Roche drug cuts asthma attacks, improves lung function -study

"Biological therapies" are the new frontier in asthma treatment, especially for patients with more severe disease. These antibody based medications provide a more targeted  strategy in asthma treatment compared to conventional asthma medications.  Dr. Susarla

Roche drug cuts asthma attacks, improves lung function -study

(Reuters) - An experimental drug reduced asthma attacks in patients with severe uncontrolled asthma by 60 percent and helped improve lung function in certain patients, indicating that the drug could offer the first personalized approach to treatment, according to data from a clinical trial released on Tuesday.

The biotech drug lebrikizumab, which was developed by Roche Holding's Genentech unit, was tested at three doses in patients whose asthma was not sufficiently controlled even with high-dose, inhaled corticosteroids and a second asthma-controlling therapy.

In the 463-patient Phase IIb study, lebrikizumab reduced asthma attacks by a statistically significant 60 percent more than a placebo in patients found to have a high level of the protein periostin, according to pooled data from the three doses tested - 37.5 milligrams, 125 mg and 250 mg. That compared with a 5 percent reduction versus placebo over 28 to 52 weeks of treatment in those with low levels of periostin.

"If this drug gets approved we would have for the first time a personalized approach other than just blanket therapy for everyone with uncontrolled disease," Dr Nicola Hanania, one of the study's lead investigators, said in a telephone interview.

Lebrikizumab works by blocking interleukin-13, or IL-13, which contributes to airway inflammation and mucous production. Periostin is believed to be a biomarker for IL-13 activity and a likely predictor of how well the Roche drug will work.

Roche is also developing a blood test for periostin in order to identify the patients most likely to benefit from lebrikizumab, which is injected once every four weeks.

Hanania, who is director of the Asthma Clinical Research Center at Baylor College of Medicine in Houston, called the data from the study "very exciting."

In those with severe asthma receiving existing treatments, "we still see patients who still have symptoms, who still have exacerbations, hospital admissions, and this is the type of patient this study was targeting," he said.

Curiously, the greatest level of asthma attack reduction, at 81 percent, was seen with the lowest dose of lebrikizumab, something that Hanania called surprising. Hanania, who presented the data at the American Academy of Allergy, Asthma and Immunology (AAAAI) meeting in San Diego, noted, "Higher is not always the better."

Fifteen percent of the estimated 25 million Americans with asthma suffer from severe asthma, according to the National Institutes of Health. About half of severe asthmatics are believed to have high periostin levels.

Among patients with high level periostin, the drug improved lung function by 9.1 percent after 12 weeks, compared with an improvement of just 2.6 percent in the low periostin group.

Lung function was tested by change in FEV1, a measure of the maximum amount of air that can be forcibly exhaled in one second. The greatest improvement in FEV1, of 10.7 percent, was seen with the 125 mg dose of lebrikizumab.

"Statistically it's significant, and I believe it is clinically significant because it goes hand in hand with reduction in exacerbations," Hanania said of the lung function improvement seen in the high periostin group.

The incidence of serious adverse side effects was low and similar in the lebrikizumab and placebo arms of the study, researchers said.

"The safety profile was very reassuring. Nothing really stood out as major side effect or major serious adverse effect," Hanania said.

If the results are replicated in large, ongoing Phase III trials that will include more than 2,000 patients, Roche said it expects to seek approval for the drug in 2016.

"As a clinician, this is important because there is a great need for additional therapy for those with poorly controlled asthma," Hanania said. "It's a light at the end of the tunnel."

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Education is the Key to Better Asthma Management

It takes time to educate patients and parents about managing asthma.  The right asthma specialist can condense volumes of evidenced based literature and practice guidelines into  more easily understandable pearls that can be practical in our busy lives.  Dr. Susarla

What Are Some Strategies to Enhance Asthma Education in My Practice?

Primary-care offices are typically very busy places. As a result, the educational needs of parents and children with asthma often go unmet.¹Lack of time is a common reason reported for not providing asthma education in the primary-care setting.² However, providing asthma care consistent with the National Asthma Education and Prevention ProgramExpert Panel Report 3 (NAEPP EPR-3) Guidelines for the Diagnosis and Management of Asthma, which includes self-management education, does not have to be time consuming. One study evaluated the effects on patients 2 years after pediatricians were taught by their peers to enhance their skills in asthma therapies and counseling. This study found that pediatricians who participated in the training benefited in important ways. Trained physicians received higher patient-rated performance scores regarding communication behaviors important to promoting patient’s satisfaction and ability to manage asthma on their own, and in addition, their patients were also less likely to incur disruption of sleep caused by asthma symptoms. Another important finding of this study was that these positive results were achieved even though there was no difference in the time that peer-trained physicians spent with their asthma patients when first diagnosing a patient, seeing a new patient, or seeing a return patient. In fact, the peer-trained physicians spent less time with patients during urgent visits.³ Such a method for enhancing education in your practice requires changing physician behavior.

