Table 2

Efficacy outcomes at week 24

TIL 200 mg
Q4W (n=78)
TIL 200 mg
Q12W (n=79)
TIL 100 mg
Q12W (n=77)
TIL 20 mg
Q12W (n=78)
PBO
Q4W (n=79)
Primary efficacy endpoint
ACR2079.5±4.6 (0.0001)*77.2±4.7 (0.0006)*71.4±5.2 (0.0088)*73.1±5.0 (0.0041)*50.6±5.6
Secondary efficacy endpoints and related analyses
 ACR5052.6±5.7 (0.0002)50.6±5.6 (0.0006)45.5±5.7 (0.0059)39.7±5.5 (0.0364)24.1±4.8
 ACR7028.2±5.1 (0.0040)29.1±5.1 (0.0033)22.1±4.7 (0.0550)16.7±4.2 (0.2495)10.1±3.4
ACR components
 TJC68, LSM CFB±SE−10.8±1.1 (0.1704)−11.8±1.1 (0.0448)−12.4±1.1 (0.0174)−10.7±1.1 (0.2037)−8.8±1.1
 SJC66, LSM CFB±SE−7.6±0.56 (0.0476)−7.2±0.56 (0.1149)−7.9±0.57 (0.0153)−6.8±0.56 (0.2916)−6.0±0.56
 PtGA, LSM CFB±SE–31.3±2.3 (0.0005)–30.9±2.3 (0.0007)–31.1±2.4 (0.0006)–26.9±2.3 (0.0321)–20.0±2.3
 PGA, LSM CFB±SE–32.7±2.1 (0.0002)–36.2±2.0 (<0.0001)–35.4±2.1 (<0.0001)–32.5±2.1 (0.0002)–21.9±2.1
 Patient pain assessment, LSM CFB±SE−31.7±2.7 (0.0029)−30.4±2.6 (0.0080)−30.3±2.7 (0.0091)−25.7±2.7 (0.1672)−20.6±2.6
 HAQ-DI, LSM CFB±SE–0.3±0.05 (0.1829)–0.3±0.05 (0.0420)–0.3±0.05 (0.0467)–0.2±0.05 (0.7267)–0.2±0.05
  Improvement ≥0.35†‡5.9±2.95.9±2.91.7±1.77.4±3.25.6±2.7
 hsCRP, mg/L, LSM CFB±SE§−4.4±1.1 (0.0003)−2.8±1.0 (0.0098)−3.6±1.0 (0.0019)−2.4±1.1 (0.0245)0.79±1.0
 DAS28-CRP <3.259.0±5.6 (0.0003)64.6±5.4 (<0.0001)58.4±5.6 (0.0005)53.9±5.6 (0.0034)30.4±5.2
 MDA33.3±5.3 (<0.0001)34.2±5.3 (<0.0001)28.6±5.2 (0.0004)19.2±4.5 (0.0172)6.3±2.7
  Tender joint count ≤130.8±5.2 (0.0107)30.4±5.2 (0.0152)18.2±4.4 (0.4556)20.5±4.6 (0.2939)13.9±3.9
  Swollen joint count ≤153.9±5.6 (0.0006)55.7±5.6 (0.0002)57.1±5.6 (0.0002)50.0±5.7 (0.0030)26.6±5.0
  VLDA†15.4±4.116.5±4.26.5±2.86.4±2.81.3±1.3
 LDI, LSM CFB±SE¶−46.7±6.5 (0.1983)−45.4±7.3 (0.1750)−45.2±7.2 (0.1692)−45.6±7.7 (0.1950)−58.5±6.8
  LDI, median (Q1, Q3)†, ¶16.6 (3.1, 28.6)21.5 (0, 28.3)19.4 (6.0, 32.1)10.5 (0.03, 33.8)3.6 (0, 26.3)
 LEI, LSM CFB±SE**−1.8±0.23 (0.1196)−1.6±0.25 (0.3496)−1.8±0.23 (0.1541)−1.6±0.22 (0.4778)−1.3±0.25
  LEI, median (Q1, Q3)†, **0 (0, 2.0)0 (0, 2.0)1.0 (0, 2.0)1.0 (0, 3.0)1.0 (0, 2.0)
  LDI/LEI=0†, ††11.1±10.514.3±9.412.5±8.317.7±9.3
 Background medication adjustment required, n (%)1 (1.3)0001 (1.3)
Other exploratory and post hoc analyses
 DAPSA, LSM CFB±SE†–25.1±1.8–25.5±1.8–27.0±1.8–23.1±1.8–19.3±1.8
 PASDAS, LSM CFB±SE†–1.5±0.1–1.5±0.1–1.5±0.1–1.4±0.1–1.0±0.1
 PsAID, LSM CFB±SE–2.1±0.2 (0.0048)–2.3±0.2 (0.0002)–2.2±0.2 (0.0010)–2.0±0.2 (0.0131)–1.3±0.2
  Decrease by ≥3†30.8±5.231.7±5.232.5±5.337.2±5.529.1±5.1
  • Data are shown as response rate (%)±SE unless otherwise noted; numbers in parentheses indicate p values unless otherwise noted. Missing responses were imputed as non-responses.

