He Dongyi, Bai Fengmin, Zhang Shu, Jiang Ting, Shen Jie, Zhu Qi, Yue Tao, Shao Lingyun, Gao Yan, Feng Yun, Weng Xinhua, Zou Hejian, Zhang Ying, Zhang Wenhong
Department of Rheumatology, Shanghai Guang Hua Hospital of Integrated Traditional and Western Medicine, Shanghai, China.
Clin Vaccine Immunol. 2013 Jun;20(6):842-7. doi: 10.1128/CVI.00049-13. Epub 2013 Apr 3.
We conducted a long-term follow-up study in patients with rheumatic diseases who were candidates for biologics treatment to evaluate the effects of biologic agents on the risk of tuberculosis infection and the effect of prophylactic treatment on tuberculosis activation. One hundred one patients with rheumatic diseases who were candidates for biologics treatment were recruited, and 57 healthy subjects were recruited as controls. Tuberculin skin test (TST) and the T-SPOT.TB test were performed for all subjects at baseline. Follow-up testing by the T-SPOT.TB assay was performed every 6 months in patients with rheumatic diseases and at 2 years of recruitment in the healthy controls. In patients with rheumatic diseases and healthy controls, the TST-positive (induration, ≥10 mm) rates were 37.6% (38/101) and 34.0% (18/53), respectively (P > 0.05), while the T-SPOT.TB-positive rates were 46.5% (47/101) and 21.1 (12/57), respectively (P = 0.0019). Fifty-two patients were followed up at month 6 with a T-SPOT.TB-positive rate of 40.4%, and 49 were followed up for ≥12 months with a T-SPOT.TB-positive rate of 36.7%, with no significant difference in the positive rate at different time points including baseline (P > 0.05). Long-term follow-up revealed that conversion to T-SPOT.TB positivity occurred only in the biologics treatment group, with a positive conversion rate of 11.2% (4/38). Most importantly, no latent tuberculosis developed into active tuberculosis during follow-up with T-SPOT.TB screening and preemptive treatment with isoniazid. Biologics treatment appears to increase the risk of tuberculosis infection. However, tuberculosis activation could be prevented by preemptive isoniazid treatment in patients with latent tuberculosis infection while receiving biologics therapy.
我们对有生物制剂治疗指征的风湿性疾病患者进行了一项长期随访研究，以评估生物制剂对结核感染风险的影响以及预防性治疗对结核激活的影响。招募了101例有生物制剂治疗指征的风湿性疾病患者，并招募了57名健康受试者作为对照。在基线时对所有受试者进行结核菌素皮肤试验（TST）和T-SPOT.TB检测。风湿性疾病患者每6个月进行一次T-SPOT.TB检测随访，健康对照在入组2年时进行检测。在风湿性疾病患者和健康对照中，TST阳性（硬结≥10 mm）率分别为37.6%（38/101）和34.0%（18/53）（P>0.05），而T-SPOT.TB阳性率分别为46.5%（47/101）和21.1%（12/57）（P = 0.0019）。52例患者在第6个月进行随访，T-SPOT.TB阳性率为40.4%，49例患者随访≥12个月，T-SPOT.TB阳性率为36.7%，包括基线在内的不同时间点阳性率无显著差异（P>0.05）。长期随访显示，仅在生物制剂治疗组出现T-SPOT.TB阳性转换，阳性转换率为11.2%（4/38）。最重要的是，在T-SPOT.TB筛查和异烟肼预防性治疗的随访期间，没有潜伏结核发展为活动性结核。生物制剂治疗似乎会增加结核感染风险。然而，在接受生物制剂治疗的潜伏结核感染患者中，预防性使用异烟肼治疗可预防结核激活。
