Principal safety outcomes
| TNFi-naïve (n=976) | TNFi-previous use (n=298) | TNFi-recent use (n=407) | All patients (n=1681) | |
|---|---|---|---|---|
| Total PY | 452.1 | 132.4 | 183.3 | 767.7 |
| AE, % (n) (95% CI) | 74.4 (726) (71.5 to 77.1) | 80.2 (239) (75.2 to 84.6) | 82.6 (336) (78.5 to 86.1) | 77.4 (1301) (75.3 to 79.4) |
| AE, rate/100PY (95% CI) | 551.1 (529.6 to 573.1) | 653.6 (610.8 to 698.6) | 652.6 (616.1 to 690.6) | 593.0 (575.9 to 610.4) |
| SAE, % (n) (95% CI) | 7.1 (69) (5.5 to 8.9) | 11.1 (33) (7.7 to 15.2) | 7.1 (29) (4.8 to 10.1) | 7.8 (131) (6.6 to 9.2) |
| SAE, rate/100PY (95% CI) | 18.6 (14.8 to 23.0) | 28.0 (19.7 to 38.5) | 18.0 (12.4 to 25.3) | 20.1 (17.0 to 23.5) |
| Deaths, % (n) | 0.3 (3) | 0 | 0.2 (1) | 0.2 (4) |
| Serious infections, % (n) (95% CI) | 1.8 (18) (1.1 to 2.9) | 2.7 (8) (1.2 to 5.2) | 2.5 (10) (1.2 to 4.5) | 2.1 (36) (1.5 to 3.0) |
| Serious infections, rate/100PY (95% CI) | 4.2 (2.5 to 6.6) | 6.8 (3.1 to 12.9) | 6.0 (3.0 to 10.7) | 5.1 (3.6 to 6.9) |
| AEs leading to withdrawal, % (n) (95% CI) | 4.5 (44) (3.3 to 6.0) | 7.0 (21) (4.4 to 10.6) | 5.2 (21) (3.2 to 7.8) | 5.1 (86) (4.1 to 6.3) |
| AEs leading to dose modification, % (n) (95% CI) | 10.5 (102) (8.6 to 12.5) | 11.1 (33) (7.7 to 15.2) | 11.3 (46) (8.4 to 14.8) | 10.8 (181) (9.3 to 12.3) |
| Infusion reactions,* % (n) (95% CI) | 6.8 (66) (5.3 to 8.5) | 7.4 (22) (4.7 to 11.0) | 6.1 (25) (4.0 to 8.9) | 6.7 (113) (5.6 to 8.0) |
| ALT shift from normal at baseline to 1.5–3×ULN at any time,† % (n) | 14.7 (143) | 9.4 (28) | 9.1 (37) | 12.4 (208) |
| ALT shift from normal at baseline to >3×ULN at any time,† % (n) | 2.4 (23) | 3.0 (9) | 0.7 (3) | 2.1 (35) |
| AST shift from normal at baseline to 1.5–3×ULN at any time,† % (n) | 5.9 (58) | 4.0 (12) | 2.9 (12) | 4.9 (82) |
| AST shift from normal at baseline to >3×ULN at any time,† % (n) | 0.6 (6) | 0.7 (2) | 0.5 (2) | 0.6 (10) |
↵* Defined as an AE that occurred during infusion.
↵† Highest postbaseline value.
AE, adverse event; ALT, alanine aminotransferase; DMARD, disease-modifying anti-rheumatic drug; IR, inadequate response; PY, patient-years; SAE, serious adverse event; TNFi, tumour necrosis factor inhibitor; TNFi-naive, patients who had never received TNFi therapy; TNFi-previous use, patients who had discontinued TNFi therapy for >2 months before baseline (washout period); TNFi-recent use, patients who had discontinued TNFi therapy for ≤2 months before baseline (no washout period); ULN, upper limit of normal.