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Article

Real-World Study of Tildrakizumab Survival in Psoriasis: Impact of Arthritis, Hypertension, and Prior Biologic Use

by
Raquel Santos-Juanes Galache
1,
Sebastian Reyes García
1,
Jimena Carrero Martín
1,
Álvaro Nuñez Domínguez
1,
Marta López Pando
1,
Irene Álvarez Losada
2,
Irene de la Fuente Villaverde
3,
Ana Lozano-Blazquez
3,
Esther Salgueiro
4,5,
Javier Bordallo
4,5,
Jorge Santos-Juanes
1,5,6,7,* and
Cristina Galache Osuna
1,5,6,7
1
Unidad de Gestion Clínica de Dermatología, Hospital Universitario Central de Asturias, 33011 Oviedo, Spain
2
Reumatology Department, Hospital Universitario de Santiago, 15706 Santiago de Compostela, Spain
3
Unidad de Gestión Clínica de Farmacia, Hospital Universitario Central de Asturias, 33011 Oviedo, Spain
4
Área de Farmacología, Departmento de Medicina, Universidad de Oviedo, 33006 Oviedo, Spain
5
Área de Dermatología, Departamento de Medicina, Universidad de Oviedo, 33006 Oviedo, Spain
6
GRIDER—Grupo de Investigación en Dermatología, Universidad de Oviedo, 33006 Oviedo, Spain
7
Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), 33011 Oviedo, Spain
*
Author to whom correspondence should be addressed.
Life 2025, 15(5), 789; https://doi.org/10.3390/life15050789
Submission received: 15 April 2025 / Revised: 10 May 2025 / Accepted: 13 May 2025 / Published: 15 May 2025
(This article belongs to the Section Physiology and Pathology)
Browse Figure
Versions Notes

Abstract

:
In routine clinical settings, identifying the factors that influence the persistence of biologic therapies is crucial for tailoring psoriasis management to individual patient profiles. This study aimed to evaluate the real-world drug survival of tildrakizumab in patients diagnosed with plaque psoriasis at the Dermatology Department of HUCA and to explore the clinical predictors of treatment discontinuation. We conducted a retrospective, hospital-based analysis involving 100 patients treated with tildrakizumab (Ilumetri®) between 1 January 2021 and 30 April 2024. Kaplan–Meier estimates were used to construct survival curves, and multivariate analyses were performed using Cox proportional hazards regression models. Both crude and adjusted hazard ratios (HRs) were calculated to assess potential differences across patient subgroups. The multivariate analysis identified statistically significant associations between reduced drug survival and the presence of psoriatic arthritis (p = 0.02), previous biologic exposure (p = 0.02), and arterial hypertension (p = 0.012). Other comorbidities did not demonstrate significant effects. The most common reasons for treatment discontinuation were primary inefficacy and suboptimal response in patients with arthritis. Overall, tildrakizumab demonstrated robust survival outcomes in this patient population, though diminished persistence was observed in those with prior biologic use, comorbid arthritis, and hypertension.

1. Introduction

Psoriasis is a chronic, immune-mediated skin condition with a multifactorial etiology, involving complex interactions between genetic predisposition and environmental triggers that culminate in immune system dysregulation [1,2]. The disease is marked by abnormal keratinocyte hyperproliferation and the infiltration of immune cells into both the epidermis and dermis. Globally, the prevalence of psoriasis is estimated to be approximately 2–4%, with reported rates varying significantly across different regions, ranging from 0.91% in the United States to 11.4% in Western populations. Discrepancies in psoriasis prevalence, reporting quality, and registration across regions lead to varied global incidence rates [3]. A peak incidence typically occurs between the ages of 20–30 and 50–60 years [4].
Clinically, psoriasis presents with a wide range of phenotypic variability in terms of lesion morphology, distribution, severity, and progression. It can be classified into several distinct subtypes, including plaque, guttate, erythrodermic, generalized pustular psoriasis, and palmoplantar pustulosis. Of these, plaque psoriasis is the most prevalent form, accounting for up to 90% of all cases [5]. The classical clinical manifestations of psoriasis consist of the presence of red, infiltrated plaques, covered with coarse, silvery scaling. Predilection sites include the elbows and knees, scalp, and periumbilical and lumbar regions, although any anatomical site might be affected. The clinical course of psoriasis is marked by frequent relapses with fluctuating rates [6]. Based on lesion distribution and extent, disease severity is categorized as mild, moderate, or severe.
Although the precise pathogenic mechanisms remain incompletely understood, substantial evidence supports a central role for the IL-23/Th17 axis, TNF-alpha, and the chemokine CCL20 in driving psoriatic inflammation [7]. Psoriatic arthritis, a related inflammatory joint disorder, occurs in approximately 5% to 30% of individuals with psoriasis and is more commonly observed in those with extensive cutaneous disease. It affects both sexes equally and typically manifests following the appearance of skin symptoms [8].
Tildrakizumab (Ilumetri®) is a fully humanized IgG1κ monoclonal antibody that received FDA approval in 2018 for the treatment of moderate-to-severe plaque psoriasis [9]. The standard dosing regimen includes subcutaneous administration of 100 mg at weeks 0 and 4, followed by maintenance dosing every 12 weeks. In patients weighing over 90 kg or in those with a high disease burden, a 200 mg dose may be considered for enhanced clinical effectiveness [10]. Mechanistically, tildrakizumab binds selectively to the p19 subunit of interleukin-23 (IL-23), thereby inhibiting its interaction with the IL-23 receptor on Th17 cells. This blockade prevents downstream activation of the JAK-STAT signaling pathway—specifically the phosphorylation of JAK2, TYK2, and STAT3—and ultimately reduces the transcription of RORγt and the subsequent differentiation of Th17 cells. This suppression leads to decreased production of IL-17A and IL-17F, key cytokines in keratinocyte activation and proliferation [11,12].
Drug survival refers to the duration over which a treatment remains effective, safe, and acceptable to the patient [13]. This metric not only reflects therapeutic effectiveness and tolerability but also captures aspects of patient satisfaction and adherence. In some cases, drug survival is also interpreted based on defined periods of treatment interruption—such as the 24-week threshold for ustekinumab, which corresponds to two dosing intervals [13,14].
Evaluating drug survival in real-world settings provides insights into long-term treatment outcomes under routine clinical conditions, where dose adjustments, concomitant therapies, and changes in patient preference are common—unlike the fixed protocols of clinical trials. Moreover, external factors such as drug cost, the availability of new therapies, and evolving prescribing behaviors may also impact drug survival, thereby necessitating caution when comparing results across different biologic agents [15,16].
The aim of this study was to assess the drug survival of tildrakizumab and to identify clinical predictors of treatment discontinuation in patients with plaque psoriasis managed at the Dermatology Department of HUCA.

