August 09, 2017
By Joan Stephenson
NEW YORK (Reuters Health) - The recombinant anti-immunoglobulin E (IgE) monoclonal antibody omalizumab has “substantial benefits” in treating various forms of chronic inducible urticaria (CIndU), according to a new systematic review.
“Omalizumab has been used as treatment for almost all forms of chronic inducible urticaria, and patients with CIndU appear to benefit quite a lot, with high responder rates,” lead author Dr. Marcus Maurer, of Charite - Universitatsmedizin Berlin, Germany, told Reuters Health by email.
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The findings suggest “that omalizumab can be an effective treatment for CIndU patients who do not respond to standard treatment and that omalizumab should be used in these patients,” he said.
Omalizumab received approval from the U.S. Food and Drug Administration in 2014 for treatment of chronic idiopathic or spontaneous urticaria for patients 12 years or older whose symptoms don’t resolve with H1-antihistamine therapy.
However, the drug is not licensed for treatment of CIndUs, which include several subtypes, including solar urticaria, cold urticaria, symptomatic dermographism and others, each triggered by external factors corresponding to the subtype.
“Treatment options for chronic inducible urticaria include antihistamines at standard or higher-than-standard doses, but many CIndU patients do not experience complete protection with antihistamine treatment,” Dr. Maurer said.
Dr. Maurer and his coauthors note that some research groups have recommended use of the drug to treat patients with a CIndU who had inadequate symptom control with conventional therapies.
They searched the published literature to examine the existing evidence for the efficacy and safety of omalizumab in treating various subtypes of CIndU, identifying three small phase 2 studies (including a randomized trial of the drug vs. placebo in patients with symptomatic dermographism and another in patients with cold urticaria), as well as an additional 40 case series, case studies and retrospective analyses.
The best evidence indicating a benefit from omalizumab was for symptomatic dermographism (the most common CIndU, studied in 72 patients), cold urticaria (the second most common, studied in 63 cases), and solar urticaria (studied in 36 cases), the researchers report in the Journal of Allergy and Clinical Immunology, online July 24.
“Variation of omalizumab use was seen between the CIndU subtypes, with the most thorough evidence available in cold urticaria (complete/partial response in 41 out of 51 patients), symptomatic dermographism (complete/partial response in 38 out of 54), and solar urticaria (complete/partial response in 28 out of 36 patients), with the level of complete responders observed in cold urticaria patients comparable to the efficacy reported from clinical trials with (chronic spontaneous urticaria),” the researchers noted.
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They found little or no evidence regarding omalizumab and vibratory angioedema, aquagenic urticaria, or contact urticaria.
“There are some CIndUs for which we have no published reports of the use of omalizumab, and physicians who have used omalizumab in these diseases are encouraged to publish their findings,” Dr. Maurer said.
The review “supports the rapid onset of action” of omalizumab in CIndUs that has been demonstrated in clinical trials of the drug for chronic urticaria. However, the researchers note, patients differ in their time to response and “future characterization of predictive factors may lead to better prognosis and treatment of distinct patient groups.”
Adverse events were infrequent overall and rarely led to discontinuing treatment. An urticaria registry (http://www.urticaria-registry.com/) has been set up to prospectively monitor adverse events in chronic urticaria patients and should also provide useful data on efficacy of treatments, the researchers said.
“This summary of the literature could lead to an off-label indication for administration of omalizumab as a way to help patients who suffer from chronic inducible urticaria,” Dr. Paul Greenberger, an allergy and immunology specialist at Northwestern University’s Feinberg School of Medicine, told Reuters Health by email.
He noted that CIndU may coexist with spontaneous urticaria, and when it does, a remission of chronic spontaneous urticaria is less likely.
Some insurance companies will not pay for omalizumab for chronic urticaria if the patient has concomitant chronic spontaneous urticaria and inducible urticaria, said Dr. Greenberger, who was not involved with the systematic review.
Antihistamines and other treatments have not been sufficient to calm the activated mast cells triggered by cold air or water in patients with severe cold urticaria, he said. These patients experience facial swelling and itching when the temperature drops to 40 degrees Fahrenheit (4.4 degrees Celsius).
“Although omalizumab is expensive, so is the suffering, missed work, and reduced quality of life that people experience,” he said.
Omalizumab is “quite safe” and the report doesn’t identify any new safety concerns, Dr. Greenberger said. “Nevertheless, many physicians and health care professionals aren’t familiar with inducible urticarias and would need education to identify potential patients for treatment.”
The study authors reported financial relationships with a number of pharmaceutical companies, including Novartis, the manufacturer of omalizumab.
J Allergy Clin Immunol 2017.
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