Table 3.
Studies (clinical trials and RWEs) on tildrakizumab
| Clinical trial | |||||||
|---|---|---|---|---|---|---|---|
| Authors, year | Study type | No. of prt | Study design (study groups) | Study period | Efficacy | Safety | Ref |
| Papp et al., 2015 |
Phase IIb, randomized, double-blind, placebo-controlled trial |
355 |
1)Tildrakizumab 5 mg at week 0, 4, and every 12 weeks until week 52 2)Tildrakizumab 25 mg at week 0, 4, and every 12 weeks until week 52 3)Tildrakizumab 100 mg at week 0, 4, and every 12 weeks until week 52 4)Tildrakizumab 200 mg at week 0, 4, and every 12 weeks until week 52 5)Placebo at week 0, 4, and every 12 weeks |
72 weeks |
Week 16: PASI75 33.3%, 64.4%, 66.3%, 74.4%, and 4.4% in the 5, 25, 100, 200 mg, and placebo respectively PGA1/0 33%, 58%, 62%, 74%, and 2.2% for tildrakizumab 5, 25, 100, 200 mg, and placebo respectively |
Most common AEs were nasopharyngitis and headache. 23 patients treated with tildrakizumab reported serious AEs: bacterial arthritis, lymphoedema, melanoma, stroke, epiglottitis, and knee infection | 22 |
| Reich et al., 2017 |
Phase III, three-part, double-blind, randomized, placebo-controlled, parallel-group studies reSURFACE 1 and 2 |
1,862 |
reSURFACE 1 1)Tildrakizumab 200 mg weeks 0, 4, and every 12 weeks 2)Tildrakizumab 100 mg weeks 0, 4, and every 12 weeks 3)Placebo → re-randomized at tildrakizumab 100 or 200 mg reSURFACE 2 1)Tildrakizumab 200 mg weeks 0, 4, and every 12 weeks 2)Tildrakizumab 100 mg weeks 0, 4, and every 12 weeks 3)Placebo → re-randomized at tildrakizumab 100 or 200 mg 4)Etanercept 50 mg twice weekly for 12 weeks, then once weekly At week 28 of both studies, > PASI75 and > PASI50 but < PASI75 were re-randomized to continue same treatment, different dose tildrakizumab, or placebo |
reSURFACE 1 64 weeks reSURFACE 1 52 weeks |
reSURFACE 1 Week 12: PASI75 was achieved by 62% and 64% in 200 mg and 100 mg tildrakizumab respectively compared to 6% in placebo group PGA 0/1 was achieved by 59% in the 200 mg group and 58% in the 100 mg group compared to 7% in placebo reSURFACE 2 Week 12: PASI75 was achieved by 66% and 61% in 200 mg and 100 mg tildrakizumab respectively compared to 6% in placebo group and 48% in etanercept group PGA 0/1 was achieved by 59% in the 200 mg group and 55% in the 100 mg group compared to 4% in placebo and 48% in etanercept group |
Most common AE was nasopharyngitis. Serious AEs were low in both groups, 1 patient in reSURFACE2 with alcoholic cardiomyopathy and steatohepatitis died and adjudication was undetermined | 23 |
| Papp et al., 2019 | Post hoc analysis of 3 randomized, controlled, multicenter trials P05495 (phase 2), reSURFACE 1, and 2 (phase 3) | 2081 | See P05495, reSURFACE 1, and 2 | 28 weeks |
Week 12: PASI 75 were better with tildrakizumab 100 and 200 mg (62.3% and 64.8%, respectively) than placebo (5.6%) Tildrakizumab was better for PASI90, PASI100, and PGA 0/1 versus placebo (p < 0.0001) |
NR | 79 |
| Elewski et al., 2019 |
Analysis of two phase III, three-part, double-blind, randomized, placebo-controlled trials reSURFACE 1 and 2 |
1,862 | See reSURFACE 1 and 2 | 52 weeks | Among patients who achieved PASI90, PASI75, or PASI50 at week 28, 89.4%, 91.1%, or 97.4% maintained the response achieved at week 52, respectively. Among patients that achieved PASI50-74, 75–89, or 90–99 at week 28, 64.8%, 33.7%, and 25.2% improved their 28th week response at week 52, respectively | NR | 80 |
| Reich et al., 2019 |
Pooled analysis of two phase III, three-part, double-blind, randomized, placebo-controlled trials reSURFACE 1 and 2 |
