On and off-label uses of interleukin-17 inhibitors for patients with plaque-type psoriasis in Thailand: a real-world study

Off-label uses of biologics in the treatment of psoriasis are usually implemented in limited-resource settings and studies regarding their response profiles are limited. This was a retrospective study performed in moderate-to-severe plaque-type psoriasis patients who had been treated with either secukinumab, ixekizumab or brodalumab at a university hospital in Thailand between 1 January 2017 and 1 April 2021. A total of 142 patients were included in the data analysis consisting of three groups of 48 patients, 86 patients, and 8 patients treated by secukinumab, ixekizumab, and brodalumab, respectively. Patients were then classified into five groups according to the dosing pattern they received; on-label, off-label with induction, off-label with specific pattern, off-label with irregular dosing interval 8 weeks. Considering both secukinumab and ixekizumab, the adjusted hazard ratios (95%CI) for complete skin clearance of the four off-label regimens were 2.2(0.9–5.2), 1.9 (0.9–3.9), 1.0 (0.4–2.2), and 1.6 (0.7–3.6), compared to on-label regimen, respectively. In each biologic drug, almost all off-label dosing regimens demonstrated higher adjusted hazard ratios compared to on-label regimen. Off-label, patient-oriented regimens could be a promising choice of IL-17 inhibitors for administration in special settings. Off-label regimens are not inferior in terms of skin clearance to an on-label regimen in the efficacy of psoriasis treatment of secukinumab and ixekizumab but do cause more flares. The decision to use off-label regimens must account for the benefits and associated risks.生物制剂（biologics）治疗银屑病（psoriasis）的超说明书用药，通常在资源受限的医疗环境中开展，且针对其应答特征的相关研究较为匮乏。本研究为回顾性研究，纳入2017年1月1日至2021年4月1日期间，泰国某大学医院中接受司库奇尤单抗（secukinumab）、依奇珠单抗（ixekizumab）或布罗利尤单抗（brodalumab）治疗的中重度斑块型银屑病患者。最终共纳入142例患者进行数据分析，其中司库奇尤单抗组、依奇珠单抗组、布罗利尤单抗组分别为48例、86例、8例。随后根据患者所采用的给药模式将其划分为5组：符合说明书给药组、诱导型超说明书给药组、特定模式超说明书给药组、不规则给药间隔（8周）超说明书给药组。以司库奇尤单抗和依奇珠单抗为例，相较于符合说明书的给药方案，四种超说明书给药方案达到完全皮肤清除的校正风险比（95%CI）分别为2.2（0.9~5.2）、1.9（0.9~3.9）、1.0（0.4~2.2）及1.6（0.7~3.6）。针对每一种生物制剂而言，几乎所有超说明书给药方案的校正风险比均高于符合说明书的给药方案。以患者为中心的超说明书给药方案，或许可作为特殊医疗环境中使用IL-17抑制剂（IL-17 inhibitor）的潜在选择。就司库奇尤单抗与依奇珠单抗的银屑病治疗疗效而言，超说明书给药方案在皮肤清除效果上并不劣于符合说明书的给药方案，但会引发更多的病情加重。采用超说明书给药方案的临床决策，需充分权衡其获益与相关风险。