Safety and tolerability
| n (%) | 120 Q2W n=386 | 120 Q4W n=389 | Placebo n=387 |
|---|---|---|---|
| Deaths | 3 (0.8)* | 2 (0.5)† | 2 (0.5)‡ |
| Serious AEs | 43 (11.1) | 56 (14.4) | 50 (12.9) |
| Discontinued due to an AE | 26 (6.7) | 29 (7.5) | 28 (7.2) |
| Treatment-emergent AEs | 317 (82.1) | 320 (82.3) | 314 (81.1) |
| AEs possibly related to study drug | 175 (45.3) | 159 (40.9) | 161 (41.6) |
| Selected treatment-emergent AEs | |||
| Pregnancies | 3 (0.8) | 3 (0.8) | 4 (1.0) |
| Infections | |||
| Serious | 20 (5.2) | 19 (4.9) | 17 (4.4) |
| Severe | 10 (2.6) | 14 (3.6) | 15 (3.9) |
| Adjudicated MACE | 5 (1.3) | 4 (1.0) | 5 (1.3) |
| Malignancies | 1 (0.3)§ | 1 (0.3)¶ | 2 (0.5)** |
| Injection-site reactions | 11 (2.8) | 7 (1.8) | 6 (1.6) |
| Allergic/hypersensitivity reactions | |||
| Anaphylaxis | 0 | 0 | 0 |
| Non-anaphylaxis hypersensitivity | 5 (1.3) | 1 (0.3) | 2 (0.5) |
| Depression and suicide-related events | |||
| Depression | 12 (3.1) | 14 (3.6) | 13 (3.4) |
| Suicide attempt | 0 | 1 (0.3) | 1 (0.3) |
| Columbia-Suicide Severity Rating Scale†† | |||
| Suicidal ideation | 1 (0.4) | 3 (1.3) | 2 (0.9) |
| Suicidal behaviour | 0 | 1 (0.4) | 2 (0.9) |
| Change in QIDS-SR16 total score, mean±SD | −1.2± 4.09 | −1.4±4.37 | −1.4±4.58 |
| Immunogenicity | |||
| TE persistent or transient ADA | 2 (0.5) | 3 (0.8) | 12 (3.1) |
| Positive neutralising ADA | 0 | 0 | 0 |
Data are n (%) unless indicated otherwise.
*Antiphospholipid syndrome, pulmonary embolism, disseminated tuberculosis.
†Pneumonia, SLE.
‡Preferred term=death (verbatim reported by investigator was unknown cause of death), CVA.
§Basal cell carcinoma.
¶Squamous cell carcinoma of the skin.
**Breast cancer, intestinal adenocarcinoma.
††Number of patients with at least one post-baseline assessment.
ADA, antidrug antibody; AE, adverse event; CVA, cerebrovascular accident; MACE, major adverse cardiovascular event; Q2W, every two weeks; Q4W, every four weeks; QIDS-SR16, Quick Inventory of Depressive Symptomatology (16-Item); SLE, systemic lupus erythematosus; TE, treatment-emergent.