Tildrakizumab Real-World Experience (T-REX) in Plaque Psoriasis: Meta-Analysis of Four Non-interventional Studies

Abstract

Introduction

Tildrakizumab, an anti-IL-23p19 antibody, is registered for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Its effectiveness in specific patient subgroups—e.g. those with high body weight, high disease burden, involvement of high-impact areas or older patients—is often underrepresented in randomised clinical trials and better captured in real-world settings. To address this gap, the present meta-analysis was undertaken to synthesise data from four observational studies conducted in Germany (TILOT, TiGER, TIL-SENIOR, TIL-TWO), each focusing on distinct psoriasis populations.

Methods

This meta-analysis of four prospective multicentre non-interventional studies evaluated the effectiveness and safety of tildrakizumab in different patient populations with moderate-to-severe plaque psoriasis. Outcome parameters assessed at baseline, week 16 and 28 included absolute Psoriasis Area Severity Index (PASI) values, proportion of patients with PASI < 1, < 3, < 5, PASI 75, PASI 90 and PASI 100, body surface area (BSA), Physician’s Global Assessment (PGA) 0/1 and Dermatology Life Quality Index (DLQI) 0/1. The meta-analysis was conducted using a random effects model.

Results

The meta-analysis included 1504 patients. The course of the absolute PASI and BSA and the proportion of patients achieving PASI < 3, PASI 75, 90, 100, PGA 0/1 and DLQI 0/1 at week 28 was comparable across all four studies. Overall, mean PASI scores decreased from 16.5 (95% confidence intervals (CI) 15.8–17.3) at baseline to 2.8 (95% CI 2.5–3.0) at week 28. The proportion of patients with PGA 0/1 and DLQI 0/1 increased from 1.8% and 3.7% at baseline to 63.5% and 51.2% at week 28, respectively. No new safety signals were identified.

Conclusions

Tildrakizumab showed consistent effectiveness across different study populations. Substantial effectiveness was achieved over 28 weeks. Safety results were comparable across populations, without outliers in older patients or patients with higher disease burden.

Graphical abstract available for this article.

Supplementary Information

The online version contains supplementary material available at 10.1007/s13555-026-01713-1.

Plain Language Summary

Psoriasis is a common chronic systemic inflammatory disease. It has a substantial impact on patients’ quality of life. Biological compounds such as tildrakizumab have become important treatment options in moderate-to-severe psoriasis. Once a medication is approved, it is important to understand how well a drug works in different types of patients, for example, in the older population, in people with higher body weight, people with psoriasis in sensitive areas such as the scalp and those suffering from particularly severe disease. To explore this, four observational studies were conducted including these patient groups. In the present analysis, we explored whether the effect of tildrakizumab was comparable between the different studies. In total, the four studies included 1504 patients. The results showed that tildrakizumab improved disease severity, reduced the size of affected skin areas and enhanced quality of life across all groups. These improvements were seen over a period of 28 weeks, and safety results were in line with previous studies. Overall, the findings suggest that tildrakizumab can be beneficial for a wide range of patients with psoriasis, regardless of age, body weight or psoriasis severity.

Graphical Abstract

Supplementary Information

The online version contains supplementary material available at 10.1007/s13555-026-01713-1.

Key Summary Points

Why carry out this study?

Tildrakizumab is approved for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

Its effectiveness in specific patient subgroups—e.g. those with high body weight, involvement of high-impact areas or older—is often underrepresented in randomised clinical trials and better captured in real-world settings.

To address this gap, the present meta-analysis was undertaken to synthesise data from four observational studies conducted in Germany (TILOT, TiGER, TIL-SENIOR, TIL-TWO), each focusing on distinct psoriasis populations.

What was learned from the study?

When focusing on special populations, tildrakizumab demonstrated similarly positive outcomes across the four studies for the parameters Psoriasis Area Severity Index, Body Surface Area, Physician’s Global Assessment and Dermatology Life Quality Index at week 28.

The results reassure clinicians about treatment reliability across diverse patient profiles and underscore the positive impact of tildrakizumab on quality of life in people living with plaque psoriasis.

Digital Features

This article is published with digital features, including a graphical abstract, to facilitate understanding of the article. To view digital features for this article, go to 10.6084/m9.figshare.31429772.

