Haematological laboratory abnormality adverse events leading to study drug interruption or permanent discontinuation (on-treatment analysis)
| Temporary study drug interruption* | Permanent study drug discontinuation | |||||||
|---|---|---|---|---|---|---|---|---|
| Placebo-controlled period up to week 24 | All Bari-RA | Placebo-controlled period up to week 24 | All Bari-RA | |||||
| Laboratory assessment | Placebo | Baricitinib 2 mg | Baricitinib 4 mg | Any baricitinib dose | Placebo | Baricitinib 2 mg | Baricitinib 4 mg | Any baricitinib dose |
| N | 1039 | 479 | 966 | 3369 | 1070 | 479 | 997 | 3492 |
| Neutrophils | 1 (0.1) | 0 | 0 | 9 (0.3) | 0 | 0 | 0 | 8 (0.2) |
| Lymphocytes | 3 (0.3) | 2 (0.4) | 2 (0.2) | 43 (1.3) | 1 (0.1) | 1 (0.2) | 1 (0.1) | 6 (0.2) |
| Platelets | 0 | 0 | 1 (0.1) | 5 (0.1) | 0 | 1 (0.2) | 1 (0.1) | 8 (0.2) |
| Haemoglobin | 1 (0.1) | 0 | 1 (0.1) | 11 (0.3) | 0 | 2 (0.4) | 1 (0.1) | 16 (0.5) |
*Excludes the JADC study as patients could not restart treatment after interruption in JADC.
MedDRA terms for neutrophils, ‘neutropenia,’ ‘neutrophil count decreased’, ‘febrile neutropenia’ and ‘neutrophilia’; for lymphocytes, ‘lymphopenia,’ and ‘lymphocyte decreased’; for platelets, ‘thrombocytosis,’ ‘thrombocytopenia’ and ‘platelet count decreased’; for haemoglobin, ‘haemoglobin decreased’ and ‘anaemia’.