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CHRONIC SPONTANEOUS URTICARIA: Worldwide AWARE study shows serious undertreatment.

GENEVA -- 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.

"This is not a swollen lip just once a year, this is angioedema weekly or monthly that really impairs quality of life. It's not just a swollen lip or a swollen eye for the day or for a couple of hours, it's the fear of going to sleep because in the morning you may wake up looking like that and not be able to go to work."

He presented year-1 results from 1,550 participants at 256 sites across Germany participating in the AWARE study (A Worldwide Antihistamine-Refractory Chronic Urticaria Patient Evaluation). AWARE is a 36-country, ongoing, 2-year, prospective, observational study sponsored by the manufacturer of a CSU therapy. It's the first-ever study designed to assess CSU in daily clinical practicc rather than in specialized centers.

At enrollment, the German participants 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 Urticaria Contro' Test (UCT) (J Allergy Clin Immunol. 2014 May; 133[5]: 1365-72). Nearly half, 44%, had experienced angioedema within the previous 6 months, and 56% 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, documenting a low level of adherence to published treatment guidelines.

When Dr. Maurer 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's use this test. Patients can fill it out quickly in your waiting room so you can monitor how good your treatment is."

In addition to routinely using a simple validated assessment tool such as the patient-reported UCT to determine a CSU patient's burden of disease, Dr. Maurer summarized the treatment guideline algorithm as follows: Prescribe second-generation, nonsedating [H.sub.1] 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 CSU 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.

In AWARE, patients had office visits every 3 months. Over the course of a year, using the treatment guideline algorithm, the proportion of patients on third-line treatment rose to 29.5%. DLQI scores indicative of a moderate or worse quality of life fell from 56% to 28%. The rate of uncontrolled CSU as defined by a UCT score below 12 dropped to 42%. At 1 year, only 16% of patients reported having an angioedema episode within the prior 12 weeks.

While the results trend well, they still leave much room for improvement, Dr. Maurer commented.

"We're on the right track, but patients who are in our treatment for a year should have their disease controlled," he said. "We have the treatments, and we should provide them. Even after 1 year, there are still patients with a DLQI score above 10, and that's not good."

In 98% of patients, control in CSU can be established, using the guideline algorithm, he said. "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."

Dr. Maurer 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 was first author of the recently published interim results of the German portion of the AWARE study (Clin Exp Allergy. 2017 May; 47[5]:684-52). The study is sponsored by Novartis, manufacturer of omalizumab, approved by the Food and Drug Administration for treating CSU. Dr. Maurer reported receiving research grants from and serving as an adviser to and paid speaker for Novartis and numerous other pharmaceutical companies.

Urticaria control test

1. How much have you suffered from the physical symptoms of the urticaria (itch, hives)?

2. How much was your quality of life affected by the urticaria in the last 4 weeks?

3. How often was the treatment for your urticaria in the last 4 weeks not enough to control your urticaria symptoms?

4. Overall, how well have you had your urticaria under control in the last 4 weeks?



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Caption: Dr. Maurer
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Author:Jancin, Bruce
Publication:Dermatology News
Date:Feb 1, 2018
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