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Dr Stephen Rozzo Explains Real-world Study Design for Tildrakizumab in Psoriasis


Stephen Rozzo, PhD, associate vice president and head, Biologics Medical Affairs, Sun Pharma, North America, spoke on the design of the 2 phase 4 real-world studies investigating severity and quality of life impact of tildrakizumab for the treatment of psoriasis.

Tildrakizumab use was investigated in community practice patients with moderate to severe psoriasis to capture the real-world efficacy implications that are not derived from clinical trials, said Stephen Rozzo, PhD, associate vice president and head, Biologics Medical Affairs, Sun Pharma, North America.

Rozzo served as co-author of 2 studies presented at the 2022 American Academy of Dermatology (AAD) Annual Meeting titled, “Real-world Effectiveness and Safety of Tildrakizumab in Patients with Moderate-to-Severe Plaque Psoriasis: Week 28 Interim Analysis of a Phase 4 Study,” and “A Phase 4, Real-World study of Tildrakizumab in Moderate-to-Severe Psoriasis: Week 28 Interim Analysis.”


Two phase 4 real-world studies presented at AAD 2022 investigated tildrakizumab for the treatment of moderate to severe psoriasis. What insights can be gleaned from real-world use metrics on severity and quality of life?

In one of the presentations, we looked at the clinical efficacy and safety and then the other we looked at quality of life, which is very impaired in patients with moderate to severe psoriasis. The design was intended to capture moderate to severe patients in real-world practice, which are not necessarily the same as in clinical trials. These are patients that had at least 3% body surface area affected, moderate to severe disease in the eyes of the clinicians or the investigators in the trial, and who are candidates for phototherapy or systemic therapy.

Some of those aspects are similar to the trials, but some are not. And dermatologists often say clinical trial patients are not the patients they choose, because they're selected patients who are not particularly vulnerable to adverse events and well-defined populations because it's research.

The exciting part about this study is that they were true community practice patients. And the interesting part was that as these patients were followed for 28 weeks, we have results at AAD that are very exciting, very closely match those in the trials. And usually [in] real world studies, they don't. So, that's very gratifying, and it's very exciting for patients and for clinicians to see that.

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