Introduction

Psoriasis is a multisystem chronic inflammatory disease with predominant skin, joint and blood vessel involvement [1, 2]. The treatment landscape for moderate-to-severe psoriasis has expanded considerably over the last 20 years [3]. In particular, the identification of the interleukin (IL) 23/T helper 17 (Th17) immune axis as the main driver of psoriasis inflammation led to the development of biologics that specifically target this pathway [4]. IL-23 was identified as a key cytokine responsible for the differentiation and survival of T helper 17 cells [5, 6]. IL-23p19 inhibitors selectively target the p19 subunit of IL-23, thereby preserving IL-12-related immunity and may thus potentially offer improved efficacy and safety [7]. The anti-IL-23p19 antibody tildrakizumab is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Approval was based on the phase 3 randomised controlled trials (RCTs) reSURFACE 1 (NCT01722331) and reSURFACE 2 (NCT01729754) that compared tildrakizumab 200 mg and 100 mg with placebo and the tumour necrosis factor (TNF)-α inhibitor etanercept. At week 12, a significantly greater proportion of patients receiving tildrakizumab achieved Psoriasis Area and Severity Index (PASI 75) and a Physician’s Global Assessment (PGA) response (score of 0 or 1 with ≥ 2 grade score reduction from baseline) compared with those receiving placebo or etanercept [8]. The beneficial effect was sustained in subsequent open-label extension studies over 3 and 5 years [9, 10]. No unexpected safety signals were identified [8–11].

In clinical practice, patient populations are more heterogeneous than those enrolled in clinical studies, and therapy outcomes under real-world conditions may differ from the controlled conditions observed in clinical trials. Therefore, non-interventional studies are important means to gain new insights in terms of effectiveness and safety in relevant real-world populations, such as older patients and patients with high body weight. In reSURFACE 1 and reSURFACE 2, the subgroup of patients with affected high-impact areas such as the scalp, nails, palms, soles or genitals have not been separately analysed [12, 13]. For psoriasis in high-impact areas, the efficacy of tildrakizumab has, so far, only been assessed in an RCT for scalp psoriasis [14, 15], while RCTs are ongoing to investigate its efficacy in patients with nail and genital involvement. Meanwhile, real-life data mostly based on small patient cohorts from different countries confirmed the effectiveness and safety of tildrakizumab in psoriasis management [16]. To address the gap between RCTs and the real-world setting in Germany, four prospective multicentre observational studies have been conducted, each focusing on a different patient population.

The TILOT study (tildrakizumab safety and efficacy in long-term use under real-world conditions) assessed the safety and effectiveness of tildrakizumab under real-world conditions along with the durability of the response over 36 months. An interim analysis at week 52 including 412 patients demonstrated a high degree of effectiveness and a reassuring safety profile of tildrakizumab [17]. The TiGER study (influence of tildrakizumab on treatment satisfaction and quality of life of patients with moderate-to-severe plaque psoriasis and involvement of particularly high-impact areas under routine conditions in Germany) assessed quality of life as well as overall treatment satisfaction and collected real-world data on efficacy and safety over 12 months. TIL-SENIOR (Needs and therapeutic benefits of older patients with moderate-to-severe plaque psoriasis and indication for treatment with tildrakizumab in routine care) investigates whether age (≥ 65 years) poses a meaningful discriminator for patients’ needs and the individual achievement of treatment goals between younger (< 65 years) and older patients with moderate-to-severe plaque psoriasis who are treated with tildrakizumab over 12 months in routine dermatological practice. The aim of TIL-TWO (tildrakizumab 200 mg for the treatment of moderate-to-severe plaque psoriasis in everyday practice in patients with high body weight or disease burden) was to gain further experience on the patient’s well-being, treatment satisfaction and health-related quality of life in a large study population treated with tildrakizumab 200 mg for 12 months.

With the purpose to compare the performance of tildrakizumab in different psoriasis populations (high body weight, high burden of disease, older, involvement of high-impact areas) in the real-world setting, a meta-analysis of the four observational studies has been performed on key effectiveness and safety results.

