Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan.
Eli Lilly Japan K.K., Kobe, Japan.
J Eur Acad Dermatol Venereol. 2019 Mar;33(3):568-576. doi: 10.1111/jdv.15292. Epub 2018 Nov 13.
Long-term management of moderate-to-severe psoriasis is usually discussed in terms of continuous administration; however, there are many situations in clinical practice where treatment may be withdrawn with subsequent retreatment.
To assess the clinical course after ixekizumab treatment withdrawal and retreatment, as well as the effectiveness of ixekizumab retreatment, in Japanese patients with plaque psoriasis.
This single-arm, open-label study (UNCOVER-J; NCT01624233) comprised 78 patients with plaque psoriasis. After ixekizumab treatment (160-mg loading dose, 80 mg every 2 weeks for the first 12 weeks, and then 80 mg every 4 weeks (IXE Q4W) until Week 52), 70 patients achieved a Psoriasis Area Severity Index (PASI)75 response at Week 52. These 70 patients withdrew from ixekizumab treatment from Weeks 52 to 100. Patients who relapsed (PASI ≤50) during the Treatment Withdrawal Period were retreated with IXE Q4W for 192 weeks.
At Weeks 52, 76 and 100, PASI75 response rates were 100%, 26% and 7%; PASI90 response rates were 87%, 11% and 3%; and PASI100 response rates were 53%, 0% and 0%. After treatment withdrawal, 87% of patients relapsed; median time to relapse was 143 days. After 12 weeks of retreatment with IXE Q4W, 83% of relapsed patients achieved PASI75, 68% achieved PASI90 and 25% achieved PASI100; improvements were maintained up to 120 weeks of retreatment. Treatment-emergent adverse events and serious adverse events were reported in 56% and 4% of patients during the Treatment Withdrawal Period, and in 88% and 14% of patients during the Retreatment Period.
In patients withdrawn from ixekizumab after achieving PASI75, approximately half relapsed within 5 months of withdrawal; however, most patients recaptured response within 12 weeks, and response was maintained for up to 120 weeks of retreatment.
中重度银屑病的长期管理通常是通过连续给药来讨论的；然而，在临床实践中有许多情况下可能会停止治疗，随后再进行治疗。
评估依奇珠单抗治疗停药和再治疗后的临床过程，以及在日本斑块状银屑病患者中依奇珠单抗再治疗的有效性。
这项单臂、开放标签研究（UNCOVER-J；NCT01624233）纳入了 78 例斑块状银屑病患者。在依奇珠单抗治疗（160mg 负荷剂量，前 12 周每 2 周 80mg，然后每 4 周 80mg[IXE Q4W]至第 52 周）后，70 例患者在第 52 周时达到了银屑病面积严重程度指数（PASI）75 缓解。这 70 例患者从第 52 周到第 100 周停止了依奇珠单抗治疗。在停药期间复发（PASI≤50）的患者接受 IXE Q4W 治疗 192 周。
在第 52、76 和 100 周时，PASI75 缓解率分别为 100%、26%和 7%；PASI90 缓解率分别为 87%、11%和 3%；PASI100 缓解率分别为 53%、0%和 0%。停药后，87%的患者复发；中位复发时间为 143 天。接受 IXE Q4W 治疗 12 周后，83%的复发患者达到了 PASI75，68%达到了 PASI90，25%达到了 PASI100；改善情况一直持续到治疗 120 周。在停药期间，56%的患者发生了治疗出现的不良事件，4%的患者发生了严重不良事件；在再治疗期间，88%的患者发生了治疗出现的不良事件，14%的患者发生了严重不良事件。
在达到 PASI75 后停止依奇珠单抗治疗的患者中，约一半在停药后 5 个月内复发；然而，大多数患者在 12 周内再次获得缓解，并且缓解持续了 120 周的再治疗。
