Mirzaei Alireza, Jahed Seyed Adel, Amini Kadijani Azade, Zabihiyeganeh Mozhdeh
Bone and Joint Reconstruction Research Center, Shafa Orthopedic Hospital, Iran University of Medical Sciences, Tehran, Iran.
Diabetes Advisory Committee, Gabric Diabetes Education Association, Tehran, Iran.
Med J Islam Repub Iran. 2021 Jan 21;35:12. doi: 10.47176/mjiri.35.12. eCollection 2021.
There is no clear consensus regarding the potential of denosumab for increasing the risk of infection in patients who concurrently receive biologic disease-modifying anti-rheumatic drugs (bDMARDs). In this study, we compared the rate of infection in postmenopausal women with rheumatoid arthritis who received concurrent bDMARDs and denosumab with those who received bDMARDs alone. In a case-control study, postmenopausal patients with a confirmed diagnosis of rheumatoid arthritis who received concurrent bDMARDs and denosumab for at least one year were identified and included as the case group (n=40). A total of 44 age-matched postmenopausal rheumatoid arthritis women who received bDMARDs alone were included as the control group of the study. Using a chi-squared test, the incidence of bacterial or viral infections was extracted from the patients' profiles and compared between the two study groups. Statistical analyses were performed by SPSS for Windows, version 16 (Chicago, Illinois, USA). A p-value of fewer than 0.05 was regarded as significant. The clinical and demographic characteristics of the patients of the two study groups were not significantly different. In total, four infections were recorded in the present series, two infections in each group. Accordingly, the rate of infection was 4.5% in the bDMARDs alone group and 5% in bDMARDs + denosumab group. This difference was not statistically significant (p=0.655, 95% CI: 0.121-6.742). Three out of four infections were herpes zoster infection. The other one was osteomyelitis of the first metatarsal bone, which occurred in the bDMARDs+denosumab group. None of the infections needed a hospitalization of IV antibiotics. The risk of infection is comparable between postmenopausal osteoporotic women with rheumatoid arthritis who receive bDMARDS alone and those who receive bDMARDS in combination with denosumab.
对于地诺单抗在同时接受生物性疾病改善抗风湿药物（bDMARDs）的患者中增加感染风险的可能性，目前尚无明确的共识。在本研究中，我们比较了同时接受bDMARDs和地诺单抗的绝经后类风湿关节炎女性与仅接受bDMARDs的女性的感染率。在一项病例对照研究中，确诊为类风湿关节炎且同时接受bDMARDs和地诺单抗至少一年的绝经后患者被确定并纳入病例组（n = 40）。共有44名年龄匹配的仅接受bDMARDs的绝经后类风湿关节炎女性被纳入研究对照组。使用卡方检验，从患者资料中提取细菌或病毒感染的发生率，并在两个研究组之间进行比较。统计分析由美国伊利诺伊州芝加哥市SPSS for Windows 16版软件进行。p值小于0.05被视为具有统计学意义。两个研究组患者的临床和人口统计学特征无显著差异。本系列研究共记录了4例感染，每组各2例。因此，仅接受bDMARDs组的感染率为4.5%，bDMARDs + 地诺单抗组为5%。这种差异无统计学意义（p = 0.655，95%可信区间：0.121 - 6.742）。4例感染中有3例为带状疱疹感染。另一例是第一跖骨骨髓炎，发生在bDMARDs + 地诺单抗组。所有感染均无需住院接受静脉抗生素治疗。仅接受bDMARDs的绝经后骨质疏松性类风湿关节炎女性与接受bDMARDs联合地诺单抗的女性相比，感染风险相当。