Methods

The present meta-analysis, tildrakizumab real-world experience (T-REX), of four single-arm, prospective multicentre non-interventional studies (TILOT, TiGER, TIL-SENIOR and TIL-TWO) evaluated the effectiveness and safety of tildrakizumab in different patient populations with moderate-to-severe chronic plaque psoriasis in Germany. TiGER was conducted from March 2022 to October 2024 at 48 sites and included 355 adult patients with involvement of at least one high-impact area, here defined as involvement of scalp, fingernails, palms or soles or genitals. TIL-SENIOR was initiated in June 2023 and is ongoing at 34 sites. A total of 202 patients ≥ 18 years of age receiving tildrakizumab according to the summary of product characteristics (SmPC) were eligible for inclusion. The cohort is stratified by age (≥ 65 years and < 65 years). The duration of the observation period is 12 months. TIL-TWO started recruiting in March 2023 and is ongoing at 46 sites. The study enrolled 359 patients who, according to their doctor’s decision and in line with the approved indication, should start treatment with 200 mg tildrakizumab, e.g. owing to elevated body weight (> 90 kg) and/or high disease burden. Dosing in TILOT, TiGER and TIL-SENIOR was at the discretion of the investigator. Whereas TiGER, TIL-SENIOR and TIL-TWO each focus on specific populations, TILOT had no pre-specified enrolment criteria in terms of special patient features or a dedicated focus on specific affected locations. The study was conducted at 122 sites from November 2018 to November 2024 and included 946 adult patients receiving tildrakizumab in clinical routine in accordance with the SmPC. Yet, registry data have shown that only about 25% of the real-world population meets the inclusion criteria for an RCT [18]. Therefore, real-world data are important and valuable, which was the rationale for including the TILOT population. Patients participating in one of the four studies were excluded from participation in the other three so that there was no overlap in participants.

All four non-interventional studies were conducted in accordance with the applicable legislation on non-interventional studies and the ethical principles set forth in the Declaration of Helsinki and the guidelines on good pharmacovigilance practices. International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use—Good Clinical Practice (ICH‐GCP) guidelines were followed whenever applicable. The studies received approval from their respective ethics committees (TILOT: ethics committee of the medical council Niedersachsen (Bo/40/2018), TiGER: ethics committee of the medical council Westfalen-Lippe and the Westphalian Wilhelms-University (2021-779-f-S), TIL-TWO: ethics committee of the University Regensburg (22-3193-101), TIL-SENIOR: ethics committee of the Charité, Berlin (EA4/031/23)). No diagnostic or therapeutic procedures beyond routine clinical practice were required, and treatment routine was not altered by these studies. All patients provided their written informed consent prior to participating in the respective study.

Objectives

The primary objective of this meta-analysis was to estimate the pooled effect size related to tildrakizumab or outcome across the four studies. The secondary objective was to assess quantitative heterogeneity among the studies.

Timepoints and Outcome Parameters

Since data from two of these studies (TIL-TWO and TIL-SENIOR) were available up to 28 weeks after treatment initiation, the meta-analysis focused on this time frame. Thus, visit timepoints considered for this meta-analysis were baseline, week 16 and week 28. The outcome parameters for the meta-analysis were selected from the endpoints shared across studies. In addition to the absolute PASI values, the proportion of patients achieving PASI < 1, < 3 and < 5 as well as the proportion of patients achieving PASI 75, PASI 90 and PASI 100 at week 28 were analysed. Further outcome parameters included the proportion of patients reaching a global PGA of 0/1, body surface area (BSA) and Dermatology Life Quality Index (DLQI) (absolute values over time and proportion reaching 0/1).

Statistics

Data were extracted from the interim or final study reports. For continuous variables, mean, standard deviation and total number were extracted. For categorial variables, proportions were calculated from the total number of patients and the number of patients with the respective outcome of interest. Missing values were not imputed, and observed cases (OC) are reported. Each study used last observation carried forward (LOCF) internally. Applying multiple imputation at the meta-analysis level would mix different approaches, creating inconsistency and potential bias. For the meta-analysis, real-world evidence was consciously used as observed, not modelled. Using OC ensures results reflect actual patient trajectories without statistical ‘correction’. Variations in dosing (100 mg versus 200 mg) were not accounted for in the statistical analysis.

