Preliminary results from an investigator-initiated single-site clinical study show that some people with chronic cutaneous lupus erythematosus — a type of lupus that can cause permanent skin damage and hair loss — are less likely to acquire life-threatening infections when taking the drug anifrolumab, an FDA-approved monoclonal antibody treatment for systemic lupus erythematosus.
Published in the Journal of the European Academy of Dermatology and Venereology (JEADV) Sept. 2, the findings of the Johns Hopkins Medicine-led study highlight how anifrolumab can provide distinct benefits over the use of conventional immunosuppressants in patients with treatment-resistant chronic skin lupus.
Designed to address the absence of specific FDA-approved treatments for skin lupus, the clinical study explores whether anifrolumab infusions are also safe and effective for patients with chronic skin lupus.
Currently, clinicians adapt existing systemic lupus erythematosus treatments for use in patients with chronic skin lupus. Immunosuppressants (medications that lower immune system activity), such as methotrexate and mycophenolate, are prescribed in cases where treatment with topical and oral medications fail; however, patients become more susceptible to life-threatening viral and bacterial infections as a result.
“We don’t have a full understanding of when and how anifrolumab should be used in patients with cutaneous lupus,” says study lead author Jun Kang , M.D., an assistant professor of dermatology at the Johns Hopkins University School of Medicine. “We’re establishing evidence-based context and understanding for how this medication can be used and what providers can expect when prescribing it to patients.”
For the study, the researchers compared the health outcomes of 71 adults with coexisting chronic cutaneous lupus erythematosus and systemic lupus erythematosus after one year of treatment. The patients were divided into three treatment groups: those taking conventional immunosuppressants (46 adults), those taking a combination of anifrolumab and conventional immunosuppressants (13 adults), and those taking anifrolumab alone (12 adults). Overall, the study group was predominantly female (90.1%) and predominantly diagnosed (94.4%) with the discoid subtype of chronic skin lupus.
After one year, the researchers found that infection rates were broadly comparable among all three groups (65.2%, 69.2% and 66.7%, respectively), but they reported distinct differences with respect to the types of infections reported and treatments required per group.
Specifically, the researchers found that patients prescribed conventional immunosuppressants had the highest number of infections requiring hospitalization (32.6% versus 23.1% and 0%). Similarly, 47.8% of patients on immunosuppressants, 38.5% of patients on both anifrolumab and a conventional immunosuppressant, and 8.3% of patients on anifrolumab had infections that required systemic antibiotics.
The researchers also observed that patients on conventional immunosuppressants were most likely to report having a bacterial infection (50.0% versus 30.8% and 8.3%), and those taking anifrolumab with an immunosuppressant or alone were more likely to report viral infections (53.8% and 41.7%, respectively).
Finally, the research team found that pneumonia (15.2%) and soft tissue infections (23.9%) were almost exclusively found in the patients who were only prescribed conventional immunosuppressants.
Kang’s research team hopes their findings will give clinicians a clearer understanding of how anifrolumab can benefit patients with chronic skin lupus who have not responded well to other treatments, and they believe their findings will ultimately help clinicians develop new guidelines for managing the disease.
“Up until now, there have been one-off case reports and case series discussing anifrolumab for chronic cutaneous lupus erythematosus, but our real-world findings should provide stronger evidence and greater clarity on how this medication can be used,” says Kang.
In addition to lead author Anjana Srikumar and senior author Jun Kang, Varsha Simha and Nicholas Urbanski authored the study.
Jun Kang reports serving as a site principal investigator for AstraZeneca’s LAVENDER trial, which is evaluating anifrolumab as a therapy targeting type I interferon signaling for adults with chronic and/or subacute cutaneous lupus erythematosus.
The study was supported by Jun Kang’s Dermatology Foundation Medical Dermatology Career Development Award.
DOI: 10.1111/jdv.70694
Journal of the European Academy of Dermatology and Venereology