Ilumetri / Ilumya 52 week Italian study

[Fred]

Results from a 52 week retrospective study to assess the effectiveness and safety of Ilumetri / Ilumya (tildrakizumab) in a real life setting.

Quote:

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Background:
Tildrakizumab is a humanized monoclonal antibody that binds selectively the p19 subunit of interleukin-23. It is approved for treatment of moderate-severe chronic plaque psoriasis.

Objectives:
We conducted a 52-week retrospective study to assess the effectiveness and safety of tildrakizumab in a real-life setting.

Methods:
Our retrospective study included 237 consecutive adults with moderate-to-severe plaque psoriasis, enrolled in 10 different Italian centers, treated with tildrakizumab up to week 52. Patient characteristics, comorbidities, previous treatments, and the PASI (Psoriasis Area and Severity Index) score at each visit (baseline, week 16, week 28 and week 52) were retrieved from the electronic medical records. The percentages of patients achieving 75%, 90% and 100% (PASI 75, PASI 90 and PASI 100) improvement in PASI with respect to baseline PASI were registered.

Results:
At week 52, 90.91%, 73.55% and 58.68% of patients achieved a PASI reduction ≥ 75% (PASI 75), PASI 90 and PASI 100, respectively. An absolute PASI ≤2 was reached by 85.95% at week 52. Compared to Phase 3 clinical trials, we observed similar rates of PASI 75/90 responses and higher percentages of patients achieving PASI 100. Patients who had not responded to previous biologic treatments and patients with cardio-metabolic comorbidities were significantly more likely to achieve PASI 100 at week 28 and PASI 90 at week 52. The higher body mass index did not interfere with the odds of reaching PASI 75/90/100 at each time-point. No significant safety findings were recorded throughout the study, and none of the patients had to interrupt the treatment because of adverse events

Conclusion:
Our data suggest that the efficacy of tildrakizumab for plaque psoriasis in “real-life” clinical practice is comparable with Phase 3 clinical trials with higher percentages of patients achieving complete skin clearance (PASI 100) at weeks 16, 28 and 52.

Source: onlinelibrary.wiley.com

*Early view funding unknown

Ilumetri / Ilumya (tildrakizumab)

[Caroline]

I have been reading the results section, but I totally don’t get it…

E.g. Patients who had not responded to previous biologic treatments and patients with cardio-metabolic comorbidities were significantly more likely to achieve PASI 100 at week 28 and PASI 90 at week 52

What does this mean?
It seems that in week 28 you reach PASI 100…. So total clearance. And then in week 52 it is back to PASI 90… only 90% clearance.

Does the stuff is working less as time moves on? Or what?

And there is more that doesn’t make sense, but that is for tomorrow. I am sleepy…

[mataribot]

Biologics dip off between 6 - 12 months. Typically, need to switch around the 3 year mark. It sounds like this occurs more frequently with a particular sub group  people.