Biologic Therapy is Associated with Reduced Risk of Malignancy in Psoriasis

Treatment of psoriasis with biologic therapies is associated with a significant reduction in patients’ risk of malignancy compared to topical monotherapies, according to recent findings.1

The analysis resulting in these findings was conducted to expand upon the lack of data on long-term effects of biologics on patients’ risk of malignancy for those with psoriasis. This research was authored by such investigators as Saori Takamura, from the Saitama Medical Center Department of Dermatology in Japan.

Takamura and colleagues highlighted conflicting data that had previously been published on the topic, including a meta-analysis which identified an increased risk of non-melanoma skin cancers (NMSC) in patients with psoriasis given tumor necrosis factor inhibitors (TNFi).2 Another previous meta-analysis, however, had not found a significant link between cumulative biologic exposure and patients’ cancer risk, other than NMSC.3

“To date, no study has directly compared the malignancy risk in psoriasis patients treated with biologic therapy versus those treated with topical monotherapy,” Takamura and coauthors wrote.1 “Therefore, this study aimed to evaluate the incidence of malignancies in psoriasis patients undergoing continuous biologic therapy compared with those treated with topical therapy alone. Additionally, we sought to provide insights into the overall malignancy burden in psoriasis patients to inform clinical decision-making.”

Study Design Details

In conducting this analysis, the investigative team aimed to compare the incidence of malignancy between individuals with psoriasis who were being treated with continuous biologic therapy and patients treated with topical monotherapy. There were a total of 446 adult subjects with psoriasis who were provided with either biologic monotherapy (n = 226) or topical monotherapy (n = 220) at the team's institution who were also included in this study.

Data on these 446 patients with psoriasis were retrospectively analyzed by Takamura et al at a single center between May 2010 - March 2023. The investigators estimated malignancy incidence through the Kaplan–Meier method. They also employed a multivariable Cox proportional hazards regression with propensity score adjustment to control for any confounding variables in their evaluation.

Additionally, Takamura and colleagues carried out a subgroup analysis within the biologic-treated cohort with the aim of identifying any additional malignancy risk factors.

Findings on Malignancy Risk with Biologics

The investigators identified malignancies among 11.2% of the 446 subjects, noting that the rates in each cohort were 4.4% and 18.2% in the biologic arm and in the topical therapy arm, respectively (P < .0001).1 Their Kaplan–Meier analysis demonstrated a significantly diminished cumulative incidence of malignancy among those included in the biologic group (P = .0035).

Confirmation of biologic therapies' significant reduction in malignancy risk was confirmed in Takamura and coauthors' Cox regression (hazard ratio [HR]: 0.316; 95% confidence interval [CI]: 0.119–0.841; P = .0211).1 Additionally, there was another notable finding highlighted in the study's subgroup analysis.

This finding, identified via Cox regression within the biologic-treated cohort, revealed that family history of malignancy had a significant association with increased risk of malignancy (HR: 9.01; 95% CI: 1.69–4.87; P < .05).1 Overall, the team's findings point to biologic therapy's link with a significantly reduced risk of malignancy in those with psoriasis compared to topical monotherapy.

“These findings highlight the importance of individualized risk assessment when selecting treatment strategies and suggest that biologic therapy may serve as a viable and potentially safer option for patients with an elevated baseline cancer risk,” they concluded.1 “Nonetheless, further large-scale, prospective studies are warranted to validate these observations and to inform personalized, risk-adapted management approaches in clinical practice.”

References

1. S Takamura, S Saito, S Sugai, et al. Biologic Therapy and Malignancy Risk in Psoriasis: A Retrospective Cohort Study. The Journal of Dermatology (2025): 1–7, https://doi.org/10.1111/1346-8138.17950. Accessed September 9, 2025.

2. Peleva E, Exton LS, Kelley K, Kleyn CE, Mason KJ, Smith CH. Risk of cancer in patients with psoriasis on biological therapies: a systematic review. Br J Dermatol. 2018 Jan;178(1):103-113. doi: 10.1111/bjd.15830. Epub 2017 Dec 18. PMID: 28722163.

3. S Vaengebjerg, L Skov, N Loft, et al. Association of Psoriasis With the Risk of Developing or Dying of Cancer: Prevalence, Incidence, and Risk of Cancer in Patients With Psoriasis and Psoriatic Arthritis: A Systematic Review and Meta-Analysis. JAMA Dermatology 156 (2020): 421–429.