Both fixed-effects and random effects models were calculated. For continuous variables, inverse variance weighting was used for pooling. Proportions were pooled on the basis of a generalised linear mixed model (random intercept logistic regression model), with logit transformation applied before pooling. A continuity correction of 0.5 was applied in studies with zero cell frequencies. Pooled estimates were reported with 95% confidence intervals. Quantitative heterogeneity was assessed by calculating the I² statistic (percentage of variability attributable to study heterogeneity rather than chance). Values of I² > 50% were considered as substantial heterogeneity, and values > 75% as considerable heterogeneity. In case of considerable heterogeneity, sensitivity analyses (i.e. repeated meta-analyses of three instead of four studies, involving all possible combinations of three studies) were performed to explore if one of the studies was the main cause for the observed heterogeneity. All analyses were performed in R (meta package/metamean and metaprop).

Results

The present meta-analysis included 824 patients from TILOT, 355 from TiGER, 180 from TIL-TWO and 145 from TIL-SENIOR with data available at week 28, reaching a total of 1504 patients. Baseline characteristics are summarised in Table 1.

Table 1.

Baseline characteristics

Parameter	TILOT		TiGER		TIL-TWO		TIL-SENIOR
							Total		< 65 years		≥ 65 years
	N		N		N		N		N		N
Patients in FAS	824		355		180		145		96		49
Age (years), mean (SD)	824	47.5 (15.3)	353	46.5 (15.1)	180	49.3 (15.6)	145	55.2 (17.1)	96	45.7 (12.3)	49	73.8 (6.7)
Sex, %
Male	502	60.9	223	63.2	110	61.1	80	55.2	58	60.4	22	44.9
Female	322	39.1	130	36.8	70	38.9	65	44.8	38	39.6	27	55.1
Height (cm), mean (SD)	821	173.9 (9.5)	350	174.2 (9.7)	177	175.3 (10.1)	145	172.5 (10.0)
Weight (kg), mean (SD)	820	87.7 (20.2)	350	86.8 (22.2)	177	99.8 (26.7)	145	84.7 (19.0)	96	86.2 (19.5)	49	81.8 (17.8)
BMI (kg/m2), mean (SD)	820	28.9 (6.0)	350	28.4 (6.2)	175	32.2 (7.6)	145	28.4 (5.3)	96	28.3 (5.5)	49	28.4 (5.0)
Years since plaque psoriasis diagnosis, mean (SD)	817	18.4 (14.7)	350	16.5 (14.4)	179	16.2 (16.3)	145	18.6 (16.1)	96	17.7 (14.2)	49	20.5 (19.3)
PASI, mean (SD)	824	16.3 (9.3)	353	16.3 (9.7)	180	18.2 (10.3)	142	15.8 (8.3)	94	15.8 (8.8)	48	15.9 (7.1)
Scalp psoriasis, %	539	65.4	316	89.5	152	84.4	119	82.1	76	79.2	43	87.8
Nail psoriasis, %	338	41.0	134	38.0	66	36.7	42	29.0	34	35.4	8	16.3
Palmoplantar psoriasis, %	91	11.0	127	36.0	55	30.6	44	30.3	29	30.2	15	30.6
Systemic therapy prior to study start, %	682	82.8	251	71.1			86	59.3
Biologic therapy prior to study start, %	179	21.7	73	20.7	52	28.4	31	21.4

BMI, body mass index; FAS, full analysis set; PASI, Psoriasis Area and Severity Index; SD, standard deviation

Effectiveness

Overall, tildrakizumab consistently reduced disease severity in all individual studies. The course of the absolute PASI was comparable across all four studies, improving to mild severity grade within 28 weeks (Fig. 1a). The meta-analysis with the random effects model yielded a decrease of mean raw PASI scores from 16.5 (95% CI 15.8–17.3) at baseline to 2.8 (95% CI 2.5–3.0) at week 28 (Fig. 1b). Considerable heterogeneity was observed at week 16. However, in a sensitivity analysis conducted for week 16, no single study was identified as a reason for quantitative heterogeneity (Supplementary Table S1). As I² > 75% was only observed for week 16 results and not for baseline or week 28, no changes to the main analysis were considered necessary, and the random effects model results were used.

Fig. 1.

