Tildrakizumab Significantly Improves Skin Symptoms in Moderate-to-Severe Psoriasis

Tildrakizumab was proven to be a safe and effective treatment option for patients with moderate-to-severe psoriasis in a diverse, real-world setting over a 52-week period, according to research published in Drugs in Context.¹

Previous research has demonstrated up to 78% of patients treated with systemic drugs for psoriasis are not sufficiently represented in randomized controlled trials due to eligibility constraints. Therefore, the patients enrolled in these trials may not accurately represent patients in clinical settings, emphasizing the need for more real-world settings post-drug approval.²

“Real-world evidence demonstrating the effectiveness and safety of tildrakizumab in diverse clinical practices and settings is therefore desirable to assist clinicians in making informed decisions,” wrote a team of investigators led by Tiago Torres, MD, PhD, professor of dermatology at the Abel Salazar Institute of Biomedical Sciences, University of Porto, Portugal.

To assess the efficacy of treatment with tildrakizumab among this patient population, eligible patients received tildrakizumab 100 mg at weeks 0 and 4, followed by a maintenance dose every 12 weeks. Patients were then monitored for 52 weeks.

Primary endpoints were the proportion of patients able to achieve Psoriasis Area and Severity Index (PASI) ≤1, PASI ≤3, and PASI ≤5, as well as the percentage who achieved PASI100, PASI90, and PASI75. These were evaluated at baseline, week 16, week 28, and week 52. Additional endpoints included discontinuation rates, drug survival, safety, and efficacy based on previous biologic use if applicable. The Body Surface Area (BSA) index and Dermatology Life Quality Index (DLQI) were assessed when possible.

In total, 54 adult patients were enrolled in the multicentric, prospective, observational study, with a mean age of 50.3 years and 56% of participants were male. Approximately half (n = 27) of patients were biologic-naïve and most (74%, n = 40) were diagnosed with ≥1 comorbidity during the study. The most prevalent comorbidity was psoriatic arthritis (29.6%).

At the end of the study, investigators noted an overall improvement of 93% in PASI scores from baseline (17.8±10.3 vs 1.3±1.9, respectively; P <.001). Additionally, more than 85% of patients were able to achieve PASI ≤5, more than 80% achieved PASI ≤3, and almost 60% achieved PASI ≤1. Most (85%) achieved PASI75 by week 52, while 80% were able to obtain PASI90 and 40% achieved PASI100.

Among a subset of patients in which BSA data were available (n = 47), mean BSA improved from baseline by 94% (20.3±13.5 vs 1.3±1.8, respectively; P <.001). Among another subset (n = 42), mean DLQI decreased from 18.5±6.7 at baseline to 0.6±1.2 at week 52 (P <.001), indicating a 97% improvement.

Interestingly, biologic-naïve patients generally achieved a better clinical response compared with biologic-experienced patients. A total of 92.6% of biologic-naïve patients were able to achieve PASI75 and 51.9% reached PASI100, compared with 77.8% and 29.6%, respectively, in the biologic-experienced cohort.

Infections were reported in 9.3% of patients, with 1 patient requiring hospitalization. Most (88.9%) patients were still receiving treatment at week 52.

Investigators mentioned the observational nature of the study, sample heterogeneity, and a lack of a control cohort as limitations of the trial; however, these factors also represent real-world clinical practice.

“Our data demonstrate that tildrakizumab’s effectiveness in a real-world setting is comparable to that seen in phase 3 clinical trials at 52 weeks,” investigators concluded. “Despite a sample comprising patients with challenging conditions, treatment response remained unaffected.”

References

1. ^{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;13:2023-12-5. Published 2024 Mar 18. doi:10.7573/dic.2023-12-5}
2. ^{Masson Regnault M, Castañeda-Sanabria J, Diep Tran MHT, et al. Users of biologics in clinical practice: would they be eligible for phase III clinical studies? Cohort study in the French psoriasis registry PSOBIOTEQ. J Eur Acad Dermatol Venereol. 2020;34(2):293–300. https://doi.org/10.1111/jdv.15878}