Nemolizumab maintains itch relief and skin clearance through 2 years in AD patients

A post hoc analysis of the ARCADIA long-term extension (LTE) programme revealed that the majority of patients who had already responded to nemolizumab maintained both itch relief and skin improvements through 104 weeks of continued therapy [1]. These findings highlight the durability of interleukin-31 (IL-31) receptor blockade as a long-term maintenance strategy in moderate-to-severe atopic dermatitis (AD).

Nemolizumab targets the IL-31 receptor, interrupting a neuroimmune signalling pathway implicated in pruritus, skin barrier dysfunction, and inflammation. Previously, the pivotal ARCADIA 1 (NCT03985943) and ARCADIA 2 (NCT03989349) trials demonstrated rapid and clinically meaningful improvements in both itch and skin manifestations of AD [2]. The current analysis evaluated the long-term durability of these responses.

The ARCADIA LTE (NCT03989206) was a prospective, multicentre, open-label extension programme that enrolled patients aged ≥12 years with moderate-to-severe AD from 7 phase 2/3 studies, as well as newly recruited adolescents. Participants received nemolizumab 30 mg every 4 weeks alongside low- or medium-potency topical corticosteroids, with or without topical calcineurin inhibitors. At the July 2024 data cut-off, 1,901 of 1,903 enrolled patients had received treatment, and 1,062 (55.9%) had completed 104 weeks of follow-up. Responders at LTE baseline were categorised according to the following criteria: a ≥4-point improvement in SCORing Atopic Dermatitis (SCORAD) VAS-itch score (n=618), a near itch-free state defined as SCORAD VAS-itch <2 (n=383), clear or almost clear skin according to the Investigator´s Global Assessment (IGA 0/1 (n=315)), Eczema Area and severity Index (EASI-75; n=441), and EASI-90 (n=291). The proportion of patients maintaining each response through week 104 was assessed using an observed-cases analysis.

Responses were highly durable over the 2-year treatment period. At week 104, 95.2% of patients maintained a ≥4-point itch improvement in itch score, while 89.6% remained itch-free or nearly itch-free. Skin responses were similarly sustained, with 96.6% and 92.3% of patients maintaining EASI-75 and EASI-90 responses, respectively, and 86.5% retaining an IGA score of 0/1. The long-term safety profile was consistent with that observed in the pivotal phase 3 studies. Treatment was well tolerated; the most frequently reported treatment-emergent adverse events were infections and respiratory disorders, and no deaths were reported.

Overall, these data support nemolizumab as an effective long-term maintenance treatment for patients with moderate-to-severe AD, providing sustained improvements in both itch and skin disease over 104 weeks.

Thaçi D, et al. Long-term (up to 104 weeks) maintenance of itch and skin responses with nemolizumab treatment in patients with moderate-to-severe atopic dermatitis – post hoc analyses from the ARCADIA long-term extension trial. Abstract 76623, American Academy of Dermatology Annual Meeting 2026, 27–31 March 2026, Denver, Colorado, USA.
Silverberg JI, et al. Lancet 2024;404 (10451):445-60.