FDA Approves New Treatment for Chronic Hives
Patient Joe LaMariana: life-changing results
The FDA has approved omalizumab, known by the brand name Xolair, for use in treating chronic idiopathic urticaria, also known as chronic hives.
Results from the drug’s clinical trials in patients over the age of 12 were “the best we’ve seen with any drug trial in this disease ever done,” says Dr. Allen Kaplan, trial investigator and professor of medicine at Medical University of South Carolina. “It’s a tremendous step forward for the people who have this disorder.”
Unlike typical allergic hives, which appear following allergen exposure to the skin, chronic idiopathic urticaria seem to have no external trigger. They also persist for more than six weeks, resulting in a huge impact on quality of life. Since only half of patients find adequate relief with antihistamines, the emergence of Xolair as an injectable treatment option is an important development.
In the omalizumab trials, 65 to 70 percent of patients responded to the treatment. Between 40 and 45 percent of these individuals saw their condition more or less disappear. “Those people feel almost like, as long as they get their shot, that they’ve been cured,” said Dr. Kaplan, who notes that the remainder also saw significant symptom reduction.
“It certainly has been a godsend for me,” says Joe LaMariana, who had chronic hives for more than a decade before becoming part of the trial. Aside from constant itching and hives all over his body, LaMariana would experience seemingly random and severe swelling of his hands, arms, feet and knees.
One time, he returned home after an especially uncomfortable flight, and decided to have a shower to get relief from the itching. What he discovered was shocking. “Literally from the back of my heels to the back of my neck was one giant welt,” says LaMariana. “It was grotesque.”
Things turned scary when the condition actually caused LaMariana to go partially blind for nine days in 2007. Doctors later concluded the amount of swelling he experienced had “choked” his optic nerves, making it impossible for his eyes to properly send information to the brain.
Once on Xolair, he saw a dramatic turnaround. “The relief came almost immediately, literally within a couple of days things started tapering down,” he says. “It’s definitely a very, very strong quality of life improvement.
“I know I sound like I work for them – I don’t. This is completely from the heart.” LaMariana wants to spread the word about omalizumab treatment to others suffering with chronic hives.
Xolair injections have been in use for a few years to help control severe allergic asthma, and the drug is now being investigated in trials for food allergy treatment, potentially to work alongside oral immunotherapy.
Omalizumab binds to freely circulating IgE antibodies (the antibodies associated with allergies) in the bloodstream. This prevents the IgE antibodies from binding to mast cells, neutralizing the ability to set off allergic symptoms. Since it only works on freely circulating IgE, omalizumab could not bind the IgE that is already attached to mast cells. In theory, this would mean reactions could still occur.
“But, what is happening – and this is an area of ongoing research now – is those cells, when you drop the blood IgE level, behave as if they’ve been desensitized,” said Dr. Kaplan. “What regulates that as a direct consequence of dropping the freely circulating IgE is what is being worked on now – that’s where we’re at at the moment.”