Hope on the Horizon: Expert Insights into Dupilumab for CSU

In a recent interview with Dermatology Times, Jason Hawkes, MD, provided an in-depth look at the potential role of dupilumab (Dupixent; Sanofi and Regeneron Pharmaceuticals) in the management of chronic spontaneous urticaria (CSU), a condition with limited therapeutic options over the past decade. As new clinical data emerges, clinicians may soon find themselves at the forefront of treating this complex inflammatory skin disease.

Dupilumab, already approved for several type 2 inflammatory diseases including atopic dermatitis and asthma, has shown significant promise in recent trials for CSU. “The dupixent clinical trial program had 2 major pivotal trials—CUPID A and CUPID C,” Hawkes explained. “These were studies looking at biologic-naive patients… [who] were not responsive, or had inadequate responses to antihistamines.”

The trials primarily assessed the reduction in patients’ itch severity score and urticaria activity score at week 24. The outcomes were compelling. “We found in those 2 trials… about two-thirds reduction in itch scores and also in their urticaria activity score,” Hawkes stated. “About one-third of patients actually had a complete response where they weren’t having really any itch or hives.”

CSU is often underdiagnosed or misattributed to allergies, a misconception that contributes to delayed or inappropriate treatment. “Both providers and patients have erroneously believed that CSU must have some underlying allergy or trigger,” Hawkes clarified. “CSU, by definition, doesn’t have an outside trigger… it’s driven by the innate or the inherent immune system.”

Historically, dermatologists have not been primary managers of CSU. Hawkes highlighted the significance of expanding their role: “Dermatology specialists are well familiar with [dupilumab]... now they have a familiar therapy for a disease that they know how to recognize but weren’t historically treating.” He emphasized how this could help bridge accessibility gaps: “It can be difficult to find an allergist… by working with allergy, we can expand access with a therapy that’s been tried and true in multiple indications.”

Safety concerns associated with existing biologic treatments like omalizumab, including rare but serious reactions such as anaphylaxis, have also created barriers for some clinicians and patients. In contrast, dupilumab’s safety profile is well established. “Dupixent comes into this landscape… with a very good safety record,” said Hawkes. “It has, in some indications, approval down to even 6 months of age.”

The potential FDA approval of dupilumab for CSU could also stimulate further research and subtyping within the disease. “We’ve uncovered a couple of specific disease mechanisms in CSU, particularly the type 1 immunity, which is IgE-dependent, and the type 2B process, where it’s IgE-independent,” Hawkes explained. “With these different selective therapies, we can start to tease out subgroups within the bigger umbrella of CSU.”

Beyond its targeted efficacy, dupilumab may benefit patients with multiple co-existing conditions. “Some of these patients who come in with CSU also have other type 2-mediated diseases,” he noted. “Here’s a therapy that we may want to start with right from the beginning, because… you may actually get benefit [in] some of these other conditions.”

For Hawkes, the advent of an additional treatment option carries personal and professional significance. “It definitely gives [clinicians] confidence because we have other options,” he said. “We want to have those options for patients so that helps the provider… and it gives [patients] hope that they’re not stuck with this disease.”

As the dermatology community awaits regulatory decisions, the momentum for dupilumab represents not just a new treatment but a potential paradigm shift in how CSU is managed—expanding the roles of dermatologists, improving access, and enhancing patient outcomes with precision-guided care.