Treatment with the interleukin-4 receptor alpha antibody dupilumab is not associated with changes in lymphoma risk in patients with atopic dermatitis or other type 2 inflammatory diseases, according to a large-scale retrospective cohort study published in Frontiers in Medicine.
Prior to this analysis, the association between atopic dermatitis (AD) and lymphoma risk remained inconclusive. Researchers added that dupilumab, approved for moderate-to-severe AD, has previously been linked to an increased lymphoma risk, raising concerns about its safety profile.
Based on their findings, lead study author Khalaf Kridin, MD, PhD, of the University of Lübeck in Germany, and colleagues commented: “[Type 2 inflammatory diseases], including AD, are associated with a significantly increased risk for lymphoma. Treatment with dupilumab partially ameliorates this risk association, especially for [non-Hodgkin lymphoma].”
Study Details
In the study, the researchers used the TriNetX database to clarify the association between AD and lymphoma risk and extend the analysis to nondermatologic type 2 inflammatory diseases. They also evaluated the impact of dupilumab on lymphoma risk in AD and nondermatologic type 2 inflammatory diseases. Propensity-score matching was applied to improve comparability between groups, and sensitivity analyses were conducted to ensure the robustness of the results.
Type 2 Inflammatory Diseases and Lymphoma
Across 801,508 cases and controls, AD was found to increase the risk of lymphoma (eg, cutaneous T-cell lymphoma and non-Hodgkin lymphoma). Nondermatologic type 2 inflammatory diseases likewise appeared to confer a heightened lymphoma risk, across 14.4 million cases and controls.
Dupilumab and Lymphoma
In the comparison of patients with AD who received dupilumab vs other systemic therapies (n = 7,840 per group), dupilumab exposure didn't seem to alter lymphoma risk but tended toward reductions. The researchers reported that this decreased risk association was most evident in nondermatologic type 2 inflammatory diseases (n = 16,908 per group).
Study limitations included the retrospective nature of the analysis, quality of the data, and possible false registration of ICD-10 codes.
The study authors concluded: “In the interim, our findings support the safety of dupilumab. Specifically, there was no observed association between dupilumab treatment and increased lymphoma risk; in contrast, lower [non-Hodgkin lymphoma] rates were associated with dupilumab use relative to other systemic treatments in nondermatologic [type 2 inflammatory diseases].”
Disclosures: Co–study author Diamant Thaçi has received honoraria or fees for serving on advisory boards; as a speaker; as a consultant from AbbVie, Amgen, Almirall, Beiersdorf, Bristol-Meiers-Squibb, Boehringer Ingelheim, Galapagos, Leo Pharma, Merck Sharp & Dohme, Morphosys, Lilly, Novartis, Janssen-Cilag, Pfizer, Regeneron, Sanofi, Hexal, Sun Pharmaceuticals, and UCB; and grants from Leo Pharma and Novartis. Co–study author Gema Hernandez was an employee of TriNetX. Co–study author Henner Zirpel has received support for attending meetings and/or travel from Pfizer, UCB Pharma, Almirall, Janssen, TriNetX. Senior study author Ralf Ludwig has received honoraria for speaking or consulting or has obtained research grants from Monasterium Laboratories, Novartis, Lilly, Bayer, Dompe, Synthon, Argen-X, TriNetX, and Incyte during the last 3 years. No other conflicts of interest were reported.
Source: Frontiers in Medicine
