Table 3.
Safety in rescued patients from RA-BEAM and patients switched in RA-BEYOND
| Rescued patients in RA-BEAM (24 weeks after rescue) |
Switched patients in RA-BEYOND (weeks 0–24 after switch) |
|||
| Baricitinib to baricitinib (n=35, PYE=15.8) |
Adalimumab to baricitinib (n=40, PYE=19.6) |
Baricitinib to baricitinib (n=381, PYE=189.4) |
Adalimumab to baricitinib (n=238, PYE=118.2) |
|
| Patients with ≥1 TEAE | 21 (60.0) (132.8) | 26 (65.0) (132.4) | 206 (54.1) (108.8) | 124 (52.1) (104.9) |
| Infections | 11 (31.4) (69.6) | 7 (17.5) (35.6) | 87 (22.8) (45.9) | 49 (20.6) (41.5) |
| Herpes zoster | 1 (2.9) (6.3) | 1 (2.5) (5.1) | 5 (1.3) (2.6) | 5 (2.1) (4.2) |
| Gastrointestinal disorders | 6 (17.1) (37.9)* | 8 (20.0) (40.7)† | 36 (9.4) (19.0) | 18 (7.6) (15.2) |
| AEs that led to permanent study drug discontinuation | 4 (11.4) (25.3) | 1 (2.5) (5.1) | 8 (2.1) (4.2) | 3 (1.3) (2.5) |
| Patients with ≥1 SAE | 6 (17.1) (37.9) | 2 (5.0) (10.2) | 26 (6.8) (13.7) | 11 (4.6) (9.3) |
| Serious infections | 0 | 0 | 8 (2.1) (4.2) | 4 (1.7) (3.4) |
Data are n (%) (EAIR).
*Gastrointestinal disorders included nausea, dental caries, constipation, gastritis, vomiting, diarrhoea, inguinal hernia, mouth ulceration and upper gastrointestinal haemorrhage.
†Gastrointestinal disorders included dyspepsia, abdominal pain, constipation, stomatitis, upper abdominal pain, diarrhoea, enterocolitis and hyperchlorhydria.
AE, adverse event;EAIR, exposure-adjusted incidence rate;PYE, patient-years of exposure;SAE, serious adverse event;TEAE, treatment-emergent adverse event.