Absolute PASI course provided as mean (95% CI) (a) and meta-analysis (b). All data are observed cases. CI, confidence interval; PASI, Psoriasis Area and Severity Index; SD, standard deviation

The proportion of patients reaching PASI < 3 (established threshold for meaningful treatment response) [19] at week 28 was comparable between the four studies (Fig. 2). A profound increase in the responder rate was already achieved at week 16. Overall, the proportion of patients with PASI < 3 increased from 2.5% at baseline to 67.6% by week 28 in the meta-analysis (Supplementary Fig. S1). Consistently, a marked increase from baseline to week 28 was observed for the proportion of patients with PASI < 1 (0.7–40.6%; Supplementary Fig. S2) and PASI < 5 (6.4–81.3%; Supplementary Fig. S3). At week 28, comparable results were also achieved for PASI 75 (range 72.1–82.0%), PASI 90 (range 48.9%-56.8%) and PASI 100 (range 23.1–28.1%) (Supplementary Figs. S4–S6).

Fig. 2.

Responders achieving PASI < 3. Bars indicate 95% CI. All data are observed cases. CI, confidence interval; PASI, Psoriasis Area and Severity Index

Global PGA improved in all studies. The proportion of patients achieving global PGA of 0 (clear) or 1 (almost clear) was comparable across studies for week 28. Overall, the proportion of patients with a global PGA of 0/1 increased from 1.8% at baseline to 63.5% at week 28 (Supplementary Fig. S7). Considerable heterogeneity was observed at baseline. In the sensitivity analysis, the TiGER study was identified as the main reason for quantitative heterogeneity (Supplementary Table S2). However, as I² > 75% was only observed for baseline results (not for weeks 16 or 28), no changes to the main analysis were considered necessary.

All studies showed comparable BSA reductions (Fig. 3). Patients in TIL-TWO exhibited a slightly greater affected body surface area which corresponds with a modestly higher PASI score at baseline. Considerable heterogeneity was observed at week 16; however, in the sensitivity analysis for week 16, no single study was identified as a reason for quantitative heterogeneity (Supplementary Table S3), and I² > 75% was only observed for week 16 results (Supplementary Fig. S8).

Fig. 3.

Course of BSA provided as mean (95% CI). All data are observed cases. BSA, body surface area; CI, confidence interval

Overall, mean DLQI absolute values decreased from 13.7 (95% CI 13.3–14.2) at baseline to 3.5 (95% CI 3.0–4.1) at week 28 (Supplementary Fig. S9). Patients in the TIL-TWO study reported a slightly delayed improvement of their DLQI score (Fig. 4). The proportion of patients with DLQI 0/1 increased from 3.7% at baseline to 51.2% at week 28. Considerable heterogeneity was observed at week 28. In the sensitivity analysis, the TILOT study identified as the main reason for quantitative heterogeneity (Supplementary Table S4). Again, as I² > 75% was only observed for week 28 results (not for baseline or week 16), the random effects model was applied (Supplementary Fig. S10).

Fig. 4.

Absolute DLQI provided as mean (95% CI). All data are observed cases. CI, confidence interval; DLQI, Dermatology Life Quality Index

Safety

Safety was not analysed in the meta-analysis, as observation periods varied significantly (28 weeks to 3 years). However, across the studies no new safety signals were identified. The most frequently reported events were ‘drug ineffective’ and different events belonging to the system organ class (SOC) ‘infections and infestations’. Two pregnancies in women were reported with unknown outcome. Three paternal exposures were reported. One case resulted in the birth of a healthy girl; the other outcomes are unknown. In total, eight deaths were reported, none of them related to tildrakizumab.

Discussion

The present meta-analysis of four observational studies consolidates effectiveness results from a large population totalling 1504 patients treated with tildrakizumab for up to 28 weeks. T-REX provides the first meta-analysis of real-world effectiveness of tildrakizumab in psoriasis, highlighting outcomes in clinically relevant subgroups often underrepresented in RCTs, including patients with high body weight, high disease burden, older age and involvement of high-impact areas. A prior comprehensive meta-analysis including European real-world studies focused on the differences between real-world evidence and RCTs [20], whereas T-REX aimed to demonstrate the robustness of the effectiveness data across a very broad and diverse patient population with a large number of patients. When focusing on special populations, tildrakizumab demonstrated similarly favourable outcomes across all endpoints in each of the individual non-interventional studies. Significant improvements were already observed at week 16, with disease severity continuing to decline through week 28. Across all four studies, safety of tildrakizumab was in line with the safety profile known from RCTs with no new or unexpected safety signals.

