Table 2.
Safety summary (SAEs and ESIs) over a 5-year follow-up period in the overall population
| System organ class MedDRA preferred term | Patients, n (N = 569) | Incidence rate a | 95% CI |
|---|---|---|---|
| Patients with ≥1 SAE, n (%) | 67 (11.8) | 5.52 | 4.27, 7.01 |
| Patients with ≥1 treatment-related SAE, n (%) | 16 (2.8) | 1.32 | 0.75, 2.14 |
| Blood and lymphatic system disorders | 1 | 0.08 | 0.00, 0.46 |
| Neutropenia | 1 | 0.08 | 0.00, 0.46 |
| Immune system disorders | 1 | 0.08 | 0.00, 0.46 |
| Anaphylactic shock | 1 | 0.08 | 0.00, 0.46 |
| Infections and infestations | 2 | 0.16 | 0.02, 0.59 |
| Respiratory tract infection | 1 | 0.08 | 0.00, 0.46 |
| Sinusitis | 1 | 0.08 | 0.00, 0.46 |
| Injury, poisoning, and procedural complications | 5 | 0.41 | 0.13, 0.96 |
| Cartilage injury | 1 | 0.08 | 0.00, 0.46 |
| Infusion-related reaction | 3 | 0.25 | 0.05, 0.72 |
| Ligament injury | 1 | 0.08 | 0.00, 0.46 |
| Musculoskeletal and CTDs | 1 | 0.08 | 0.00, 0.46 |
| Arthralgia | 1 | 0.08 | 0.00, 0.46 |
| Neoplasms benign, malignant, and unspecified (including cysts and polyps) | 1 | 0.08 | 0.00, 0.46 |
| Medulloblastoma | 1 | 0.08 | 0.00, 0.46 |
| Nervous system disorders | 3 | 0.25 | 0.05, 0.72 |
| Demyelination | 1 | 0.08 | 0.00, 0.46 |
| Migraine | 1 | 0.08 | 0.00, 0.46 |
| Optic neuritis | 1 | 0.08 | 0.00, 0.46 |
| Seizure | 1 | 0.08 | 0.00, 0.46 |
| Reproductive system and breast disorders | 1 | 0.08 | 0.00, 0.46 |
| Perineal ulceration | 1 | 0.08 | 0.00, 0.46 |
| Skin and s.c. tissue disorders | 1 | 0.08 | 0.00, 0.46 |
| Psoriasis | 1 | 0.08 | 0.00,0.46 |
| Patients with ≥1 SAE causing permanent discontinuation, n (%) | 9 (1.6) | 0.74 | 0.34, 1.41 |
| Gastrointestinal disorders | 1 | 0.08 | 0.00, 0.46 |
| IBD | 1 | 0.08 | 0.00, 0.46 |
| General disorders and administration-site conditions | 1 | 0.08 | 0.00, 0.46 |
| Malaise | 1 | 0.08 | 0.00, 0.46 |
| Immune system disorders | 1 | 0.08 | 0.00, 0.46 |
| Anaphylactic shock | 1 | 0.08 | 0.00, 0.46 |
| Infections and infestations | 2 | 0.16 | 0.02, 0.59 |
| Respiratory tract infection | 1 | 0.08 | 0.00, 0.46 |
| Sinusitis | 1 | 0.08 | 0.00, 0.46 |
| Injury, poisoning, and procedural complications | 2 | 0.16 | 0.02, 0.59 |
| Infusion-related reaction | 2 | 0.16 | 0.02, 0.59 |
| Neoplasms benign, malignant, and unspecified (including cysts and polyps) | 1 | 0.08 | 0.00, 0.46 |
| Medulloblastoma | 1 | 0.08 | 0.00, 0.46 |
| Skin and s.c. tissue disorders | 1 | 0.08 | 0.00, 0.46 |
| Psoriasis | 1 | 0.08 | 0.00, 0.46 |
| Patients with SAE resulting in death b , n (%) | 1 (0.2) | 0.08 | 0.00, 0.46 |
| Patients with at least 1 ESI, n (%) | 44 (7.7) | 3.62 | 2.63, 4.86 |
| Serious/targeted infections | 18 | 1.48 | 0.88, 2.34 |
| Skin and s.c. tissue disorders | 8 | 0.66 | 0.28, 1.30 |
| Eye disorders | 3 | 0.25 | 0.05, 0.72 |
| Infusion-related reaction | 2 | 0.16 | 0.02, 0.59 |
| Demyelination | 1 | 0.08 | 0.00, 0.46 |
| IBD | 1 | 0.08 | 0.00, 0.46 |
| Investigations | 1 | 0.08 | 0.00, 0.46 |
| Neoplasm (medulloblastoma) | 1 | 0.08 | 0.00, 0.46 |
| Neoplasm (ovarian adenoma) | 1 | 0.08 | 0.00, 0.46 |
| Neutropenia | 1 | 0.08 | 0.00, 0.46 |
| Optic neuritis | 1 | 0.08 | 0.00, 0.46 |
| Other autoimmune diseasesc | 8 | 0.66 | 0.28, 1.30 |
| Eye disorders | 6 | 0.49 | 0.18, 1.08 |
| Musculoskeletal and CTDs | 1 | 0.08 | 0.00, 0.46 |
| Skin and s.c. tissue disorders | 1 | 0.08 | 0.00, 0.46 |
Patients with >1 SAE in a category are counted only once in each preferred term category, and only once in each system organ class category.
a
Incidence rate reported per 100 person-years of follow-up. MedDRA was used to code SAEs.
b
Due to a cardiovascular event related to pre-existing disease and assessed as unrelated to abatacept treatment.
c
Repetition of some SAEs as other autoimmune diseases occurred as a result of clinician data input.
ESI: event of special interest; MedDRA: Medical Dictionary for Regulatory Activities; SAE: serious adverse event.