Table 3

Safety and tolerability

n (%)120 Q2W
n=371
120 Q4W
n=374
Placebo
n=376
Deaths1 (0.3)*2 (0.5)†3 (0.8)‡
Serious AEs46 (12.4)60 (16.0)71 (18.9)
Discontinued due to an AE20 (5.4)18 (4.8)27 (7.2)
TEAEs305 (82.2)308 (82.4)303 (80.6)
AEs possibly related to study drug153 (41.2)152 (40.6)136 (36.2)
Selected TEAEs
 Pregnancies3 (0.8)2 (0.5)4 (1.1)
 Infections213 (57.4)216 (57.8)212 (56.4)
  Serious16 (4.3)22 (5.9)25 (6.6)
  Severe14 (3.8)16 (4.3)19 (5.1)
 Adjudicated MACE1 (0.3)5 (1.3)6 (1.6)
 Malignancies04 (1.1)§2 (0.5)¶
 Injection-site reactions35 (9.4)28 (7.5)19 (5.1)
 Allergic/hypersensitivity reactions
  Anaphylaxis000
  Non-anaphylaxis hypersensitivity9 (2.4)**11 (2.9)††4 (1.1)‡‡
Depression and suicide-related events
 Depression15 (4.0)17 (4.5)3 (0.8)
 Suicide attempts1 (0.3)2 (0.5)0
 C-SSRS§§
  Suicidal ideation7 (3.0)¶¶12 (5.3)¶¶1 (0.4)
  Suicidal behaviour2 (0.9)3 (1.3)1 (0.4)
 Change in QIDS-SR16 Total score, mean±SD−1.7±4.8−1.2±±4.2−1.0±±4.5
Immunogenicity
 TE persistent or transient ADA3 (0.8)4 (1.1)7 (1.0)
 Positive neutralising ADA001 (14.3)
  • Data are n (%) unless indicated otherwise.

  • *Traffic accident.

  • †Septic shock, metastatic squamous cell carcinoma of the vagina.

  • ‡Brain oedema, cardiopulmonary failure, cardiac failure.

  • §Lung adenocarcinoma, mycosis fungoides, papillary thyroid cancer, squamous cell carcinoma of the vagina.

  • ¶Basal cell carcinoma, breast cancer.

  • **Allergic dermatitis (2), severe allergic dermatitis (1), rash (2), injection-site rash (1), dermatitis psoriasiform (1), hypersensitivity (1), injection-site hypersensitivity (1).

  • ††Allergic dermatitis (2), rash (2), drug hypersensitivity (3), injection-site rash (1), angioedema (1), macular rash (1), urticarial (1).

  • ‡‡Swelling face (1), lip oedema (1), rash (1), allergic dermatitis (1).

  • §§Number of patients with at least one post-baseline assessment.

  • ¶¶p<0.05, p value calculated using Fisher’s exact to test for a difference between each tabalumab group and placebo.

  • ADA, anti-drug antibody; AE, adverse event; C-SSRS, Columbia-Suicide Severity Rating Scale; MACE, major adverse cardiovascular events; Q2W, every 2 weeks; Q4W, every 4 weeks; QIDS-SR16, Quick Inventory of Depressive Symptomatology (16-Item); TE, treatment-emergent; TEAE, treatment-emergent adverse event.