May 20, 1997 — UNMC Research Study Discovers Minocycline Antibiotic Effective in Early Treatment of Rheumatoid Arthritis

A research study conducted by the University of Nebraska Medical Center
and involving 14 rheumatologists in f our Midwestern states has found that
minocycline, an antibiotic used to treat acne, also provides significant
improvement for people with early rheumatoid arthritis.

The study appears in the May issue of Arthritis & Rheumatism, the
national journal of the American College of Rheumatology. Rheumatoid arthritis
is an autoimmune disorder that affects more than 2 million Americans and
usually strikes women between the ages of 20 and 45. It is a chronic disease
that causes pain, stiffness, swelling and loss of function in the joints
and inflammation in other body organs.

It’s estimated that rheumatoid arthritis results in more than 9 million
physician visits and more than 250,000 hospitalizations per year. There
is no cure for rheumatoid arthritis, so the goal of treatment is to achieve
remissions or near remissions.

James O’Dell, M.D., was principal investigator of the study. Dr. O’Dell
is a professor in the internal medicine department at UNMC in the section
of rheumatology. A total of 46 rheumatoid arthritis patients were studied
at the six participating sites. The study was a six-month, double-blind,
randomized study with half the patients taking a placebo and the other
half taking 100 mg. twice daily of minocycline.

Results of the study found that 65 percent of patients receiving minocycline
showed at least 50 percent improvement at three months and maintained at
least a 50 percent improvement for six months with no significant drug
toxicity. Only 13 percent of the patients taking the placebo showed comparable
improvement. Improvement criteria included joint tenderness, stiffness
and swelling.

The patients were selected based on having rheumatoid arthritis for
less than one year and being diagnosed as being rheumatoid factor positive
— a blood test when positive that is considered an accurate predictor
that a person will be significantly affected by arthritis for the rest
of their life.

The six sites included Omaha, Lincoln and Kearney in Nebraska; Sioux
City, Iowa; Sioux Falls, S.D.; and Rockford, Ill. Approximately one-third
of the patients were seen at UNMC with the remaining patients seen at the
other sites. At UNMC, Dr. O’Dell was assisted by two rheumatologists, Gerald
Moore, M.D. and Lynell Klassen, M.D., a nurse, Claire Haire, R.N., M.S.N.,
and a pharmacist, Pierre Maloley, Pharm.D.

Previous studies had linked minocycline to improvements in rheumatoid
arthritis, though two large studies in patients with advanced disease showed
the drug provided only modest improvement. These studies did not address
why an antibiotic would provide such relief in a disease not commonly associated
with infection.

In addition to its effects as an antibiotic, minocycline has been shown
in other studies to reduce inflammation, protect cartilage that lines the
joints, and cause changes in the immune system. Dr. O’Dell said the study
leaves open the possibility that an infectious agent is involved in the
disease process causing rheumatoid arthritis. Alternatively, since minocycline
protects cartilage from damage, this may be responsible for its efficacy.

"This study was short and included a small number of people, so
more research is necessary before we conclude that minocycline is the drug
of choice for people with early rheumatoid arthritis," Dr. O’Dell
said. "But, these results are important, especially in light of the
other studies which seemed to indicate that minocycline was not associated
with major improvement of rheumatoid arthritis. This study also highlights
the importance of early diagnosis for patients with rheumatoid arthritis,
since most medications are much more effective when used early."

Dr. O’Dell praised the private rheumatologists for their work in the
study. "The study would not have been possible without the cooperation
of these people," he said. "They were instrumental in identifying
and enrolling the majority of the patients who participated in the study."

In addition to the UNMC rheumatologists listed previously, other rheumatologists
who participated in the study included:

OMAHA — William Palmer, M.D., Steven Wees, M.D., and Deborah Doud,

LINCOLN — Art Weaver, M.D., and Melvin Churchill M.D.

KEARNEY — Kent Blakely, M.D.

SIOUX CITY — Nils Erikson, M.D. (formerly of Sioux City and now working
for the U.S. Navy)

SIOUX FALLS — Walter Drymalski, M.D. (now deceased), and P. James Eckhoff,

ROCKFORD — Frederick Dietz, M.D., and Richard Olson, M.D.

To find out more about this study, people should call Dr. O’Dell’s office
at (402) 559-7288.