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

Abstract

Background

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.

Method

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.

Results

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 and >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.

Conclusion

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.

Keywords:

• Psoriasis
• biologics
• interleukin-17 inhibitors
• secukinumab
• ixekizumab
• brodalumab

Ethical approval and consent to participate

The study was approved by the Institutional Review Board of the Faculty of Medicine, Chulalongkorn University (IRB 1024/2021). According to the Institutional Review Board of the Faculty of Medicine, Chulalongkorn University, informed consent was waived due to the retrospective nature of the study.

Author contributions

PS, CW, and PA developed the main conceptual idea and design of the research protocol. PS, CW, VC collected data, analyzed data. PS and CW wrote the manuscript. PA supervised, critically reviewed and edited the manuscript. All authors approved the final version of the manuscript.

Disclosure statement

The authors declare no conflicts of interest regarding the publication of this paper.

Data availability statement

The data sets are available from the corresponding author on reasonable request.