University Hospital Southampton NHS Foundation Trust, Southampton, UK.
MSK Research Unit, NIHR Wellcome Trust Clinical Research Facility, University of Southampton, UK.
Autoimmun Rev. 2016 Jul;15(7):742-6. doi: 10.1016/j.autrev.2016.03.013. Epub 2016 Mar 10.
Biologic dose reduction strategies, for patients with inflammatory rheumatic diseases, have been assessed in multiple studies to assess outcomes compared to ongoing maintenance dosing. Whilst cessation in established disease usually leads to disease flare, dose tapering approaches for those achieving low disease activity often appear to be successful in the short term. However, tapering can be associated with a higher risk of losing disease control and rates of recapture of disease control using the original biologic dose vary between studies. Over relatively short periods of follow-up, a number of studies have shown no statistical difference in radiographic progression in patients tapering or discontinuing biologics. However, a Cochrane review found that radiographic and functional outcomes may be worse after TNF inhibitor discontinuation, and over long-term disease follow-up flares have been associated with radiographic progression and worse patient reported outcomes. To date, no studies of biological therapy dose reduction have specifically investigated the risk of increased immunogenicity or the effects on cardiovascular risk and other co-morbidities, although these remain important potential risks. In addition, whether there are greater dangers in certain dose reduction approaches such as a reduction in dose at the same frequency or a spacing of doses is not established.
生物制剂剂量降低策略已在多项研究中评估，以评估与持续维持剂量相比的结果。虽然在已确诊的疾病中停止治疗通常会导致疾病复发，但对于达到低疾病活动度的患者，逐渐减少剂量的方法在短期内似乎是成功的。然而，逐渐减少剂量可能会增加失去疾病控制的风险，并且在不同的研究中，使用原始生物制剂剂量重新获得疾病控制的比例也有所不同。在相对较短的随访期间，一些研究表明，在逐渐减少或停止使用生物制剂的患者中，放射学进展没有统计学差异。然而，一项 Cochrane 综述发现，在停止使用 TNF 抑制剂后，放射学和功能结果可能更差，并且在长期疾病随访中，复发与放射学进展和患者报告的更差结果相关。迄今为止，尚无专门研究生物治疗剂量降低风险的研究调查增加免疫原性的风险或对心血管风险和其他合并症的影响，尽管这些仍然是潜在的重要风险。此外，在某些剂量降低方法（如相同频率降低剂量或间隔剂量）中是否存在更大的危险尚不确定。
