Safety summary
| Event | SC abatacept+MTX (N=318) | Adalimumab+MTX (N=328) |
|---|---|---|
| Deaths | 1 (0.3) | 1 (0.3) |
| SAEs | 44 (13.8) | 54 (16.5) |
| Related SAEs | 11 (3.5) | 20 (6.1) |
| Discontinued due to SAEs | 5 (1.6) | 16 (4.9) |
| Infections and infestations | 12 (3.8) | 19 (5.8) |
| Pneumonia | 3 (0.9) | 4 (1.2) |
| Urinary tract infection | 3 (0.9) | 0 |
| Gastroenteritis | 1 (0.3) | 1 (0.3) |
| Helicobacter gastritis | 1 (0.3) | 0 |
| Oral candidiasis | 1 (0.3) | 0 |
| Peritonsillar abscess | 1 (0.3) | 0 |
| Pneumonia, mycoplasmal | 1 (0.3) | 0 |
| Soft tissue infection | 1 (0.3) | 0 |
| Arthritis, bacterial | 0 | 3 (0.9) |
| Diverticulitis | 0 | 2 (0.6) |
| Bronchitis | 0 | 1 (0.3) |
| Staphlyococcal bursitis | 0 | 1 (0.3) |
| Cellulitis | 0 | 1 (0.3) |
| Chest wall abscess | 0 | 1 (0.3) |
| Clostridial infection | 0 | 1 (0.3) |
| Groin abscess | 0 | 1 (0.3) |
| Disseminated histoplasmosis | 0 | 1 (0.3) |
| Meningitis | 0 | 1 (0.3) |
| Pulmonary tuberculosis | 0 | 1 (0,3) |
| Disseminated tuberculosis | 0 | 1 (0.3) |
| AEs | 295 (92.8) | 300 (91.5) |
| Related AEs | 132 (41.5) | 164 (50.0) |
| Discontinued due to AEs | 12 (3.8) | 31 (9.5) |
| Malignancies | 7 (2.2) | 7 (2.1) |
| Autoimmune events | 12 (3.8) | 6 (1.8) |
| Psoriasis | 3 (0.9) | 2 (0.6) |
| Erythema nodosum | 2 (0.6) | 1 (0.3) |
| Leucocytoclastic vasculitis | 1 (0.3) | 0 |
| Raynaud's phenomenon | 2 (0.6) | 1 (0.3) |
| Vasculitis | 2 (0.6) | 0 |
| Episcleritis | 1 (0.3) | 0 |
| Sjőgren's syndrome | 1 (0.3) | 1 (0.3) |
| Anti-dsDNA autoantibody | 0 | 1 (0.3) |
| Local injection site reactions* | 13 (4.1) | 34 (10.4) |
| Haematoma | 5 (1.6) | 3 (0.9) |
| Pruritis | 1 (0.3) | 10 (3.0) |
| Erythema | 3 (0.9) | 14 (4.3) |
| Rash | 2 (0.6) | 3 (0.9) |
| Haemorrhage | 2 (0.6) | 0 |
| Pain | 0 | 10 (3.0) |
| Reaction | 3 (0.9) | 4 (1.2) |
Data are patients with events, n (%).
*Most common local injection site reactions reported.
AE, adverse event; dsDNA, double stranded DNA; MTX, methotrexate; SAE, serious adverse event; SC, subcutaneous.