Monday, March 5, 2012

Hizentra Cuts Infections in Immune Disorders

Hizentra Cuts Infections in Immune Disorders

Mar 4, 2012

By Nancy Walsh, Staff Writer, MedPage Today

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco.

ORLANDO -- Subcutaneous immune globulin (Hizentra) remains safe and effective up to two years in the treatment of patients with primary immunodeficiency diseases, researchers reported here.

The overall rate of infections was 2.4 per patient-year (95% CI 1.9 to 2.9) among patients receiving once-weekly infusions of the subcutaneous immune globulin, according to Robert P. Nelson, Jr., MD, of Indiana University in Indianapolis, and colleagues.

And the rate of serious bacterial infections was 0.06 per patient-year, which consisted of two cases of bacterial pneumonia, the researchers reported in a poster session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Conventional therapy for conditions such as common variable immunodeficiency or X-linked agammaglobulinema has been monthly infusions of intravenous immune globulin.

The treatment is needed lifelong to prevent patients from recurrent bacterial infections and chronic pulmonary disease.

In a previous shorter-term study (52 weeks), the subcutaneous route of delivery was associated with fewer systemic adverse events than the intravenous formulation.

"The weekly subcutaneous treatment leads to stable serum IgG levels, and smooths out the peaks and troughs," Nelson told MedPage Today during a poster session.

To assess longer-term outcomes, he and his colleagues followed 21 patients from four U.S. centers from 11 to 104 weeks. Most patients were white women, and their mean age was 42.

Patients who had lymphoid malignancies, hypoalbuminemia, and proteinuria were excluded from the study.

Maximum infusion rates were 35 mL/h (one pump) or 70 mL/h (two pumps) with the maximum volume being 40 mL/site (≤4 sites/infusion). Premedication was not given.

]Most infusion were given at home and self-administered. The median duration of treatment was 87 weeks.

Five patients withdrew but only one because of an adverse event, which was thyroid cancer unrelated to treatment.

Adverse event and local reaction rates were similar among subjects infused at low (<35 mL/h), medium (35-50 mL/h), and high (>50-70 mL/h) rates.

The most common infections were sinusitis, nasopharyngitis, bronchitis, and upper respiratory tract infections.

The annual rate of school or work days lost because of infection was 4.3 per patient-year, while the rate of hospitalized days was 0.55 per patient-year.

The rate of days on antibiotics for prophylaxis or treatment was 84 per patient-year.

Mean serum IgG levels remained steadily in the range of 11.71 g/L and 12.76 g/L throughout the follow-up period.

Treatment-related adverse events occurring within 72 hours of the infusion included headache, at an incidence of 0.004 events per patient-year, and fatigue, at a rate of 0.005 per patient-year.

Headache tends to occur more frequently with intravenous administration, the investigator said.

No patients experienced oropharyngeal pain or had an increase in creatinine.

Infusion reactions were similar regardless of whether patients had low, medium, or high infusion rates.

The rate of any temporally associated, treatment-related adverse events was 0.013 per patient year, which was "substantially lower" than in a previous study (0.034), despite higher mean infusion rates being used in this longer follow-up trial, Nelson reported.

Patient satisfaction was high, with overall scores on measures of health being close to those reported by healthy individuals, and there was no clinically significant deterioration in health-related quality of life.

Med Page Today

FDA approves breath test to determine bacterial infection in kids Read more:

FDA approves breath test to determine bacterial infection in kids

U.S. health regulators have approved Otsuka America Pharmaceutical's breath test to detect bacterial infection that causes stomach inflammation and ulcer, for use in children aged 3 to 17 years.

A press release from the U.S.Food and Drug Administrationsaid BreathTek UBT was the first breath test to detect Helicobacter pylori bacterial infections in children.

Rockville, Maryland-based Otsuka America, a unit of Japan's Otsuka Holdings Co Ltd, was granted approval to market its breath test for use in adults in 1996.

"Results from this test, when considered with a physician's assessment of thepatient'shistory, other risk factors, and professional guidelines, can quickly indicate infection," the FDA release said.

U.S.Centers for Disease Control and Prevention estimate that about two-thirds of the world's population is infected with Helicobacter pylori, which increases the risk of developing gastric cancer and a type of lymphoma.

Read more: Fox News

Friday, March 2, 2012

Infectious Disease Doctor

Infectious Disease Doctor

Why Do I Need an Infectious Disease Doctor?

