Table 2.
Summary of AEs and those occurring with a frequency of ≥ 25 adverse events/100 PYs
| n (%) | Dose received in preceding phase II trial | Total (N = 611) | ||||
|---|---|---|---|---|---|---|
| Placebo (n = 116) | Peficitinib 25 mg (n = 112) | Peficitinib 50 mg (n = 124) | Peficitinib 100 mg (n = 128) | Peficitinib 150 mg (n = 131) | ||
| AE | 80 (69.0) | 85 (75.9) | 98 (79.0) | 101 (78.9) | 99 (75.6) | 463 (75.8) |
| Serious AE | 14 (12.1) | 11 (9.8) | 14 (11.3) | 25 (19.5) | 16 (12.2) | 80 (13.1) |
| Death | 0 | 0 | 0 | 1 (0.8) | 1 (0.8) | 2 (0.3) |
| Malignancy | 1 (0.9) | 0 | 1 (0.8) | 3 (2.4) | 1 (0.8) | 6 (1.0) |
| Herpes zoster | 1 (0.9) | 2 (1.8) | 4 (3.2) | 2 (1.6) | 5 (3.8) | 14 (2.3) |
| Herpes zoster ophthalmic | 1 (0.9) | 0 | 0 | 0 | 0 | 1 (0.2) |
| Grade ≥ 3* | 1 (0.9) | 0 | 0 | 0 | 0 | 1 (0.2) |
| AE leading to discontinuation | 9 (7.8) | 9 (8.0) | 8 (6.5) | 11 (8.6) | 6 (4.6) | 43 (7.0) |
| Serious AEs leading to discontinuation | 2 (1.7) | 1 (0.9) | 3 (2.4) | 5 (3.9) | 2 (1.5) | 13 (2.1) |
| Anaemia | 2 (1.7) | 0 | 0 | 1 (0.8) | 0 | 3 (0.5) |
| Diverticulitis | 1 (0.9) | 0 | 0 | 0 | 1 (0.8) | 2 (0.3) |
| Herpes zoster ophthalmic | 1 (0.9) | 0 | 0 | 0 | 0 | 1 (0.2) |
| Myocardial infarction | 0 | 0 | 0 | 1 (0.8) | 0 | 1 (0.2) |
| Pericarditis | 0 | 0 | 0 | 1 (0.8) | 0 | 1 (0.2) |
| Chronic lymphocytic leukaemia | 0 | 0 | 0 | 1 (0.8) | 0 | 1 (0.2) |
| Chronic myeloid leukaemia | 0 | 0 | 0 | 1 (0.8) | 0 | 1 (0.2) |
| Headache | 0 | 0 | 1 (0.8) | 0 | 0 | 1 (0.2) |
| Lacunar infarction | 0 | 1 (0.9) | 0 | 0 | 0 | 1 (0.2) |
| Drug hypersensitivity | 0 | 0 | 1 (0.8) | 0 | 0 | 1 (0.2) |
| Road traffic accident | 0 | 0 | 0 | 0 | 1 (0.8) | 1 (0.2) |
| Renal failure acute | 0 | 0 | 1 (0.8) | 0 | 0 | 1 (0.2) |
| Interstitial lung disease | 1 (0.9) | 0 | 0 | 0 | 0 | 1 (0.2) |
| Events (rate) | 100 PYs = 192.5 | 100 PYs = 182.7 | 100 PYs = 193.4 | 100 PYs = 212.0 | 100 PYs = 213.3 | 100 PYs = 993.9 |
|---|---|---|---|---|---|---|
| AE | 360 (187.0) | 313 (171.4) | 342 (176.8) | 465 (219.3) | 333 (156.1) | 1813 (182.4) |
| URTI | 24 (12.5) | 12 (6.6) | 21 (10.9) | 21 (9.9) | 20 (9.4) | 98 (9.9) |
| UTI | 19 (9.9) | 13 (7.1) | 8 (4.1) | 23 (10.8) | 9 (4.2) | 72 (7.2) |
| Nasopharyngitis | 7 (3.6) | 11 (6.0) | 16 (8.3) | 16 (7.5) | 6 (2.8) | 56 (5.6) |
| Bronchitis | 17 (8.8) | 12 (6.6) | 14 (7.2) | 3 (1.4) | 6 (2.8) | 52 (5.2) |
| Hypercholesterolaemia | 6 (3.1) | 9 (4.9) | 11 (5.7) | 6 (2.8) | 10 (4.7) | 42 (4.2) |
| Diarrhea | 10 (5.2) | 4 (2.2) | 7 (3.6) | 15 (7.1) | 4 (1.9) | 40 (4.0) |
| Blood CPK increase | 10 (5.2) | 9 (4.9) | 4 (2.1) | 5 (2.4) | 8 (3.8) | 36 (3.6) |
| Headache | 7 (3.6) | 5 (2.7) | 8 (4.1) | 13 (6.1) | 3 (1.4) | 36 (3.6) |
| RA | 7 (3.6) | 4 (2.2) | 12 (6.2) | 8 (3.8) | 3 (1.4) | 34 (3.4) |
| UTI bacterial | 5 (2.6) | 7 (3.8) | 4 (2.1) | 8 (3.8) | 9 (4.2) | 33 (3.3) |
| Influenza | 3 (1.6) | 4 (2.2) | 10 (5.2) | 10 (4.7) | 5 (2.3) | 32 (3.2) |
| Nausea | 10 (5.2) | 2 (1.1) | 5 (2.6) | 9 (4.2) | 2 (0.9) | 28 (2.8) |
| Hypertension | 3 (1.6) | 4 (2.2) | 7 (3.6) | 6 (2.8) | 7 (3.3) | 27 (2.7) |
*Grade 3 event of ophthalmic herpes zoster led to treatment discontinuation
CPK creatine phosphokinase, RA rheumatoid arthritis, AE treatment-emergent adverse event, URTI upper respiratory tract infection, UTI urinary tract infection