Disposition of patients and baseline* patient and disease characteristics in the dose-escalation and active treatment extension phases
| n (%) | Dose escalation | ATEP | |||||
| Placebo (n=8) | Iberdomide 0.3 mg QOD (n=8) | Iberdomide 0.3 mg QD (n=8) | Iberdomide 0.6/0.3 mg ALTN (n=9) | Iberdomide 0.6 mg QD (n=9) | Iberdomide 0.3 mg QD (n=9) | Iberdomide 0.6/0.3 mg ALTN (n=8) | |
| Completed | 7 (88) | 6 (75) | 7 (88) | 7 (78) | 6 (67) | 6 (67) | 1 (13) |
| Discontinued | 1 (13) | 2 (25) | 1 (13) | 2 (22) | 3 (33) | 3 (33) | 7 (88) |
| Reasons for discontinuation | |||||||
| Adverse event | 1 (13) | 0 | 0 | 2 (22) | 3 (33) | 1 (11) | 4 (50) |
| Withdrawal by patient | 0 | 1 (13) | 0 | 0 | 0 | 1 (11) | 1 (13) |
| Lack of efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Lost to follow-up | 0 | 1 (13) | 0 | 0 | 0 | 0 | 2 (25) |
| Other | 0 | 0 | 1 (13) | 0 | 0 | 1 (11) | 0 |
| Continued to part 2 | 3 (38) | 2 (25) | 5 (63) | 3 (33) | 4 (44) | NA | NA |
| Age, mean (SD), years | 44.8 (6.6) | 46.0 (8.6) | 48.0 (10.9) | 49.8 (13.1) | 47.2 (13.6) | 51.2 (10.2) | 47.1 (13.7) |
| Female, n (%) | 7 (88) | 8 (100) | 7 (88) | 8 (89) | 9 (100) | 8 (89) | 8 (100) |
| Race | |||||||
| White | 5 (63) | 6 (75) | 4 (50) | 7 (78) | 5 (56) | 4 (44) | 6 (75) |
| Black or African American | 2 (25) | 2 (25) | 4 (50) | 1 (11) | 4 (44) | 5 (56) | 1 (13) |
| Other | 1 (13) | 0 | 0 | 1 (11) | 0 | 0 | 1 (13) |
| Weight, mean (SD), kg | 82.0 (13.2) | 78.5 (13.7) | 96.3 (26.1) | 74.3 (14.8) | 76.5 (21.5) | 87.5 (9.4) | 67.5 (11.8) |
| Duration of SLE, mean (SD), years | 13.3 (10.0) | 7.9 (9.7) | 9.8 (9.2) | 8.2 (4.3) | 10.5 (8.3) | 8.9 (9.0) | 12.2 (8.3) |
| CLASI score, mean (SD) | 4.3 (5.9) | 17.6 (12.9) | 6.3 (9.1) | 8.4 (8.6) | 12.4 (16.5) | 7.2 (9.0) | 12.3 (10.1) |
| ≥1 tender joint, n (%) | 6 (75) | 6 (75) | 7 (88) | 8 (89) | 6 (67) | 7 (78)† | 3 (38)† |
| ≥1 swollen joint, n (%) | 5 (63) | 5 (63) | 6 (75) | 8 (89) | 4 (44) | 6 (67)† | 2 (25)† |
| Hybrid SELENA-SLEDAI score, mean (SD) | 6.8 (1.8) | 8.4 (4.1) | 5.5 (2.1) | 6.7 (3.2) | 5.7 (1.9) | 4.9 (2.9) | 6.3 (2.1) |
| PGA score, mean (SD) | 0.95 (0.52) | 1.50 (0.65) | 1.50 (0.61) | 1.22 (0.35) | 1.40 (0.60) | 1.17 (0.78) | 1.08 (0.62) |
*For patients in ATEP previously enrolled in dose escalation, values are from time of ATEP enrolment.
†For ATEP population, number of patients with non-zero tender/swollen joint counts.
ALTN, alternating once daily; ATEP, active treatment extension phase; CLASI, Cutaneous Lupus Erythematosus Disease Area and Severity Index; NA, not applicable; PGA, Physician’s Global Assessment; QD, once daily; QOD, every other day; SELENA-SLEDAI, Safety of Estrogens in Systemic Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index.