Regardless of patients’ baseline characteristics, tildrakizumab was consistently effective across different patient populations. Results from TIL-TWO showed a slightly delayed treatment effect, which may be attributed to a more severely affected patient population, reflecting a negative selection bias [21]. Nevertheless, the improvement achieved with tildrakizumab was in line with findings from the other studies (TILOT, TiGER) whose patients had been more extensively pretreated with non-biologic systemic therapies. Tildrakizumab also demonstrated benefits in patients with involvement of high-impact areas, particularly scalp and nails.

In terms of effectiveness, real-world data align well with results from RCTs. The results at week 16 across different patient populations for the endpoints PASI 75, PASI 90, PASI 100, PGA 0/1 and DLQI 0/1 were consistent with those achieved with the selected populations at week 12 in the pivotal clinical studies reSURFACE1 and reSURFACE2, which enrolled the special populations from TiGER, TIL-TWO and the older SENIOR arm only in minor numbers and thus did not capture the entire constellations found in psoriatic disease [8]. A meta-analysis of 25 real-word studies across Europe observed even a generally higher level of tildrakizumab effectiveness in the real-world compared with the efficacy observed in the reSURFACE trials [20]. PASI values were slightly higher in this meta-analysis with PASI 90 ranging from 49.4% to 93.3% at weeks 12–28 compared with those achieved in T-REX (34.8% and 51.8% achieving PASI 90 at weeks 16 and 28, respectively) [20]. However, a comparison between studies from different countries is difficult as patient characteristics and baseline disease severity may vary significantly.

Compared with another real-world study evaluating tildrakizumab in an unselected patient cohort in Germany, the proportion of patients achieving DLQI 0/1 at week 28 was lower in T-REX (61% versus 51.2%) [22]. Similarly higher proportions of patients reaching PASI 75 (81.4%), PASI 90 (64.4%) and PASI < 3 (79.7%) at week 28 were reported from a prior real-world study including 59 patients [23]. Also, the results achieved in the present meta-analysis for PASI 90 and PASI 100 were considerably lower compared with data from a retrospective cohort study including 42 patients (76.1% PASI 90; 61.9% PASI 100 at week 28) [24]. Higher PASI values at baseline and longer history of psoriatic disease in T-REX may account for this difference as patients with a shorter disease duration were reported to have a higher probability of PASI 90 and PASI 100, suggesting a benefit from early treatment intervention with tildrakizumab [25].

Whereas the present meta-analysis does not show a strong variation from ReSURFACE results, deviations between clinical trial and real-world data were observed for the other IL-23 inhibitors guselkumab and risankizumab [16, 20]. The real-world study PERSIST found lower proportions of patients reaching PASI 90 with guselkumab compared with the clinical trials VOYAGE 1 and VOYAGE 2, which was attributed to prior conventional systemic and biologic therapies or comorbidities at baseline [26].

The results presented here are limited by the non-interventional design of the original studies. As OC were used in the meta-analysis, measured variables may have been influenced by responder bias. Patients experiencing a favourable treatment response may have been more likely to continue treatment, while those who were not experiencing a favourable treatment response may have tended to discontinue treatment. However, the meta-analysis adds benefits regarding the interpretation of single study results. Meta-analysis is a statistical method used to quantitatively pool data from multiple studies to derive more precise estimates. In consequence, performing a meta-analysis enhances statistical power. Effect sizes become more reliable and less dependent on chance. Results refer not only to a single sample but to different populations, which broadens the generalisability. With a total of 1504 patients, T-REX is the second-largest tildrakizumab cohort after the PsoBest registry, which has 1732 tildrakizumab patients as of 15 October 2025 [27]. Thus, the T-REX population can be considered a representative cross-section of the total German psoriasis population.

