Background and importance Over the past 10 years, a pharmacotherapy revolution in the treatment of moderate to severe plaque psoriasis (MS-PP) has occurred. In our country, the prescription of ustekinumab has increased greatly since its approval in 2009. Therefore, it is now time to reflect on its use and to assess the real world setting, before the arrival of newly approved drugs.
Aim and objectives The primary end point was to assess drug survival for ustekinumab for MS-PP treatment. The secondary end point was to assess the effectiveness of ustekinumab for MS-PP treatment.
Material and methods A retrospective observational study was conducted. All patients who had started treatment with ustekinumab for MS-PP from January 2009 to December 2017 were included. Data collected were demographics, line of biological treatment, dates for therapy start and discontinuation, reason for discontinuation, intensification, optimisation, and psoriasis area severity index (PASI) before starting ustekinumab and at weeks 24, 52 and at the last evaluation available.
Drug survival was analysed using Kaplan–Meier plots and effectiveness was evaluated by PASI50, 75, 90 and 100. Subsequently, data were analysed with SPSS21.
Results A total of 130 patients were included, 64.6% men, with a mean age of 44.4 (11–83) years. Treatment line of ustekinumab: firstline 65.4%, secondline 23.1%, third and subsequent lines, 11.5%. Intensification and optimisation was performed in 59.2% and 53.1%, respectively. Mean drug survival was 6.7 years (95% CI 6.06–7.42).
Effectiveness was calculated for 101 patients because of lack of data. Mean PASI at the start was 11.3 (SD 6.8). At week 24, the relation of PASI 50/75/90/100 achieved was 74.3%/67.3%/56.4%/45.5%, respectively (no data available for 11patients). At week 52, the relation of PASI 50/75/90/100 achieved was 90.0%/75.0%/62.5%/51.3%, respectively (no data available for 21patients). At the end of the study, 84 patients continued treatment with ustekinumab and their mean PASI at that time was 1.2 (SD 2.3). Reasons for discontinuation were drug failure in 20.8%, no reason described in 7.7%, improvement in 3.1%, neoplasms in 2.3%, intolerance in 0.8% and patient preference in 0.8%.
Conclusion and relevance The PHOENIX trials opened the window to PASI90 and we have confirmed the effectiveness of ustekinumab in real life. Furthermore, the results reported here indicated that this effectiveness persisted for a long time, as recently reported data by Salgüero-Fernandez. Therefore, this fact should be an unbiased factor to consider before changing psoriasis therapy to newer drugs based on our long term data.
References and/or acknowledgements 1. Salgüero-Fernández I, et al. https://doi.org/10.1016/j.ad.2018.02.019
No conflict of interest.
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