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 | |||||
| ACR20 | 79.5±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 | |||||
| ACR50 | 52.6±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 |
| ACR70 | 28.2±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±2.9 | 5.9±2.9 | 1.7±1.7 | 7.4±3.2 | 5.6±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 <3.2 | 59.0±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 |
| MDA | 33.3±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 ≤1 | 30.8±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 ≤1 | 53.9±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±4.1 | 16.5±4.2 | 6.5±2.8 | 6.4±2.8 | 1.3±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±10.5 | 14.3±9.4 | 12.5±8.3 | 17.7±9.3 |
| Background medication adjustment required, n (%) | 1 (1.3) | 0 | 0 | 0 | 1 (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±5.2 | 31.7±5.2 | 32.5±5.3 | 37.2±5.5 | 29.1±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.