Background: Anifrolumab, a human monoclonal antibody against IFN-I receptor subunit-1, was recently approved for the treatment of systemic lupus erythematosus (SLE) with promising results. However, it has not yet been formally approved for isolated cutaneus lupus erythematosus (CLE), and its effectiveness in different CLE subtypes remains nuclear.

Objectives: To describe a case series of patients with SLE and CLE treated with anifrolumab, and the longitudinal dynamics of type-I IFN signature during treatment.

Methods: Retrospective and descriptive analysis of a series of patients with CLE and SLE treated with anifrolumab followed at Hospital Clínic of Barcelona. Demographic, clinical, and analytical data were collected. Data are presented as mean ± SD or median (IQR).

Results: We enrolled 13 patients: 12 women (9 Caucasian, 1 Mestizo, 1 Maghreb, and 1 Asian) and 1 Caucasian man, with a median age of 44 years (range 26-59) (Table 1). The median time since lupus diagnosis was 16 years (range 8-34). All patients had previously received prednisone and antimalarials, in addition to an average of 2.8 immunosuppressant/biologic drugs: azathioprine (n=6), methotrexate (n=7), mycophenolate (n=8), rituximab (n=3), or belimumab (n=9). Despite these treatments, the average SLE Disease Activity Index (SLEDAI) was 6.4 (range 0-14), and the average CLE Disease Area and Severity Index (CLASI) was 11.5 (range 6-20) before starting anifrolumab. Clinically, all patients responded to anifrolumab (response rate: 100%), with 70% achieving complete response in SLEDAI and 60% in CLASI. The median number of anifrolumab administrations was 10 (range 3-13). Response was observed quickly, with initial improvements detected after the first infusion, and the complete response within the following months (mean 5 months; range 2-9 months). Similar cutaneous response evidenced by CLASI reduction was observed in patients with and without SLE (92% and 88%, respectively). No differences were observed between patients who had previously received biologics and those who were biologic-naive. Peripheral blood type-I IFN signature was assessed in six patients. All of them showed high z-scores before starting anifrolumab, and a significant reduction was detected after a few months of treatment. Interestingly, no significant differences in efficacy were observed across CLE subtypes (including chilblain and lupus panniculitis), with all subtypes showing reductions in disease severity (in both specific and non-specific CLE manifestations). Only four patients experienced non-serious adverse events during treatment: mild gluteal hidradenitis; gastrointestinal symptoms (abdominal pain, nausea, and diarrhea); bacterial bronchitis that resolved with oral antibiotics; and reactivation of anal-genital human papilloma virus infection. The vaccination schedule was completed before starting anifrolumab, so no cases of herpes zoster or other infections were observed. The limitations of this analysis include a small sample size, the retrospective nature of the study and the non-homogeneous timing of data collection.

Conclusion: Our findings suggest that anifrolumab is broadly effective in reducing SLE and CLE disease activity across various patient demographics and CLE subtypes. Type-I IFN signature could be a potential biomarker for monitoring clinical response to treatment.

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[4] Viedma-Martínez M, Garrido-Gamarro B, Villegas-Romero I, et al. Real-life experience of anifrolumab for cutaneous lupus erythematous. J Eur Acad Dermatol Venereol 2024 Jul; 38 (7):e576-e583.

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Acknowledgements: NIL.

Disclosure of interests: Maria Cecilia Garbarino: None declared, Xavier Bosch Astra-Zeneca, Lluis Corbella: None declared, Maria Ayguasanosa: None declared, Priscila Giavedoni Astra-Zeneca, Olga Araujo Loperena: None declared, Gerard Espinosa Astra-Zeneca, Ignasi Rodriguez Pintó: None declared, Ricard Cervera Segura Astra-Zeneca, José A Gómez-Puerta Astra-Zeneca, Juan Arostegui: None declared, Anna Mensa: None declared, José Manuel Mascaró Astra-Zeneca.

© The Authors 2025. This abstract is an open access article published in Annals of Rheumatic Diseases under the CC BY-NC-ND license ( http://creativecommons.org/licenses/by-nc-nd/4.0/ ). Neither EULAR nor the publisher make any representation as to the accuracy of the content. The authors are solely responsible for the content in their abstract including accuracy of the facts, statements, results, conclusion, citing resources etc.