Until I acquired lymphoma, the most pressing complication that I experienced with my leg lymphedema was recurrent and severe cellulitiis. It was apparent long ago that we desperately needed a way to control it (try to prevent) and if it did occur to promptly and successfully treat the infection.

The result is that I have been under the care of an ID doctor now for over twenty years.

Because of our susceptibility to infections and because our lymphedema arm or leg is immunocompromised, it is essential that any lymphedema patient with recurrent infections enlist the aide of an “ID” doctor. They are specially trained in infections and are far more qualified to treat them then any other type of doctor.

My ID doc, Dr. Elliott Raizes has been a life saver and a God send in my own battle with lymphedema. Not only does he has that “old fashioned” and rapidly disappearing concern for his patients, but his knowledge of bacterial infections is unbelievable.

How do I Find an Infectious Disease Doctor?

The easiest way is to simply ask or if need be insist on a referral to one in your area from your PCP. They may already know of a good doctor within your community.

You can also find participating ID doctors in your insurance plan through their “Find a Doctor” service or you can locate one through the internet.

What is an Infectious Disease Specialist?

Infectious Disease Specialists are like medical detectives. They examine difficult cases, looking for clues to identify the culprit and solve the problem.

Your ID Physician Has 9-10 Years of Specialized Education & Training

  • 4 years of medical school
  • 3 years training as a doctor of internal medicine
  • 2-3 years specialized training in infectious diseases

Most ID specialists who treat patients also are board certified. They have passed a difficult certification examination by the American Board of Internal Medicine in both internal medicine and infectious diseases.

Reducing the Risk of Infectious Disease

One of the best strategies for preventing infectious diseases is immunization. Make sure you and your children receive all recommended vaccinations.

Ask your doctor for advice about other things you and your family can do to prevent infectious diseases.

When you Need an ID Specialist

Many common infections can be treated by your personal physician. Your doctor might refer you to an ID specialist in cases where an infection is difficult to diagnose, is accompanied by a high fever, or does not respond to treatment. ID specialists also see healthy people who plan to travel to foreign countries or locations where infection risk is higher. In these cases, ID specialists can help determine whether special immunizations or other preventive measures are necessary to protect travelers from disease.

Typical Procedures

ID specialists review your medical data, including X-rays and laboratory reports such as blood work and culture data. They also may perform a physical exam to help determine the cause of the problem.


D specialists often order laboratory tests to examine samples of blood or other body fluids or cultures from wounds. A blood serum analysis can help the ID specialist detect antibodies that indicate what type of infection you have. These advanced tests can further explain the results of earlier tests, helping to pinpoint the problem.


Treatments consist of medicines—usually antibiotics—to help battle the infection and prevent it from returning. These medicines may be given to you orally (in the form of pills or liquids) or administered directly into your veins, via an IV tube. Many ID specialists have IV antibiotic therapy available in their offices, which decreases the likelihood that you will need to be hospitalized.

What Information Should You Give to Your ID Specialist?

  • All medical records related to your condition

X-rays, laboratory reports and immunization records. Often your personal physician will forward this information to the specialist before your scheduled appointment.

  • A list of all medications you take

This list should include over-the-counter and prescription medications

  • A list of any allergies you have.
  • Let the ID specialist know if you are taking birth control pills.

Some antibiotics may interfere with the effectiveness of oral contraceptives.

How Does My ID Specialist Work With Other Medical Professionals?

The ID specialist works with your personal physician to determine which diagnostic tests are appropriate. If treatment is necessary, your doctor and the ID specialist will work together to develop a treatment plan best suited to your needs. Often you will be asked to return to the ID specialist for a follow-up visit. This allows the specialist to check on your progress, confirm that the infection is gone and help prevent it from coming back. If you acquire an infection while in the hospital, the ID specialist will work with other hospital physicians to help direct your care. The specialist also might provide follow-up care after you go home.

If your ID specialist is also your personal physician, he or she will coordinate your care, referring you to other specialists when necessary.

ID Specialists Are Experts in the Diagnosis and Treatment of Illnesses Caused by Microorganisms.

ID specialists see patients to determine whether their symptoms are due to an infection. Patients often see ID specialists due to a fever.

Some ID specialists serve as primary care physicians, for example, for people with HIV/AIDS, treating most illnesses and coordinating their patients’ overall care.

In all of these cases, the specialized training and diagnostic tools of the ID specialist can help determine the cause of your infection and the best approach to treatment.