Table 3 Summary of treatment-emergent AEs in the safety population and most common treatment-emergent AEs
Placebo-controlled period Sarilumab | Non-placebo-controlled period Sarilumab | ||||||
|---|---|---|---|---|---|---|---|
Placebo + MTX (n = 81) | 150 mg q2w + MTX (n = 81) | 200 mg q2w + MTX (n = 80) | Placebo + MTX to sarilumab 150 mg q2w + MTX (n = 14)a | Placebo + MTX to sarilumab 200 mg q2w + MTX (n = 15)a | 150 mg q2w + MTX (n = 81) | 200 mg q2w + MTX (n = 80) | |
AEs | 49 (60.5) | 65 (80.2) | 60 (75.0) | 12 (85.7) | 13 (86.7) | 76 (93.8) | 71 (88.8) |
Serious AEs | 6 (7.4) | 4 (4.9) | 4 (5.0) | 0 | 2 (13.3) | 8 (9.9) | 5 (6.3) |
AEs leading to permanent treatment discontinuation | 3 (3.7) | 6 (7.4) | 7 (8.8) | 1 (7.1) | 2 (13.3) | 11 (13.6) | 8 (10.0) |
AEs leading to death | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Most common AEs by system organ class | |||||||
Infections and infestations | 23 (28.4) | 36 (44.4) | 24 (30.0) | 9 (64.3) | 8 (53.3) | 55 (67.9) | 42 (52.5) |
Nasopharyngitis | 12 (14.8) | 16 (19.8) | 12 (15.0) | 5 (35.7) | 4 (26.7) | 27 (33.3) | 23 (28.8) |
Upper respiratory tract infection | 4 (4.9) | 6 (7.4) | 4 (5.0) | 0 | 0 | 8 (9.9) | 7 (8.8) |
Gastroenteritis | 1 (1.2) | 1 (1.2) | 3 (3.8) | 0 | 0 | 2 (2.5) | 6 (7.5) |
Cystitis | 1 (1.2) | 3 (3.7) | 1 (1.3) | 0 | 0 | 5 (6.2) | 1 (1.3) |
Blood and lymphatic system disorders | 0 | 11 (13.6) | 12 (15.0) | 2 (14.3) | 3 (20.0) | 15 (18.5) | 13 (16.3) |
Neutropenia | 0 | 7 (8.6) | 9 (11.3) | 2 (14.3) | 1 (6.7) | 10 (12.3) | 9 (11.3) |
Vascular disorders | 0 | 3 (3.7) | 4 (5.0) | 0 | 1 (6.7) | 5 (6.2) | 5 (6.3) |
Hypertension | 0 | 2 (2.5) | 4 (5.0) | 0 | 0 | 4 (4.9) | 5 (6.3) |
Gastrointestinal disorders | 11 (13.6) | 10 (12.3) | 20 (25.0) | 4 (28.6) | 4 (26.7) | 19 (23.5) | 25 (31.3) |
Stomatitis | 3 (3.7) | 5 (6.2) | 8 (10.0) | 2 (14.3) | 1 (6.7) | 6 (7.4) | 8 (10.0) |
Hepatobiliary disorders | 4 (4.9) | 9 (11.1) | 11 (13.8) | 1 (7.1) | 2 (13.3) | 11 (13.6) | 10 (12.5) |
Hepatic function abnormal | 4 (4.9) | 6 (7.4) | 8 (10.0) | 0 | 0 | 8 (9.9) | 7 (8.8) |
Skin and subcutaneous tissue disorders | 8 (9.9) | 15 (18.5) | 12 (15.0) | 1 (7.1) | 2 (13.3) | 25 (30.9) | 19 (23.8) |
Eczema | 1 (1.2) | 4 (4.9) | 3 (3.8) | 1 (7.1) | 0 | 7 (8.6) | 4 (5.0) |
General disorders and administration site conditions | 3 (3.7) | 11 (13.6) | 12 (15.0) | 1 (7.1) | 0 | 16 (19.8) | 15 (18.8) |
Injection site erythema | 0 | 7 (8.6) | 7 (8.8) | 1 (7.1) | 0 | 8 (9.9) | 7 (8.8) |
Injection site pruritus | 0 | 4 (4.9) | 4 (5.0) | 1 (7.1) | 0 | 5 (6.2) | 4 (5.0) |
Investigations | 6 (7.4) | 11 (13.6) | 12 (15.0) | 4 (28.6) | 0 | 14 (17.3) | 14 (17.5) |
ALT increased | 4 (4.9) | 5 (6.2) | 3 (3.8) | 3 (21.4) | 0 | 7 (8.6) | 4 (5.0) |