Clinical Briefs

By Louis Kuritzky, MD, Clinical Assistant Professor, University of Florida, Gainesville. Dr. Kuritzky is an advisor for Endo, Kowa, Pricara, and Takeda.

Omalizumab for Asthma in Real Life

Source: Grimaldi-Bensouda L, et al. Does omalizumab make a difference to the real-life treatment of asthma exacerbations?: Results from a large cohort of patients with severe uncontrolled asthma. Chest 2013;143:398-405.

In evidence-based medicine terminology, “efficacy” is the term used to reflect results achieved within a clinical trial, whereas “effectiveness” indicates the results seen in “typical practice settings,” commonly called “real-life settings.” Clinical trials are anticipated to provide results superior to those in practice settings, where patients cannot be so readily de-selected or excluded, where resources may be more limited, and where rigorous regimentation for administration of treatment is less abundant.

Omalizumab (OMA) is not generally regarded as a first-line asthma medication, but rather an appropriate add-on when guideline-based foundation therapies (inhaled steroids, long-acting beta agonists, and leukotriene receptor antagonists) are insufficient to provide control. Although only 30-50% of asthmatics have a prominent underlying allergic component, among difficult-to-control asthmatics, the number may be as high as 80%. Clinical trials indicate that OMA, by blocking IgE, is a useful add-on in such resistant asthma cases. But do “real-life” settings reflect similar benefit?

Grimaldi-Bensouda et al report on refractory asthma patients (n = 767) recruited by more than 100 physicians who prescribed OMA as an add-on treatment. During a follow-up period of almost 2 years, study subjects who received any doses of OMA enjoyed a 43% relative risk reduction in likelihood of hospitalization or emergency department visits for asthma. Subjects on treatment with OMA demonstrated an even greater benefit: 60% relative risk reduction.

In real-life settings, OMA provides substantial improvement in clinically important endpoints for patients with difficult-to-treat asthma.


Tenofovir: New Hope for Hepatitis B Patients

Source: Marcellin P, et al. Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: A 5-year open-label follow-up study. Lancet 2013;381:468-475.

Hepatitis B (HEP-B) is responsible for approximately half of hepatic carcinoma cases worldwide. While HEP-B treatment has been shown to reduce risk for liver failure and hepatic cancer in cirrhosis, whether currently available antiviral therapies actually reverse the underlying disease process is less well studied. Indeed, previous prevailing wisdom had opined that the fibrotic changes of cirrhosis might not be amenable to attempts at regression.

Tenofovir (TFV) is a potent HEP-B polymerase/reverse transcriptase inhibitor. Marcellin et al report on the results of an open-label trial of TFV in patients who had completed a 48-week antiviral treatment with either adefovir or TFV. Subjects were subsequently assigned to once-daily TFV for up to 7 years. Approximately one-fourth of patients had cirrhosis at baseline, and all subjects agreed to follow-up liver biopsy in the fifth year of the trial (240 weeks).

TFV was well tolerated and confirmed to be associated with regression of fibrosis (in the cirrhosis group) and improvement in liver histology (in the non-cirrhosis group) at 240 weeks. This large dataset is very supportive of a role for TFV not just in arresting disease progression, but actually in regression of cirrhosis.


H. pylori: Frequency of Recurrence After Successful Eradication

Source: Morgan DR. Risk of recurrent Helicobacter pylori infection 1 year after initial eradication therapy in 7 Latin American communities. JAMA 2013; 309:578-586.

Worldwide, Helicobacter pylori appears to be responsible for the majority of cases of gastric cancer. A Chinese clinical trial of H. pylori eradication through pharmacotherapy noted an almost 40% reduction in gastric cancer over the subsequent 15-year observation period. Initial eradication of H. pylori provides important risk reduction. Of course, initial treatment is sometimes not effective, and even when initial treatment is effective, there is potential for recurrence.

From a population of study subjects (n = 1091) cleared of H. pylori (confirmed by post-treatment negative urea breath tests), only 125 evidenced recurrence over a 1-year follow-up (11.5%). Factors associated with recurrence included non-adherence to H. pylori treatment regimens and methodology of the treatment regimen (i.e., 14-day triple therapy, sequential therapy, or concomitant therapy, with sequential therapy being most successful). These recurrence rates are typical of low-income countries, whereas recurrence rates are as much as 30% less in high-income countries. Overall, H. pylori treatment is well tolerated, provides important risk reduction for gastric cancer, and is associated with few recurrences that can be managed by appropriate retreatment.