A recent comprehensive study unveiled the real-world evidence of the effectiveness and safety of a biological drug, tildrakizumab, in treating patients with moderate-to-severe psoriasis. The key highlights of this study were published in the recent edition of Drugs in Context journal.

PAUSE
UNMUTE
:
FULLSCREEN
This multicentric, prospective, observational study marks a significant stride forward to help understand the treatments performed outside the controlled environment of clinical trials in patients with this chronic skin condition. This study followed a total of 54 adult patients who were administered tildrakizumab over the course of 52 weeks.

The primary measure of the efficacy of the drug was the change in the Psoriasis Area and Severity Index (PASI) which is a widely recognized metric for assessing the severity of psoriasis. The patients received an initial dose of 100 mg of tildrakizumab at the outset and at week 4, followed by a maintenance dose every 12 weeks thereafter.
The crucial findings of this study were;

From an average PASI score of 17.8 at the onset of the study, the participants observed their scores plummet to an average of 1.3 by week 52, which translates to an overall improvement of 93%.
This significant reduction of the symptoms underscored the potential of tildrakizumab as a very powerful treatment option. Notably, by the study's end, over 85% of patients achieved a PASI of 5 or less, with nearly 60% reaching an even more remarkable milestone of PASI 1 or less.
The safety profiles were equally encouraging where only 9.3% of participants experienced infections and a singular case required hospitalization. The retention rate of this study further emphasized the tolerability of tildrakizumab, with nearly 89% of patients continuing the treatment throughout the year-long observation period.
This study represented a real-world population, including patients with various comorbidities where psoriatic arthritis was the most common. This diversity, along with the inclusion of individuals both new to and experienced with biologic treatments which enhanced the generalizability of the findings. Overall, this study affirms the efficacy and safety of tildrakizumab in the real-world clinical setting and elucidates the crucial role of real-world evidence in validating the effectiveness of biologic drugs beyond the constraints of randomized trials.
Reference:
Torres, T., Varela, P., Mendes Bastos, P., Magina, S., Henrique, M., & Ferreira, P. (2024). Tildrakizumab for the treatment of moderate-to-severe psoriasis: a 52-week, real-world Portuguese multicentric study. In Drugs in Context (Vol. 13, pp. 1–10). BioExcel. https://doi.org/10.7573/dic.2023-12-5