Table 2

Summary of all-causality TEAEs and prespecified TEAEs of special interest (safety population)

Patients with all-causality TEAEsADL-PF/ADL-PF
(n=283)
ADL-EU/ADL-EU
(n=135)
ADL-EU/ADL-PF
(n=133)
Number of TEAEs243112100
Patients with ≥1 TEAE, n (%)123 (43.5)60 (44.4)51 (38.3)
Patients with SAEs, n (%)4 (1.4)6 (4.4)3 (2.3)
Patients with TEAEs leading to treatment discontinuation, n (%)6 (2.1)8 (5.9)2 (1.5)
Patients with TEAEs leading to study discontinuation, n (%)5 (1.8)8 (5.9)1 (0.8)
Patients with TEAEs grade ≥3, n (%)7 (2.5)7 (5.2)4 (3.0)
Deaths, n000
Patients with all-causality TEAEs of special interest
Category and PT, n (%)
 Infections and infestations49 (17.3)23 (17.0)28 (21.1)
 Blood and lymphatic system disorders12 (4.2)9 (6.7)4 (3.0)
 Hypersensitivity10 (3.5)6 (4.4)5 (3.8)
 Cardiac disorders9 (3.2)4 (3.0)3 (2.3)
 Other9 (3.2)3 (2.2)2 (1.5)
 Gastric/hepatic events8 (2.8)6 (4.4)4 (3.0)
 Neoplasms4 (1.4)*1 (0.7) 0
 Opportunistic infections 3 (1.1)4 (3.0)1 (0.8)
  Latent TB2 (0.7)2 (1.5)1 (0.8)
  Herpes zoster1 (0.4)00
  Bronchopulmonary aspergillosis01 (0.7)0
  Gastroenteritis salmonella01 (0.7)0
 Injection-site reaction1 (0.4)01 (0.8)
 Anaphylaxis/angioedema/urticaria000
 Demyelinating conditions000
  • *A total of seven events of neoplasms were reported in four patients in the ADL-PF/ADL-PF group, including one event each of seborrheic keratosis, kidney angiomyolipoma and melanocytic nevus, and two events each of basal cell carcinoma and squamous cell carcinoma. None of the events were considered to be serious.

  • †A total of one event of neoplasms (non-Hodgkin diffuse large B-cell lymphoma) was reported in one patient in the ADL-EU/ADL-EU group. The event of lymphoma was considered to be serious.

  • ‡Opportunistic infections were predefined in the study as including latent TB.

  • ADL-EU, reference adalimumab sourced from the European Union; ADL-PF, PF-06410293; PT, preferred term; SAE, serious adverse event; TB, tuberculosis; TEAE, treatment-emergent adverse event.