In a recent study, patients with refractory chronic cutaneous lupus erythematosus (CLE) experienced greater efficacy and had fewer serious infections during treatment with anifrolumab (Saphnelo), compared with patients who took conventional immunosuppressants.
Anifrolumab, a monoclonal antibody that acts as a type 1 interferon receptor antagonist, was “remarkably effective in treating the skin manifestations,” the study’s first author Jun Kang, MD, assistant professor of dermatology at the Johns Hopkins University School of Medicine, Baltimore, told Medscape Medical News. In addition, “patients were much less likely” to be hospitalized or require antibiotic therapy when they were treated with anifrolumab compared with those treated with some of the older medications used to treat lupus, he added.
The findings were published on September 2 in a letter to the editor in the Journal of the European Academy of Dermatology and Venereology.
Anifrolumab was originally approved by the FDA in 2021 for treating moderate-to-severe systemic lupus erythematosus (SLE). In April, the FDA approved a once-weekly autoinjector version.
- Refractory chronic CLE: anifrolumab ↑ skin efficacy vs conventional immunosuppressants.
- CLASI-A ↓ at 6 mo: 8.0 with anifrolumab vs 2.5 with conventional therapy.
- 1-year overall infection rates similar across groups (~65%-69%).
- Antibiotic-requiring infections ↓ with anifrolumab monotherapy: 8.3% vs 47.8%.
- No hospitalizations on anifrolumab monotherapy; retrospective single-center, small sample.
There is currently no FDA-approved treatment specifically for CLE, although the FDA has approved hydroxychloroquine for treatment of discoid lupus erythematosus. A phase 3 study (the LAVENDER trial) is currently underway evaluating the efficacy and safety of anifrolumab in patients with chronic and/or subacute CLE who are refractory or intolerant to antimalarial therapy, with a December scheduled completion date.

Older immunosuppressants “are very nonspecific in how they control the immune system,” while anifrolumab is targeted toward the underlying mechanism of lupus, Kang noted.
The study retrospectively assessed adults with hydroxychloroquine-refractory chronic CLE and SLE, identified from a prospectively maintained registry at a tertiary center. Eligible patients were escalated to conventional immunosuppressants — methotrexate, mycophenolate mofetil/mycophenolic acid, and azathioprine — or anifrolumab with or without conventional immunosuppressants, with at least 12 months of follow-up and no other systemic autoimmune disease.
Ultimately, 71 patients met inclusion criteria: 46 on conventional immunosuppressants, 13 on anifrolumab with immunosuppressants, and 12 on anifrolumab monotherapy.
After 6 months, Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity scores favored anifrolumab, with an average reduction of 2.5 among those on conventional immunosuppressants and 8.0 for each anifrolumab group (P < .01).
Overall infection rates were similar at the 1-year mark at 65.2%, 69.2%, and 66.7% for patients taking conventional immunosuppressants, a combination of anifrolumab and conventional immunosuppressants, and anifrolumab monotherapy, respectively. However, infections requiring systemic antibiotics were significantly less frequent for patients taking anifrolumab, at 47.8%, 38.5%, and 8.3% for the respective groups (P = .04).
Further, no hospitalizations occurred in patients on anifrolumab monotherapy, compared with 32.6% of those on conventional immunosuppressants and 23.1% receiving combination therapy (P = .06).
Patients taking conventional immunosuppressants were more likely to develop bacterial infections (50%) than 30.8% among those on combination therapy and 8.3% of those on anifrolumab alone. Viral infections were more common among those taking anifrolumab either alone (41.7%) or with conventional immunosuppressants (53.8%), compared with those on immunosuppressants alone (32.6%).
Limitations of the study included the retrospective single-center design and small sample size, and the results “should be interpreted as exploratory and hypothesis-generating,” the authors concluded. Prospective studies, they added, “are needed to define the optimal role and timing of anifrolumab” for treating patients with chronic CLE.
While emphasizing the need for more research, Kang said the results provide some reassurance of anifrolumab’s potential as a treatment not just for SLE but chronic CLE.
The study provides evidence “to show that, compared to the older medications that most dermatologists are familiar with using, the newer medication might be safer and more effective,” he said. “More and more evidence is coming out that targeted therapies, specifically for skin lupus, are likely to be better tolerated and more efficacious for our patients,” he added.
The study was supported by Kang’s Dermatology Foundation Medical Dermatology Career Development Award. Kang reported serving as a site principal investigator for AstraZeneca’s LAVENDER trial. No other study author disclosed any relevant financial relationship.
Scott Harris has covered dermatology for more than a decade. He lives near Washington, DC.
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