2. Materials and Methods

We conducted a retrospective, single-center study at the Dermatology Department of HUCA, including patients treated between 1 February 2021 and 30 April 2024. The study protocol received approval from the Ethics and Research Committee of the Principality of Asturias, Spain (Ref. 2023-468). A total of 100 patients who received tildrakizumab (Ilumetri®) (Almirall, Barcelona, Spain) at doses of 100 mg or 200 mg (for body weight >90 kg) for the treatment of plaque psoriasis were included. Only patients receiving the drug for dermatological indications were considered.
Electronic medical records were reviewed to collect the following baseline data: sex, age, weight, height, family history of psoriasis (defined as the presence of psoriasis in at least one first-degree relative), age at disease onset, previous biologic exposure (classified as naïve or non-naïve), and presence of psoriatic arthritis (confirmed by a rheumatologist). Comorbid conditions such as hypertension, diabetes mellitus (DM), and dyslipidemia were also documented. Patients were classified as having these comorbidities if they reported a prior diagnosis; if such a diagnosis appeared in their clinical records; or if they were taking antihypertensive, antidiabetic, or lipid-lowering agents. Additionally, patients with a blood pressure > 135/85 mmHg at consultation were categorized as hypertensive.
Relevant laboratory parameters were assessed to define dyslipidemia. Patients with triglyceride levels > 150 mg/dL, total cholesterol > 200 mg/dL, or LDL cholesterol > 160 mg/dL were considered to have dyslipidemia. Body mass index (BMI) was calculated as weight (kg) divided by height squared (m2), and obesity was defined as BMI ≥ 30, following the World Health Organization (WHO) criteria.
Descriptive statistics were reported as absolute frequencies and percentages. Drug survival, defined as the duration from treatment initiation to permanent discontinuation, was calculated retrospectively. Treatment response was classified as primary failure when there was no initial clinical improvement, defined as failure to achieve a PASI 75 response after 16 weeks of treatment. Secondary failure was defined as loss of PASI 75 response during follow-up after initially achieving it beyond week 16. Lack of control of joint activity included either no improvement in pre-existing joint symptoms or the development of new-onset arthritis.

3. Results

3.1. Patient Characteristics

The study cohort comprised 100 patients, all identified as of White ethnicity. The baseline characteristics are detailed in Table 1. Notably, there was a high prevalence of individuals with a positive family history of psoriasis and early disease onset, suggesting a potential genetic predisposition within the sample population.

3.2. Drug Survival

The survival of the drug is shown in Figure 1.
In this cohort, the number of prior biologic therapies had a substantial impact on tildrakizumab survival at week 52. Drug persistence was 100% among biologic-naïve patients, declined to 93% in those with exposure to a single prior biologic, and further decreased to 67% in patients who had received two or more previous biologic agents (Table 2). These findings indicate a potential inverse association between the extent of prior biologic treatment and long-term persistence of tildrakizumab.

3.3. Univariate and Multivariate Analyses

Univariate analyses revealed statistically significant differences between subgroups based on the presence of psoriatic arthritis, hypertension arterial, and dyslipidemia and prior exposure to biologic therapies (Table 3). Patients with psoriatic arthritis had a 6.9-fold increased likelihood of treatment discontinuation compared to those without arthritis. Similarly, individuals with arterial hypertension exhibited a 6.3-fold higher risk of discontinuation relative to normotensive patients. Moreover, those with a history of more than one prior biologic therapy demonstrated a 5.6-fold greater risk of discontinuing tildrakizumab compared to patients who had received none or only one prior biologic agent.
In the univariate analysis according to the number of previously used biological treatments, the risk of discontinuation increases with each treatment line, with an unadjusted HR of 2.239, 95% CI (1.398–3.084)

3.4. Adverse Effects

All recorded adverse effects were mild: one patient with nasopharyngitis (1%), one patient with nausea after the first dose (1%), and one patient with an injection site reaction after the third dose (1%). No serious adverse effects were observed that required discontinuation of the drug.

3.5. Patients Discontinuing Treatment

At the end of the study, we observed that of the 100 patients who initiated treatment, 86 (86%) remained under follow-up. The 14 patients (14%) who discontinued treatment cited the following reasons: primary failure (8 patients), secondary failure (1 patient), and lack of control of joint activity (6 patients). One patient experienced both primary failure and an arthritis flare as reasons for discontinuation.

