Efficacy and Safety of Anifrolumab in Patients with Cutaneous Lupus Erythematosus: A Systematic Review
DOI:
https://doi.org/10.37287/ijghr.v8i5.2515Keywords:
aniflorumab, CLASI, cutaneous lupus erythematosusAbstract
Cutaneous lupus erythematosus (CLE) significantly impacts patient quality of life, and many cases remain refractory to standard-of-care treatments such as antimalarials and corticosteroids. Anifrolumab, a type I interferon receptor antagonist, has shown efficacy in systemic lupus erythematosus (SLE), but its specific impact on diverse CLE subtypes in real-world settings requires further synthesis. To systematically review the clinical efficacy, safety, and steroid-sparing potential of anifrolumab in patients with CLE. A systematic literature search was conducted across PubMed, ScienceDirect, and Cochrane Library for articles published between 2021 and 2026. From an initial yield of 217 articles, 5 studies reporting on anifrolumab treatment for CLE subtypes were ultimately included after rigorous screening. Data on clinical response, specifically the cutaneous lupus erythematosus disease area and severity index (CLASI) scores and onset of action, were extracted and synthesized. Five studies involving a total of 40 patients were included. The majority of patients had failed multiple prior therapies. Results consistently showed a rapid and significant decrease in CLASI activity scores, often within the first 4 to 12 weeks of aniflorumab treatment. Notably, one major cohort reported that 50% of patients were able to discontinue prednisone entirely. Efficacy was observed across various subtypes, including discoid lupus erythematosus (DLE) and subacute CLE (SCLE) cases. Adverse events were consistent with previously reported safety profiles. Real-world evidence suggests that anifrolumab is a potent and rapid-acting treatment for refractory CLE, offering significant clinical improvement and a vital steroid-sparing effect. These findings support its use in patients failing conventional therapies, though large-scale prospective trials specifically for CLE are warranted.
References
Azuma, N., Natsuaki, M., Hashimoto, N., Abe, T., Ueda, S., Ohno, Y., Jinnin, M., & Matsui, K. (2024). Efficacy of anifrolumab in long-term intractable alopecia due to discoid lupus erythematosus. Modern Rheumatology Case Reports, 8(2), 267–271. https://doi.org/10.1093/mrcr/rxae018
Bao, A., Petri, M. A., Fava, A., & Kang, J. (2023). Case series of anifrolumab for treatment of cutaneous lupus erythematosus and lupus-related mucocutaneous manifestations in patients with SLE. Lupus Science and Medicine, 10(2). https://doi.org/10.1136/lupus-2023-001007
Bruce, I. N., van Vollenhoven, R. F., Psachoulia, K., Lindholm, C., Maho, E., & Tummala, R. (2023). Time to onset of clinical response to anifrolumab in patients with SLE: pooled data from the phase III TULIP-1 and TULIP-2 trials. Lupus Science and Medicine, 10(1). https://doi.org/10.1136/lupus-2022-000761
Calvo-Río, V., Secada-Gómez, C., Martín Gutiérrez, A., Retuerto-Guerrero, M., Font, J., Casafont-Solé, I., Mayo-Juanatey, A., Alegre Sancho, J. J., Freites, D., Hormigos, C., Garrido Puñal, N., González Arribas, G., Miguélez Sanchez, J. R., García-Valle, A., Ibañez, M., Lozano Morillo, F., García Manzanares, Á., Sandoval-Moreno, S., Cortes-Hernandez, J., … Blanco, R. (2026). Anifrolumab in systemic lupus erythematosus: real-world evidence from a Spanish multicentre cohort of 206 patients and literature review. RMD Open, 12(1). https://doi.org/10.1136/rmdopen-2025-006549
Carter, L. M., Wigston, Z., Laws, P., & Vital, E. M. (2023). Rapid efficacy of anifrolumab across multiple subtypes of recalcitrant cutaneous lupus erythematosus parallels changes in discrete subsets of blood transcriptomic and cellular biomarkers. British Journal of Dermatology, 189(2), 210–218. https://doi.org/10.1093/bjd/ljad089
Chatham, W. W., Furie, R., Saxena, A., Brohawn, P., Schwetje, E., Abreu, G., & Tummala, R. (2021). Long-Term Safety and Efficacy of Anifrolumab in Adults With Systemic Lupus Erythematosus: Results of a Phase II Open-Label Extension Study. Arthritis and Rheumatology, 73(5), 816–825. https://doi.org/10.1002/art.41598
Doria, A., van Vollenhoven, R. F., Morand, E. F., Mosca, M., Nåtman, J., Waratani, M., Knagenhjelm, J., Lindholm, C., & Kielar, D. (2026). Efficacy and safety of anifrolumab in patients with systemic lupus erythematosus without prior immunosuppressant use: post hoc analysis of phase 3 TULIP-1 and TULIP-2 trials. Lupus Science and Medicine, 13(1). https://doi.org/10.1136/lupus-2025-001891
E. Parriel. (2023). Rapid clearance of cutaneous lesions with anifrolumab in SLE (systemic lupus erythematosus) and DLE (discoid lupus erythematosus).
