Table 2.
Overall safety profile (up to Week 52)
|
SEC LD, N = 40 n (%) |
SEC HD, N = 40 n (%) |
ETN, N = 41 n (%) |
Any SEC LD, N = 56 n (%) |
Any SEC HD, N = 58 n (%) |
Any SEC dose, N = 114 n (%) |
|
|---|---|---|---|---|---|---|
| Patients with AEs | 34 (85.0) | 34 (85.0) | 34 (82.9) | 45 (80.4) | 47 (81.0) | 92 (80.7) |
| Patients with serious or other significant events | ||||||
| Death | 0 | 0 | 0 | 0 | 0 | 0 |
| Non‐fatal SAEs | 3 (7.5) | 4 (10.0) | 5 (12.2) | 5 (8.9) | 5 (8.6) | 10 (8.8) |
| Discontinued study treatment due to any AEs | 1 (2.5) | 1 (2.5) | 1 (2.4) | 2 (3.6) | 1 (1.7) | 3 (2.6) |
| Most frequent AEs (by SOC) | ||||||
| Infections and infestations | 30 (75.0) | 27 (67.5) | 27 (65.9) | 39 (69.6) | 36 (62.1) | 75 (65.8) |
| Gastrointestinal disorders | 12 (30.0) | 13 (32.5) | 14 (34.1) | 14 (25.0) | 17 (29.3) | 31 (27.2) |
| Skin and subcutaneous tissue disorders | 12 (30.0) | 12 (30.0) | 10 (24.4) | 14 (25.0) | 17 (29.3) | 31 (27.2) |
| Most frequent AEs (by PT) | ||||||
| Nasopharyngitis | 12 (30.0) | 16 (40.0) | 11 (26.8) | 14 (25.0) | 20 (34.5) | 34 (29.8) |
| Headache | 5 (12.5) | 6 (15.0) | 4 (9.8) | 8 (14.3) | 9 (15.5) | 17 (14.9) |
| Pharyngitis | 4 (10.0) | 4 (10.0) | 3 (7.3) | 6 (10.7) | 6 (10.3) | 12 (10.5) |
| Rhinitis | 2 (5.0) | 3 (7.5) | 1 (2.4) | 3 (5.4) | 6 (10.3) | 9 (7.9) |
| AEs of interest | ||||||
| Hypersensitivity (SMQ) (narrow) | 3 (7.5) | 9 (22.5) | 5 (12.2) | 4 (7.1) | 11 (19.0) | 15 (13.2) |
| Neutropenia (NMQ) | 2 (5.0) | 1 (2.5) | 1 (2.4) | 2 (3.6) | 1 (1.7) | 3 (2.6) |
| Neutropenia (PT) | 2 (5.0) | 1 (2.5) | 1 (2.4) | 2 (3.6) | 1 (1.7) | 3 (2.6) |
| Candida infections | 1 (2.5) | 1 (2.5) | 0 | 1 (1.8) | 1 (1.7) | 2 (1.8) |
| Nail candida (PT) | 0 | 1 (2.5) | 0 | 0 | 1 (1.7) | 1 (0.9) |
| Vulvovaginal candidiasis (PT) | 1 (2.5) | 0 | 0 | 1 (1.8) | 0 | 1 (0.9) |
| Hepatitis viral infections (HLT) | 0 | 0 | 0 | 0 | 0 | 0 |
| Inflammatory bowel disease (NMQ) | 0 | 0 | 0 | 0 | 0 | 0 |
| Vaccination related complications (HLT) | 0 | 0 | 0 | 0 | 0 | 0 |
| MACE (NMQ) | 0 | 0 | 0 | 0 | 0 | 0 |
| Malignant or unspecified tumours (SMQ) | 0 | 0 | 0 | 0 | 0 | 0 |
| Suicide/self‐injury (SMQ) | 1 (2.5) | 0 | 0 | 1 (1.8) | 0 | 1 (0.9) |
| Suicidal ideation (PT) | 1 (2.5) | 0 | 0 | 1 (1.8) | 0 | 1 (0.9) |
| Injection site reactions † | 3 (7.5) | 4 (10.0) | 4 (9.8) | 3 (5.4) | 4 (6.9) | 7 (6.1) |
AE, adverse event; ETN, etanercept; HD, high dose; HLT, high level term; LD, low dose; NMQ, Novartis customized MedDRA Query; PT, preferred term; SAE, serious adverse event; SEC, secukinumab; SMQ, Standardised MedDRA Query; SOC, system organ class; ‘Any secukinumab’ for both the treatment groups (LD and HD) includes all patients treated with secukinumab from the start of the study and also those who switched from placebo treatment to secukinumab at Week 12.
Injection site reactions corresponding to event coded with HLT ‘Injection site reaction’ and some with HLT ‘Administration site reaction’ or ‘Application and instillation site reactions’.