4. Discussion

This retrospective study evaluates the overall survival of tildrakizumab in a cohort of 100 patients treated at the Dermatology Department of HUCA. A notable strength of this investigation is the relatively large sample size drawn from a single tertiary care center, which enhances the consistency of clinical management and data collection. A recent study showed significant differences in survival rates among the different hospitals included in the study [17].
Real-world clinical practice studies of tildrakizumab have been published [18,19,20,21,22,23,24,25,26,27,28,29,30,31], but very few of the published ones report the survival of tildrakizumab in the treatment of psoriasis [17,32,33,34,35,36,37,38], and we did not find a single hospital series with this number of patients.
The demographic profile of our patient cohort is consistent with the findings reported in previous studies by Torres [31], Becher [32], Berenguer [17], and Melgosa [37], particularly regarding the predominance of male patients (54%) and the mean age at initiation of tildrakizumab therapy, which was 48 years.
The high proportion of bio-experienced patients is one of the most distinctive characteristics of our cohort (98.6%). In the literature, we found that studies on tildrakizumab were controversial and difficult to compare, given the different real-world evidence studies (97%), which showed much higher proportions than in studies such as that of Tsianakas (25%) [39] and o el de Narcisi (19%) [22]. These findings can be attributed to regional prescribing practices, as the local regulatory authority strongly advises that all patients with moderate-to-severe biologic-naïve psoriasis initiate treatment with a TNF inhibitor biosimilar as first-line therapy. In our series, there was no washout period between treatments [37]. Treatment with tildrakizumab was initiated immediately or within a few weeks after the discontinuation of the previous treatment.
The mean age of our patient cohort is similar to that of previous studies with TIL: 48.4 vs. 47.6 years [40], 47.8 years [39], and 51.4 years [34]. In our clinical practice, the mean age is also comparable to our series with other biologic drugs: ustekinumab (48 years) [41], adalimumab (46 years) [42], and secukinumab (50 years) [43].
Regarding the overall drug survival, the retention rates were 85% (first year), 81% (second year), and 81% (third year). The one-year drug survival observed in our study was at the upper end of the range reported in the literature, exceeded only by the findings of Ruiz-Villaverde, who reported a survival rate of 86% [35]. Our results were comparable to those of Torres [32] and notably higher than those reported by Becher (73%) [17] and Elgaard (64.3%) [36]. We observed that patients who reach one year tend to continue with the drug, as previously noted in the literature [17,44], especially if the patients do not have arthritis (89% in the first, second, and third years) or hypertension (90% in the first year and 85% in the second and third years).
Our analysis indicated that tildrakizumab survival was largely unaffected by the majority of patient- or disease-specific variables. Tildrakizumab survival was not affected by gender, obesity, age at treatment initiation, or disease duration, similar to findings reported in previous studies [22,32,35,45,46]. At this point, it is important to highlight the flexibility offered by the 200 mg dose of tildrakizumab as an effective therapeutic option, particularly for patients with high body weights, significant disease burden, or involvement of sensitive areas, as has been noted in previous studies [47,48]. We found statistically significant differences in the univariate analysis and in the Kaplan–Meier analysis regarding the use of prior biologics, and the presence or absence of arthritis, hypertension, and dyslipidemia. The latter lost its statistical significance in the multivariate analysis.
We found statistically significant differences between the use of a smaller number of previous biological lines of treatment (none or one) and a large number of previous biological lines of treatment from the Kaplan–Meier, univariate, and multivariate analyses, similar to what has been reported in the literature [17,20,30,32,35,49], though different from what other authors have noted [22,34,37].
We find it particularly interesting that, when introducing the variable for the number of previously used biologics, we observed in the univariate analysis that for each previously used biologic, the survival rate decreases by 22%, lower than what was found by Becher et al. [17]. Becher et al. stated that the number of previous biological treatments in the multivariate logistic regression model predicts that with every single additional treatment, the probability of the response to tildrakizumab decreases by 40% [17]. This is consistent with the findings of a greatest response when it was used as the first- or second-line biologic [17,20]. Conversely other studies have suggested that tildrakizumab response was not modified by prior biological therapy [30,37,50]. Our three naïve patients remain on treatment.
In this regard, we found a one-year survival rate similar to that reported by Ruiz-Villaverde and colleagues: naïve patients 100%, one prior biologic 92% vs. 90%, and more than one prior biologic 68% vs. 81% [35].
In our cohort, 28% of patients had psoriatic arthritis—a prevalence lower than that reported for other monoclonal antibody therapies used in our clinical setting, including ustekinumab (43%) [41], secukinumab (53%) [43], adalimumab (57%) [42], and apremilast (45%) [51]. This rate is comparable to those described by Ruiz (34%) [35] and Torres [32] but considerably higher than that reported by Melgosa (10%) [37]. In our series of biological treatments for psoriasis, only the survival of ustekinumab, an anti-IL12/23 molecule, decreases due to the presence of arthritis. In our series, 6 out of the 14 patients who discontinued treatment did so due to poor joint control (42.8%).
In the literature, we have not found a relationship between the presence of arthritis and differences in drug effectiveness, because the variable arthritis is not recorded, its relationship is not studied, or it is not statistically significant: Berenguer (17%) [34], Narcisi (15.2%) [22], Mastorino (16%) [49], Caldarola (16%) [23], Melgosa [37], Becher (21%) [17], and Di Brizzi (17.6%) [52]. At this point, it is important to note that our study has a high percentage of patients with arthritis diagnosed by a rheumatologist (28%), so the underrepresentation of this group in other studies could result in a type II error (the differences exist, but the low numbers prevent them from being detected). Alternatively, our patients may have more severe arthritis compared to those in other studies.
On the other hand, in our patients, the presence of hypertension predicts treatment discontinuation. We have not found this association in any other study. However, it has been reported that discontinuation rates are higher with an increasing number of comorbidities [17]. Conversely, in a 5-year study, no differences were found between patients with metabolic syndrome and those without it [53]. In a study evaluating risankizumab, an anti-IL-23 biologic, no significant differences in treatment outcomes were observed between patients with metabolic comorbidities and those without [54]. Interestingly, another study reported a better response in patients with a higher number of comorbidities, which was attributed to a worse initial PASI score in these patients [22].
Similar to what has been reported in the literature [55], we did not find differences in survival between patients younger and older than 65 years, in contrast to Chiricozzi et al., who found lower survival in patients over 65 years treated with anti-IL23 therapies [56].
Of the total number of patients, 14% discontinued treatment due to therapeutic failure, a lower rate than that reported by Becher (20%) [17]. The reasons were, primarily, primary failure (8%), followed by poor joint control (6%), and one patient with secondary failure (1%). While the observed rates of primary and secondary treatment failure are within the range of previously published results, there were no discontinuations due to serious adverse effects, similar to what has been described [22,57], and the number of discontinuations was lower than that in other studies, which range between 1% and 2% [17,34,40].
Regarding adverse effects, we found a rate of 3%, similar to those reported in the literature, which range from 5% [17,22] to 8.7% [40], and up to 15% in the study by Tsianakas [39]. Our findings align with pooled data from the reSURFACE clinical trials, real-world studies of tildrakizumab, and safety outcomes from other IL-23 inhibitor studies. These collectively report a low incidence of infections, minimal serious adverse events, and no significant signals for complications such as major cardiovascular events, malignancies, inflammatory bowel disease, or Candida infections [22,32].

