Real-world results show tildrakizumab’s efficacy in psoriasis
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BOSTON — Patients with moderate to severe plaque psoriasis experienced significant improvement after treatment with tildrakizumab in a real-world study, according to a poster presented at the American Academy of Dermatology Annual Meeting.
“There is a knowledge gap on the effectiveness of biologic therapies for psoriasis in real-world clinical contexts compared with efficacy in the clinical trial setting,” Neal Bhatia, MD, of Therapeutics Clinical Research in San Diego, and colleagues wrote. “Tildrakizumab is an anti-interleukin 23p19 monoclonal antibody approved for treatment of moderate to severe plaque psoriasis.”
This phase 4 multicenter, 64-week, uncontrolled, open-label, real-world study included 55 patients who received 100 mg of tildrakizumab at weeks 0 and 4, and then every 12 weeks through 52 weeks. Interim data of 52 patients through week 28 was presented in this poster.
A 90% improvement in Psoriasis Area Severity Index scores occurred in only 1.8% at week 4 after the first dose but rose to 46.3% at week 16 and 55.8% at week 28.
The mean ± standard deviation (SD) PASI score decreased from 11.6 ± 7.1 at baseline to 6.5 ± 5.1 at week 4, 2.2 ± 3.4 at week 16 and 1.8 ± 3 at week 28, resulting in a mean percentage change of –82.1 at week 28.
Mean Body Surface Area ± SD was 14.5 ± 11.5 at baseline and improved to 11.6 ± 10.6 at week 4 and 2.9 ± 6.4 at week 28, a total –73.1% mean percentage change.
Treatment emergent adverse events occurred in 31 (56.4%) patients, with the most common being skin and subcutaneous tissue disorders, infections and infestations, musculoskeletal and connective tissue disorders and gastrointestinal disorders.
Serious adverse events occurred in three (5.5%) patients and one patient withdrew due to adverse events.
“These results in community practice patients were encouraging in Sun Pharma’s efforts to provide moderate to severe plaque psoriasis patients with safe and effective treatment and Sun Pharma looks forward to presenting additional real-world data for tildrakizumab later this year,” Stephen Rozzo, PhD, associate vice president and head of biologics medical affairs at Sun Pharma, told Healio.
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Bhatia N, et al. Poster. Real-world effectiveness and safety of tildrakizumab in patients with moderate to severe plaque psoriasis: Week 28 interim analysis of a phase 4 study. Presented at: American Academy of Dermatology Annual Meeting; March 25-29, 2022; Boston.
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