and
billing concerns cause more patient complaints than the quality of their health
care, despite the fact that problems with health-care quality are as common as
administrative problems.
- The study showed that even when they have serious problems with the
quality of their health care, many people do not complain.
- Complaints haven't increased, despite recent government regulations that
make it easier to file grievances about health-care quality.
- People who did complain about health-care quality were five times as
likely to have their concerns resolved in a successful manner.
- People were most likely to complain about simple problems (instead of
complex ones) and about repeated and costly problems.
- People were more likely to complain and have their problem resolved when a
third party, such as a family member, doctor, or outside mediator, was
involved.
- Half of the survey participants reported at least one problem linked to
their health-care plan in the previous year.
- Of those who had a problem, 59% complained directly to their health plan,
and 13% made their complaint to their employer.
- African Americans and Asian Americans were half as likely to complain
about problems as whites, but their complaints were just as effective as
complaints made by whites.
This study used data from the 1999 Kaiser Family Foundation's National Survey
on Consumer Experiences with Health Plans.
More than 6,000 physicians from around the nation have been invited to
participate in a pilot interactive "Generics First eEducation
Program". It will provide physicians with clinical and cost information on
generic drugs, emphasizing their value and efficacy. The program includes three
10-minute programs on general generic drug information on the four largest
therapeutic categories for generics based on drug spend and prescribing
opportunity: gastrointestinal and non-steroidal anti-inflammatory drugs (NSAIDs),
antihypertensives, and antidepressants.
The "Generics eEducation Program" is an expansion of Medco Health's
Generics First one-on-one education program, in which pharmacists visit
physicians to discuss the clinical benefits and economic value of generic drugs
and to encourage their use. Results of the highly successful two-year pilot
program used 12 pharmacists in 10 states who visited 1,700 physicians. Each
Generics First pharmacist averaged $1 million in drug spend savings as a result
of office visits in 2001. Prescribing rates of generic medications by
participating physicians increased 22% over a comparison physician group not
involved with the Generics First program.
"Physicians are very busy people. Offering Generics First information
online will allow physicians to participate in this very valuable program at
their convenience," says Dr. Robert Epstein, the chief medical office of
Medco Health.
Generic medications have become a highly touted counter to rising healthcare
costs. Nationwide, every 1% increase in generic utilization yields a $1.16
billion savings in prescription drug costs per year. Generic drugs must meet the
same Food and Drug Administration (FDA) standards required of the equivalent
brand-name product. However, generics can cost up to 70% less than brand-name
medications.