5. Conclusions

Our data show that tildrakizumab survival in real-world clinical settings is in the higher range of published studies. The presence of arthritis, hypertension, and prior use of biologics reduces the drug’s survival. These findings, which have not been previously reported in the literature, need to be confirmed in prospective studies.

Author Contributions

Conceptualization, J.S.-J., C.G.O. and R.S.-J.G.; methodology, E.S. and J.B.; validation, A.L.-B. and C.G.O.; formal analysis, J.S.-J. and R.S.-J.G.; investigation, I.Á.L. and I.d.l.F.V.; resources, C.G.O.; data curation, S.R.G., J.C.M., Á.N.D. and M.L.P.; writing—original draft preparation, R.S.-J.G.; writing—review and editing, S.R.G., J.C.M., Á.N.D., M.L.P. and E.S.; visualization, E.S. and J.B.; supervision, C.G.O. and J.S.-J. All authors have read and agreed to the published version of the manuscript.

Funding

This research received no external funding.

Institutional Review Board Statement

This study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee Ethics and Research Committee of the Principality of Asturias, Spain (2023-468 and 3 November 2023).

Informed Consent Statement

Patient consent was waived due to it being exempted by the ethics committee.

Data Availability Statement

The data presented in this study are available from the corresponding author on request.

Conflicts of Interest

The authors declare no conflicts of interest.

