Table 4.
Summary of events of special interest and clinical laboratory values
| Events (rate) | Dose received in preceding phase II trial | Total (N = 611) 100 PYs = 993.9 |
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|---|---|---|---|---|---|---|---|
| Placebo (n = 116) 100 PYs = 192.5 |
Peficitinib 25 mg (n = 112) 100 PYs = 182.7 |
Peficitinib 50 mg (n = 124) 100 PYs = 193.4 |
Peficitinib 100 mg (n = 128) 100 PYs = 212.0 |
Peficitinib 150 mg (n = 131) 100 PYs = 213.3 |
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| Serious infections occurring in ≥ 2 patients | |||||||
| UTI | 0 | 0 | 0 | 3 (1.4) | 1 (0.5) | 4 (0.4) | |
| Appendicitis | 1 (0.5) | 0 | 0 | 1 (0.5) | 1 (0.5) | 3 (0.3) | |
| Diverticulitis | 1 (0.5) | 0 | 0 | 0 | 1 (0.5) | 2 (0.2) | |
| Gastroenteritis | 0 | 0 | 1 (0.5) | 0 | 1 (0.5) | 2 (0.2) | |
| Pneumonia | 0 | 1 (0.5) | 0 | 0 | 1 (0.5) | 2 (0.2) | |
| Herpes zoster | 1 (0.5) | 2 (1.1) | 5 (2.6) | 2 (0.9) | 5 (2.3) | 15 (1.5) | |
| Herpes zoster ophthalmic | 1 (0.5) | 0 | 0 | 0 | 0 | 1 (0.1) | |
| Malignancies | |||||||
| Basal cell carcinoma | 0 | 0 | 1 (0.5) | 1 (0.5) | 0 | 2 (0.2) | |
| Chronic lymphocytic leukaemia | 0 | 0 | 0 | 1 (0.5) | 0 | 1 (0.1) | |
| Chronic myeloid leukaemia | 0 | 0 | 0 | 1 (0.5) | 0 | 1 (0.1) | |
| Gastrointestinal carcinoma | 0 | 0 | 0 | 0 | 1 (0.5) | 1 (0.1) | |
| Thyroid cancer | 1 (0.5) | 0 | 0 | 0 | 0 | 1 (0.1) | |
| Liver enzyme changes | |||||||
| Hepatic enzyme increase | 0 | 2 (1.1) | 2 (1.0) | 1 (0.5) | 1 (0.5) | 6 (0.6) | |
| GGT increase | 2 (1.0) | 0 | 0 | 1 (0.5) | 1 (0.5) | 4 (0.4) | |
| ALT increase | 0 | 2 (1.1) | 0 | 0 | 1 (0.5) | 3 (0.3) | |
| Liver function test abnormal | 1 (0.5) | 0 | 0 | 1 (0.5) | 1 (0.5) | 3 (0.3) | |
| Transaminases increase | 0 | 3 (1.6) | 0 | 0 | 0 | 3 (0.3) | |
| AST increase | 0 | 0 | 0 | 1 (0.5) | 1 (0.5) | 2 (0.2) | |
| Hyperbilirubinaemia | 0 | 0 | 0 | 1 (0.5) | 0 | 1 (0.1) | |
| Liver injury | 1 (0.5) | 0 | 0 | 0 | 0 | 1 (0.1) | |
| Shift from baseline to week 105 for laboratory values, n (%) | |||||||
| ANC, cells/µl | |||||||
| < 500 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 500 to < 1000 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 1000 to < 1500 | 1 (0.9) | 0 | 1 (0.8) | 1 (0.8) | 0 | 3 (0.5) | |
| ALC, cells/µl | |||||||
| < 200 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 200 to < 500 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Hb, g/dl | |||||||
| < 8.0 | 0 | 1 (0.9) | 0 | 0 | 0 | 1 (0.2) | |
| 8.0 to < 10.0 | 0 | 2 (1.8) | 0 | 0 | 0 | 2 (0.3) | |
| Grade 2 or 3 | 2 (1.7) | 2 (1.8) | 0 | 1 (0.8) | 0 | 5 (0.8) | |
| Plt, cells/µl | |||||||
| ≤ 2 × 104 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 2 × 104 to ≤ 5 × 104 | 0 | 0 | 0 | 0 | 0 | 0 | |
| CPK | |||||||
| > 3 × ULN to ≤ 5 × ULN | 0 | 0 | 0 | 0 | 0 | 0 | |
| > 5 × ULN to ≤ 10 × ULN | 0 | 0 | 0 | 0 | 1 (0.8) | 1 (0.2) | |
| > 10 × ULN | 0 | 0 | 0 | 0 | 0 | 0 | |
| ALT | |||||||
| > 2 × ULN to ≤ 3 × ULN | 1 (0.9) | 2 (1.8) | 0 | 1 (0.8) | 0 | 4 (0.7) | |
| > 3 × ULN to ≤ 5 × ULN | 1 (0.9) | 0 | 0 | 1 (0.8) | 0 | 2 (0.3) | |
| > 5 × ULN | 0 | 0 | 0 | 0 | 0 | 0 | |
| AST | |||||||
| > 2 × ULN to ≤ 3 × ULN | 0 | 1 (0.9) | 0 | 0 | 0 | 1 (0.2) | |
| > 3 × ULN to ≤ 5 × ULN | 0 | 0 | 0 | 1 (0.8) | 0 | 1 (0.2) | |
| > 5 × ULN | 0 | 0 | 0 | 0 | 0 | 0 | |
| Creatinine | |||||||
| > 1.5 × baseline to ≤ 3.0 × baseline | 1 (0.9) | 0 | 0 | 0 | 0 | 1 (0.2) | |
| > 3.0 × baseline | 0 | 0 | 0 | 0 | 0 | 0 | |
| LDL, mg/dl | |||||||
| > 160 | 3 (2.6) | 10 (8.9) | 6 (4.8) | 7 (5.5) | 4 (3.1) | 30 (9.6) | |
| ≤ 160 | 60 (51.7) | 47 (42.0) | 55 (44.4) | 57 (44.5) | 62 (47.3) | 281 (46.0) | |
All shift data are reported as shift from this LTE study baseline to week 105
ALC absolute lymphocyte count, ALT alanine aminotransferase, ANC absolute neutrophil count, AST aspartate aminotransferase, CPK creatine phosphokinase, GGT gamma glutamyltransferase, Hb haemoglobin, LDL low-density lipoprotein, Plt platelets, PY patient-year, ULN upper limit of normal, UTI urinary tract infection