Relapse Rate in the Real World Following Biologic Discontinuation in Psoriasis 真实世界中生物制剂停药后银屑病复发率

In real-world settings, the relapse rate following discontinuation of biologic therapy in patients with psoriasis is high, with most patients experiencing relapse within the first year after stopping treatment. For example, in a multicenter cohort of patients who discontinued ustekinumab after achieving response, only 49.3% remained relapse-free at 6 months, dropping to 12.6% at 12 months, and less than 5% at 18 months post-withdrawal.[1] Similarly, a large Polish registry study found that 95% of relapses occurred within 613 days (approximately 20 months) after the end of the first biologic treatment cycle, with the time to relapse shortening with each subsequent discontinuation.[2]

A systematic review of biologic discontinuation in psoriasis reported that the median time to relapse (defined as 50% loss of maximum PASI improvement) ranged from 12 to 34 weeks for biologics, with IL-23 antagonists associated with the longest time to relapse (21–42 weeks) and IL-17 antagonists with shorter times (7–24 weeks).[3] Predictors of earlier relapse include non-naïve biologic status, higher baseline disease activity, and comorbidities such as psoriatic arthritis and chronic kidney disease.[1-2][4]

Across three of the four studies, roughly 8–9 out of 10 patients flared again after stopping their biologic. Even the IL-23 group, which many doctors think is longer-lasting, showed most relapses within a year. One study that mixed mainly IL-17 drugs saw a lower figure (about 1 in 2 relapsed by 6 months), but the authors only tracked that 6-month window, so the final total would likely be higher. Bottom line: biologics control psoriasis well while you take them, but stopping usually leads to a comeback fairly quickly.[1][4-6]

In summary, the majority of patients relapse within 6–12 months after discontinuing biologic therapy for psoriasis, and relapse risk is influenced by drug class, patient characteristics, and prior treatment history.[1-6]

在真实世界临床实践中，银屑病患者停用生物制剂后复发率很高，大多数患者在停药后一年内出现复发。以乌司奴单抗为例，多中心队列研究显示，停药后6个月仍无复发的比例为49.3%，12个月降至12.6%，18个月后低于5%[1]。波兰真实世界数据也显示，95%的复发发生在首次生物制剂治疗结束后约613天内，且每次再次停药后复发时间会缩短[2]。

系统综述显示，生物制剂停药后中位复发时间（定义为最大PASI改善丧失50%）为12至34周，其中IL-23拮抗剂复发时间最长（21-42周），IL-17拮抗剂较短（7-24周）。复发的预测因素包括：既往使用生物制剂、基线疾病活动度高、合并银屑病关节炎或慢性肾病等。

除了一项主要观察 6 个月的数据外，其余三项研究显示停药后约 80–90 % 的患者会在一年内复发。即便是被认为“维持时间较长”的 IL-23 抑制剂，也有多数病人在 12 个月内复发。总体来看，生物制剂能有效控制银屑病，但一旦停药，大多数病人仍会较快地再次发作[1-2][4]。

多项研究一致发现，80–90%的患者在停用生物制剂后复发，包括使用IL-23和IL-17拮抗剂的患者。综上，绝大多数银屑病患者在停用生物制剂后6–12个月内复发，且复发风险受药物类别、患者特征及既往治疗史影响[1][4-6]。

综上，绝大多数银屑病患者在停用生物制剂后6-12个月内复发，复发风险受药物类别、患者特征及既往治疗史影响[1-6]。

 

Reference

  1. Predictors of time to relapse following ustekinumab withdrawal in patients with psoriasis who had responded to therapy: An 8-year multicenter study Chiu HY, Hui RC, Tsai TF, et al. Journal of the American Academy of Dermatology. 2023;88(1):71-78.
  2. Real-World Evidence on Time to Relapse of Plaque Psoriasis After Discontinuation of Biologic Treatment in Poland. Owczarek W, Dzik M, Narbutt J, Walecka I, Kowalczyk M. Dermatologic Therapy. 2021;34(5):e15052.
  3. Time to Relapse After Discontinuing Systemic Treatment for Psoriasis: A Systematic Review. Masson Regnault M, Shourick J, Jendoubi F, Tauber M, Paul C. American Journal of Clinical Dermatology. 2022;23(4):433-447.
  4. Development and external validation of a prediction model for the risk of relapse in psoriasis after discontinuation of biologics. Huang S, Chen B, Qi Y, Duan X, Bai Y. Frontiers in Medicine. 2024;11:1488096.
  5. Huang YH, Hung SJ, Lee CN, Wu NL, Hui RC, Tsai TF, Huang CM, Chiu HY. Predicting the Time to Relapse Following Withdrawal from Different Biologics in Patients with Psoriasis who Responded to Therapy: A 12-Year Multicenter Cohort Study. Am J Clin Dermatol. 2024 Nov;25(6):997-1008.
  6. Hsieh CY, Hsu FL, Tsai TF. Comparison of Drug-Free Remission after the End of Phase III Trials of Three Different Anti-IL-23 Inhibitors in Psoriasis. Dermatol Ther (Heidelb). 2024 Sep;14(9):2607-2620. doi: 10.1007/s13555-024-01229-6. Epub 2024 Jul 29. PMID: 39073712; PMCID: PMC11393235.