Table 2 Overview of TEAEs by age
n/N (%) | Combination therapy with MTX in MTX-IR patients 52 weeks | Combination therapy with csDMARDs in TNF-IR/INT patients 24 weeks | Monotherapy in MTX-IR/INT patients 24 weeks | |||||
|---|---|---|---|---|---|---|---|---|
Placebo | Sarilumab 150 mg q2w | Sarilumab 200 mg q2w | Placebo | Sarilumab 150 mg q2w | Sarilumab 200 mg q2w | Adalimumab 40 mg q2w | Sarilumab 200 mg q2w | |
TEAEs | ||||||||
 Patients aged < 65 years | 217/356 (61.0) | 268/360 (74.4) | 267/345 (77.4) | 76/152 (50.0) | 99/150 (66.0) | 102/154 (66.2) | 105/144 (72.9) | 113/158 (71.5) |
 Patients aged ≥ 65 years | 29/41 (70.7) | 32/41 (78.0) | 45/51 (88.2) | 14/29 (48.3) | 20/31 (64.5) | 18/30 (60.0) | 36/40 (90.0) | 14/26 (53.8) |
Serious AEs | ||||||||
 Patients aged < 65 years | 17/356 (4.8) | 31/360 (8.6) | 33/345 (9.6) | 4/152 (2.6) | 6/150 (4.0) | 6/154 (3.9) | 7/144 (4.9) | 7/158 (4.4) |
 Patients aged ≥ 65 years | 4/41 (9.8) | 6/41 (14.6) | 12/51 (23.5) | 2/29 (6.9) | 0/31 (0.0) | 4/30 (13.3) | 11/40 (27.5) | 3/26 (11.5) |
AE leading to death | ||||||||
 Patients aged < 65 years | 2/356 (0.6) | 1/360 (0.3) | 1/345 (0.3) | 1/152 (0.7) | 0/150 (0.0) | 0/154 (0.0) | 1/144 (0.7) | 1/158 (0.6) |
 Patients aged ≥ 65 years | 0/41 (0.0) | 1/41 (2.4) | 0/51 (0.0) | 0/29 (0.0) | 0/31 (0.0) | 0/30 (0.0) | 0/40 (0.0) | 0/26 (0.0) |
AE leading to discontinuation | ||||||||
 Patients aged < 65 years | 17/356 (4.8) | 44/360 (12.2) | 42/345 (12.2) | 6/152 (3.9) | 11/150 (7.3) | 13/154 (8.4) | 10/144 (6.9) | 10/158 (6.3) |
 Patients aged ≥ 65 years | 5/41 (12.2) | 8/41 (19.5) | 12/51 (23.5) | 2/29 (6.9) | 3/31 (9.7) | 4/30 (13.3) | 4/40 (10.0) | 3/26 (11.5) |
Infections | ||||||||
 Patients aged < 65 years | 112/356 (31.5) | 149/360 (41.4) | 133/345 (38.6) | 43/152 (28.3) | 35/150 (23.3) | 45/154 (29.2) | 49/144 (34.0) | 54/158 (34.2) |
 Patients aged ≥ 65 years | 15/41 (36.6) | 19/41 (46.3) | 26/51 (51.0) | 5/29 (17.2) | 5/31 (16.1) | 11/30 (36.7) | 15/40 (37.5) | 4/26 (15.4) |
Serious infections | ||||||||
 Patients aged < 65 years | 9/356 (2.5) | 7/360 (1.9) | 13/345 (3.8) | 1/152 (0.7) | 1/150 (0.7) | 2/154 (1.3) | 2/144 (1.4) | 2/158 (1.3) |
 Patients aged ≥ 65 years | 1/41 (2.4) | 4/41 (9.8) | 2/51 (3.9) | 1/29 (3.4) | 0/31 (0.0) | 0/30 (0.0) | 1/40 (2.5) | 0/26 (0.0) |
Opportunistic infections | ||||||||
