Tildrakizumab: Efficacy, Safety and Survival in Mid-Term (52 Weeks) in Three Tertiary Hospitals in Andalucia (Spain)

Abstract

Tildrakizumab (TIL) binds selectively to the p19 subunit of interleukin 23. Its introduction has managed to increase the levels of efficacy, safety (improving that previously presented by the anti-IL-12/23 class) and survival. Retrospective analysis of a multicenter, observational study of real clinical practice including patients with moderate-to-severe plaque psoriasis in treatment with TIL. This cross-sectional analysis includes information of patients between February 2019 to February 2022. A total of three tertiary hospitals in Andalusia (Spain) participated in this study. Analyses were performed “as observed” using IBM SPSS v28 for Windows. A total of 61 patients were included in the analysis. The mean age of our patients was 49.5 years; 50.18% of the patients were female and 34.42% of the patients had a BMI greater than 30. It was notable that 44.26% of our patients had scalp involvement. Almost 35% of the patients had psoriatic arthropathy, although skin involvement was predominant. At week 52 (n = 34), 68% of the patients presented an absolute PASI equal to or less than 1. Regarding the drug survival, eight patients discontinued treatment due to inefficacy: five primary and three secondary failures, and one death due to causes not drug related showing survival of 86% at week 52. In the analysis of subgroups of patients, we found that scalp involvement determined greater survival (94%), as well as a shorter duration of the disease (91.7% vs. 84.4% in those with less than 10 years versus more than 15 years of evolution) and with a lower number of previous biological therapies (100% naïve, 90% in those who have used one line of biological therapy and 82.1% in those who have completed two or more lines of biological treatment. Tildrakizumab showed excellent results in the control of psoriasis in the mid-term with an elevated number of patients maintaining treatment after 52 weeks. There were no statistically significant differences in the efficiency, safety or survival results of TIL between patients coming from previous therapies.

Effectiveness and safety of tildrakizumab for the treatment of psoriasis in real‐world settings at 24 weeks: A retrospective, observational, multicentre study by the Spanish Psoriasis Group

“…In the literature, we found that studies in the aforementioned area were controversial and difficult to replicate, given the different time frames and methodologies used in different RWE studies. As in some prior studies, our analysis at Week 24 yielded no response predicting factors 11,12,14 . Surprisingly, Narcisi et al 16 found that a significantly higher proportion of bio‐experienced patients reached PASI100 at Week 28 compared to bio‐naïve patients.…”

“…Unlike the previously mentioned series, in which the percentage of bio‐experienced patients was between 19% and 25.5%, 11,15,16 almost 80% of our patients had previously received BT. In their cohort of 61 patients, Ruíz‐Villaverde et al 14 included the lowest rate of bio‐naïve patients (5%) and still reported high efficacy responses as 76% of their patients achieved PASI ≤3 and 45% achieved PASI ≤1 at week 24. Our results support those presented by Ruíz‐Villaverde et al in a larger population, suggesting that tildrakizumab is an effective treatment even when it is not received as a first‐line treatment.…”

“…As in some prior studies, our analysis at Week 24 yielded no response predicting factors. 11,12,14 Surprisingly, Narcisi et al 16 found that a significantly higher proportion of bioexperienced patients reached PASI100 at Week 28 compared to bio-naïve patients. These results were not statistically significant at 52 weeks and this fact might be explained by the small number of patients in the bio-experienced group.…”

“…As previously found, none of the patients with a history of neoplasia (n = 7) experienced worsening of their disease or recurrence. 14…”

“…Our group has addressed the realworld performance of several psoriasis treatments including some biologic molecules. 8,9 As we have identified limited RWE on the long-and short-term effectiveness and safety of, tildrakizumab [10][11][12][13][14][15][16][17][18] we decided to address the problem and analyse the outcomes of patients treated with tildrakizumab in routine clinical practice in Spain.…”