The long-term (≥12-month) use of tumor necrosis factor-α (TNF-α) inhibitor therapy in patients with psoriasis may increase their malignancy risk. A nested case-control analysis, published in the Journal of the American Academy of Dermatology, was conducted in patients with psoriasis and no prior history of malignancy to evaluate the effect of systemic psoriasis treatment on risk for malignancy.
Cases were retrieved from the Psoriasis Longitudinal Assessment and Registry (PSOLAR). The PSOLAR registry comprised a long-term, prospective, observational cohort of patients with moderate to severe psoriasis, ≥18 years of age, who were either currently receiving or were candidates to receive systemic psoriasis therapy (including phototherapy) at North American, South American, and European clinics.
Planned follow-up for each patient was at least 8 years. As of the August 23, 2015, cutoff for the study analysis, a total of 12,090 registry participants had been followed for a median of 4.17 years (maximum follow-up, 8.2 years).
Study treatments included methotrexate, ustekinumab (anti-interleukin 12/23 antibody), and TNF-α inhibitors (etanercept, adalimumab, infliximab). Exposure was defined as ≥1 doses of study therapy within 12 months of malignancy onset, which was further stratified according to duration of treatment.
Of the 12,090 participants, 252 malignancy cases were detected and 1008 control patients were matched. Treatment with methotrexate or ustekinumab for >0 to <3 months, 3 months to <12 months, or ≥12 months was not associated with increased risk for malignancy compared with no exposure.
In contrast, longer-term (≥12 months) treatment with a TNF-α inhibitor was significantly associated with increased malignancy risk (odds ratio [OR], 1.54; 95% CI, 1.10-2.15; P =.01).
According to the researchers, long-term treatment with a TNF-α inhibitor, but not with methotrexate or ustekinumab, may increase overall malignancy risk among patients with psoriasis. Additional studies are warranted to further investigate these associations and help clinicians make informed therapeutic decisions.
Fiorentino D, Ho V, Lebwohl MG, et al. Risk of malignancy with systemic psoriasis treatment in the Psoriasis Longitudinal Assessment Registry. J Am Acad Dermatol. 2017;77(5):845-854.