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Huge AWARE study shows chronic spontaneous urticaria is seriously undertreated



– Partial results of the first worldwide observational study on the burden of chronic spontaneous urticaria (CSU) and its treatment in real-world clinical practice can be summarized succinctly: “It’s worse than we thought,” Marcus Maurer, MD, said at the annual congress of the European Academy of Dermatology and Venereology.

“We knew it was bad, but what comes out of looking at the daily life and treatment patterns in patients with CSU is a nightmare,” said Dr. Maurer, professor of dermatology and allergy and director of research in the department of dermatology at Charite University Hospital in Berlin.

Dr. Marcus Maurer professor of dermatology and allergy and director of research in the department of dermatology at Charite University Hospital in Berlin. Bruce Jancin/Frontline Medical News

Dr. Marcus Maurer

He presented partial interim results of the AWARE study (A Worldwide Antihistamine-Refractory Chronic Urticaria Patient Evaluation), a large, ongoing, 2-year, prospective, observational study underway in 36 countries, sponsored by the manufacturer of a CSU therapy. It’s the first-ever study designed to assess CSU in daily clinical practice rather than in specialized centers.

Dr. Maurer presented the year-1 results in 1,550 AWARE participants at 256 sites across Germany. The results, he said, are sobering and reflective of what is being found in the other participating countries. The findings document a low level of adherence to the published treatment guidelines, and a lot of miserable CSU patients.

“My talk here is a clear call to action,” he declared. “The AWARE study shows we have two problems. One, patients don’t get treatment – and we can solve that. And number two, patients don’t get the right treatment. And the right treatment is treatment that controls the disease. In the guidelines we say, ‘Treat the disease until it is gone.’ That’s a great sentence. It means we should give enough treatment to control the disease: as much as needed, as little as possible, and in that order. First we establish control, then we have all the time in the world to find a treatment that gets patients to stay that way in the long run.”

He is a coauthor of the guidelines, a joint initiative of the European Academy of Allergy and Clinical Immunology, the EU-funded Global Allergy and Asthma European Network of centers of excellence, the European Dermatology Forum, and the World Allergy Organization (Allergy. 2014 Jul;69[7]:868-87).

He asked a packed hall of dermatologists how many of them like taking care of patients with CSU. One lonely hand went up. Dr. Maurer was unsurprised.

CSU is a common problem. It’s a big inflammatory disease with a huge impact on patients, and it’s one where we struggle. No question, we struggle with these patients, maybe more so than with our psoriasis and atopic dermatitis patients. But the good news is there are new concepts of this disease and new treatment approaches,” he said. “We know that in 98% of patients, using the guideline algorithm, we can establish control in CSU.”

He summarized the joint guideline algorithm as follows: Routinely use a simple validated assessment tool such as the patient-reported Urticaria Control Test (UCT) (J Allergy Clin Immunol. 2014 May;133[5]:1365-72) to determine a CSU patient’s burden of disease, prescribe second-generation, nonsedating H1 antihistamines as first-line therapy, updose those agents to up to four times standard dosing as second-line therapy if the follow-up UCT results show the disease is still uncontrolled, and if it remains uncontrolled then move on to third-line treatment with add-on omalizumab (Xolair) or a maximum of 10 days of montelukast (Singulair) or cyclosporine.

When he asked how many audience members use the UCT, which assesses disease control over the previous 4 weeks, a mere handful responded affirmatively. “Please,” he urged his colleagues, “this test is so simple. It’s four questions, it’s free, it’s available online in more than 30 languages. It allows us to identify patients with uncontrolled disease. We have the ability to control the disease now, so let use this test. Patients can fill it out quickly in your waiting room so you can monitor how good your treatment is.”

AWARE study bears bad news

At study enrollment, the 1,550 German participants in the AWARE study had been diagnosed with CSU a mean of 4.9 years previously. Yet fully 78% had uncontrolled CSU as defined by a score below 12 points on the 0-16 UCT. Forty-four percent of patients had experienced angioedema within the previous 6 months, and 56% percent of patients had a baseline Dermatology Life Quality Index (DLQI) score indicating CSU had a moderate, very large, or extremely large effect on their quality of life. Yet 36% of patients weren’t receiving any treatment at baseline, and only 6.5% of patients were receiving guideline-recommended add-on third-line therapy.

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