Hsieh Chang-Yu, Hsu Francis Li-Tien, Tsai Tsen-Fang
Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, No. 7, Zhongshan S. Rd., Zhongzheng Dist., Taipei City, 100, Taiwan, Republic of China.
Dermatol Ther (Heidelb). 2024 Sep;14(9):2607-2620. doi: 10.1007/s13555-024-01229-6. Epub 2024 Jul 29.
Knowing the remission duration after biologics discontinuation in patients with psoriasis is important, especially when disease relapse is defined as the restart of systemic agents, because it also reflects the real-world clinical practice when topical treatment alone is not adequate for disease control, and a systemic treatment, including biologic, is needed. Biologics are currently indicated for patients with psoriasis who are candidates for systemic treatments.
We included 42 patients who were followed up with regularly after the end of risankizumab, guselkumab and mirikizumab trials and investigated the drug-free remission (DFR). A Kaplan-Meier survival analysis and Cox regression model were employed to identify the possible risk factors for relapse.
Overall, 38/42 (90.5%) patients experienced relapses after discontinuing trial biologics during the follow-up period of at least 96 weeks and up to 227 weeks. In all patients with relapse, the median DFR was 104 days. Kaplan-Meier survival analysis revealed a significant 1-year drug-free survival (DFS) difference between risankizumab (Z) and guselkumab (T) + mirikizumab (M) (p = 0.0462). A difference in DFS curves was noted when patients were categorized by disease duration > or ≤ 2 years (p = 0.1577) and maintenance of a psoriasis area and severity index score (PASI) of 90 at the end of trials (p = 0.1177). Univariate Cox regression model identified that age [hazard ratio (HR) = 1.030 (1.000-1.060), p = 0.0467] and disease duration [HR = 1.046(1.009-1.084), p = 0.0134] were significantly associated with relapse risk. A risk model was established on the basis of multivariable Cox regression results. Risk value = 0.021038 * Age + 0.515628 * Biologic_type (Z = 0,T/M = 1) + 0.025048 * Disease_Duration. The validated patients were divided into two groups by median risk value (1.5). The high-risk group (risk value > 1.5) had a non-significant higher relapse risk than the low-risk group (risk value < 1.5), with a hazard ratio of 1.62 [95% confidence interval (CI) = 0.82-3.23, p = 0.1809].
Types of biologics used, disease duration > or ≤ 2 years, and PASI 90 improvement at the end of trial affect the 1-year DFS after biologics discontinuation. Further studies consisting of a larger patient number and longer follow-up period are needed to verify our findings.
ClinicalTrials.gov identifiers NCT02694523, NCT03047395, NCT02207224, NCT02576431, NCT03482011, and NCT03556202.
了解银屑病患者停用生物制剂后的缓解持续时间很重要，尤其是当疾病复发被定义为重新开始使用全身治疗药物时，因为这也反映了仅用局部治疗不足以控制疾病时的实际临床实践，此时需要包括生物制剂在内的全身治疗。目前生物制剂适用于适合全身治疗的银屑病患者。
我们纳入了42例在瑞莎珠单抗、古塞库单抗和mirikizumab试验结束后定期随访的患者，并调查了无药缓解情况（DFR）。采用Kaplan-Meier生存分析和Cox回归模型来确定复发的可能风险因素。
总体而言，在至少96周且最长227周的随访期内，38/42（90.5%）例患者在停用试验生物制剂后出现复发。在所有复发患者中，无药缓解的中位持续时间为104天。Kaplan-Meier生存分析显示，瑞莎珠单抗（Z）与古塞库单抗（T）+mirikizumab（M）之间的1年无药生存率（DFS）存在显著差异（p = 0.0462）。当根据疾病持续时间＞或≤2年（p = 0.1577）以及试验结束时银屑病面积和严重程度指数评分（PASI）维持在90（p = 0.1177）对患者进行分类时，DFS曲线存在差异。单因素Cox回归模型确定年龄[风险比（HR）= 1.030（1.000 - 1.060），p = 0.0
