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 TEAE21 (60.0) (132.8)26 (65.0) (132.4)206 (54.1) (108.8)124 (52.1) (104.9)
Infections11 (31.4) (69.6)7 (17.5) (35.6)87 (22.8) (45.9)49 (20.6) (41.5)
 Herpes zoster1 (2.9) (6.3)1 (2.5) (5.1)5 (1.3) (2.6)5 (2.1) (4.2)
Gastrointestinal disorders6 (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 discontinuation4 (11.4) (25.3)1 (2.5) (5.1)8 (2.1) (4.2)3 (1.3) (2.5)
Patients with ≥1 SAE6 (17.1) (37.9)2 (5.0) (10.2)26 (6.8) (13.7)11 (4.6) (9.3)
 Serious infections008 (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.