Tildrakizumab Effective in Real-World Settings for Psoriasis Over 76 Weeks

A new analysis has confirmed tildrakizumab’s efficacy in patients with psoriasis in a real-world setting, with significant improvements in Psoriasis Area and Severity Index (PASI) scores in a heterogeneous patient cohort and notable quality of life improvements.1

These findings were the result of a study authored by investigators such as Caroline Glatzel, MD, from the University Hospital Würzburg’s Department of Dermatology, Venereology and Allergology. Glatzel and colleagues set out to assess tildrakizumab’s use in daily practice within a heterogeneous cohort of individuals with psoriasis often impacted by comorbid diseases.

The investigative team highlighted that while the use of biologic drugs in large randomized controlled trials has been observed, such data cannot be directly transferred to patients seen in everyday clinical settings.2

“The objective of this analysis was to assess the real-world effectiveness of tildrakizumab, with a particular focus on common comorbidities and factors that may explain discrepancies with the results of the pivotal trials,” Glatzel and coauthors wrote.1

Study Design Details

Patients evaluated in the investigative team's retrospective, dual-center study were assessed provided they had received tildrakizumab treatment for psoriasis at the University Hospitals of Würzburg and Erlangen between April 2018 - June 2024. Follow-up interactions extending to 76 weeks. Those deemed eligible to be participants were ≥18 years of age and were administered subcutaneous tildrakizumab (100 mg or 200 mg) based on the current standard clinical guidelines. They had been monitored at the 4-week mark and subsequently at 12-week intervals.

Assessments conducted included demographic and clinical data such as body mass index (BMI), duration of psoriasis, sex, previous systemic drug use (non-biologic or biologic), PASI score, age at initiation of tildrakizumab, Dermatology Life Quality Index (DLQI), starting dose, and the presence of comorbidities. Comorbidities were identified by Glatzel et al via patient reports and medical records. Follow-up assessments recorded DLQI scores (Weeks 4–16), PASI outcomes, and any modifications in dosage.

The efficacy analysis concluded with 111 subjects. The investigators determined that the median PASI score declined from 12.6 (IQR 11.0–18.6) at the point of baseline to 6.0 (IQR 1.0–10.4) at the 4-week mark, 1.8 (IQR 1.0–10.4) at the 16-week mark, and 0.0 (IQR 0.0–0.0) at the 76-week mark. Glatzel and coauthors further concluded that the proportion of participants attaining a PASI < 3 was 64.6% at 16 weeks, 79.7% at 52 weeks, and 94.4% at 76 weeks. Additionally, they noted PASI < 5 was achieved by 83.3%, 94.2%, and 100% of subjects at those respective time points.

By the 76-week mark, PASI75, PASI90, and PASI100 responses were attained by 97.2%, 83.3%, and 58.3% of those involved in the study, respectively. Individuals shown to have arterial hypertension (AHT) had a lower PASI response than those without AHT beginning at the 28-week mark (P = .035) and continuing through follow-up, although those with AHT still reported a score of PASI < 3 by Week 28 and beyond.

Glatzel and colleagues highlighted that individuals with at least a single cardiovascular risk factor (CRF)—defined as dyslipidemia, obesity, AHT, or type 2 diabetes mellitus (46.8%)—were found to have a weaker PASI improvement at the 16, 28, and 64-week marks versus those without such factors (P = .023, P = .012, and P = .014, respectively). They further concluded that improvements in median DLQI went from 16.0 (IQR 9.5–22.0) at baseline to 3.0 (IQR 1.0–8.0) during Weeks 4–16, suggesting a substantial enhancement in participants' quality of life.

“Based on these findings, tildrakizumab could be cautiously considered as a potential first-line treatment option for psoriasis patients requiring systemic therapy, especially those with AHT and CRF, though further studies are necessary to confirm its role in this context,” the investigators concluded.1

References

1. Glatzel C, Fleißner J, Kerstan A, et al. Effectiveness of Tildrakizumab in the Long-Term Treatment of Plaque Psoriasis: A Retrospective, Multicenter Analysis Over 76 Weeks. Dermatologic Therapy, 2025, 6691386, 13 pages, 2025. https://doi.org/10.1155/dth/6691386.

2. Reich K, Warren RB, Thaçi D, et al. Long-term efficacy and safety of tildrakizumab for moderate-to-severe psoriasis: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2) through 148 weeks. Br J Dermatol. 2020 Mar;182(3):605-617. doi: 10.1111/bjd.18232. Epub 2019 Jul 18. Erratum in: Br J Dermatol. 2022 Jul;187(1):131-132. doi: 10.1111/bjd.20960. PMID: 31218661; PMCID: PMC7064936.