Longer Omalizumab Use Eases Itch From Chronic Hives

Fran Lowry

March 05, 2018

ORLANDO — Improvements in quality of life are better when patients with chronic idiopathic urticaria take omalizumab (Xolair, Genentech/Novartis) for 48 weeks instead of 24 weeks, data from the Xolair Treatment Efficacy of Longer Duration in Chronic Idiopathic Urticaria (XTEND-CIU) study show.

Thomas Casale

This study is one of the largest to look at "the effects of any treatment on patient-reported outcomes, especially the things we think are very important for patients with chronic idiopathic urticaria, such as insomnia, work productivity, anxiety, and quality of life," said investigator Thomas Casale, MD, from the University of South Florida in Tampa.

"Patients with chronic urticaria have severe impairments of these things, and with appropriate treatment, they can get quite a bit better," Casale said during a late-breaking poster session here at the American Academy of Allergy, Asthma and Immunology and World Allergy Organization 2018 Joint Congress.

Chronic urticaria is defined as near-daily symptoms of urticaria for a minimum of 6 weeks. It is estimated that 0.5% to 1.0% of people will develop the condition at some point in their lives. Standard treatment has been high doses of nonsedating antihistamines, but this leaves more than 50% of patients without significant relief, he told Medscape Medical News.

"They still have problems," he explained. "Because of the itchiness and cosmetic issues associated with chronic idiopathic urticaria, many patients are afraid to go out, they don't want to go to work, and they feel anxious about the way they look. The impact on their quality of life is comparable to that experienced by patients with coronary artery disease waiting for bypass surgery. Sleep deprivation is common."

Omalizumab, a monoclonal antibody, is administered subcutaneously once a month for the treatment of moderate to severe persistent allergic asthma and chronic idiopathic urticaria.

The XTEND-CIU study involved 206 participants, 12 years and older, who reported that urticaria was a substantial burden at study entry. Mean 7-day Urticaria Activity Score (UAS7) score at enrolment was 32.2, despite treatment with H₁-antihistamines or H₂-blockers with or without leukotriene-receptor modifiers.

After a 24-week open-label phase, patients deemed to be responders to omalizumab — defined by a UAS7 of 6 or less — were randomized, during the double-blind phase of the trial, to an additional 24 weeks of omalizumab or placebo.

The extended use of omalizumab led to significant improvements in quality of life. With the extra 24 weeks of treatment, scores on the Insomnia Severity Index (ISI) and Work Productivity and Activity Impairment Questionnaire (WPAI) were significantly lower.

Scores on the Generalized Anxiety Disorder 7-item (GAD-7) scale decreased during the 48-week period in all patients, and the mean change in GAD-7 score was not significantly different between the omalizumab and placebo groups during the double-blind period of the study.

Because the data for omalizumab are looking strong, recent guidelines on the treatment of chronic urticaria have placed the agent higher in the treatment paradigm, Casale reported.

Part of the reason for doing these patient-reported outcomes studies is to justify the expense of the agents needed to treat these difficult conditions.

"We can now use it sooner," he said. "But the issue is cost. It's a monoclonal antibody. It's an anti-IgE monoclonal antibody that is given, in this case, 300 mg subcutaneously every 4 weeks."

"Part of the reason for doing these patient-reported outcomes studies is to justify the expense of the agents needed to treat these difficult conditions. You have to show that these patients are really, significantly impaired. If they are missing work or school or things like that, that justifies the higher cost of some of these medications," Casale said.

When you have chronic hives, there is this incessant itching that can drive you to the brink.

This study shows that "longer-term treatment with omalizumab really benefited the patients in a number of independent measures," said Matthew Greenhawt, MD, from Children's Hospital Colorado in Aurora.

Matthew Greenhawt

"When you have chronic hives, there is this incessant itching that can drive you to the brink," Greenhawt told Medscape Medical News. "Think about just being so uncomfortably itchy all the time. These are patients who are not being treated well on standard therapies, and now they go on to this next-generation drug. The base study on omalizumab showed that this really is a miracle worker for this patient population" (N Engl J Med. 2013;368:924-935).

"Consider the Insomnia Severity Index," he said. "You're talking about somebody's sleep being so disrupted that you not only get absenteeism effects from being absent from work, but you also get presenteeism effects, when you're there but you're not there. And when you look at other burdens of illness, like rhinitis, where you are there but you are not being attentive, those things are responsible for millions of dollars of lost productivity.

"Drugs like this are worth the expense because their effects are dramatic and they show improvement on multiple measures. These results are great and justify a longer-term course of therapy," he added.

Mary Beth Fasano

"This particular disease is chronic and really affects patients' overall quality of life," said Mary Beth Fasano, MD, from the University of Iowa in Iowa City.

"As one looks at the cost–benefit of certain treatments, included in that equation should be more than just asking how many hives you get and how long they last, but should assess the quality of life as an important outcome marker with respect to treatments," Fasano added.

This study was funded by Genentech and Novartis. Casale reports that his employer, the University of South Florida, has received grants and consulting fees from Genentech and Novartis. Greenhawt and Fasano have disclosed no relevant financial relationships.

American Academy of Allergy, Asthma and Immunology (AAAAI) and World Allergy Organization (WAO) 2018 Joint Congress: Abstract L20. Presented March 5, 2018.

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