Table II.
Efficacy outcomes at week 16 in ITT population
| Characteristic | Variable | Part 1 |
Part 2 |
||||
|---|---|---|---|---|---|---|---|
| Telazorlimab |
Placebo (n = 80) | Telazorlimab 600 mg q2w (n = 75) | Placebo (n = 74) | ||||
| 300 mg q2w (n = 76) | 300 mg q4w (n = 78) | 75 mg q4w (n = 77) | |||||
| Primary end point | LS mean (SE) % change from baseline in EASI | −54.4 (5.1) | −48.6 (5.4) | −31.0 (5.7) | −34.2 (5.5) | −59.0 (4.6) | −41.8 (4.7) |
| P value vs placebo | .008 | .061 | .691 | .008 | |||
| LS mean difference vs placebo (95% CI) | −20.2 (−34.9, −5.4) | −14.4 (−29.6, 0.7) | 3.1 (−12.4, 18.7) | −17.2 (−29.9, −4.5) | |||
| Secondary end points | EASI-75, no. (%) | 18 (23.7) | 16 (20.5) | 9 (11.7) | 9 (11.3) | 19 (25.3) | 14 (18.9) |
| Odds ratio vs placebo (95% CI) | 2.5 (1.0, 6.0) | 2.1 (0.8, 5.0) | 1.1 (0.4, 2.8) | 1.4 (0.6, 3.2) | |||
| EASI-50, no. (%) | 37 (48.7) | 27 (34.6) | 21 (27.3) | 22 (27.5) | 33 (44.0) | 25 (33.8) | |
| Odds ratio vs placebo (95% CI) | 2.5 (1.3, 5.0) | 1.4 (0.7, 2.8) | 1.0 (0.5, 2.0) | 1.5 (0.8, 3.0) | |||
| IGA 0/1 response, no. (%) | 10 (13.2) | 8 (10.3) | 5 (6.5) | 4 (5.0) | 9 (12.0) | 4 (5.4) | |
| Odds ratio vs placebo (95% CI) | 2.9 (0.9, 9.6) | 2.2 (0.6, 7.8) | 1.4 (0.3, 5.4) | 2.5 (0.7, 8.6) | |||
| Pruritus NRS score improvement ≥4, no. (%) | 6 (7.9) | 9 (11.5) | 4 (5.2) | 8 (10.0) | 10 (13.3) | 7 (9.5) | |
| Odds ratio vs placebo (95% CI) | 0.8 (0.3, 2.3) | 1.2 (0.4, 3.3) | 0.5 (0.1, 1.7) | 1.5 (0.5, 4.1) | |||
| LS mean (SE) % change from baseline in SCORAD | −24.3 (2.4) | −21.2 (2.6) | −14.3 (2.7) | −13.8 (2.6) | −26.8 (2.0) | −17.2 (2.0) | |
| LS mean difference vs placebo (95% CI) | −10.5 (−17.6, 3.4) | −7.4 (−14.6, 0.2) | −0.6 (−8.0, 6.9) | −9.6 (−15.0, −4.1) | |||
| LS mean (SE) change from baseline in GISS | −3.2 (0.3) | −2.5 (0.4) | −1.9 (0.4) | −1.7 (0.4) | −3.5 (0.3) | −2.2 (0.3) | |
| LS mean difference vs placebo (95% CI) | −1.5 (−2.5, −0.5) | −0.8 (−1.8, 0.2) | −0.2 (−1.3, 0.8) | −1.3 (−2.1, −0.5) | |||
| LS mean (SE) change from baseline in DLQI | −6.0 (0.8) | −5.5 (0.9) | −3.4 (0.9) | −3.7 (0.9) | −6.7 (0.7) | −4.4 (0.7) | |
| LS mean difference vs placebo (95% CI) | −2.4 (−4.8, 0.1) | −1.8 (−4.3, 0.7) | 0.3 (−2.2, 2.8) | −2.3 (−4.2, −0.4) | |||
| LS mean (SE) change from baseline in POEM | −6.3 (0.9) | −3.9 (1.0) | −2.6 (1.0) | −3.1 (1.0) | −6.8 (1.0) | −5.0 (1.0) | |
| LS mean difference vs placebo (95% CI) | −3.1 (−5.8, −0.5) | −0.7 (−3.4, 1.9) | 0.6 (−2.2, 3.4) | −1.8 (−4.4, 0.8) | |||
| LS mean (SE) change from baseline in HADS (Anxiety) | −1.7 (0.4) | −0.7 (0.4) | −0.8 (0.5) | −0.4 (0.4) | −1.8 (0.5) | −1.4 (0.5) | |
| LS mean difference vs placebo (95% CI) | −1.3 (−2.5, −0.2) | −0.4 (−1.6, 0.8) | −0.4 (−1.7, 0.8) | −0.4 (−1.6, 0.9) | |||
| LS mean (SE) change from baseline in HADS (Depression) | −1.0 (0.4) | −0.6 (0.4) | −0.3 (0.4) | 0.0 (0.4) | −0.8 (0.4) | −0.8 (0.4) | |
| LS mean difference vs placebo (95% CI) | −1.0 (−2.1, 0.1) | −0.6 (−1.7, 0.5) | −0.3 (−1.5, 0.8) | 0.0 (−1.1, 1.1) | |||
Primary end point was assessed by mixed-effect model for repeated measures (MMRM) with baseline value as covariate, and treatment group, region, disease severity, and visit as fixed effect factors, and interactions of treatment by visit and baseline by visit. Odds ratios were analyzed by stratified Cochran-Mandel-Haenzsel (CMH) test with region and IGA severity as stratification variables. Descriptive statistics were used for continuous variables. Analyses of secondary end points were not adjusted for multiplicity. q2w, Every 2 weeks; q4w, every 4 weeks, SE, standard error.