Incidence of AEs during OL-LI period and DB randomised period
| AE, n (%) | OL-LI treated population (n=146) | DB population | Rescue population (n=39) | |
| Taper arm (n=102) | Withdrawal arm (n=20) | |||
| Any AE | 36 (25) | 62 (61) | 12 (60) | 24 (62) |
| Serious AE* | 4 (3) | 1 (1) | 0 | 3 (8) |
| Any AE leading to discontinuation† | 1 (1) | 2 (2) | 0 | 0 |
| Any AE related to study drug | 11 (8) | 26 (25) | 5 (25) | 9 (23) |
| Any serious AE related to study drug* | 0 | 1 (1) | 0 | 1 (3) |
| Infection | 11 (8) | 34 (33) | 8 (40) | 15 (38) |
| Serious infection | 1 (1)‡ | 0 | 0 | 0 |
| Opportunistic infections§ | 0 | 0 | 0 | 0 |
| Tuberculosis | 0 | 0 | 0 | 0 |
| Malignancy¶ | 0 | 1 (1)** | 0 | 0 |
| NMSC | 0 | 0 | 0 | 0 |
| Lymphoma | 0 | 0 | 0 | 0 |
| Demyelinating disorder | 0 | 0 | 0 | 0 |
| Death | 0 | 0 | 0 | 0 |
In the OL-LI population, a treatment-emergent AE was defined as any AE with an onset date on or after the first dose of study drug and before the first DB dose or up to 70 days after the last dose if the patient discontinued prematurely.
In the DB population, a treatment-emergent AE was defined as any AE with an onset date on or after the first DB dose and before the open-label rescue period or up to 70 days after the last dose of study drug if the patient discontinued prematurely from the DB period.
In the rescue population, a treatment-emergent AE was defined as any AE with an onset date on or after the first dose of open-label rescue adalimumab and up to 70 days after the last dose of study drug.
*Serious AEs (and serious AEs possibly related to study drug as assessed by the investigator) included atrial fibrillation, pneumonia, comminuted fracture and transient ischaemic attack (OL-LI treated population), breast cancer (possibly related) (DB taper arm), and retinal vein occlusion, osteoarthritis and pleural effusion (possibly related) (rescue population).
†AEs leading to discontinuation included herpes zoster (OL-LI treated population) and breast cancer and cough (DB taper arm).
‡Pneumonia.
§Excluding oral candidiasis and tuberculosis.
¶Other than lymphoma, hepatosplenic T-cell lymphoma, leukaemia, NMSC or melanoma.
**Breast cancer.
AE, adverse event; DB, double-blind; NMSC, non-melanoma skin cancer; OL-LI, open-label lead-in.