Real-World Use of Anifrolumab for Articular Involvement in Systemic Lupus Erythematosus: A Monocentric Case Series and Systematic Review
Abstract
1. Introduction
2. Case Series
2.1. Patient 1
2.2. Patient 2
2.3. Patient 3
2.4. Patient 4
3. Summary of Clinical Data
4. Review of the Literature
4.1. Methods
4.2. Results
| Author, Year | Type of Article | Number of SLE Patients | Ultrasound-Proven | Outcome | Concomitant Treatment |
|---|---|---|---|---|---|
| Maicas, 2024 [11] | Case series | 3 patients | No | Resolution of arthritis in 2 patients | Not specified |
| Tani, 2024 [10] | Multicenter, prospective | 25 patients | No | Resolution of arthritis in 13 patients; significant reduction in TJ/SJ count at 4 months (p: 0.026), 12 months (p: 0.021), and 24 months (p: 0.012) | NA |
| Ceccarelli, 2025 [9] | Case series | 3 patients | Yes | Reduction in DAS 28, US synovitis score, and US PD score in all patients | HCQ (3 pts), MTX (2 pts), PDN 10 mg/daily (3 pts) |
5. Discussion
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
- Hoi, A.; Igel, T.; Mok, C.C.; Arnaud, L. Systemic lupus erythematosus. Lancet 2024, 403, 2326–2338. [Google Scholar] [CrossRef] [PubMed]
- Navarra, S.V.; Guzman, R.M.; Gallacher, A.E.; Hall, S.; Levy, R.A.; Jimenez, R.E.; Li, E.K.-M.; Thomas, M.; Kim, H.-Y.; León, M.G.; et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: A randomised, placebo-controlled, phase 3 trial. Lancet 2011, 377, 721–731. [Google Scholar] [CrossRef] [PubMed]
- Stohl, W.; Schwarting, A.; Okada, M.; Scheinberg, M.; Doria, A.; Hammer, A.E.; Kleoudis, C.; Groark, J.; Bass, D.; Fox, N.L.; et al. Efficacy and Safety of Subcutaneous Belimumab in Systemic Lupus Erythematosus: A Fifty-Two-Week Randomized, Double-Blind, Placebo-Controlled Study. Arthritis Rheumatol. 2017, 69, 1016–1027. [Google Scholar] [CrossRef] [PubMed]
- Gatto, M.; Zen, M.; Cruciani, C.; Iaccarino, L.; Doria, A. Navigating the landscape of SLE treatment: An expert viewpoint on the rationality and limitations of early biologic intervention. Autoimmun. Rev. 2024, 23, 103612. [Google Scholar] [CrossRef] [PubMed]
- Furie, R.; Petri, M.; Zamani, O.; Cervera, R.; Wallace, D.J.; Tegzová, D.; Sanchez-Guerrero, J.; Schwarting, A.; Merrill, J.T.; Chatham, W.W.; et al. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum. 2011, 63, 3918–3930. [Google Scholar] [CrossRef] [PubMed] [PubMed Central]
- Furie, R.A.; Morand, E.F.; Bruce, I.N.; Manzi, S.; Kalunian, K.C.; Vital, E.M.; Lawrence Ford, T.; Gupta, R.; Hiepe, F.; Santiago, M.; et al. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): A randomised, controlled, phase 3 trial. Lancet Rheumatol. 2019, 1, e208–e219. [Google Scholar] [CrossRef] [PubMed]
- 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.; et al. Trial of Anifrolumab in Active Systemic Lupus Erythematosus. N. Engl. J. Med. 2020, 382, 211–221. [Google Scholar] [CrossRef] [PubMed]
- Fanouriakis, A.; Kostopoulou, M.; Andersen, J.; Aringer, M.; Arnaud, L.; Bae, S.-C.; Boletis, J.; Bruce, I.N.; Cervera, R.; Doria, A.; et al. EULAR recommendations for the management of systemic lupus erythematosus: 2023 update. Ann. Rheum. Dis. 2024, 83, 15–29. [Google Scholar] [CrossRef]
- Ceccarelli, F.; Ciancarella, C.; Natalucci, F.; Scorda, A.; Tripodi, G.; Garufi, C.; Mancuso, S.; Spinelli, F.R.; Alessandri, C.; Conti, F. Rapid response to anifrolumab in lupus related joint involvement as assessed by ultrasonography: A case series study. Jt. Bone Spine 2025, 92, 105830. [Google Scholar] [CrossRef]
- Tani, C.; Cardelli, C.; Zen, M.; Moroni, L.; Piga, M.; Ceccarelli, F.; Fasano, S.; De Marchi, G.; Coladonato, L.; Emmi, G.; et al. Anifrolumab in Refractory Systemic Lupus Erythematosus: A Real-World, Multicenter Study. J. Rheumatol. 2024, 51, 1096–1101. [Google Scholar] [CrossRef]
