Table 5.
Overview of special safety topics
| All-PC Week 0–16 | All-LEBa (N = 1720) |
||
|---|---|---|---|
| Placebo (N = 404) |
LEB 250 mg Q2W (N = 783) |
||
| Conjunctivitis, n (adj %) [adj IR/100 PYR]b | |||
| Conjunctivitis clusterc | 10 (2.5) [8.9] | 67 (8.5) [30.6] | 183 (10.6) [12.2] |
| Conjunctivitis | 7 (1.8) [6.2] | 51 (6.5) [22.8] | 112 (6.5) [7.2] |
| Conjunctivitis, allergic | 3 (0.7) [2.6] | 14 (1.8) [6.1] | 70 (4.1) [4.4] |
| Conjunctivitis, bacterial | 0 | 3 (0.4) [1.3] | 11 (0.6) [0.7] |
| Conjunctivitis, viral | 0 | 0 | 2 (0.1) [0.1] |
| Keratitis cluster | 1 (0.3) [0.9] | 5 (0.6) [2.2] | 9 (0.5) [0.6] |
| Keratitis | 1 (0.3) [0.9] | 1 (0.1) [0.4] | 3 (0.2) [0.2] |
| Vernal keratoconjunctivitis | 0 | 2 (0.2) [0.8] | 3 (0.2) [0.2] |
| Atopic keratoconjunctivitis | 0 | 2 (0.3) [0.9] | 3 (0.2) [0.2] |
| Blepharitis | 1 (0.2) [0.9] | 6 (0.8) [2.6] | 11 (0.6) [0.7] |
| Infections, n (adj %) [adj IR/100 PYR]b | |||
| Treatment-emergent infections | 77 (18.9) [76.6] | 166 (21.2) [82.1] | 615 (35.8) [50.2] |
| Herpes infection | 15 (3.7) [13.4] | 23 (2.9) [10.0] | 87 (5.1) [5.5] |
| Oral herpes | 9 (2.3) [8.1] | 15 (1.9) [6.5] | 50 (2.9) [3.1] |
| Herpes zoster | 0 | 5 (0.6) [2.1] | 14 (0.8) [0.9] |
| Herpes simplex | 0 | 2 (0.3) [0.9] | 13 (0.8) [0.8] |
| Eczema herpeticum | 3 (0.7) [2.6] | 0 | 1 (0.1) [0.1] |
| Skin infectionsd | 24 (5.9) [21.8] | 17 (2.2) [7.5] | 63 (3.7) [3.9] |
| Parasitic helminth infections | 0 | 0 | 1 (0.1) [0.1] |
| Confirmed opportunistic infections | 0 | 0 | 0 |
| Injection site reactionse | 6 (1.5) [5.4] | 20 (2.6) [9.0] | 53 (3.1) [3.3] |
| Malignancy, n (adj %) [adj IR/100 PYR]b | |||
| Malignancy excluding NMSC | 0 | 0 | 8 (0.5) [0.5] |
| Prostate cancer | 0 | 0 | 1 (0.1) [0.1] |
| Cutaneous T-cell lymphoma | 0 | 0 | 2 (0.1) [0.4] |
| Endometrial adenocarcinoma | 0 | 0 | 1 (0.1) [0.1] |
| Invasive breast cancer | 0 | 0 | 1 (0.1) [0.1] |
| Ovarian germ cell teratomaf | 0 | 0 | 1 (0.1) [0.1] |
| Neuroendocrine tumor | 0 | 0 | 1 (0.1) [0.1] |
| Pancreatic carcinoma metastatic | 0 | 0 | 1 (0.1) [0.1] |
| Metastases to boneg | 0 | 0 | 1 (0.1) [0.1] |
| Metastases to liverg | 0 | 0 | 1 (0.1) [0.1] |
| NMSC | 2 (0.5) [1.7] | 2 (0.3) [0.8] | 5 (0.3) [0.3] |
| Squamous cell carcinoma | 1 (0.2) [0.9] | 1 (0.1) [0.4] | 1 (0.1) [0.1] |
| Keratoacanthoma | 0 | 1 (0.1) [0.4] | 1 (0.1) [0.1] |
| Bowen’s disease | 1 (0.2) [0.9] | 0 | 1 (0.1) [0.1] |
| Squamous cell carcinoma of skin | 0 | 0 | 1 (0.1) [0.1] |
| Basal cell carcinoma | 0 | 0 | 1 (0.1) [0.1] |
| Penile squamous cell carcinomah | 0 | 0 | 1 (0.1) [0.1] |
| Eosinophiliai, n (adj %) [adj IR/100 PYR]b | 3 (0.8) [2.7] | 5 (0.6) [2.1] | 27 (1.6) [1.7] |
| Eosinophil-related disordersj, n (adj %) [adj IR/100 PYR]b | 0 | 0 | 0 |
adj adjusted, AE adverse event, IR incidence rate, n number of patients in the specified category, N number of patients in the analysis set, NMSC nonmelanoma skin cancer, PYR patient-years at risk, Q2W every 2 weeks, Q4W every 4 weeks, SAE serious adverse event, TEAE treatment-emergent adverse event
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 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 PYR or patient-years exposed
cThe conjunctivitis cluster includes the preferred terms of conjunctivitis; conjunctivitis, allergic; conjunctivitis, bacterial; conjunctivitis, viral; and giant papillary conjunctivitis
dSkin infections were defined using the MedDRA high-level term of ‘Skin structures and soft tissue infections’ and included the following preferred terms: cellulitis, eczema impetiginous, folliculitis, staphylococcal skin infection, cellulitis staphylococcal, furuncle, erysipelas, fungal skin infection
eInjection site reactions were defined using MedDRA high-level term of injection site reactions excluding joint-related preferred terms
fAfter database lock, pathology showed that the ovarian germ cell teratoma was benign
gThe metastases to the bone and liver were in the same patient with pancreatic carcinoma
hDenominator adjusted for gender-specific events for males, All-LEB: N = 843 and PYE = 798.4
iEosinophilia is defined as two preferred terms of eosinophilia and allergic eosinophilia and the following preferred terms under the high-level term of white blood cell analysis: eosinophil count abnormal, eosinophil count increased, and eosinophil percentage increased
jEosinophil-related disorder is defined as all preferred terms under the high-level term of eosinophil disorders except the following: eosinophilia and allergic eosinophilia