System-level changes have also been evaluated. In one such study, researchers evaluated the effectiveness of 2 asthma-care improvement strategies in the primary-care setting. One was less time consuming and less expensive and consisted of peer leader education. The other was more intensive and more expensive and consisted of allocating a nurse to conduct planned asthma-care visits. This group also received peer education. Findings revealed that, although both strategies decreased asthma symptom days, the peer leader group did not reach statistical significance.⁴ Therefore, when attempting to enhance educational practices in your office, it may be more effective to institute changes that target systems-oriented improvements, for example, developing a system that ensures all patients with asthma receive a written asthma action plan as per NAEPP EPR-3 Guidelines. One way to accomplish this is to automate the process by using an electronic medical record system. Such an approach makes it easy for the provider, legible for the patient and family, and a permanent part of the medical record. If instituting an electronic medical record is not feasible in your practice, having asthma action plans that are preprinted with medication names allowing you to check off or circle the treatment prescribed or having asthma action plans with a preprinted short-acting beta-agonist so that you only need to write the long-term control medications are 2 time-saving options. Creative shortcuts can also be useful. For example, color-coded labels for long-term control and quick-relief medications can be preprinted and then added to the action plan at the end of the visit. An example of such a plan can be found in Figure 39-1. All action plans described allow for individualization in an efficient manner.

Figure 39-1.Sample written asthma action plan with preprinted labels. 

Having written asthma action plans is only one step in the process for enhancing education in your office; using them is an even more important step. To encourage use of the action plans in your office, it is important to keep them readily available. Some suggestions include keeping the asthma action plans in each exam room so that they are easily accessible during each patient visit or having them clipped to the front of each asthma patient’s chart before the visit begins.

Another method for enhancing education in your practice is to make resources available to your patients and to view each opportunity as a teachable moment. For example, providing patients and families with internet opportunities (such as the Quest for the Code asthma game found at www.asthma.starlight.org) for self-education while they are sitting in the waiting room or providing them with a list of resources (Table 39-1) that they can access at their convenience allows them to learn at their own pace. However, it is extremely vital to recognize that merely providing patients and families educational materials without providing explanation is not true education. All educational materials and resources provided to patients must be reviewed and reinforced by all members of your health care team. One way to accomplish this is to develop asthma-specific visit forms that include a list of key educational messages. This list can be used to prompt providers to introduce or review a message or messages at each visit. Thus, providing consistent and repeated educational messages by all members of your health care team is another step to enhancing education in your practice.

 

An alternative or supplementary method for providing self-management education and addressing key educational messages is to offer asthma education classes and resources in your office. Asthma education classes allow you to personally review important self-management concepts in a group setting, thus promoting efficiency as well as education. Numerous examples and forms (print, audio-video, online) of asthma educational resources are available that can also be tailored to meet the needs of an individual practice.

Two final recommendations for enhancing education in your practice include hiring a nationally certified asthma educator to provide education during patient visits as well as via telephone in between visits, and developing a system for referring patients who need additional education to asthma specialists. Both of these strategies are supported by the NAEPP EPR-3 Guidelines. The Guidelines recommend using health professionals and others trained in asthma self-management education to implement and teach asthma self-management. They also recommend referring patients who need additional education to improve adherence to asthma specialists.⁵National certification for asthma educators has been available since 2002; thus, it is relatively new, and the effectiveness of education provided by certified asthma educators has not been reported. However, numerous randomized controlled studies have reported improved asthma outcomes when patients and families were educated by someone specially trained in asthma care and self-management.⁶

Summary

There are many options for enhancing education in your practice; some are more labor-intensive and costly than others. Developing a system that fits within the confines of your practice makes quality asthma education accessible to all of your patients with asthma and their families, and using all members of your health care team is the best approach to enhancing asthma education in your practice.

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Why might this be? Children with allergies and asthma are known to have elevated risk of sleep disturbance, which could manifest with snoring in those with allergies, increased cough and respiratory symptoms during sleep for poorly controlled asthma. And finally, poor sleep quality can lead to symptoms of ADHD. Dr. Susarla

Children With Allergy, Asthma May Be at Higher Risk for ADHD

 The number of children being diagnosed with attention-deficit disorder (ADHD), allergy and asthma is increasing in the United States. And according to a new study, there might be a link between the growth of these three conditions.

