Mogalizumab—the World's First Innovative Asthma Targeted Drug to Treat Desensitized Food Allergies

In a double-blind, randomized, controlled phase II trial, the asthma-targeting drug mogalizumab combined with oral immunotherapy can increase the speed, efficacy, and safety of desensitization treatment for children with multiple food allergies.

About 30% of people with allergies are allergic to a variety of foods, increasing the risk of fatal foods. Oral immunotherapy involves taking small amounts of allergen protein daily and gradually increasing the dose to achieve tolerance. There have been many reports on the efficacy of oral immunotherapy in patients with a single food allergy. But because this technology can cause allergic reactions, it is riskier to use in people who are allergic to multiple foods.

Studies have shown that omalimumab can improve this situation. Omarizumab is a humanized monoclonal antibody that targets IgE, prevents IgE from binding to the IgE receptor (FcεRI), reduces the circulating amount of IgE, and inhibits allergic responses.

Clinical research

The study was conducted in 48 children between the ages of 4 and 15 who are allergic to multiple foods. Researchers randomly divided participants into two groups: the injection of mogalizumab (36 children) and the placebo (12 children) for 16 weeks. After 8 weeks, all children started oral immunotherapy with 2-5 allergen protein-containing foods, and the allergen protein dose increased with time and maintained at 2 g. After discontinuing mogalizumab or placebo, all children continued to receive oral immunotherapy for 20 weeks, and at week 36, 83% of children in the injection group could tolerate 2 grams of allergen protein compared to placebo 33%. Compared to the placebo group, the injection group was 10 times more likely to obtain tolerance. Children who tolerate 2 grams of allergenic protein can also tolerate 4 grams, or an average level (about 1 tablespoon of peanut butter). According to the authors, this finding is noteworthy, as achieving average levels is important for nutritional intake and quality of life.

Clinical results

Accelerate desensitization and improve the safety of oral immunotherapy

At the same time, mogalizumab also showed accelerated desensitization. Children in the injection group reached a maintenance dose of 2 g in 12 weeks, compared to 20 weeks in children taking a placebo.

In addition, receiving omalimumab improves the safety of oral immunotherapy. The most common adverse reactions at 8 to 16 weeks were gastrointestinal problems, which were more common in the placebo group (54%) than in the injection group (22%). Compared with the placebo group (1%), respiratory adverse reactions were significantly less (0%), and all subjects did not see serious adverse reactions such as anaphylactic shock.

Limitations of the study:

However, Dr. Lars Poulsen from the University of Copenhagen Hospital pointed out the limitations of the study, an important point being that the study was unable to assess whether tolerance persisted over time. In this regard, the author emphasizes that more research is needed in clinical practice.

"While our findings are promising, they are only preliminary and show that children with multiple food allergies can one day safely use this combination of treatments to cope with multiple food allergies." The study ’s first author, from Stanford University, Sharon Chinthrajah said.

Tips

Mogalizumab (solal xolair) is the world's first innovative targeted drug for the treatment of asthma. It was first approved for marketing in Australia in 2002, and subsequently approved by EMA and FDA. It has been approved for marketing in more than 90 countries worldwide. In 2014, the FDA approved the expansion of its indications for chronic idiopathic urticarial (CIU). In August 2017, it was approved by the Chinese CFDA for marketing. It is used to treat adults and adolescents (12 years old and above). After ICS / LABA treatment, they still cannot effectively control the symptoms of moderate to severe persistent allergic asthma. It is the current domestic treatment. The only monoclonal antibody for asthma. You can query the drug crossing database for clinical guidelines, clinical trials, and marketing approval of mogalizumab.