Conclusions

Tildrakizumab showed a consistent effectiveness profile across different patient populations. Substantial effectiveness was achieved over 28 weeks. Focusing on special populations, tildrakizumab was effective in high-impact areas, older patients and patients with high body weight or burden of disease. Safety results were comparable without outliers in the older population or patients with higher burden of disease. Future longer-term data from TILOT, TiGER, TIL-TWO and TIL-SENIOR will deepen the understanding of the real-world effectiveness of tildrakizumab and its impact on the quality of life in people with plaque psoriasis.

Supplementary Information

Below is the link to the electronic supplementary material.

Author Contribution

Afra Kempf and Astrid Kirsch made substantial contributions to the conception and design. Athanasios Tsianakas, Nina Magnolo, Georgios Kokolakis and Dennis Niebel made substantial contributions to data acquisition and interpretation. Frank Andersohn made substantial contributions to data analysis and interpretation. Athanasios Tsianakas drafted the article. Nina Magnolo, Afra Kempf, Frank Andersohn, Astrid Kirsch, Georgios Kokolakis and Dennis Niebel critically revised the article for important intellectual content. All authors provided final approval of the version to be published and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Funding

This study was financially supported by Almirall Hermal GmbH, Reinbek, Germany. The journal’s Rapid Service Fee was funded by Almirall Hermal GmbH, Reinbek, Germany.

Data Availability

The datasets generated and/or analysed during the current study are available from Almirall on reasonable request.

Declarations

Conflict of Interest

Athanasios Tsianakas: AT received honoraria for speaker and advisor activities from Almirall. AT acted as investigator in the presented TILOT trial. Nina Magnolo: speaker’s/advisor’s honoraria from Abbvie, Almirall, Amgen, BMS, Böhringer-Ingelheim, Celltrion, Dr. Wolff, Janssen-Cilag, La Roche-Posay, Leo Pharma, Lilly, Novartis, Pfizer, Sanofi and UCB. Afra Kempf and Astrid Kirsch are employees of Almirall Hermal GmbH. Frank Andersohn: fees or honoraria from: Abbott, Almirall, AstraZeneca, Berlin Chemie, Boehringer Ingelheim, InGef, Lundbeck, Novartis, Novo Nordisk and Xcenda. Georgios Kokolakis reports consulting fees from Bayer; payment or honoraria from AbbVie, Abbott, Actelion Pharmaceuticals, Amgen, Basilea Pharmaceutica, Biogen IDEC, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Hexal, Janssen-Cilag, LEO Pharma, Eli Lilly, MSD, Mylan, Novartis, Parexel, Pfizer and UCB Pharma; support for attending meetings or travel from AbbVie, Abbott, Amgen, Basilea Pharmaceutica, Celgene, Janssen-Cilag, LEO Pharma, MSD, Novartis, Pfizer, Sanofi and UCB Pharma; and serving on a data safety monitoring board or advisory board for AbbVie, Abbott, Amgen, Basilea Pharmaceutica, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Janssen-Cilag, LEO Pharma, Eli Lilly, Novartis, Takeda and UCB Pharma. Dennis Niebel: travel reimbursements, speaker’s/advisor’s honoraria or research funding from: Abbvie, Almirall, Apogee Therapeutics, AstraZeneca, Boehringer Ingelheim, Celltrion, Bristol Myer Squibb, Eli Lilly, GlaxoSmithKline, Hexal AG/Sandoz Group, Incyte, Johnson and Johnson, Kyowa Kirin, LEO Pharma, L’Oreal, MSD, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma and UCB Pharma.

Ethical Approval

The present meta-analysis included two completed and two ongoing non-interventional studies. All were designed, implemented and performed in accordance with the applicable legislation on non-interventional studies and the ethical principles set forth in the Declaration of Helsinki and the guidelines on good pharmacovigilance practices. ICH-GCP guidelines were followed whenever possible. The studies included in the meta-analysis received approval from their respective ethics committees (TILOT: ethics committee of the medical council Niedersachsen (Bo/40/2018), TiGER: ethics committee of the medical council Westfalen-Lippe and the Westphalian Wilhelms-University (2021-779-f-S), TIL-TWO: ethics committee of the University Regensburg (22-3193-101), TIL-SENIOR: ethics committee of the Charité, Berlin (EA4/031/23)). No diagnostic or therapeutic procedures beyond routine clinical practice were required, and treatment routine was not altered by these studies. All patients provided their written informed consent prior to participating in the respective study.