Tildrakizumab, an IL-23 inhibitor, showed real-world long-term efficacy and safety for patients with moderate to severe plaque psoriasis, according to data from an interim analysis of an ongoing prospective, noninterventional, multicenter study published in the Journal of the European Academy of Dermatology & Venereology.
The noninterventional study, TILOT, encompasses 144 weeks of treatment; the interim analysis reported here is at 52 weeks of treatment. Adults with moderate to severe plaque psoriasis eligible for tildrakizumab treatment under routine clinical conditions were included. To assess effectiveness, investigators conducted the Psoriasis Area Severity Index (PASI), Body Surface Area (BSA), Physician Global Assessment (PGA), scalp- and nail-PGA, Dermatology Life Quality Index (DLQI), and patient and physician treatment satisfaction surveys. Investigators assessed itch and skin pain with a visual analogue scale (VAS).
The efficacy analysis included 412 patients from the full analysis set, and there were 441 patients in the safety analysis including those who joined the study after initiating tildrakizumab treatment.
Of the 412 patients, 17.7% withdrew before 52 weeks mostly due to lack of efficacy and intolerance, 87.6% had previously received systemic therapy, and 25.0% had received prior biologic agent treatment. The mean total PASI score decreased from 16 at baseline to 4.5 at week 16 and 2.1 at week 52, corresponding to an improvement of 82.4%. The mean affected BSA with tildrakizumab declined from 26.2 at baseline to 9.3 at week 16 and 4.0 at week 52 (P <.0001). The percentage of patients with clear or almost clear skin (PGA 0/1) increased from 1.7% at baseline to 51.8% at week 16 and 72.6% at week 52. Mean scalp-PGA decreased from 2.7 at baseline to 0.6 at week 52 for an overall improvement of 79.8%, with no scalp involvement in 63.8% of patients. Mean nail-PGA decreased from 1.8 at baseline to 0.4 at week 52 for an overall improvement of 72.7%, with no nail involvement in 66.7% of patients. Median itch VAS decreased from 63.0 at baseline to 4.0 at week 52. Skin pain improved by week 52 with 92.8% reporting no or only mild skin pain via numerical rating scale.
By week 52, DLQI score improved from 13.0 at baseline to 2.0 (P <.0001), 92.2% and 99.3% of physicians were satisfied or very satisfied with effectiveness and tolerability, respectively, and 91.4% and 97.1% of patients were satisfied or very satisfied with tildrakizumab effectiveness and tolerability, respectively.
Exposure-adjusted incidence rates (EAIRs) of patients with adverse drug reactions were 16.5 per 100 patient-years (PY). The EAIR for serious adverse reactions was 3.4 per 100 PY occurring in 14 patients, and mortality was 0.8 per 100 PY occurring in 3 patients. The deaths were not related to tildrakizumab. The most common adverse drug reactions were nausea and folliculitis.
The study was limited by its observational design, lack of a control group, and reported outcomes documented according to routine practice instead of being strictly controlled, leading to data gaps.
“Our results are fairly in line with prior reports on effectiveness and safety of TIL in routine practice,” the study authors wrote, adding that it “also supports real-world performance of TIL in reducing subjective symptoms of disease such as itch and improving psoriasis in visible areas such as the scalp and nails.”
Disclosure: Several study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Tsianakas A, Schwichtenberg U, Pierchalla P, Hinz T, Diemert S, Korge B. Real-world effectiveness and safety of tildrakizumab in long-term treatment of plaque psoriasis: results from the noninterventional, prospective, multicentre study TILOT. J Eur Acad Dermatol Venereol. Published online September 6, 2022. doi:10.1111/jdv.18572