Tildrakizumab Effective for Psoriasis, Yet Patients Note Specific Points of Dissatisfaction

While tildrakizumab’s efficacy and safety have been confirmed among clinicians and among patients with moderate-to-severe psoriasis, new findings suggest some patients continue to be dissatisfied despite solid disease control.1

These data represent the conclusion of an analysis conducted by a team of investigators, 1 of which was Ziad Reguiai, from the Department of Dermatology at the Polyclinique Courlancy in Reims-Bezannes, France. Reguiai et al. highlighted that prior real-world data on tildrakizumab use for psoriasis had been primarily from clinicians’ perspectives.

In France, the Observatory of Chronic Inflammatory Skin Diseases (OMCCI) register was initiated with the aim of prospectively assessing patients’ long-term impairments resulting from chronic inflammatory skin conditions.2 In this study, data on patients with moderate-to-severe psoriasis given tildrakizumab were assessed 1 year following their inclusion in the OMCCI register.

“We aimed to analyze the efficacy and safety of tildrakizumab in a real-life setting, and to describe the impact of psoriasis and its treatment both globally and in some more specific locations from the patient's perspective in the long term,” Reguiai and colleagues wrote.1

Real-World Analysis of Tildrakizumab for Psoriasis

The investigative team presented findings from a set of 3 key points in time, looking at patients included in the aforementioned OMCCI registry. Those in this register are scheduled for follow-up over a 4-year timeframe, with annual evaluations carried out by clinicians and bi-annual self-reported data collection. The 3 key time points from which they drew this data were baseline (initiation of treatment), the 6-month mark, and 12 months post-initiation.

The team involved individuals being treated with routine care for moderate-to-severe psoriasis consecutively at the time of their treatment initiation. The medication was administered under real-world conditions using the standard regimen for dosing: 100 mg per injection for those weighing less than 90 kg, and 200 mg for patients exceeding 90 kg or reporting a high level of disease burden. There was not a washout period mandated prior to starting tildrakizumab at the inclusion visit.

The Psoriasis Area and Severity Index (PASI) was used to assess disease severity levels, with a range of scores from 0 - 72. In general, the investigators gathered patient information via standardized forms capturing age during diagnoses, sociodemographic data, records of hospitalizations, sick leave within the past 6 months, consultations with specialists, and adherence to tildrakizumab.

Short questionnaires were provided to participants every 6 months, with assessments including the Dermatology Life Quality Index (DLQI). They looked at health-related quality of life through the 12-Item Short-Form Health Survey (SF-12), with 2 composite scores: physical and mental. Additionally, they implemented an Individual Burden of Psoriasis (I-BOP) survey for participants to assess the multidimensional impact of the disease.

Additionally, the Simplified Index Psoriasis (Sa-SPI) self-evaluation was required among trial participants, with ratings highlighting disease effects on family life, daily activities, and professional life over the week prior to enrollment via a Numerical Rating Scale (NRS) from 0 - 10 (where 0 = "my skin condition does not bother me at all," 5 = "moderately bothersome," and 10 = "extremely bothersome, I cannot imagine anything worse").

An overall evaluation was also provided by subjects regarding how psoriasis impacts daily life, with selections including a complete lack of impact, minor life impairment, moderate impairment, or a severe level of impairment that prevents typical daily activities.

The investigative team could choose from 4 predefined categories to highlight rationale for discontinuation of tildrakizumab: a lack of treatment efficacy, adverse effects, decisions among patients, or other (without specifying details). Additionally, they only documented serious adverse events or those leading to cessation.

In terms of quantitative variables assessed by the research team, their analyses included the mean, the number of non-missing values, standard deviation, and 95% confidence interval (CI) where applicable. They also reported qualitative variables as frequencies and percentages.

Overall, psoriasis at baseline was shown in the team's findings to have significantly impaired the lives of study subjects. Specifically, they noted that 42% showed signs of clinical depression and added that 34.6% reported disease involvement in the genital region that led to negative impacts in their sexual well-being.

Following the 1-year mark, the investigators concluded that tildrakizumab demonstrated overall safety and efficacy among patients, and they noted this included efficacy in regions of the body deemed challenging-to-treat. There was also a decline in PASI score from 13.6 to 2.3, and the team further noted that an increase in the SF-12 mental component score was observed from 41 to 48.7.

The analysis further highlighted DLQI improvements from 10.4 to 2.5. Despite such gains, it was noted that some participants remained dissatisfied. This dissatisfaction was noted along with a citation of concerns about psoriasis relapse and the persistent mental health burden linked to the inflammatory disease in the long term.

"Psoriasis is a complex disease from the point of view of its pathophysiology, which involves tissue-resident memory T cells (TRM) that perpetuate the disease and its relapses," the investigators concluded. "It is also a complex pathology when we consider the psychology of our patients."1

References

1. Reguiai, Z., Becherel, P.A., Maccari, F, et al. (2025). Patient's Perspective on the Impact of Psoriasis on Their Quality of Life After 1 Year of Tildrakizumab Treatment: Despite Clinical Improvement, Persistence of a Potential Mental Cicatricial Memory of the Disease. JEADV Clinical Practice. https://doi.org/10.1002/jvc2.70021.

2. P. A. Becherel, Z. Reguiai, A. C. Fougerousse, et al., “Compared Burden of Psoriasis, Atopic Dermatitis, Hidradenitis Suppurativa, and Chronic Urticaria: Baseline Characteristics of the Patients Included in the OMCCI Cohort - A French, Prospective Multicenter Study of Chronic Inflammatory Dermatoses,” Dermatology Published ahead of print, (2024), https://doi.org/10.1159/000540250.