1,862 | See reSURFACE 1, and 2 | 148 weeks | PASI75, 90, and 100 was achieved by 72.6%, 53.8%, and 28.9% of tildrakizumab 100 mg and 80.2%, 59.9%, and 32.6% of tildrakizumab 200 mg | Treatment-related AEs for tildrakizumab 100 mg, 200 mg, placebo, and etanercept were 35.2, 37.2, 148.6, and 148.6 events per 100 PYs, respectively. The most common AE was nasopharyngitis in all groups. 9 deaths occurred, none related to the study medication. The most common severe AEs were cellulitis, herpes zoster, and urosepsis | 76 |
| Kimball et al., 2020 |
Post hoc analysis of two phase III, three-part, double-blind, randomized, placebo-controlled trials reSURFACE 1 and 2 |
1,862 | See reSURFACE 1, and 2 |
reSURFACE 1 64 weeks reSURFACE 1 52 weeks |
In T100/T100 and T200/T200 partial responders at week 28 the proportion of patients that achieved PASI75 increased over time. In T100/T200 week 28 partial responders PASI75 increased from 38.5% at week 32 to 63.2% at week 52 and PASI75 remained constant in T200/T100. Among the patients that relapsed in T100/PBO and T200/PBO, 86% and 83% of those who reinitiated tildrakizumab achieved PASI75 by week 64 | See reSURFACE 1, and 2 | 81 |
| Menter et al., 2020 |
Post hoc analysis of a phase III, three-part, double-blind, randomized, placebo-controlled trial reSURFACE 1 |
463 |
See reSURFACE 1 Patients receiving tildrakizumab 100 mg and placebo were included |
28 weeks |
Week 12: 36.2% and 30.9% of patients with baseline PASIh ≥ 1.4 and ≥ 2.4, respectively achieved PASIh = 0.0 Week 28: 40.5% and 34% of patients with baseline PASIh ≥ 1.4 and ≥ 2.4, respectively, achieved PASIh = 0.0 |
NR | 82 |
| Gordon et al., 2020 |
Post hoc analysis of two phase III, three-part, double-blind, randomized, placebo-controlled trials reSURFACE 1 and 2 |
925 |
See reSURFACE 1 and 2 Patients on tildrakizumab 100 mg and placebo were included |
28 weeks |
Week 12: median PASI was 2.9, dichotomous PASI90 was 36.9%, and absolute PASI < 5, < 3, and < 1 were 64%, 50.8%, and 23.3%, respectively Week 28: median PASI was 1.7, PASI90 was 51.9%, and absolute PASI < 5, < 3, and < 1 were 75.3%, 62.8%, and 38%, respectively |
NR | 83 |
| Imafuku et al., 2021 |
Subgroup analysis of phase III, three-part, double-blind, randomized, placebo-controlled trial reSURFACE 1 |
120 Japanese | See reSURFACE 1 | 192 weeks | Of Japanese patients with PASI75 / 90 / 100 and PGA 0/1 at week 64 85%/88% receiving T100/T200 maintained PASI75, 70%/96% maintained PASI100, and 68%/72% maintained PGA 0/1 at week 192 | Incidence of severe infections, malignancies, adverse cardiac events, and hypersensitivity were low in both groups | 84 |
| Cantrell et al., 2021 |
Post hoc analysis of phase III, three-part, double-blind, randomized, placebo-controlled trial reSURFACE 1 |
221 |
See reSURFACE 1 Patients on tildrakizumab 100 mg were included |
64 weeks | Patients continuously treated with tildrakizumab 100 mg 92.6%, 81.5%, and 49.6% achieved PASI50, 75, and 90 at week 64, respectively. Of patients re-randomized to placebo 80.8%, 48.1%, and 21.2% achieved PASI50, 75, and 90 at week 64. Of patients that relapsed and were retreated the proportion of PASI50, 75, and 90 was of 86.9%, 72.1%, and 31.2% | NR | 85 |
| Real world experience | |||||||
| No study available (last access January 22, 2021) | |||||||
Abbreviations: AEs, adverse events; PASI, Psoriasis Area Severity Index; PASIh, head PASI; PBO, placebo; PGA, Physician’s Global Assessment; prt, participants; ref, reference