References

  1. Griffiths, C.E.; Barker, J.N. Pathogenesis and Clinical Features of Psoriasis. Lancet 2007, 370, 263–271. [Google Scholar] [CrossRef] [PubMed]
  2. Vičić, M.; Kaštelan, M.; Brajac, I.; Sotošek, V.; Massari, L.P. Current Concepts of Psoriasis Immunopathogenesis. Int. J. Mol. Sci. 2021, 22, 11574. [Google Scholar] [CrossRef] [PubMed]
  3. Ferrándiz, C.; Bordas, X.; García-Patos, V.; Puig, S.; Pujol, R.; Smandía, A. Prevalence of Psoriasis in Spain (Epiderma Project: Phase I). J. Eur. Acad. Dermatol. Venereol. 2001, 15, 20–23. [Google Scholar] [CrossRef] [PubMed]
  4. Wang, K.; Zhao, Y.; Cao, X. Global burden and future trends in psoriasis epidemiology: Insights from the global burden of disease study 2019 and predictions to 2030. Arch. Dermatol. Res. 2024, 316, 114. [Google Scholar] [CrossRef]
  5. Dogra, S.; Mahajan, R. Psoriasis: Epidemiology, Clinical Features, Co-Morbidities, and Clinical Scoring. Indian Dermatol. Online J. 2016, 7, 471–480. [Google Scholar] [CrossRef]
  6. Christophers, E. Psoriasis—Epidemiology and clinical spectrum. Clin. Exp. Dermatol. 2001, 26, 314–320. [Google Scholar] [CrossRef]
  7. Sharma, A.; Upadhyay, D.K.; Gupta, G.D.; Narang, R.K.; Rai, V.K. IL-23/Th17 Axis: A Potential Therapeutic Target of Psoriasis. Curr. Drug Res. Rev. 2022, 14, 24–36. [Google Scholar] [CrossRef]
  8. Gladman, D.D. Psoriatic Arthritis. Dermatol. Ther. 2004, 17, 350–363. [Google Scholar] [CrossRef]
  9. U.S. Food and Drug Administration (FDA). Available online: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761067Orig1s000MultdisciplineR.pdf (accessed on 12 May 2025).
  10. Dapavo, P.; Burlando, M.; Guarneri, C.; Megna, M.; Narcisi, A.; Talamonti, M.; Gisondi, P. Tildrakizumab: The Value of a Personalized and Flexible Approach for Treating Moderate-to-Severe Plaque Psoriasis in Patients with High Body Weight or High Disease Burden. Expert. Opin. Biol. Ther. 2024, 24, 133–138. [Google Scholar] [CrossRef]
  11. Banaszczyk, K. Tildrakizumab in the Treatment of Psoriasis—Literature Review. Reumatologia 2019, 57, 234–238. [Google Scholar] [CrossRef]
  12. Girolomoni, G.; Strohal, R.; Puig, L.; Bachelez, H.; Barker, J.; Boehncke, W.H.; Prinz, J.C. The Role of IL-23 and the IL-23/TH 17 Immune Axis in the Pathogenesis and Treatment of Psoriasis. J. Eur. Acad. Dermatol. Venereol. 2017, 31, 1616–1626. [Google Scholar] [CrossRef] [PubMed]
  13. Dávila-Seijo, P.; Dauden, E.; Carretero, G.; Ferrandiz, C.; Vanaclocha, F.; Gómez-García, F.-J.; Herrera-Ceballos, E.; De la Cueva-Dobao, P.; Belinchón, I.; Sánchez-Carazo, J.-L.; et al. Survival of Classic and Biological Systemic Drugs in Psoriasis: Results of the BIOBADADERM Registry and Critical Analysis. J. Eur. Acad. Dermatol. Venereol. 2016, 30, 1942–1950. [Google Scholar] [CrossRef] [PubMed]
  14. Van Den Reek, J.M.P.A.; Kievit, W.; Gniadecki, R.; Goeman, J.J.; Zweegers, J.; Van De Kerkhof, P.C.M.; Seyger, M.M.B.; De Jong, E.M.G.J. Drug Survival Studies in Dermatology:Principles, Purposes, and Pitfalls. J. Investig. Dermatol. 2015, 135, 1–5. [Google Scholar] [CrossRef] [PubMed]
  15. Garcia-Doval, I.; Dávila-Seijo, P. How Real Are “real-Life Studies” in Psoriasis, and the Uncertain Meaning of Drug Persistence. Br. J. Dermatol. 2019, 180, 15–16. [Google Scholar] [CrossRef]
  16. Carrascosa, J.M.; Notario, J. Supervivencia en terapia biológica. ¿Sabemos a qué nos referimos? ¿ Podemos usarla? Actas Dermo-Sifiliogr. 2014, 105, 729–733. [Google Scholar] [CrossRef]
  17. Becher, G.; Conner, S.; Ingram, J.A.; Stephen, K.E.; McInnes, A.C.; Heald, A.H.; Riley, P.A.; Davies, M.; Domenech, A.; Kasujee, I. A Retrospective Real-World Study of the Effectiveness and Tolerability of Tildrakizumab in UK Adults with Moderate-to-Severe Chronic Plaque Psoriasis. Dermatol. Ther. 2022, 12, 2343–2354. [Google Scholar] [CrossRef]
  18. Ruggiero, A.; Fabbrocini, G.; Cinelli, E.; Ocampo Garza, S.S.; Camela, E.; Megna, M. Anti-interleukin-23 for Psoriasis in Elderly Patients: Guselkumab, Risankizumab and Tildrakizumab in Real-world Practice. Clin. Experimental. Derm. 2022, 47, 561–567. [Google Scholar] [CrossRef]
  19. Ruggiero, A.; Picone, V.; Martora, F.; Fabbrocini, G.; Megna, M. Guselkumab, Risankizumab, And Tildrakizumab in the Management of Psoriasis: A Review of the Real-World Evidence. Clin. Cosmet. Investig. Dermatol. 2022, 15, 1649–1658. [Google Scholar] [CrossRef]
  20. Burlando, M.; Maul, J.-T.; Salvi, I.; Simic, D.; Cozzani, E.; Ak, M.; Birkenmaier, I.; Parodi, A. Psoriasis Patients’ Characteristics Associated with High PASI Response to Tildrakizumab: An International Dual Center Study. Eur. Rev. Med. Pharmacol. Sci. 2022, 26, 6772–6776. [Google Scholar] [CrossRef]
  21. Burlando, M.; Castelli, R.; Cozzani, E.; Parodi, A. Treatment of Moderate-to-Severe Plaque Psoriasis with Tildrakizumab in the Real-Life Setting. Drugs Context 2021, 10, 2021-2-6. [Google Scholar] [CrossRef]
  22. Narcisi, A.; Valenti, M.; Gargiulo, L.; Ibba, L.; Amoruso, F.; Argenziano, G.; Bardazzi, F.; Burlando, M.; Carrera, C.G.; Damiani, G.; et al. Real-Life Effectiveness of Tildrakizumab in Chronic Plaque Psoriasis: A 52-Week Multicentre Retrospective Study-IL PSO (Italian Landscape Psoriasis). J. Eur. Acad. Dermatol. Venereol. 2023, 37, 93–103. [Google Scholar] [CrossRef] [PubMed]
  23. Caldarola, G.; Galluzzo, M.; Bernardini, N.; Calabrese, L.; Grimaldi, M.; Moretta, G.; Pagnanelli, G.; Shumak, R.G.; Talamonti, M.; Tofani, L.; et al. Tildrakizumab in Moderate-to-Severe Plaque Psoriasis: A Multicenter, Retrospective, Real-Life Study. Dermatol. Ther. 2022, 35, e15488. [Google Scholar] [CrossRef] [PubMed]
  24. Heim, J.; Vasquez, J.G.; Bhutani, T.; Koo, J.; Mathew, J.; Gogineni, R.; Ferro, T.; Bhatia, N. Tildrakizumab Real-World Effectiveness and Safety Over 64 Weeks in Patients with Moderate-to-Severe Plaque Psoriasis. J. Drugs Dermatol. 2024, 23, 612–618. [Google Scholar] [CrossRef] [PubMed]
  25. Bhatia, N.; Heim, J.; Vasquez, J.G.; Bhutani, T.; Schenkel, B.; Gogineni, R.; Koo, J. Long-Term Quality of Life Outcomes from a Phase 4 Study of Tildrakizumab in Patients with Moderate-to-Severe Plaque Psoriasis in a Real-World Setting. J. Dermatolog. Treat 2024, 35, 2310631. [Google Scholar] [CrossRef]
  26. Cacciapuoti, S.; Potestio, L.; Gallo, L.; Musumeci, M.L.; Caldarola, G.; D’Amico, D.; Caudullo, F.; Papaianni, V.; De Simone, C.; Peris, K.; et al. Short-Term Efficacy of Tildrakizumab on Difficult-to-Treat Areas: A Real-World Experience. Int. J. Dermatol. 2024, 64, 319–324. [Google Scholar] [CrossRef]
  27. Bhutani, T.; Koo, J.; Heim, J.; Bhatia, N.; Mathew, J.; Ferro, T.; Vasquez, J.G. Improvements in Psoriasis-Related Work Productivity with Tildrakizumab: Results from a Phase 4 Real-World Study in Patients with Moderate-to-Severe Plaque Psoriasis. Dermatol. Ther. 2024, 14, 1019–1025. [Google Scholar] [CrossRef]
