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Risks of Melanoma, Other Skin Cancers Are Higher in Patients Treated With Biologics for Psoriasis
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It is important to study the safety of targeted therapies in populations at increased risk of skin cancer, according to the researchers.
Patients treated with biologics for psoriasis had higher risks of melanoma and nonmelanoma skin cancer (NMSC) compared with the general population, according to a recent study.
These findings suggest a need for a better understanding of skin cancer risks associated with targeted therapies in patients with psoriasis.
This meta-analysis is published in Pharmaceuticals (Basel).
“Our systematic review and meta-analysis aimed to analyze the risk of melanoma and [NMSC] in patients with psoriasis and psoriatic arthritis treated with targeted therapies,” the researchers wrote. “To the best of our knowledge, this is the first analysis to summarize the risk of skin malignancy in patients undergoing treatment with IL-17 and IL-23 inhibitors.”
While the introduction of biologic agents, such as tumor necrosis factor (TNF-α) inhibitors, inhibitors of the IL-17 pathway, inhibitors of IL-23, and related cytokines, as well as Janus kinase (JAK) inhibitors, have been a huge breakthrough in the treatment of psoriasis and psoriatic arthritis, there is concern that these biologics may increase the risk for infections and malignancies.
The researchers searched databases MEDLINE/PubMed, EMBASE, Web of Science, and Cochrane Library to find studies that reported on the incidence rates (IRs) of melanoma and NMSC in patients with psoriasis or psoriatic arthritis treated with biologics or JAK inhibitors.
Eligible studies were randomized controlled trials (RCTs), open-label studies, long-term extension studies, or observational studies. Additionally, eligible studies included adult patients with psoriasis or psoriatic arthritis treated with IL-17 inhibitors, IL-12/23 inhibitors, IL-23 inhibitors, or JAK inhibitors. Furthermore, studies included reported IRs of melanoma and NMSC presented as number of events per 100 patient-years (PY) or clearly reported numbers of skin cancer events with the total number of PY of exposure.
The extracted information included the title of the article, name of the first author, year of publication, study design, database or clinical trial identifier, diagnosis, patient characteristics (sample size, sex, age), type(s) of biologic therapy, total PY exposure, the use of concomitant therapy, and outcomes of interest.
In total, 19 studies were included for analysis, including 13,739 patients. Overall, the IR of melanoma was 0.08 (95% CI, 0.05-0.15) events per 100 PYs and the overall IR of NMSC was 0.45 (95% CI, 0.33-0.61) events per 100 PYs. The researchers noted that the CDC has estimated the IRs in the general population to be 0.02 for melanoma and 0.08 for NMSC per 100 persons.
Furthermore, the IRs of melanoma were comparable across patients treated with IL-17 inhibitors, IL-23 inhibitors, and JAK inhibitors, and the IR of NMSC was higher in patients treated with JAK inhibitors compared with those treated with biologics.
However, the researchers acknowledged some limitations to the study. First, the number of studies evaluated was relatively small, which was partly because the established inclusion criteria required the expression of IR as events per 100 PY. Second, the follow-up duration in the included studies may have been insufficient, resulting in an underestimation of the associated risks. The researchers were also unable to compare the safety of these drugs with a healthy population or with biologic-naïve patients. Moreover, RCTs including patients with psoriatic arthritis allowed for the concomitant use of targeted drugs and methotrexate, which may have influenced the risk of skin cancers.
Despite these limitations, the researchers believe the study provides a comprehensive review of skin cancer risk associated with biologics, finding that the risk of melanoma and NMSC is higher in patients who receive biologic treatments for psoriasis or psoriatic arthritis.
“Prospective, long-term cohort studies using an active or placebo comparator are required to reliably assess the risks associated with novel targeted therapies,” wrote the researchers. “Furthermore, an assessment of the safety of targeted therapies in populations at increased risk of skin cancer is recommended, along with the establishment of guidelines for their use and monitoring in these specific populations.”
Reference
Krzysztofik M, Brzewski P, Cuber P, et al. Risk of melanoma and non-melanoma skin cancer in patients with psoriasis and psoriatic arthritis treated with targeted therapies: a systematic review and meta-analysis. Pharmaceuticals (Basel). 2023;17(1):14. doi:10.3390/ph17010014
