PASI Scores Can Indicate Who Will, Will Not Respond to Tildrakizumab for Psoriasis, Study Says

A recent post-hoc analysis of tildrakizumab—approved last year by the FDA and marketed under the name Ilumya for patients with moderate-to-severe psoriasis—shows that looking at Psoriasis Area and Severity Index (PASI) improvement scores early in treatment can indicate who is most likely to respond to treatment.

Tildrakizumab is a biologic that blocks interleukin-23 (IL-23) and is given by injection every 12 weeks.

The results come from an analysis of the 2 phase 3 trial data sets (reSURFACE 1 and 2) that led to tildrakizumab’s approval last year. PASI scores were separated in 5 groups, 0—49, 50–74, 75–89, 90–99, and 100, meaning the percentage of skin cleared of lesions. Nonresponders, or those who achieved PASI scores of under 50% by week 28, can be identified as early as week 8, the study reported.

Patients who responded extremely well—those who reached PASI scores of 90% or more by week 28—could be identified as early as week 4, with about a 50% improvement.

The authors wrote that “it is of potential interest to physicians, patients and payers to understand how different groups of patients have better or worse responses and how patients respond over time using different efficacy parameters.” Using the results, patients and providers can decide whether to continue tildrakizumab therapy or not by week 12 or 16, or before the third dose, the authors said.

Patients treated with tildrakizumab 100 mg or 200 mg from baseline to week 28 were pooled from the 2 studies and classified into the 5 mutually exclusive week-28 PASI improvement groups for each dose. Only 8.3% and 4% of patients with psoriasis treated with tildrakizumab 100 mg and 200 mg, respectively, failed to achieve at least 50% PASI improvement at week 28. As early as week 8, these patients had a lower percentage of PASI improvement.

Among patients achieving PASI scores of 90% or more at week 28, tildrakizumab 100 mg and 200 mg were associated with rapid PASI improvement from baseline (approximately 50%) by week 4. Patients with a higher PASI response demonstrated better quality of life improvement.

Among patients achieving PASI greater than 50% at week 28 who continued the same dose of tildrakizumab to week 52, mean PASI improvement was maintained or improved over time. Similar results were observed for both doses.

In addition, tildrakizumab had similar efficacy in patients with and without prior use of biologics.

Reference

Blauvelt A, Sofen H, Papp K, et al. Tildrakizumab efficacy and impact on quality of life up to 52 weeks in patients with moderate-to-severe psoriasis: a pooled analysis of two randomized controlled trials [published online August 13, 2019]. J Eur Acad Dermatol Venereol. doi: 10.1111/jdv.15862.