  28. Armstrong, A.; González-Cantero, A.; Khattri, S.; Muzy, G.; Malatestinic, W.N.; Lampropoulou, A.; Feely, M.; See, S.K.; Mert, C.; Blauvelt, A. Comparing Achievement of National Psoriasis Foundation Treatment Targets among Patients with Plaque Psoriasis Treated with Ixekizumab versus Other Biologics in Clinical and Real-World Studies. Dermatol. Ther. 2024, 14, 933–952. [Google Scholar] [CrossRef]
  29. Orsini, D.; Caldarola, G.; Dattola, A.; Campione, E.; Bernardini, N.; Frascione, P.; De Simone, C.; Richetta, A.G.; Galluzzo, M.; Skroza, N.; et al. Efficacy and Safety of Tildrakizumab in Elderly Patients: Real-World Multicenter Study (ESTER-Study). J. Dermatolog. Treat. 2024, 35, 2319304. [Google Scholar] [CrossRef]
  30. Campione, E.; Lambiase, S.; Gaeta Shumak, R.; Galluzzo, M.; Lanna, C.; Costanza, G.; Borselli, C.; Artosi, F.; Cosio, T.; Tofani, L.; et al. A Real-Life Study on the Use of Tildrakizumab in Psoriatic Patients. Pharmaceuticals 2023, 16, 526. [Google Scholar] [CrossRef]
  31. Burlando, M.; Salvi, I.; Parodi, A.; Cozzani, E. A 3-Year Experience with Tildrakizumab Treatment for Patients with Plaque Psoriasis in Clinical Practice. Dermatol. Ther. 2024, 14, 2645–2652. [Google Scholar] [CrossRef]
  32. Torres, T.; Varela, P.; Mendes Bastos, P.; Magina, S.; Henrique, M.; Ferreira, P. Tildrakizumab for the Treatment of Moderate-to-Severe Psoriasis: A 52-Week, Real-World Portuguese Multicentric Study. Drugs Context 2024, 13, 2023-12-15. [Google Scholar] [CrossRef] [PubMed]
  33. Heim, J.; Vasquez, J.G.; Schenkel, B.; Bhatia, N. Real-World Effectiveness and Safety of Tildrakizumab in Patients with Moderate-to-Severe Psoriasis: Week 28 Interim Analysis of a Phase 4 Study. J. Drugs Dermatol. 2023, 22, 754–760. [Google Scholar] [CrossRef] [PubMed]
  34. Berenguer-Ruiz, S.; Aparicio-Domínguez, M.; Herranz-Pinto, P.; Ruíz-Villaverde, R.; López-Ferrer, A.; Santos-Juanes, J.; Rodríguez Fernández-Freire, L.; Hospital-Gil, M.; Arias-Santiago, S.; Carretero-Hernández, G.; et al. 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. J. Eur. Acad. Dermatol. Venereol. 2023, 37, 2517–2525. [Google Scholar] [CrossRef] [PubMed]
  35. Ruiz-Villaverde, R.; Rodriguez Fernandez-Freire, L.; Font-Ugalde, P.; Galan-Gutierrez, M. Tildrakizumab: Efficacy, Safety and Survival in Mid-Term (52 Weeks) in Three Tertiary Hospitals in Andalucia (Spain). J. Clin. Med. 2022, 11, 5098. [Google Scholar] [CrossRef]
  36. Elgaard, C.D.B.; Iversen, L.; Hjuler, K.F. Guselkumab, Tildrakizumab, and Risankizumab in a Real-World Setting: Drug Survival and Effectiveness in the Treatment of Psoriasis and Psoriatic Arthritis. J. Dermatolog. Treat 2023, 34, 2133531. [Google Scholar] [CrossRef]
  37. Melgosa Ramos, F.J.; Mateu Puchades, A.; Matáix-Díaz, J.; Schneller-Pavelescu, L.; Belinchón-Romero, I.; Santos Alarcón, S. 52-Week Mid-Term Efficacy of Tildrakizumab in Moderate-to-Severe Psoriasis: A Real-Life Multicenter Experience. Actas Dermosifiliogr. 2024, 115, T722–T726. [Google Scholar] [CrossRef]
  38. Gargiulo, L.; Ibba, L.; Malagoli, P.; Balato, A.; Bardazzi, F.; Burlando, M.; Carrera, C.G.; Damiani, G.; Dapavo, P.; Dini, V.; et al. Drug Survival of IL-12/23, IL-17 and IL-23 Inhibitors for Moderate-to-Severe Plaque Psoriasis: A Retrospective Multicenter Real-World Experience on 5932 Treatment Courses–IL PSO (Italian Landscape Psoriasis). Front. Immunol. 2024, 14, 1341708. [Google Scholar] [CrossRef]
  39. Tsianakas, A.; Schwichtenberg, U.; Pierchalla, P.; Hinz, T.; Diemert, S.; Korge, B. Real-World Effectiveness and Safety of Tildrakizumab in Long-Term Treatment of Plaque Psoriasis: Results from the Non-Interventional, Prospective, Multicentre Study TILOT. J. Eur. Acad. Dermatol. Venereol. 2023, 37, 85–92. [Google Scholar] [CrossRef]
  40. Drerup, K.A.; Seemann, C.; Gerdes, S.; Mrowietz, U. Effective and Safe Treatment of Psoriatic Disease with the Anti-IL-23p19 Biologic Tildrakizumab: Results of a Real-World Prospective Cohort Study in Nonselected Patients. Dermatology 2022, 238, 615–619. [Google Scholar] [CrossRef]
  41. Galache Osuna, C.; Gómez-Vila, B.; Aubán Pariente, J.; Vázquez Losada, B.; Gómez de Castro, C.; Requena López, S.; de Dios Velázquez, Á.; Palacios García, L.; Ordoñez Fernández, L.; Gómez Diez, S.; et al. Ustekinumab Drug Survival in Patients with Psoriasis: A Retrospective Study of Real Clinical Practice. Medicina 2020, 56, 584. [Google Scholar] [CrossRef]
  42. Gómez-de Castro, C.; Mir-Bonafé, M.; Arias-Martínez, A.; Martínez-Camblor, P.; Díaz-Coto, S.; Santos-Juanes, J. Comment on ‘Baseline Patients’ Characteristics as Predictors for Therapeutic Survival and Response in Patients with Psoriasis on Biological Treatments’. Australas J. Dermatol. 2019, 60, 13016. [Google Scholar] [CrossRef] [PubMed]
  43. Palacios-García, L.; Gómez-de Castro, C.; Mir-Bonafé, M.; Calzón, C.; Galache, C.; Santos-Juanes, J. Comment on “Secukinumab Drug Survival in Patients with Psoriasis: A Multicenter, Real-World, Retrospective Study”. J. Am. Acad. Dermatol. 2019, 81, e81–e82. [Google Scholar] [CrossRef] [PubMed]
  44. Thaci, D.; Piaserico, S.; Warren, R.B.; Gupta, A.K.; Cantrell, W.; Draelos, Z.; Foley, P.; Igarashi, A.; Langley, R.G.; Asahina, A.; et al. Five-Year Efficacy and Safety of Tildrakizumab in Patients with Moderate-to-Severe Psoriasis Who Respond at Week 28: Pooled Analyses of Two Randomized Phase III Clinical Trials (reSURFACE 1 and reSURFACE 2). Br. J. Dermatol. 2021, 185, 323–334. [Google Scholar] [CrossRef]
  45. Ricceri, F.; Chiricozzi, A.; Peris, K.; Prignano, F. Successful Use of Anti-IL-23 Molecules in Overweight-to-Obese Psoriatic Patients: A Multicentric Retrospective Study. Dermatol. Ther. 2022, 35, e15793. [Google Scholar] [CrossRef]
  46. Griss, J.; Ratzinger, G.; Maul, J.-T.; Weger, W.; Thaçi, D.; Carrascosa, J.M.; Jonak, C. No Impact of Disease Duration on Response to Tildrakizumab Treatment among Patients with Moderate-to-Severe Plaque Psoriasis: Post Hoc Analyses from Two Phase 3 (reSURFACE 1 and reSURFACE 2) and One Phase 4 (TRIBUTE) Studies. Skin Health Dis. 2023, 3, e263. [Google Scholar] [CrossRef]
  47. Dattola, A.; Bernardini, N.; Svara, F.; Balato, A.; Caldarola, G.; D’Amico, D.; De Simone, C.; Di Brizzi, E.V.; Esposito, M.; Giofrè, C.; et al. Effectiveness of tildrakizumab 200 mg: An Italian multicenter study. J. Dermatolog. Treat. 2024, 35, 2420825. [Google Scholar] [CrossRef] [PubMed]
  48. Valenti, M.; Ibba, L.; Di Giulio, S.; Gargiulo, L.; Malagoli, P.; Balato, A.; Bardazzi, F.; Loconsole, F.; Burlando, M.; Cagni, A.E.; et al. Optimizing Tildrakizumab Dosing in Psoriasis: A 52-Week Multicenter Retrospective Study Comparing 100 mg and 200 mg-IL PSO (Italian Landscape Psoriasis). Dermatol. Ther. 2025. Online ahead of print. [Google Scholar] [CrossRef] [PubMed]
