Table 3. Summary of Treatment-Emergent Adverse Events (TEAEs) in the Safety Populationa.
| Variable | No. (%) | ||||
|---|---|---|---|---|---|
| Placebo Every 2 wk (n = 52) | Lebrikizumab | ||||
| 125 mg Every 4 wk (n = 73) | 250 mg Every 4 wk (n = 80) | 250 mg Every 2 wk (n = 75) | All (n = 228) | ||
| Patients reporting ≥1 TEAE | 24 (46.2) | 42 (57.5) | 39 (48.8) | 46 (61.3) | 127 (55.7) |
| No. of TEAEs | 61 | 104 | 115 | 143 | 362 |
| Patients reporting ≥1 serious TEAEs | 2 (3.8) | 2 (2.7) | 0 | 2 (2.7) | 4 (1.8) |
| No. of serious TEAEs | 3 | 2 | 0 | 2 | 4 |
| Deaths | 0 | 0 | 0 | 0 | 0 |
| Patients who discontinued study because of TEAEs | 1 (1.9) | 2 (2.7) | 4 (5.0) | 3 (4.0) | 9 (3.9) |
| Maximum severity | |||||
| Mild | 12 (23.1) | 21 (28.8) | 12 (15.0) | 20 (26.7) | 53 (23.2) |
| Moderate | 8 (15.4) | 18 (24.7) | 25 (31.3) | 23 (30.7) | 66 (28.9) |
| Severe | 4 (7.7) | 3 (4.1) | 2 (2.5) | 3 (4.0) | 8 (3.5) |
| Strongest relationship to study drug | |||||
| Not related | 21 (40.4) | 34 (46.6) | 24 (30.0) | 31 (41.3) | 89 (39.0) |
| Related | 3 (5.8) | 8 (11.0) | 15 (18.8) | 15 (20.0) | 38 (16.7) |
| Common TEAEs reported in ≥5% in any lebrikizumab treatment group | |||||
| Upper respiratory tract infection | 3 (5.8) | 6 (8.2) | 9 (11.3) | 2 (2.7) | 17 (7.5) |
| Nasopharyngitis | 2 (3.8) | 4 (5.5) | 2 (2.5) | 9 (12.0) | 15 (6.6) |
| Headache | 3 (5.8) | 3 (4.1) | 1 (1.3) | 4 (5.3) | 8 (3.5) |
| Injection site pain | 1 (1.9) | 0 | 3 (3.8) | 4 (5.3) | 7 (3.1) |
| Fatigue | 0 | 0 | 4 (5.0) | 0 | 4 (1.8) |
| TEAEs of clinical interest | |||||
| Injection site reactionsb | 1 (1.9) | 2 (2.7) | 4 (5.0) | 7 (9.3) | 13 (5.7) |
| Herpesvirus infectionsc | 2 (3.8) | 2 (2.7) | 4 (5.0) | 2 (2.7) | 8 (3.5) |
| Conjunctivitisd | 0 | 1 (1.4) | 3 (3.8) | 2 (2.7) | 6 (2.6) |
Treatment-emergent adverse events are those with an onset on or after the date of first study drug injection. Percentages are based on the number of patients in the safety population.
Includes the following injection site–related MedDRA (version 20.1; MedDRA MSSO) preferred terms: injection site pain, erythema, pruritus, edema, swelling, rash, dermatitis, infection, and reaction.
Includes the following MedDRA (version 20.1; MedDRA MSSO) preferred terms: oral herpes, herpes zoster, genital herpes, herpes simplex, and eczema herpeticum. Individual term rates were as follows: 0% (0 of 52) (placebo) vs 1.4% (1 of 73), 2.5% (2 of 80), and 1.3% (1 of 75) (for the 3 lebrikizumab groups, respectively) for oral herpes; 0% (0 of 52) (placebo) vs 0% (0 of 73), 2.5% (2 of 80), and 1.3% (1 of 75) (for the 3 lebrikizumab groups, respectively) for herpes zoster; 0% (0 of 52) (placebo) vs 1.4% (1 of 73), 0% (0 of 80), and 0% (0 of 75) (for the 3 lebrikizumab groups, respectively) for genital herpes; 1.9% (1 of 52) (placebo) vs 0% (0 of 73), 0% (0 of 80), and 0% (0 of 75) (for the 3 lebrikizumab groups, respectively) for herpes simplex; and 1.9% (1 of 52) (placebo) vs 0% (0 of 73), 0% (0 of 80), and 0% (0 of 75) (for the 3 lebrikizumab groups, respectively) for eczema herpeticum.
Includes the following MedDRA (version 20.1; MedDRA MSSO) preferred terms: conjunctivitis, conjunctivitis bacterial, and conjunctivitis allergic.