Assessment of Primary Malignancy Risk after Initiation of Biologic Therapy in Patients with Psoriasis

Chunghwan Ro , Ana Ormaza Vera , Waleed Adawi , Alexander Yap , Clinton W. Enos
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Abstract

Limited evidence exists regarding the long-term oncologic safety of biologic therapies, particularly IL-17 inhibitors and IL-23 inhibitors, in the management of psoriasis. This propensity score–matched retrospective cohort study assessed the risk of developing a primary malignancy within 10 years after exposure to a Food and Drug Administration–approved biologic among patients with psoriasis compared with that among biologic-naïve controls. After propensity score matching, 32,230 biologic-exposed patients were further grouped into cohorts of TNF inhibitors (n = 16,011), IL-23 inhibitors (n = 5604), IL-12/23 inhibitors (n =3856), and IL-17 inhibitors (n = 5467). During a 10-year period, TNF inhibitor–treated patients had a reduced risk of developing any primary malignancy compared with biologic-naïve patients with psoriasis (hazard ratio [HR] = 0.80; 95% confidence interval [CI] = 0.73–0.87). Similarly, a lower incidence of any malignancy was observed among patients on IL-23 inhibitors (HR = 0.83; 95% CI = 0.68–1.02), IL-12/23 inhibitors (HR = 0.85; 95% CI = 0.71–1.03), or IL-17 inhibitors (HR = 0.87; 95% CI = 0.73–1.04); however, the differences did not reach statistical significance. TNF inhibitor users were less likely to develop nonmelanoma skin cancer (HR = 0.82; 95% CI = 0.71–0.96) than controls, and the risk of nonmelanoma skin cancer did not significantly differ among users of IL-23 inhibitors (HR = 1.09; 95% CI = 0.77–1.55), IL-12/23 inhibitors (HR = 1.22; 95% CI = 0.90–1.64), or IL-17 inhibitors (HR = 1.03; 95% CI = 0.77–1.38). Exposure to any biologic class did not associate with the risk of developing melanoma or lymphoid/hematopoietic malignancies. Overall, these results provide evidence for the long-term oncologic safety of biologic therapies in the management of psoriasis.
银屑病患者开始生物治疗后原发性恶性肿瘤风险的评估
关于生物疗法,特别是IL-17抑制剂和IL-23抑制剂治疗银屑病的长期肿瘤学安全性的证据有限。这项倾向评分匹配的回顾性队列研究评估了银屑病患者暴露于食品和药物管理局批准的生物制剂后10年内发生原发性恶性肿瘤的风险,并与biologic-naïve对照组进行了比较。在倾向评分匹配后,32,230名生物暴露患者被进一步分组为TNF抑制剂(n = 16,011), IL-23抑制剂(n = 5604), IL-12/23抑制剂(n =3856)和IL-17抑制剂(n = 5467)。在10年期间,与biologic-naïve银屑病患者相比,TNF抑制剂治疗的患者发生任何原发性恶性肿瘤的风险降低(风险比[HR] = 0.80;95%置信区间[CI] = 0.73-0.87)。同样,在使用IL-23抑制剂的患者中,任何恶性肿瘤的发生率都较低(HR = 0.83;95% CI = 0.68-1.02), IL-12/23抑制剂(HR = 0.85;95% CI = 0.71-1.03)或IL-17抑制剂(HR = 0.87;95% ci = 0.73-1.04);但差异无统计学意义。TNF抑制剂使用者发生非黑色素瘤皮肤癌的可能性较低(HR = 0.82;95% CI = 0.71-0.96),非黑色素瘤皮肤癌的风险在使用IL-23抑制剂的人群中没有显著差异(HR = 1.09;95% CI = 0.77-1.55), IL-12/23抑制剂(HR = 1.22;95% CI = 0.90-1.64)或IL-17抑制剂(HR = 1.03;95% ci = 0.77-1.38)。暴露于任何生物类与发生黑色素瘤或淋巴/造血恶性肿瘤的风险无关。总之,这些结果为银屑病生物治疗的长期肿瘤学安全性提供了证据。
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