The study, published in the August issue of Annals of Allergy, Asthma & Immunology, the scientific journal of the American College of Allergy, Asthma and Immunology (ACAAI), found there is an increased risk of ADHD in boys that have a history of allergy or asthma.

"ADHD, a chronic mental health disorder, is most commonly found in males, while asthma is also more common in young boys than girls," said Eelko Hak, lead study author. "We found there is an increased risk of ADHD in boys with a history of asthma and an even stronger risk associated with milk intolerance."

Researchers in the Netherlands and Boston studied 884 boys with ADHD and 3,536 boys without the disorder. Of the children with ADHD, 34 percent had asthma and 35 percent had an allergic disorder. The study suggests medications used to treat these conditions may be associated with an increased ADHD risk.

"Further research is needed to understand why there appears to be an increased risk of developing ADHD in children with allergy and asthma," said Gailen Marshall, MD, editor-in-chief of Annals of Allergy, Asthma & Immunology. "Medications for these conditions far outweigh the risks, and can be life-saving in some conditions. Treatment should not be stopped, unless advised by a board-certified allergist."

According to the ACAAI, allergy and asthma often run in families. If both parents have an allergy a child has a 75 percent chance of being allergic. If neither parent has allergy, the chance of a child developing an allergy is only 10 to 15 percent. Allergists also know allergies and asthma are linked. An estimated 60 to 80 percent of children with asthma also have an allergy. While the cause of ADHD is unknown, this disorder is also thought to run in families
.

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Dealing with a new asthma diagnosis

A move to the gulf coast followed by new respiratory symptoms is a common theme in my practice.  Getting proactive by consulting a pediatric pulmonologist can make coping with a new asthma diagnosis a lot easier.  Dr. Susarla

Asthma arrives with move to Florida

My son did not win a perfect attendance award at school last year.

Instead, he set a personal record for the most days spent at the pediatrician's office.

Since moving from Colorado to Florida six months ago, my 7-year-old son, Ryan, developed asthma. He did not have allergies or any respiratory problems before we moved, but once we got to Florida, everything changed.

I noticed that he was constantly sneezing and sniffling, and his eyes were red and itchy, especially after being outside. These symptoms were manageable with the help of an over-the-counter antihistamine, but it was the cough that was troublesome.

Every few weeks, Ryan would start coughing and it would get so bad that and we'd end up at the pediatrician's office. At first, the doctor prescribed an oral steroid to alleviate the symptoms. This worked, but eventually the cough came back. After several more trips to the pediatrician's office due to severe coughing and wheezing, she determined that Ryan had asthma, or a reactive airway.

Ryan's body was reacting to something it perceived as harmful, and the airways of his lungs became inflamed and constricted. Since Ryan grew up in Colorado, he had never been exposed to certain allergy triggers that are common in Florida.

Working with Ryan's doctor, we came up with an asthma plan. He now has two prescribed inhalers to help control his asthma. He uses one inhaler on a daily basis to prevent asthma symptoms, and another he uses before playing sports to help his breathing. The doctor also had Ryan allergy tested so we could discover what his allergic triggers were. It turns out that he is highly allergic to mold, oak, and certain grasses, all things which are not common in Colorado.

In doing research, I found one website that was particularly helpful and has a lot of great information, asthma.com. It has a "For Parents" tab that discusses triggers and how to minimize exposure, and even a guideline for when your child should stay home from school due to symptoms.

Since Ryan is 7, he's old enough to understand and learn about his condition, so I found two websites that have informative and interactive games for him to play. Ryan likes watching Arthur, and pbskids.org has the Buster Baxter, Lung Defender game. There is also lungtropolis.com, which has a game for kids and a separate, informative section for parents.

Finding out that your child has asthma can be scary, but working with your doctor and arming yourself with information can help ease that anxiety. My goal is that Ryan won't have to miss any school because of his asthma, and he can win a perfect attendance award this year.

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Health Tip: Does Asthma Affect Your Sleep?

Take medications as your doctor prescribes

By Diana Kohnle

Friday, January 25, 2013

(HealthDay News) -- Asthma can affect your sleep, as symptoms often worsen at night.

The National Sleep Foundation offers this advice to help control asthma and enjoy a better night's sleep:

• Take all medications as prescribed, at the same time each day.
• Use a peak flow meter regularly to monitor changes in lung function.
• Learn what your asthma triggers are, and take steps to avoid those triggers.
• Get plenty of sleep each night.
• Ask your doctor about the potential benefits of an anti-inflammatory medication.

HealthDay