  • Some post hoc analyses are grouped with the related secondary endpoint for ease of reading.

  • *Statistically significant. P values for other comparisons are not multiplicity-controlled and are presented for informational purposes only.

  • †Post hoc analysis; no formal hypothesis testing was performed.

  • ‡Improvement in HAQ-DI scores was assessed in patients with baseline HAQ-DI score ≥0.35; tildrakizumab 200 mg Q4W, n=68; tildrakizumab 200 mg Q12W, n=68; tildrakizumab 100 mg Q12W, n=58; tildrakizumab 20 mg Q12W, n=68; placebo Q4W, n=72.

  • §hsCRP change from baseline reported for tildrakizumab 200 mg Q4W, n=71; tildrakizumab 200 mg Q12W, n=76; tildrakizumab 100 mg Q12W, n=73; tildrakizumab 20 mg Q12W, n=71; placebo Q4W, n=74.

  • ¶LDI change from baseline is reported in patients with baseline LDI ≥1; tildrakizumab 200 mg Q4W, n=27; tildrakizumab 200 mg Q12W, n=21; tildrakizumab 100 mg Q12W, n=21; tildrakizumab 20 mg Q12W, n=19; placebo Q4W, n=25.

  • **LEI change from baseline is reported in patients with baseline LEI ≥1; tildrakizumab 200 mg Q4W, n=48; tildrakizumab 200 mg Q12W, n=43; tildrakizumab 100 mg Q12W, n=51; tildrakizumab 20 mg Q12W, n=55; placebo Q4W, n=43.

  • ††Complete resolution for both LDI and LEI is reported in patients with both LDI and LEI ≥1 at baseline; tildrakizumab 200 mg Q4W, n=0; tildrakizumab 200 mg Q12W, n=9; tildrakizumab 100 mg Q12W, n=14; tildrakizumab 20 mg Q12W, n=16; placebo Q4W, n=17.

  • ACR, American College of Rheumatology response criteria; DAPSA, disease activity in psoriatic arthritis; DAS28-CRP, Disease Activity Score in 28 joints with C reactive protein; HAQ-DI, Health Assessment Questionnaire-Disability Index; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; LSM, least squares mean; MDA, minimal disease activity; PASDAS, psoriatic arthritis disease activity score; PBO, placebo; PGA, physician’s global assessment; PsAID, psoriatic arthritis impact of disease; PtGA, patient’s general assessment; Q1, 25th percentile; Q3, 75th percentile; Q4W, every 4 weeks; Q12W, every 12 weeks; SJC66, swollen joint count in 66 joints; TIL, tildrakizumab; TJC68, tender joint count in 68 joints; VLDA, very low disease activity.