Table 4 Safety of abatacept administered in combination with MTX or pooled data for other non-MTX csDMARDs in the ATTAIN, ASSURE, and ARRIVE studies
ATTAIN | ASSURE | ARRIVE | ||||
|---|---|---|---|---|---|---|
ABA + MTX (n = 175) | ABA + all non-MTX csDMARDs (n = 42) | ABA + MTX (n = 535) | ABA + all non-MTX csDMARDs (n = 143) | ABA + MTX (n = 490) | ABA + all non-MTX csDMARDs (n = 176) | |
Deaths | 0 | 1 (2.4) | 3 (0.6) | 1 (0.7) | 1 (0.2) | 0 |
SAEs | 16 (9.1) | 5 (11.9) | 54 (10.1) | 24 (16.8) | 45 (9.2) | 13 (7.4) |
Related SAEs | 4 (2.3) | 1 (2.4) | 9 (1.7) | 6 (4.2) | 14 (2.9) | 1 (0.6) |
Discontinuations due to SAEs | 3 (1.7) | 4 (9.5) | 12 (2.2) | 4 (2.8) | 7 (1.4) | 1 (0.6) |
AEs | 139 (79.4) | 30 (71.4) | 480 (89.7) | 127 (88.8) | 383 (78.2) | 131 (74.4) |
Related AEs | 73 (41.7) | 15 (35.7) | 299 (55.9) | 83 (58.0) | 217 (44.3) | 67 (38.1) |
Discontinuations due to AEs | 5 (2.9) | 4 (9.5) | 28 (5.2) | 8 (5.6) | 20 (4.1) | 7 (4.0) |
AEs of interest (system organ class) | ||||||
Infections and infestations | 67 (38.3) | 17 (40.5) | 292 (54.6) | 90 (62.9) | 203 (41.4) | 63 (35.8) |
Skin and subcutaneous tissue disorders | 27 (15.4) | 7 (16.7) | 133 (24.9) | 37 (25.9) | 61 (12.4) | 24 (13.6) |
Eye disorders | 8 (4.6) | 2 (4.8) | 45 (8.4) | 22 (15.4) | 24 (4.9) | 6 (3.4) |
Cardiac disorders | 7 (4.0) | 5 (11.9) | 28 (5.2) | 11 (7.7) | 16 (3.3) | 5 (2.8) |
Blood and lymphatic system disorders | 2 (1.1) | 3 (7.1) | 28 (5.2) | 10 (7.0) | 10 (2.0) | 3 (1.7) |
Immune system disorders | 2 (1.1) | 1 (2.4) | 13 (2.4) | 5 (3.5) | 7 (1.4) | 4 (2.3) |
Neoplasms (benign, malignant and unspecified) | 3 (1.7) | 2 (4.8) | 20 (3.7) | 3 (2.1) | 6 (1.2) | 2 (1.1) |