Huang Yi-Wei, Tsai Tsen-Fang
National Taiwan University Hospital, Taipei, Taiwan.
Department of Dermatology, National Taiwan University Hospital, Taipei, Taiwan.
Dermatol Ther (Heidelb). 2019 Sep;9(3):553-569. doi: 10.1007/s13555-019-0310-5. Epub 2019 Jul 3.
Relapse is common after treatment discontinuation for patients with moderate-to-severe psoriasis. The objective of this study was to understand the remission duration and long-term outcomes in psoriasis patients after biologic withdrawal.
We retrospectively included the follow-up data of 184 patients with moderate-to-severe psoriasis after the end of 11 biologic or tofacitinib trials conducted between 2004 and 2016.
Among the 232 treatment courses, 95 achieved (psoriasis area and severity index) PASI 75 at the end of the studies. At 6 months after treatment discontinuation, the systemic treatment-free rates of our patients who entered the PRESTA, PRISTINE, PEARL, ERASURE, CLEAR, the global tofacitinib study, and the IXORA-P study were 66.7%, 66.7%, 75.0%, 16.7%, 22.2%, 33.3%, and 29.2%, respectively. Pooled data showed a serious adverse event incidence rate of 1.5/100 person-years. The proportions of systemic treatment-free episodes were 16.8%, 7.4%, 4.3%, 3.2%, and 3.2% at 1, 2, 3, 4, and 5 years, respectively. Biologics were reinitiated in 41.9%, 66.7%, 77.1%, 83.5%, and 86.1% at 1, 2, 3, 4, and 5 years, respectively. Multivariate generalized estimating equation (GEE) regression analysis demonstrated that predictors for a longer relapse-free duration were baseline PASI, PASI improvement, biologic naivety, and early biologic intervention. Patients who received early biologic intervention, who achieved PASI 90, and who were biologic naive showed significantly higher relapse-free rate by Kaplan-Meier analysis with log rank test.
Systemic treatment was required in 86.1% of patients within 12 months after biologic withdrawal and biologics were reinitiated in 77.1% of patients after 3 years. However, early biologic administration within 2 years after diagnosis demonstrated a lower risk of relapse in patients with moderate-to-severe psoriasis.
中重度银屑病患者在停止治疗后复发很常见。本研究的目的是了解银屑病患者停用生物制剂后的缓解持续时间和长期预后。
我们回顾性纳入了2004年至2016年间进行的11项生物制剂或托法替布试验结束后184例中重度银屑病患者的随访数据。
在232个治疗疗程中，95个在研究结束时达到（银屑病面积和严重程度指数）PASI 75。在停药6个月时，进入PRESTA、PRISTINE、PEARL、ERASURE、CLEAR、全球托法替布研究和IXORA-P研究的患者的无全身治疗率分别为66.7%、66.7%、75.0%、16.7%、22.2%、33.3%和29.2%。汇总数据显示严重不良事件发生率为1.5/100人年。在1、2、3、4和5年时，无全身治疗发作的比例分别为16.8%、7.4%、4.3%、3.2%和3.2%。在1、2、3、4和5年时，分别有41.9%、66.7%、77.1%、83.5%和86.1%的患者重新开始使用生物制剂。多变量广义估计方程（GEE）回归分析表明，复发-free持续时间较长的预测因素是基线PASI、PASI改善、未使用过生物制剂和早期生物制剂干预。通过Kaplan-Meier分析和对数秩检验，接受早期生物制剂干预、达到PASI 90且未使用过生物制剂的患者显示出显著更高的无复发率。
生物制剂停用后12个月内，86.1%的患者需要进行全身治疗，3年后77.1%的患者重新开始使用生物制剂。然而，在诊断后2年内早期使用生物制剂表明中重度银屑病患者复发风险较低。