- Maicas, L.S.; Fragio, J.J.; Calabuig, P.M.; Mazarío, R.G.; Martínez, M.L.; Almela, C.M.; Cid, A.R.; Garrido, J.J.L.; Fernaíndez, C.C. Real-life data of anifrolumab as a treatment for systemic lupus erythematosus (SLE). Lupus Sci. Med. 2024, 11, A177. [Google Scholar] [CrossRef]
- Chatham, W.W.; Furie, R.; Saxena, A.; Brohawn, P.; Schwetje, E.; Abreu, G.; Tummala, R. Long-Term Safety and Efficacy of Anifrolumab in Adults with Systemic Lupus Erythematosus: Results of a Phase II Open-Label Extension Study. Arthritis Rheumatol. 2021, 73, 816–825. [Google Scholar] [CrossRef]
- Morand, E.F.; Furie, R.A.; Bruce, I.N.; Vital, E.M.; Dall, M.; Maho, E.; Pineda, L.; Tummala, R. Efficacy of anifrolumab across organ domains in patients with moderate-to-severe systemic lupus erythematosus: A post-hoc analysis of pooled data from the TULIP-1 and TULIP-2 trials. Lancet Rheumatol. 2022, 4, e282–e292. [Google Scholar] [CrossRef]
- Miyazaki, Y.; Funada, M.; Nakayamada, S.; Sonomoto, K.; Tanaka, H.; Hanami, K.; Fukuyo, S.; Kubo, S.; Yamaguchi, A.; Miyagawa, I.; et al. Safety and efficacy of anifrolumab therapy in systemic lupus erythematosus in real-world clinical practice: LOOPS registry. Rheumatology 2024, 63, 2345–2354. [Google Scholar] [CrossRef] [PubMed]
- Díaz-Planellas, S.; Katsifis-Nezis, D.; Fanouriakis, A. Clinical Trials of Interferon Inhibitors in Systemic Lupus Erythematosus and Preliminary Real-World Efficacy of Anifrolumab. Mediterr. J. Rheumatol. 2024, 35, 381–391. [Google Scholar] [CrossRef] [PubMed]
- Paolino, G.; Ramirez, G.A.; Calabrese, C.; Moroni, L.; Bianchi, V.G.; Bozzolo, E.P.; Mercuri, S.R.; Dagna, L. Anifrolumab for Moderate and Severe Muco-Cutaneous Lupus Erythematosus: A Monocentric Experience and Review of the Current Literature. Biomedicines 2023, 11, 2904. [Google Scholar] [CrossRef] [PubMed]
- Jayne, D.; Rovin, B.; Mysler, E.; Furie, R.; Houssiau, F.; Trasieva, T.; Knagenhjelm, J.; Schwetje, E.; Tang, W.; Tummala, R.; et al. Anifrolumab in lupus nephritis: Results from second-year extension of a randomised phase II trial. Lupus Sci. Med. 2023, 10, e000910. [Google Scholar] [CrossRef]
- Karagenova, R.; Vodusek, Z.; Krimins, R.; Krieger, A.; Timlin, H. Treatment with Voclosporin and Anifrolumab in a Patient with Lupus Nephritis and Refractory Discoid Lupus Erythematosus: A Case Report and Literature Review. Cureus 2024, 16, e55321. [Google Scholar] [CrossRef]
- Kobayashi, Y.; Hanai, S.; Iwamoto, T.; Nakagomi, D. Refractory systemic lupus erythematosus with neuropsychiatric manifestations successfully treated with anifrolumab. Scand. J. Rheumatol. 2024, 53, 226–228. [Google Scholar] [CrossRef]
- Cervera, R.; Khamashta, M.A.; Font, J.; Sebastiani, G.D.; Gil, A.; Lavilla, P.; Mejía, J.C.; Aydintug, A.O.; Chwalinska-Sadowska, H.; de Ramón, E.; et al. Morbidity and mortality in systemic lupus erythematosus during a 10-year period: A comparison of early and late manifestations in a cohort of 1000 patients. Medicine 2003, 82, 299–308. [Google Scholar] [CrossRef]
- Mathias, S.D.; Berry, P.; De Vries, J.; Pascoe, K.; Colwell, H.H.; Chang, D.J.; Askanase, A.D. Patient experience in systemic lupus erythematosus: Development of novel patient-reported symptom and patient-reported impact measures. J. Patient Rep. Outcomes 2018, 2, 11. [Google Scholar] [CrossRef]
- Germain, G.; Worley, K.; MacKnight, S.D.; Rubin, B.; Bell, C.F.; Laliberté, F.; Urosevic, A.; Duhl, M.S.; Concoff, A. Evaluating the real-world effectiveness of belimumab in patients with SLE using SLE-related laboratory values and rheumatoid arthritis-derived disease activity measures: RAPID3, swollen joint count and tender joint count. Lupus Sci. Med. 2024, 11, e001111. [Google Scholar] [CrossRef]

