Breakout Bulletin: October 4-10

You’re busy. Between patients, prior authorizations, inbox messages, and everything else on your plate, keeping up with the literature is the first thing that slips. Dermatology Times NP/PA Connect is here to make sure it doesn’t. Each week, we pull the most clinically relevant news from across dermatology and bring it straight to your inbox — what’s new, what it means, and what’s worth watching. This week: This week: the first FDA-approved treatment specifically for symptomatic dermographism, a new interchangeable omalizumab biosimilar enters US practice, skin biopsy data reveal biological differences between upadacitinib and dupilumab in atopic dermatitis, and nemolizumab responses hold through 3 years.

Symptomatic Dermographism Finally Has an FDA-Approved Treatment

The FDA approved remibrutinib (Rhapsido; Novartis) for adults with symptomatic dermographism inadequately controlled by H1 antihistamines, making the oral Bruton's tyrosine kinase (BTK) inhibitor the first FDA-approved treatment specifically for the condition. The new indication follows remibrutinib’s previous approval for chronic spontaneous urticaria (CSU).¹

The approval was supported by the phase 3 RemIND study, in which 29.3% of patients receiving remibrutinib achieved complete response from hives at week 12 compared with 14.0% receiving placebo. More than half of patients with symptomatic dermographism remain symptomatic despite H1 antihistamines, according to Novartis. Remibrutinib is now approved for both symptomatic dermographism and CSU in adults whose symptoms remain inadequately controlled with antihistamines.¹

Through week 24, its safety profile was consistent across symptomatic dermographism and CSU studies. The most common adverse events included nasopharyngitis, bleeding, headache, nausea, and abdominal pain, and routine laboratory monitoring is not required.¹

“Now, with a new FDA approved indication for symptomatic dermatographism, it will continue to elevate care for patients with another type of urticarial rash whose treatment has previously been limited to ineffective topical corticosteroids or oral antihistamines.”— Christopher G. Bunick, MD, PhD, editor in chief of Dermatology Times

▶ Why it matters: Symptomatic dermographism has moved from an off-label treatment landscape to one with a dedicated FDA-approved systemic option, giving clinicians a new pathway when antihistamines are not enough.

The First Interchangeable Xolair Biosimilar Is Now Available in the US

Omlyclo (omalizumab-igec; Celltrion), the first FDA-approved interchangeable biosimilar to Xolair (omalizumab), is now commercially available in the US. For dermatology clinicians, its chronic spontaneous urticaria indication covers adults and adolescents aged 12 years and older who remain symptomatic despite H1 antihistamine therapy.²

For CSU, Omlyclo is administered subcutaneously at 150 mg or 300 mg every 4 weeks, with dosing independent of serum IgE level or body weight. The product is available in single-dose prefilled syringes at 75 mg/0.5 mL, 150 mg/mL, and 300 mg/2 mL.²

Its interchangeable designation is an important distinction: under applicable state pharmacy laws, an interchangeable biosimilar may be substituted for its reference biologic at the pharmacy level without first consulting the prescriber. Interchangeability does not mean Omlyclo has superior efficacy or safety to Xolair; both biosimilars and interchangeable biosimilars must meet FDA standards demonstrating no clinically meaningful differences from the reference product.²

Omlyclo carries a boxed warning for anaphylaxis. Treatment should initially be administered in a health care setting equipped to manage anaphylaxis, with self-administration reserved for appropriately selected patients.²

▶ Why it matters: The launch gives practices another way to deliver established anti-IgE therapy for CSU, while making biosimilar interchangeability, coverage, and patient counseling increasingly relevant to day-to-day dermatology practice.

