Tralokinumab beneficial for patients with prurigo nodularis-like phenotype atopic dermatitis: JAAD

Various phenotypes of atopic dermatitis (AD) exist. Nearly one-half of the patients with AD have prurigo nodularis (PN). The chronic itch usually results in an itch-scratch cycle with secondary lesions development in all AD phenotypes. These include, in the PN-like phenotype, excoriated hyperkeratotic, intensely itchy papules and nodules in areas accessible to scratch.

An emergent role has been suggested of the type 2 cytokines, including interleukin (IL) 4, IL-5, IL-31, and IL-13, in the pathogenesis underlying AD itch. IL-13 is a potent enhancer of the neuronal response to different itch stimuli. Tralokinumab is a novel treatment that has demonstrated efficacy and safety in clinical trials treating adult patients with moderate-to-severe AD. Tralokinumab is a fully human IgG4 monoclonal antibody neutralizing IL-13.

Elena Pezzolo, Department of Dermatology, San Bortolo Hospital, Vicenza, Italy, and colleagues had reported that tralokinumab improved clinical manifestations in two patients presenting with PN-like phenotype. Therefore, they prospectively investigated the safety and efficacy of treating for at least 16 weeks. The study included 17 adult patients with moderate-to-severe PN-like phenotype AD at five dermatology tertiary referral centres from July 2021 to November 2022.

Patients were eligible for tralokinumab treatment after failing the first-line approved biologic treatment dupilumab without achieving EASI (eczema area and severity index-50) after treatment for 16 weeks. For each patient, the authors obtained written informed consent.

At baseline, patients (mean age 60.75 years; 76.5% women) presented moderate-to-severe PN-like phenotype atopic dermatitis with means EASI of 27.2, numeric rating scale (NRS)-itch of 9.8, Investigator Global Assessment (IGA) of 3.7, dermatology life and quality index (DLQI) of 16.3, and NRS-sleeplessness of 8.9. At baseline, seventy percent of patients used concomitant topical corticosteroids.

The authors reported the following findings:

• Patients reached EASI-50 within four weeks, EASI-75 within 12 weeks, and EASI-90 within 32 weeks (mean EASI reduction from 27.2-1.7).
• The mean NRS-itch, sleeplessness, and DLQI values significantly decreased as early as week four and progressively reduced after 16-week continuous treatment.
• Tralokinumab resulted in complete or almost complete clinical remission (IGA 0 or 1) in 76% of patients, 47% within week 12, 23% within week 32, and 6% within week 64, and an at least 2-grade IGA reduction in others (24%).
• Both patients with 16 weeks of treatment observation (8/17) and 32 or 64 weeks of continuous treatment (9/17) maintained clinical efficacy without reporting any serious adverse effects.
• Mild conjunctivitis represented the main adverse effect (12%), followed by injection-site reaction, localized urticaria, and mild herpetic stomatitis.

"Our findings showed that tralokinumab effectively treated patients with prurigo nodularis–like phenotype of atopic dermatitis refractory to dupilumab," the researchers concluded.

Reference:

Pezzolo E, Gambardella A, Guanti M, Bianchelli T, Bertoldi A, Giacchetti A, Donini M, Argenziano G, Naldi L. Tralokinumab shows clinical improvement in patients with prurigo nodularis-like phenotype atopic dermatitis: A multicenter, prospective, open-label case series study. J Am Acad Dermatol. 2023 May 5:S0190-9622(23)00760-0. doi: 10.1016/j.jaad.2023.04.056. Epub ahead of print. PMID: 37150301.