 Patients aged < 65 years | 2/356 (0.6) | 2/360 (0.6) | 3/345 (0.9) | 1/152 (0.7) | 0/150 (0.0) | 2/154 (1.3) | 0/144 (0.0) | 1/158 (0.6) |
 Patients aged ≥ 65 years | 0/41 (0.0) | 0/41 (0.0) | 1/51 (2.0) | 0/29 (0.0) | 0/31 (0.0) | 0/30 (0.0) | 1/40 (2.5) | 0/26 (0.0) |
Tuberculosis | ||||||||
 Patients aged < 65 years | 0/356 (0.0) | 0/360 (0.0) | 0/345 (0.0) | 0/152 (0.0) | 0/150 (0.0) | 0/154 (0.0) | 0/26 (0.0) | 1/158 (0.6) |
 Patients aged ≥ 65 years | 0/41 (0.0) | 0/41 (0.0) | 0/51 (0.0) | 0/29 (0.0) | 0/31 (0.0) | 0/30 (0.0) | 1/40 (2.5) | 0/26 (0.0) |
ANC < 1.5 × 109/L* | ||||||||
 Patients aged < 65 years | 5/356 (1.4) | 66/360 (18.3) | 81/345 (23.5) | 1/152 (0.7) | 24/150 (16.0) | 32/154 (20.8) | 31/144 (21.5) | 52/158 (32.9) |
 Patients aged ≥ 65 years | 1/41 (2.4) | 7/41 (17.1) | 12/51 (23.5) | 1/29 (3.4) | 7/31 (22.6) | 10/30 (33.3) | 9/40 (22.5) | 10/26 (38.5) |
ANC ≥ 0.5–1 × 109/L (grade 3) | ||||||||
 Patients aged < 65 years | 0 (0.0) | 16 (4.4) | 26 (7.5) | 0 (0.0) | 9 (6.0) | 11 (7.1) | 15 (10.4) | 23 (14.6) |
 Patients aged ≥ 65 years | 0 (0.0) | 3 (7.3) | 3 (5.9) | 1 (3.4) | 1 (3.2) | 5 (16.7) | 3 (7.5) | 4 (15.4) |
ANC < 0.5 × 109/L (grade 4) | ||||||||
 Patients aged < 65 years | 0 (0.0) | 4 (1.1) | 1 (0.3) | 0 (0.0) | 2 (1.3) | 1 (0.6) | 0 (0.0) | 0 (0.0) |
 Patients aged ≥ 65 years | 0 (0.0) | 0 (0.0) | 1 (2.0) | 0 (0.0) | 2 (6.5) | 1 (3.3) | 0 (0.0) | 3 (11.5) |
Platelets < 50 × 109/L | ||||||||
 Patients aged < 65 years | 0/356 (0.0) | 0/360 (0.0) | 2/345 (0.6) | 0/152 (0.0) | 0/150 (0.0) | 1/154 (0.6) | 0/144 (0.0) | 1/158 (0.6) |
 Patients aged ≥ 65 years | 0/41 (0.0) | 0/41 (0.0) | 0/51 (0.0) | 0/29 (0.0) | 0/31 (0.0) | 0/30 (0.0) | 0/40 (0.0) | 0/26 (0.0) |
ALT > 3 to ≤ 5× ULN | ||||||||
 Patients aged < 65 years | 7/356 (2.0) | 24/360 (6.7) | 24/345 (7.0) | 2/152 (1.3) | 4/150 (2.7) | 6/154 (3.9) | 8/144 (5.6) | 9/158 (5.7) |
 Patients aged ≥ 65 years | 1/41 (2.4) | 1/41 (2.4) | 0/51 (0.0) | 0/29 (0.0) | 0/31 (0.0) | 1/30 (3.3) | 1/40 (2.5) | 0/26 (0.0) |
ALT > 5 to ≤ 10× ULN | ||||||||
 Patients aged < 65 years | 1/356 (0.3) | 9/360 (2.5) | 9/345 (2.6) | 0/152 (0.0) | 0/150 (0.0) | 0/154 (0.0) | 2/144 (1.4) | 3/158 (1.9) |
 Patients aged ≥ 65 years | 0/41 (0.0) | 0/41 (0.0) | 0/51 (0.0) | 0/29 (0.0) | 0/31 (0.0) | 0/30 (0.0) | 0/40 (0.0) | 0/26 (0.0) |