Table 4.
Common treatment-emergent adverse events reported in ≥ 1% of patients in All-LEB
| All-PC Week 0–16 | All-LEBa (N = 1720) [PY = 1637.0] |
||
|---|---|---|---|
| Placebo (N = 404) [PY = 113.8] |
LEB 250 mg Q2W (N = 783) [PY = 233.3] |
||
| TEAE by PT reported in ≥ 1.0% of patients in All-LEB, n (adj %) [adj IR]b | |||
| Nasopharyngitis | 13 (3.2) [11.8] | 34 (4.4) [15.2] | 157 (9.1) [10.2] |
| COVID-19 | 5 (1.3) [4.4] | 9 (1.1) [3.8] | 133 (7.7) [8.4] |
| Atopic dermatitis | 74 (18.4) [76.9] | 47 (6.0) [21.2] | 128 (7.4) [8.3] |
| Conjunctivitis | 7 (1.8) [6.2] | 51 (6.5) [22.8] | 112 (6.5) [7.2] |
| Headache | 12 (2.9) [10.5] | 34 (4.4) [15.0] | 81 (4.7) [5.1] |
| Conjunctivitis, allergic | 3 (0.7) [2.6] | 14 (1.8) [6.1] | 70 (4.1) [4.4] |
| Upper respiratory tract infection | 7 (1.7) [6.3] | 3 (0.4) [1.3] | 66 (3.8) [4.1] |
| Oral herpes | 9 (2.3) [8.1] | 15 (1.9) [6.5] | 50 (2.9) [3.1] |
| Pruritus | 7 (1.8) [6.4] | 9 (1.2) [3.9] | 33 (1.9) [2.0] |
| Urinary tract infection | 2 (0.5) [1.7] | 5 (0.6) [2.1] | 32 (1.9) [2.0] |
| Hypertension | 4 (1.0) [3.6] | 9 (1.1) [3.8] | 31 (1.8) [1.9] |
| Diarrhea | 1 (0.2) [0.9] | 4 (0.5) [1.7] | 29 (1.7) [1.8] |
| Arthralgia | 3 (0.7) [2.5] | 6 (0.8) [2.6] | 27 (1.6) [1.7] |
| Cough | 1 (0.3) [0.9] | 5 (0.7) [2.2] | 27 (1.6) [1.7] |
| Acne | 3 (0.7) [2.6] | 2 (0.3) [0.8] | 26 (1.5) [1.6] |
| Vaccination complication | 0 | 3 (0.4) [1.3] | 25 (1.5) [1.5] |
| Dry eye | 4 (0.9) [3.4] | 11 (1.4) [4.8] | 25 (1.5) [1.5] |
| Fatigue | 3 (0.7) [2.6] | 5 (0.6) [2.2] | 25 (1.5) [1.5] |
| Anxiety | 3 (0.7) [2.6] | 6 (0.8) [2.6] | 23 (1.3) [1.4] |
| Nausea | 2 (0.5) [1.8] | 6 (0.8) [2.6] | 21 (1.2) [1.3] |
| Folliculitis | 5 (1.2) [4.3 | 5 (0.6) [2.2] | 21 (1.2) [1.3] |
| Alanine aminotransferase increased | 0 | 3 (0.4) [1.3] | 21 (1.2) [1.3] |
| Injection site reaction | 1 (0.30 [0.9] | 5 (0.6) [2.1] | 21 (1.2) [1.3] |
| Asthma | 1 (0.3) [0.9] | 5 (0.6) [2.1] | 20 (1.2) [1.2] |
| Rhinitis, allergic | 1 (0.2) [0.9] | 8 (1.0) [3.5] | 18 (1.0) [1.1] |
| Herpes dermatitis | 2 (0.5) [1.7] | 1 (0.1) [0.4] | 18 (1.0) [1.1] |
| Abdominal pain | 0 | 2 (0.3) [0.9] | 17 (1.0) [1.0] |
| Impetigo | 6 (1.5) [5.4] | 6 (0.8) [2.6] | 17 (1.0) [1.0] |
| Back pain | 2 (0.5) [1.8] | 2 (0.3) [0.9] | 17 (1.0) [1.0] |
aAll-LEB AD includes lebrikizumab exposure to doses of 250 mg Q2W, 250 mg Q4W, 125 mg single dose, 125 mg Q4W, and 250 mg single dose
bAdjusted percentages and adjust IRs are only shown for the placebo-controlled dataset; IRs in this analysis are exposure-adjusted IRs calculated as the number of patients reporting an event per 100 PY at risk or patient-years exposed
adj adjusted, IR incidence rate, n number of patients in the specified category, LEB lebrikizumab, N number of patients in the analysis set, PY patient years, PT preferred term, Q2W every 2 weeks, Q4W every 4 weeks, TEAE treatment-emergent adverse event