Upadacitinib and Dupilumab May Be Doing More Differently Than Clinical Scores Show

New skin biopsy analyses from the head-to-head Level Up study suggest that upadacitinib (Rinvoq) may produce broader and earlier molecular changes than dupilumab (Dupixent) in moderate-to-severe atopic dermatitis (AD). The findings were presented at the 2026 European Academy of Dermatology and Venereology Congress in Vienna, Austria.³

Researchers evaluated skin biopsies to better understand the biological changes underlying clinical responses to the 2 therapies. Upadacitinib demonstrated effects on inflammatory signaling extending beyond type 2 inflammation. Among patients achieving EASI 75, histologic analyses also showed reductions in epidermal thickening and increased filaggrin staining, suggesting early structural restoration of the epidermal barrier.³

The findings offer a potential biological explanation for differences previously observed between the therapies in clinical outcomes. However, the biopsy analysis is mechanistic and should not by itself be interpreted as establishing that one therapy is appropriate for every patient with moderate-to-severe AD.

“Skin biopsies from the head-to-head Level Up study showed broader effects on inflammatory signals with upadacitinib than with dupilumab, including signals beyond Type 2 inflammation. Histology in EASI75 responders also showed reduced epidermal thickening and increased filaggrin staining, supporting early structural skin barrier restoration.”— Christopher G. Bunick, MD, PhD, associate professor of dermatology at Yale School of Medicine and editor in chief of Dermatology Times

▶ Why it matters: Head-to-head efficacy numbers tell you whether treatments perform differently; biopsy data may begin to explain why. Understanding those mechanistic differences could eventually help clinicians think more precisely about treatment selection and switching in AD.

Nemolizumab’s Skin and Itch Responses Hold Through 3 Years

New long-term data from the ARCADIA extension study suggest that patients with moderate-to-severe AD who respond early to nemolizumab (Nemluvio; Galderma) can maintain substantial improvements in both skin disease and itch through 3 years of treatment.⁴

In a post hoc analysis of patients who achieved a response by week 16, improvements were largely sustained through week 152. At 3 years, 80% achieved EASI 90 and 80% reached an itch-free or nearly itch-free state. The findings add to evidence surrounding IL-31 pathway inhibition, which targets a pathway closely associated with pruritus in AD.⁴

The long-term findings arrive alongside additional phase 2 data in children aged 2 to 11 years with moderate-to-severe AD. In that study, clinically meaningful reductions in skin lesions and itch observed at week 16 were sustained through week 52.⁴

Together, the adult, adolescent, and pediatric findings continue to build the long-term evidence base for nemolizumab, although the pediatric data remain investigational.

▶ Why it matters: For a chronic disease like AD, getting a patient clear is only part of the equation. Three-year data suggesting that deep skin and itch responses can persist give clinicians more information for conversations about what long-term disease control may look like.

References

1. Bader K. FDA approves remibrutinib for symptomatic dermographism. Dermatology Times. October 7, 2026. Accessed October 9, 2026. https://www.dermatologytimes.com/view/fda-approves-remibrutinib-for-symptomatic-dermographism
2. Heaning S. Omlyclo, first interchangeable Xolair biosimilar, launches in the US. Dermatology Times. October 6, 2026. Accessed October 9, 2026. https://www.dermatologytimes.com/view/omlyclo-first-interchangeable-xolair-biosimilar-launches-in-the-us
3. Heaning S. Upadacitinib shows broader inflammatory effects and earlier skin barrier restoration than dupilumab in atopic dermatitis. Dermatology Times. October 8, 2026. Accessed October 9, 2026. https://www.dermatologytimes.com/view/upadacitinib-shows-broader-inflammatory-effects-and-earlier-skin-barrier-restoration-than-dupilumab-in-atopic-dermatitis
4. Heaning S. Nemolizumab maintains deep skin and itch responses through 3 years in atopic dermatitis. Dermatology Times. October 9, 2026. Accessed October 9, 2026. https://www.dermatologytimes.com/view/nemolizumab-maintains-deep-skin-and-itch-responses-through-3-years-in-atopic-dermatitis

Dermatology Times NP/PA Connect | The Breakout Bulletin