Elhage, K. G., Zhao, R., & Nakamura, M. (2022). Advancements in the Treatment of Cutaneous Lupus Erythematosus and Dermatomyositis: A Review of the Literature. In Clinical, Cosmetic and Investigational Dermatology (Vol. 15, pp. 1815–1831). Dove Medical Press Ltd. https://doi.org/10.2147/CCID.S382628
Furie, R., Khamashta, M., Merrill, J. T., Werth, V. P., Kalunian, K., Brohawn, P., Illei, G. G., Drappa, J., Wang, L., & Yoo, S. (2017). Anifrolumab, an Anti–Interferon-α Receptor Monoclonal Antibody, in Moderate-to-Severe Systemic Lupus Erythematosus. Arthritis and Rheumatology, 69(2), 376–386. https://doi.org/10.1002/art.39962
Han, S., Ferrer, J., Bittar, M., & Jones, A. (2023). Alopecia secondary to severe discoid lupus responding to anifrolumab. In International Journal of Women’s Dermatology (Vol. 9, Number 3, p. E098). Wolters Kluwer Medknow Publications. https://doi.org/10.1097/JW9.0000000000000098
Herron, E. D., Fortugno, A., & Graham, L. (2024). A Retrospective Review of 22 patients on Anifrolumab in Refractory Cutaneous Lupus (Vol. 8).
Hile, G. A., & Werth, V. P. (2025). Understanding the Role of Type I Interferons in Cutaneous Lupus and Dermatomyositis: Toward Better Therapeutics. In Arthritis and Rheumatology (Vol. 77, Number 1, pp. 1–11). John Wiley and Sons Inc. https://doi.org/10.1002/art.42983
Kalyniuk, K., Fetter, T., Grützbach, M., Guel, T., Novak, N., & Wenzel, J. (2025). Anifrolumab has a direct immunoregulatory effect on inflamed keratinocytes: implications for the treatment of lupus erythematosus skin lesions. Frontiers in Immunology, 16. https://doi.org/10.3389/fimmu.2025.1648001
Karagenova, R., Vodusek, Z., Krimins, R., Krieger, A., & Timlin, H. (2024). Treatment With Voclosporin and Anifrolumab in a Patient With Lupus Nephritis and Refractory Discoid Lupus Erythematosus: A Case Report and Literature Review. Cureus. https://doi.org/10.7759/cureus.55321
Khan, M. A., Khan, F. H., Khan, H. B., Saadeh, C., & Davey, N. (2023). Role of Anifrolumab in Refractory Cutaneous Manifestations of Lupus Erythematosus: A Case Series and Literature Review. Cureus. https://doi.org/10.7759/cureus.39553
Kowalski, E. H., Stolarczyk, A., & Richardson, C. T. (2023). Successful treatment of severe chronic cutaneous lupus with anifrolumab: A series of 6 cases. JAAD Case Reports, 37, 21–29. https://doi.org/10.1016/j.jdcr.2023.04.024
Loricera, J., Bejerano, C., Estébanez, A., García, I., Mohammad, N., Sanmartín, M., González-Fernández, M., Amaro, I. F., González-López, M. A., García-Contreras, M. V., López-Hoyos, M., & Blanco, R. (2025). Anifrolumab for Nonsystemic Cutaneous Lupus Erythematosus: Clinical Experience, Immunologic Insights, and Review of the Literature. Journal of Clinical Medicine, 14(16). https://doi.org/10.3390/jcm14165683
Maeshima, K., Abe, T., Imada, C., Ozaki, T., & Shibata, H. (2024). Anifrolumab for refractory lupus erythematosus panniculitis in systemic lupus erythematosus. In Rheumatology (United Kingdom) (Vol. 63, Number 3, pp. E115–E117). Oxford University Press. https://doi.org/10.1093/rheumatology/kead553
Mayo-Juanatey, A., Castañeda, S., Calvo-Río, V., Garijo-Bufort, M., Retuerto-Guerrero, M., Olivares, M. S., & Alegre-Sancho, J. J. (2026). Anifrolumab in Systemic Lupus Erythematosus With Severe Hematological Manifestations: A Spanish Multicenter Study. In Journal of Rheumatology (Vol. 53, Number 1, pp. 112–115). Journal of Rheumatology. https://doi.org/10.3899/jrheum.2025-0658
Morand, E. F., Furie, R., Tanaka, Y., Bruce, I. N., Askanase, A. D., Richez, C., Bae, S.-C., Brohawn, P. Z., Pineda, L., Berglind, A., & Tummala, R. (2020). Trial of Anifrolumab in Active Systemic Lupus Erythematosus. New England Journal of Medicine, 382(3), 211–221. https://doi.org/10.1056/nejmoa1912196
Paolino, G., Ramirez, G. A., Calabrese, C., Moroni, L., Bianchi, V. G., Bozzolo, E. P., Mercuri, S. R., & Dagna, L. (2023). Anifrolumab for Moderate and Severe Muco-Cutaneous Lupus Erythematosus: A Monocentric Experience and Review of the Current Literature. Biomedicines, 11(11). https://doi.org/10.3390/biomedicines11112904
Plüß, M., Piantoni, S., Wincup, C., & Korsten, P. (2022). Rapid Response of Refractory Systemic Lupus Erythematosus Skin Manifestations to Anifrolumab—A Case-Based Review of Clinical Trial Data Suggesting a Domain-Based Therapeutic Approach. In Journal of Clinical Medicine (Vol. 11, Number 12). MDPI. https://doi.org/10.3390/jcm11123449
Ramadhan, A., Troung, A., Yacyshyn, E., & Gniadecki, R. (2025). Successful use of anifrolumab in refractory cutaneous lupus erythematosus with systemic lupus erythematosus: A case report. SAGE Open Medical Case Reports, 13. https://doi.org/10.1177/2050313X251350376
Shaw, K. S., Rajeh, A., Le, T., Kahn, P. J., Oza, V. S., Arkin, L. M., & Vleugels, R. A. (2023). Anifrolumab for Adolescent Discoid Lupus Erythematosus. JAMA Network Open, 6(10), E2338200. https://doi.org/10.1001/jamanetworkopen.2023.38200
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