  49. Mastorino, L.; Dapavo, P.; Susca, S.; Cariti, C.; Siliquini, N.; Verrone, A.; Stroppiana, E.; Ortoncelli, M.; Quaglino, P.; Ribero, S. Drug Survival and Clinical Effectiveness of Secukinumab, Ixekizumab, Brodalumab, Guselkumab, Risankizumab, Tildrakizumab for Psoriasis Treatment. JDDG J. Dtsch. Dermatol. Ges. 2024, 22, 34–42. [Google Scholar] [CrossRef]
  50. Mastorino, L.; Cariti, C.; Susca, S.; Sciamarrelli, N.; Borriello, S.; Ortoncelli, M.; Stroppiana, E.; Verrone, A.; Dapavo, P.; Quaglino, P.; et al. Tildrakizumab in Real-Life Shows Good Efficacy in Moderate-to-Severe Psoriasis Regardless of Previous Use of Biologic Drugs and Joint Involvement. Dermatol. Ther. 2022, 35, e15818. [Google Scholar] [CrossRef]
  51. Galache-Osuna, C.; Reyes-García, S.; Salgueiro, E.; Bordallo-Landa, J.; Lozano, A.; Vázquez-López, F.; Santos-Juanes, J. Retrospective Study of Apremilast Drug Survival in Psoriasis Patients in a Daily Practice Setting: A Long-Term Experience. Dermatol. Ther. 2022, 35, e15583. [Google Scholar] [CrossRef]
  52. Di Brizzi, E.V.; Buononato, D.; Benvenuto, P.; Argenziano, G.; De Pasquale, R.; Fiorella, C.S.; Giofrè, C.; Musumeci, M.L.; Palazzo, G.; Zichichi, L.; et al. Effectiveness and Safety After a Switch to Tildrakizumab: A Real World Multicenter Italian Study in Psoriasis. Dermatol. Pract. Concept 2023, 13, e2023215. [Google Scholar] [CrossRef] [PubMed]
  53. Fernandez, A.P.; Dauden, E.; Gerdes, S.; Lebwohl, M.G.; Menter, M.A.; Leonardi, C.L.; Gooderham, M.; Gebauer, K.; Tada, Y.; Lacour, J.P.; et al. Tildrakizumab Efficacy and Safety in Patients with Psoriasis and Concomitant Metabolic Syndrome: Post Hoc Analysis of 5-Year Data from reSURFACE 1 and reSURFACE 2. J. Eur. Acad. Dermatol. Venereol. 2022, 36, 1774–1783. [Google Scholar] [CrossRef] [PubMed]
  54. Ibba, L.; Di Giulio, S.; Gargiulo, L.; Facheris, P.; Perugini, C.; Costanzo, A.; Narcisi, A.; Valenti, M. Long-term effectiveness and safety of risankizumab in patients with moderate-to-severe psoriasis with and without cardiometabolic comorbidities: A single-center retrospective study. J. Dermatolog. Treat. 2024, 35, 2425029. [Google Scholar] [CrossRef] [PubMed]
  55. Ter Haar, E.L.M.; Van den Reek, J.M.P.A.; Gaarn Du Jardin, K.; Barbero-Castillo, A.; De Jong, E.M.G.J.; Lubeek, S.F.K. Efficacy and Safety of Tildrakizumab in Older Patients: Pooled Analyses of Two Randomized Phase III Clinical Trials (reSURFACE 1 and reSURFACE 2) Through 244 Weeks. Acta. Derm. Venereol. 2023, 103, adv17752. [Google Scholar] [CrossRef]
  56. Chiricozzi, A.; Coscarella, G.; Puig, L.; Vender, R.; Yeung, J.; Carrascosa, J.-M.; Piaserico, S.; Gisondi, P.; Lynde, C.; Ferreira, P.; et al. Age Affects Drug Survival Rates of Interleukin (IL)-17 and IL-23 Inhibitors in Patients with Plaque Psoriasis: Results from a Retrospective, Multicentric, Multi-Country, Cohort Study. J. Eur. Acad. Dermatol. Venereol. 2024, 38, 2175–2185. [Google Scholar] [CrossRef]
  57. Galluzzo, M.; Talamonti, M.; Cioni, A.; Maffei, V.; Shumak, R.G.; Tofani, L.; Bianchi, L.; Campione, E. Efficacy of Tildrakizumab for the Treatment of Difficult-to-Treat Areas: Scalp, Nail, Palmoplantar and Genital Psoriasis. J. Clin. Med. 2022, 11, 2631. [Google Scholar] [CrossRef]
Life 15 00789 g001
Figure 1. (A) Kaplan–Meier curve of tildrakizumab survival. (B) Kaplan–Meier curves of tildrakizumab survival according to arthritis (p < 0.001). (C) Kaplan–Meier curves of tildrakizumab survival according to arterial hypertension (p < 0.001). (D) Kaplan–Meier curves of tildrakizumab according to dyslipidemia (p < 0.028) (E) Kaplan–Meier curves of tildrakizumab survival according to previous biological treatments (p < 0.001).
Figure 1. (A) Kaplan–Meier curve of tildrakizumab survival. (B) Kaplan–Meier curves of tildrakizumab survival according to arthritis (p < 0.001). (C) Kaplan–Meier curves of tildrakizumab survival according to arterial hypertension (p < 0.001). (D) Kaplan–Meier curves of tildrakizumab according to dyslipidemia (p < 0.028) (E) Kaplan–Meier curves of tildrakizumab survival according to previous biological treatments (p < 0.001).
Life 15 00789 g001
Table 1. Baseline characteristics of patients.
Table 1. Baseline characteristics of patients.
Total Patients (n = 100)
Sex (male), n (%)54 (54%) male
Age at start of biologic treatment (years), mean ± SD48.4 ± 15.6
Positive family history of psoriasis (yes), n (%)63 (63%)
Onset before 40 years of age (%)74 (74%)
Duration of treatment (months); mean ± SD26.7 (IC95% = 23–29.72)
Initial PASI13.2 ± 6.1
Tildrakizumab start age48.23 ± 15.26
Age ≥ 6516 (16%)
Comorbidities, n (%)
Obesity (BMI ≥ 30)40 (30%)
Diabetes mellitus17%
Arterial hypertension21 (21%)
Dyslipidemia50 (50%)
Arthritis28 (28%)
Prior treatments with biologics (%)97 (97%)
One biologic69 (69%)
Two biologics18 (18%)
Three biologics4 (4%)
Four biologics3 (3%)
Five Biologics3 (3%)
Table 2. Cumulative probability of tildrakizumab survival and cumulative probability according to arthritis status at different time intervals.
Table 2. Cumulative probability of tildrakizumab survival and cumulative probability according to arthritis status at different time intervals.
Percentage (95% CI)1 Year2 Years3 Years4 Years
Global85 (78–93)81 (71–91)81 (71–91)81 (71–91)
Arthritis no93 (87–99)93 (87–99)93 (87–99)93 (87–99)
Arthritis yes68 (58–48)54 (42–66)54 (42–66)54 (42–66)
Table 3. Cox regression analyses. Hazard ratios of risk of tildrakizumab discontinuation.
Table 3. Cox regression analyses. Hazard ratios of risk of tildrakizumab discontinuation.
Univariate AnalysisHR (CI = 95%)p-Value
Psoriasis onset ≥ 40 years 0.3321.718 (0.575–5.135)0.332
Sex (male) 0.8101.137 (0.398–3.244)0.810
Obesity: BMI ≥ 301.942 (0.674–5.598)0.219
Arthritis: yes6.851 (2.141–21,920)0.001
Hypertension arterial: yes6.275 (2.142–18.382)<0.001
Dyslipidemia: yes3.677 (1.026–13.185)0.030
Family history: yes1.134 (0.380–3.384)0.822
Diabetes: yes2.008 (0.628–6.413)0.240
Previous biologics treatment > 15.581 (1.868–16.678)<0.001
Older than 651.436 (0.400–5.153)0.579
Multivariate AnalysisHR (CI = 95%)p-Value
Arthritis4.098 (1.206–13.925)0.024
Hypertension arterial4.673 (1.410–15.488)0.012
Previous biologic treatments > 13.704 (1.192–11.514)0.024
Dyslipidemia1.245 (0.299–5.178)0.763
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Santos-Juanes Galache, R.; Reyes García, S.; Carrero Martín, J.; Nuñez Domínguez, Á.; López Pando, M.; Álvarez Losada, I.; de la Fuente Villaverde, I.; Lozano-Blazquez, A.; Salgueiro, E.; Bordallo, J.; et al. Real-World Study of Tildrakizumab Survival in Psoriasis: Impact of Arthritis, Hypertension, and Prior Biologic Use. Life 2025, 15, 789. https://doi.org/10.3390/life15050789

