19 November 2018

High hopes for helping with hives

Dermatology General Practice Patients

After years of having little joy in terms of treatment, patients with chronic spontaneous urticaria (CSU) now look set to have a choice of effective therapies available to them.

Results presented at the European Academy of Dermatology meeting in Paris showed that the new biologic completely resolved CSU symptoms in 40% of patients at 12 weeks, while the older generation biologic had this effect in only 26% of patients.

Ligelizumab also had a faster onset of action than omalizumab and the time to relapse after treatment discontinuation was markedly longer with Ligelizumab. 

The placebo-controlled trial involved 382 patients and was designed and sponsored by manufacturer, Novartis.

The new biologic was only available through clinical trials in Australia, Professor Rod Sinclair, a dermatologist at The University of Melbourne, said.

Interested parties could contact Sinclair Dermatology for further information, Professor Sinclair said. “Really, the key thing for GPs is that it’s game on for urticaria. Dermatologists spent years telling GPs, ‘Don’t bother sending us your urticaria patients, we’ve got nothing we can offer’. And now the landscape is totally different,” he said.

Omalizumab used to cost around $300 to $400 per injection out-of-pocket, and some patients with CSU were willing to pay because the constant itchiness was “driving them crazy”, Professor Sinclair said.

Some patients with CSU used to have to take six to seven anti-histamines every day to prevent their symptoms from becoming debilitating, which would cause drowsiness.

Now, omalizumab is PBS-listed for patients with CSU, with a co-payment of just $38, and $5.50 for a pensioner or health care card holder. Only specialists can initiate the omalizumab treatment, but GPs can administer the monthly subcutaneous injections after that.

Patients need to be supervised 30 minutes after every injection in case they have an allergic reaction. Omalizumab typically had an “all or nothing” effect on CSU, Professor Sinclair said.

“So it either works or it doesn’t work,” he said. “And if it does work, it’s total. So basically their urticaria disappears and they don’t need to take antihistamines.”

Where the treatment is effective, patients will be on it for life. “They will gladly have it forever because they’ve got their urticaria forever,” said Professor Sinclair.

“Almost everyone gets urticaria at some stage in their life and for the vast majority, it’s gone within two weeks. Sometimes it takes a little bit longer. But if you still have it at six weeks, you’re going to have it in six years, 16 years, 26 years, you’re going to have it forever.”

While RCTs of omalizumab showed that chronic hives resolve completely in around 26% of patients, a review of real-world use published in JAMA Dermatology this month showed that the benefits of omalizumab vastly exceeded expectations.

The review of 67 studies found that, on average, 72% of CSU patients taking omalizumab saw their symptoms disappear completely to the point where they no longer needed to take anti-histamines.

The review included mostly small studies, which could explain the huge difference in the response rates compared with RCTs.

“Patients included in trials do not always reflect the complexity patients with chronic idiopathic urticaria seen in routine clinical practice,” Professor Christopher Lee, the senior author on the paper and a cardiovascular nurse scientist at the Boston College Connell School of Nursing, said.

Sampling methods and definitions of response varied considerably between RCTs and real-world studies, he said.

“The results of this meta-analysis of real-world studies are meant to complement and extend, but not necessarily mirror, the efficacy data from trials.”

JAMA Dermatology, 14 November