Table 2.
Summary of treatment-emergent adverse events
| Atopic Dermatitis | Psoriasis | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Pooled | 10 μg/kg | 12 μg/kg | 24 μg/kg | Overall | Pooled | 10 μg/kg | 24 μg/kg | Overall | |
| Placebo | REZPEG | REZPEG | REZPEG | REZPEG | Placebo | REZPEG | REZPEG | REZPEG | |
| Adverse Event Category, n (%) | n = 10 | n = 1 | n = 16 | n = 17 | n = 34 | n = 5 | n = 3 | n = 21 | n = 24 |
| Any TEAE | 8 (80.0) | 0 | 10 (62.5) | 13 (76.5) | 23 (67.6) | 0 | 3 (100) | 14 (66.7) | 17 (70.8) |
| Severe TEAEs | 3 (30.0) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (4.8) | 1 (4.2) |
| SAEs | 2 (20.0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| TEAEs related to treatment | 3 (30.0) | 0 | 2 (12.5) | 5 (29.4) | 7 (20.6) | 0 | 1 (33.3) | 10 (47.6) | 11 (45.8) |
| TEAEs leading to discontinuation of study | 0 | 0 | 1 (6.3) | 3 (17.6) | 4 (11.8) | 0 | 0 | 4 (19.0) | 4 (16.7) |
| All deaths | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Adverse events in at least 5% of patients in the overall REZPEG groupa | |||||||||
| Infections and infestations | 2 (20.0) | 0 | 7 (43.8) | 7 (41.2) | 14 (41.2) | 0 | 1 (33.3) | 6 (28.6) | 7 (29.2) |
| Coronavirus infection | 0 | 0 | 2 (12.5) | 2 (11.8) | 4 (11.8) | N/A | N/A | N/A | N/A |
| Folliculitis | 0 | 0 | 2 (12.5) | 0 | 2 (5.9) | N/A | N/A | N/A | N/A |
| Sinusitis | 0 | 0 | 2 (12.5) | 0 | 2 (5.9) | N/A | N/A | N/A | N/A |
| Upper respiratory tract infection | N/A | N/A | N/A | N/A | N/A | 0 | 1 (33.3) | 1 (4.8) | 2 (8.3) |
| Urinary tract infection | 0 | 0 | 0 | 2 (11.8) | 2 (5.9) | N/A | N/A | N/A | N/A |
| Gastrointestinal disorders | 3 (30.0) | 0 | 1 (6.3) | 3 (17.6) | 4 (11.8) | 0 | 1 (33.3) | 1 (4.8) | 2 (8.3) |
| Nausea | 0 | 0 | 1 (6.3) | 1 (5.9) | 2 (5.9) | N/A | N/A | N/A | N/A |
| General disorders and administration site conditions | 1 (10.0) | 0 | 2 (12.5) | 2 (11.8) | 4 (11.8) | 0 | 0 | 4 (19.0) | 4 (16.7) |
| Pain | 0 | 0 | 1 (6.3) | 1 (5.9) | 2 (5.9) | N/A | N/A | N/A | N/A |
| Pyrexia | N/A | N/A | N/A | N/A | N/A | 0 | 0 | 3 (14.3) | 3 (12.5) |
| Musculoskeletal and connective tissue disorders | N/A | N/A | N/A | N/A | N/A | 0 | 1 (33.3) | 2 (9.5) | 3 (12.5) |
| Arthralgia | N/A | N/A | N/A | N/A | N/A | 0 | 1 (33.3) | 1 (4.8) | 2 (8.3) |
| Investigations | 0 | 0 | 0 | 4 (23.5) | 4 (11.8) | 0 | 0 | 2 (9.5) | 2 (8.3) |
| Eosinophil count increased | N/A | N/A | N/A | N/A | N/A | 0 | 0 | 2 (9.5) | 2 (8.3) |
| Nervous system disorders | 0 | 0 | 2 (12.5) | 2 (11.8) | 4 (11.8) | N/A | N/A | N/A | N/A |
| Headache | 0 | 0 | 2(12.5) | 0 | 2 (5.9) | N/A | N/A | N/A | N/A |
| Blood and lymphatic system disorders | 0 | 0 | 1 (6.3) | 1 (5.9) | 2 (5.9) | 0 | 0 | 2 (9.5) | 2 (8.3) |
| Lymphadenopathy | N/A | N/A | N/A | N/A | N/A | 0 | 0 | 2 (9.5) | 2 (8.3) |
| Eye disorders | 0 | 0 | 2 (12.5) | 0 | 2 (5.9) | N/A | N/A | N/A | N/A |
| Respiratory, thoracic and mediastinal disorders | 0 | 0 | 1 (6.3) | 1 (5.9) | 2 (5.9) | 0 | 0 | 2 (9.5) | 2 (8.3) |
| Skin and subcutaneous tissue disorders | 1 (10.0) | 0 | 1 (6.3) | 1 (5.9) | 2 (5.9) | 0 | 0 | 3 (14.3) | 3 (12.5) |
| Injection site reactionsb | 1 (10.0) | 1 (100.0) | 12 (75.0) | 10 (58.8) | 23 (67.6) | 0 | 3 (100) | 15 (71.4) | 18 (75.0) |
Adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA) version 23.0 (AD) or version 22.0 (PsO). For each system organ class and preferred term, patients were included only once. Data are presented from the adjusted safety population. aN/A indicates < 5% of patients in the overall REZPEG group which includes 0. bNumber of patients with at least one injection site occurrence. AD atopic dermatitis, PsO psoriasis SAE serious adverse event, TEAE treatment-emergent adverse event.