0244: Effectiveness and safety of Anifrolumab in Non-Systemic Cutaneous Lupus

Background/Purpose: Anifrolumab is a human monoclonal antibody targeting the type I interferon receptor, approved for the treatment of systemic lupus erythematosus (SLE), with demonstrated efficacy in managing cutaneous involvement. However, its potential role in non-systemic subacute and chronic cutaneous lupus remains undefined, as its use in this setting is off-label.

This study aimed to assess the effectiveness and safety of anifrolumab in patients with non-systemic subacute or chronic cutaneous lupus in routine clinical practice.

Methods: This multicenter study evaluated patients with non-systemic subacute or chronic cutaneous lupus treated with anifrolumab. Given that non-systemic lupus represents an off-label indication, informed consent was obtained from all participants.

Cutaneous involvement was assessed using the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), evaluating both disease activity (CLASI-A, score range: 0–70) and damage (CLASI-D, score range: 0–56). The primary outcome was the reduction in CLASI-A and CLASI-D scores. Comparisons were conducted between baseline and months 1, 3, and 6 using Wilcoxon’s signed-rank test.

Furthermore, considering the role of natural killer (NK) cells in the pathogenesis of cutaneous lupus, we analyzed NK cell dynamics in three patients over the study period.

Results: A total of 10 patients (8 females, 2 males) with cutaneous lupus treated with anifrolumab were included in the analysis (TABLE). The diagnoses were discoid lupus (n=7) and subacute lupus (n=3). The mean disease duration prior to anifrolumab initiation was 32.9±30.2 months.

Before starting anifrolumab, patients had received the following treatments: topical glucocorticoids (n=10), hydroxychloroquine (n=10), methotrexate (n=7), oral glucocorticoids (n=5), chloroquine (n=3), azathioprine (n=2), belimumab (n=2), rituximab (n=2), mepacrine (n=1), thalidomide (n=1), apremilast (n=1), and mycophenolate mofetil (n=1).

Anifrolumab was administered at a dose of 300 mg intravenously every 4 weeks, either in combination with other therapies (n=9) or as monotherapy (n=1). All patients experienced a rapid and significant improvement in cutaneous disease activity (CLASI-A and CLASI-D) following anifrolumab initiation (FIGURE 1).

During a mean follow-up of 5.3±4.6 months, the median [IQR] CLASI-A score decreased from 16.5 [12.7–21.5] to 1 [1–3.2] (p=0.032), while the median [IQR] CLASI-D score decreased from 8 [4.2–9.7] to 4 [2.5–6.7] (p=0.044). No adverse effects were reported during follow-up. Additionally, an upregulation trend in inhibitory markers was observed in NK cell subtypes among the three patients in whom this analysis was performed (FIGURE 2).

Conclusion: Anifrolumab appears to be an effective and well-tolerated treatment for patients with refractory non-systemic cutaneous lupus.