AMA Style

Santos-Juanes Galache R, Reyes García S, Carrero Martín J, Nuñez Domínguez Á, López Pando M, Álvarez Losada I, de la Fuente Villaverde I, Lozano-Blazquez A, Salgueiro E, Bordallo J, et al. Real-World Study of Tildrakizumab Survival in Psoriasis: Impact of Arthritis, Hypertension, and Prior Biologic Use. Life. 2025; 15(5):789. https://doi.org/10.3390/life15050789

Chicago/Turabian Style

Santos-Juanes Galache, Raquel, Sebastian Reyes García, Jimena Carrero Martín, Álvaro Nuñez Domínguez, Marta López Pando, Irene Álvarez Losada, Irene de la Fuente Villaverde, Ana Lozano-Blazquez, Esther Salgueiro, Javier Bordallo, and et al. 2025. "Real-World Study of Tildrakizumab Survival in Psoriasis: Impact of Arthritis, Hypertension, and Prior Biologic Use" Life 15, no. 5: 789. https://doi.org/10.3390/life15050789

APA Style

Santos-Juanes Galache, R., Reyes García, S., Carrero Martín, J., Nuñez Domínguez, Á., López Pando, M., Álvarez Losada, I., de la Fuente Villaverde, I., Lozano-Blazquez, A., Salgueiro, E., Bordallo, J., Santos-Juanes, J., & Galache Osuna, C. (2025). Real-World Study of Tildrakizumab Survival in Psoriasis: Impact of Arthritis, Hypertension, and Prior Biologic Use. Life, 15(5), 789. https://doi.org/10.3390/life15050789

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