| Gender, Ethnicity | Age | Diagnosis | Autoimmunity | Comorbidities | Organ Involvement at Diagnosis | Previous Therapies | Treatment Intolerance | Outcome | |
|---|---|---|---|---|---|---|---|---|---|
| Pt. 1 | F, Cuban | 49 | 2023 | anti-U1RNP, anti-SSA/Ro, anti-dsDNA | None | Alopecia, inflammatory arthralgias, symmetrical polyarthritis, sicca syndrome, neutropenia, and lymphopenia | GCs, HCQ, MMF, AZA | HCQ, MMF, AZA | Persistent alopecia, lymphopenia, complement consumption, high titer of anti-dsDNA, active arthritis |
| Pt. 2 | F, Caucasian | 38 | 2018 | anti-SSA/Ro, anti-SSB/La, anti-dsDNA (ELISA), FR, anti-CCP | None | Subacute LE and arthritis | GCs, HCQ, MTX | HCQ | Arthritis relapse |
| Pt. 3 | F, Caucasian | 56 | 2007 | anti-SSA | Hepatic steatosis, multinodular thyroid goiter, prolactin-secreting pituitary microadenoma | Raynaud phenomenon, arthritis, and subacute LE | GCs, HCQ, LEF, SLZ, CIC, MTX; RTX, TOCI, BARI, BELI | CIC, MTX, RTX, TOCI | Recurrent joint and skin manifestations; GC dependence with side effects (SLICC 6) |
| Pt. 4 | F, African | 50 | 2009 | anti-Sm, anti-RNP70, anti-dsDNA | Occult HBV infection, Strongyloides stercoraris infection, Enterococcus faecium meningitis | Articular, cutaneous, hematological, and renal | GCs, HCQ, MMF, CIC, CFX; RTX, BELI | None; poor compliance | GC dependence with signs of cortisolism |
| Disease Duration (Months) * | Arthritis (Characteristics) | Erosive Arthritis | Other Organ Involvement * | Concomitant Therapy * | Duration of ANI Therapy (Months) | SLEDAI before ANI | SLEDAI Last Clinical Evaluation | DAS28 before ANI | DAS28 Last Clinical Evaluation | GCs Last Clinical Evaluation | Side Effects | Response | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pt. 1 | 15 | Symmetrical polyarthritis | No | Cutaneous, Hematological, and serositis | GCs (40 mg IV monthly during the first two infusions) | 12 | 13 | 2 | 7.22 | 2.18 | 0 | None | Yes |
| Pt. 2 | 60 | Symmetrical polyarthritis | No (Rhupus) | MTX, GCs (8 mg) | 9 | 6 | 1 | 5.59 | 1.89 | 0 | None | Yes | |
| Pt. 3 | 192 | Symmetrical polyarthritis | Yes | Cutaneous | HCQ, MTX, GCs (6 mg) | 14 | 6 | 0 | 4.57 | 2.31 | 4 mg | None | Yes |
| Pt. 4 | 168 | Polyarthritis | No | Cutaneous | GCs (8 mg) | 4 | 0 | 0 | 2.38 | 2.38 | 2 mg | None | Yes |
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Cassone, G.; Santoro, F.; Nuara, M.; Cabassi, C.; Vacchi, C.; Secchi, O.; Giuggioli, D. Real-World Use of Anifrolumab for Articular Involvement in Systemic Lupus Erythematosus: A Monocentric Case Series and Systematic Review. J. Pers. Med. 2025, 15, 546. https://doi.org/10.3390/jpm15110546
Cassone G, Santoro F, Nuara M, Cabassi C, Vacchi C, Secchi O, Giuggioli D. Real-World Use of Anifrolumab for Articular Involvement in Systemic Lupus Erythematosus: A Monocentric Case Series and Systematic Review. Journal of Personalized Medicine. 2025; 15(11):546. https://doi.org/10.3390/jpm15110546
Chicago/Turabian StyleCassone, Giulia, Filippo Santoro, Mariagrazia Nuara, Chiara Cabassi, Caterina Vacchi, Ottavio Secchi, and Dilia Giuggioli. 2025. "Real-World Use of Anifrolumab for Articular Involvement in Systemic Lupus Erythematosus: A Monocentric Case Series and Systematic Review" Journal of Personalized Medicine 15, no. 11: 546. https://doi.org/10.3390/jpm15110546
APA StyleCassone, G., Santoro, F., Nuara, M., Cabassi, C., Vacchi, C., Secchi, O., & Giuggioli, D. (2025). Real-World Use of Anifrolumab for Articular Involvement in Systemic Lupus Erythematosus: A Monocentric Case Series and Systematic Review. Journal of Personalized Medicine, 15(11), 546. https://doi.org/10.3390/jpm15110546

