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与用于治疗银屑病和银屑病关节炎的生物制剂、改善病情抗风湿药及皮质类固醇相比,阿普米司特治疗带状疱疹、丙型肝炎和结核病的风险

Herpes Zoster, Hepatitis C, and Tuberculosis Risk with Apremilast Compared to Biologics, DMARDs and Corticosteroids to Treat Psoriasis and Psoriatic Arthritis.

作者信息

Hagberg Katrina Wilcox, Persson Rebecca, Vasilakis-Scaramozza Catherine, Niemcryk Steve, Peng Michael, Paris Maria, Lindholm Anders, Jick Susan

机构信息

Boston Collaborative Drug Surveillance Program, Lexington, MA 02421, USA.

Celgene Corporation, Summit, NJ 07901, USA.

出版信息

Clin Epidemiol. 2020 Feb 12;12:153-161. doi: 10.2147/CLEP.S239511. eCollection 2020.

Abstract

PURPOSE

Psoriasis and psoriatic arthritis (PsA) are associated with an increased infection risk. In this cohort study of patients with treated psoriasis or PsA, we used MarketScan (2014-2018) to estimate rates of herpes zoster, hepatitis C (HepC) and tuberculosis (TB) with apremilast compared to other systemic treatments.

MATERIALS AND METHODS

Patients were exposed from first apremilast [APR], DMARD, TNF-inhibitor [TNF], IL-inhibitor [IL], or corticosteroids [CS] prescription after March 21, 2014. Study exposures were APR, DMARDs only, TNF-only, IL-only, CS-only, DMARDs+CS, TNF+DMARDs and/or CS, IL+DMARDs and/or CS. Cases had treated herpes zoster, HepC, or TB event. We calculated incidence rates (IRs) [95% confidence intervals] per 1000 patient-years.

RESULTS

The study population included 131,604 patients. For herpes zoster (N=2271), IRs were highest for users of DMARDs+CS (12.5 [9.8-15.7]), CS-only (12.5 [10.4-14.1]), and TNF+DMARDs and/or CS (11.9 [10.6-13.4]), compared with DMARDs only (9.9 [8.7-11.2]). IRs were lowest for users of IL-only (6.7 [5.8-7.8]) and APR (7.0 [5.8-8.4]). IRs of HepC (N=150) and TB (N=81) were low and between-treatment differences were not significant.

CONCLUSION

Rates of herpes zoster varied by treatment: highest among those who received polytherapy, lowest in users of apremilast only. IRs for HepC and TB were low for all exposures.

摘要

目的

银屑病和银屑病关节炎(PsA)与感染风险增加相关。在这项针对接受治疗的银屑病或PsA患者的队列研究中,我们使用MarketScan(2014 - 2018年)来估计与其他全身治疗相比,阿普米司特治疗带状疱疹、丙型肝炎(HepC)和结核病(TB)的发生率。

材料和方法

患者自2014年3月21日首次开具阿普米司特[APR]、改善病情抗风湿药(DMARD)、肿瘤坏死因子抑制剂[TNF]、白细胞介素抑制剂[IL]或皮质类固醇[CS]处方后开始纳入研究。研究暴露因素包括阿普米司特、仅使用DMARDs、仅使用TNF、仅使用IL、仅使用CS、DMARDs + CS、TNF + DMARDs和/或CS、IL + DMARDs和/或CS。病例为发生治疗过的带状疱疹、HepC或TB事件的患者。我们计算了每1000患者年的发病率(IRs)[95%置信区间]。

结果

研究人群包括131,604名患者。对于带状疱疹(N = 2271),与仅使用DMARDs(9.9 [8.7 - 11.2])相比,DMARDs + CS使用者(12.5 [9.8 - 15.7])、仅使用CS者(12.5 [10.4 - 14.1])以及TNF + DMARDs和/或CS使用者(11.9 [10.6 - 13.4])的发病率最高。仅使用IL者(6.7 [5.8 - 7.8])和阿普米司特使用者(7.0 [5.8 - 8.4])的发病率最低。HepC(N = 150)和TB(N = 81)的发病率较低,且治疗组间差异不显著。

结论

带状疱疹的发病率因治疗方式而异:接受联合治疗的患者中发病率最高,仅使用阿普米司特的患者中发病率最低。所有暴露因素下HepC和TB的发病率均较低。

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