Tildrakizumab Presented Consistent Reduction of Detectable Psoriasis Through 5 Years Advances

Recent data from 2 randomized phase 3 control studies (reSURFACE 1 and reSURFACE 2) showed that tildrakizumab-asmn demonstrated a measurable reduction in the Psoriasis Area and Severity Index (PASI) score at 83% after 2 initial injections, and about 94% or more from week 28 through year 5.^1,2

In the reSURFACE 1 Phase 3, multicenter, double-blind, placebo-controlled trial, patients with moderate to severe plaque psoriasis who were candidates for phototherapy or systemic therapy were randomized at tildrakizumab 100 mg or placebo.^1-3 In the tildrakizumab group, 58% of patients achieved a Physician Global Assessment (PGA) score of 0 or 1 after 2 doses by week 12 compared with 7% of those in the placebo group. Sixty four percent of patients in the tildrakizumab group achieved PASI 75 (75% or greater reduction in PASI score from baseline), whereas only 6% of those in the placebo group did so. At week 28, patients who achieved at least PASI 75 were rerandomized for the continuation of initial tildrakizumab treatment or to receive a placebo for up to 64 weeks.

The reSURFACE 2 study was also a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial of tildrakizumab dosed at weeks 0, 4, and continuing 12 weeks after.^1-3 Patients with moderate to severe plaque psoriasis who were candidates for phototherapy or systemic therapy were randomized at tildrakizumab 100 mg or placebo. About 55% patients in the tildrakizumab group achieved a PGA score of 0 or 1 compared with 4% of those in the placebo group following 2 doses by week 12. Additionally, 61% of patients in the tildrakizumab group achieved PASI 75 compared with 6% of those in the placebo group in the same time frame.

In both studies, tildrakizumab met all primary and secondary endpoints at week 12.¹ In a pooled analysis through 148 weeks of the reSURFACE 1 and reSURFACE 2 Phase 3 trials, researchers reported that the median time to relapse occurred over 32 weeks after the last dose, with a PASI score improvement loss of 50% or more in the reSURFACE 1 trial.⁴ They noted that the median time to relapse was 226 days following the last dose at week 16.

Tildrakizumab continued to showcase a low adverse events rate over 5 years of clinical trials, and no new safety signals were observed in the extension studies.^2,3 It also displayed consistent PASI score improvement despite high body mass index and other metabolic risk factors.⁵ It is also noted that tildrakizumab does not require weight-based dosing.³ Currently, tildrakizumab is an IL-23 inhibitor approved for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

References

1. ILUMYA® (tildrakizumab-asmn) provided consistent reduction of detectable psoriasis activity through 5 years. Press Release. Sun Pharmaceutical Industries, Inc; 2021. Accessed April 12, 2022. https://www.ilumyapro.com/ilumya-results/

2. Thaçi D, Piaserico S, Warren RB, et al. Five-year efficacy and safety of tildrakizumab in patients with moderate-to-severe psoriasis who respond at week 28: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2). Br J Dermatol. 2021;185(2):323-334. doi:10.1111/bjd.19866

3. ILUMYA. Package insert. Sun Pharmaceutical Industries Inc; 2021.

4. Thaçi D, Iversen L, Pau-Charles I, et al. Long-term efficacy and safety of tildrakizumab in patients with moderate-to-severe psoriasis who were responders at week 28: pooled analysis through 3 years (148 weeks) from reSURFACE 1 and reSURFACE 2 phase 3 trials. Poster presented at: 27th Congress of the European Academy of Dermatology and Venereology; September 12-16, 2018; Paris, France.

5. Lebwohl MG, Leonardi CL, Mehta NN, et al. Tildrakizumab efficacy, drug survival, and safety are comparable in patients with psoriasis with and without metabolic syndrome: long-term results from 2 phase 3 randomized controlled studies (reSURFACE 1 and reSURFACE 2). J Am Acad Dermatol. 2021;84(2):398-407. doi:10.1016/j.jaad.2020.09.047