Dupilumab May Simplify Chronic Spontaneous Urticaria Treatment

In this exclusive MedPage Today video, Thomas B. Casale, MD, of the University of South Florida in Tampa, discusses new analyses from the LIBERTY-CUPID studies evaluating dupilumab (Dupixent) in chronic spontaneous urticaria, which were presented at the American Academy of Allergy, Asthma & Immunology annual meeting.

The results suggest dupilumab may offer consistent benefit across patient subgroups without the need for extensive stratification.

Following is a transcript of his remarks:

So, up until the approval of omalizumab [Xolair], the anti-IgE [immunoglobulin E] monoclonal antibody for patients who had antihistamine resistant chronic spontaneous urticaria, there really hasn’t been much progress, but over the last year, we’ve had two new approvals for treatments for that same population. And one is dupilumab, the anti-IL [interleukin]-4 alpha monoclonal antibody.

So, it blocks the signaling for both IL-4 and IL-13, two critical cytokines for the pathogenesis of urticaria. In this particular study, we looked at whether the effects of dupilumab were altered based on several factors for the patients — that is, whether they were old or younger, male or female, BMI [body mass index], and whether they had angioedema or not.

So, basically what we found is that the response to dupilumab — the improvement noted with dupilumab — was the same whether the patients were older or younger than 65 years of age, and that was assessed by the itch severity score as well as the urticaria activity score. It didn’t matter whether the patient was male or female; again, the responses were similar. We do know, however, that the prevalence of chronic spontaneous urticaria tends to be higher in females than males.

And we also looked at BMI — so, whether they were lean with a BMI less than 25, overweight (so, between 25 and 30), or in the obese category (greater than 30). And again, dupilumab performed equally well, improving the itch and urticaria activity scores, regardless of those factors.

And then finally, for this particular study, we also looked at the presence of angioedema. We know that patients who have angioedema accompanying urticaria tend to have a more severe course and the duration of disease might be a little bit longer, and this occurs in about 40% of patients with chronic spontaneous urticaria. So, we looked at the two groups and again, found no difference in the effectiveness of dupilumab in those two groups — that is, whether patients had or did not have angioedema.

Now, the other thing that we looked at in a different abstract — it was the same study — but looking at patients who had low and high IgE levels. And the reason that was done is because the anti-IgE monoclonal antibody, omalizumab, has been shown in some studies that the effectiveness might be a little less in patients who have low IgE levels, and the onset of action appears to be somewhat delayed in those patients who have low IgE levels.

So, we looked at a couple of categories as we examined patients who had IgE levels less than or greater than 50, and less than or greater than approximately 100, and what we found again is that there was no difference in the responsiveness.

So, regardless of whether the IgE was low (less than 50), or high (greater than 100), it didn’t affect the ability of dupilumab to have a positive clinical response.