Table 3

Serious TEAEs reported during the safety follow-up extension

n (%) [EAIR]Double-blind period: Weeks 0–52SFE: Weeks 52–156
CZP 200 mg Q2W
(n=159)
PY=144.4
Placebo
(n=158)
PY=93.3
All SFE patients
(N=243)
PY=459.8
Serious TEAE8 (5.0) [5.6]4 (2.5) [4.4]15 (6.2) [3.3]
 Glaucoma1 (0.6) [0.7]00
 Diarrhoea1 (0.6) [0.7]00
 Neuroborreliosis1 (0.6) [0.7]00
 Malignant melanoma1 (0.6) [0.7]00
 Ovarian cyst ruptured1 (0.6) [0.7]00
 Ovarian enlargement*1 (0.6) [0.7]00
 Pharyngeal oedema1 (0.6) [0.7]00
 Tooth extraction1 (0.6) [0.7]00
 Deep vein thrombosis1 (0.6) [0.7]00
 Sarcoidosis*01 (0.6) [1.1]0
 Malignant melanoma stage I01 (0.6) [1.1]0
 Uterine leiomyoma01 (0.6) [1.1]1 (0.4) [0.2]
 Abortion spontaneous01 (0.6) [1.1]0
 Uveitis002 (0.8) [0.4]
 Pancreatitis001 (0.4) [0.2]
 Gastrointestinal obstruction001 (0.4) [0.2]
 Inguinal hernia001 (0.4) [0.2]
 Cholelithiasis001 (0.4) [0.2]
 Encephalitis001 (0.4) [0.2]
 Gastroenteritis rotavirus001 (0.4) [0.2]
 Tuberculosis002 (0.8) [0.4]
 Chronic tonsillitis*001 (0.4) [0.2]
 Obesity001 (0.4) [0.2]
 Spinal pain001 (0.4) [0.2]
 Cervical polyp001 (0.4) [0.2]
 Erythema multiforme*001 (0.4) [0.2]
 Hypersensitivity vasculitis001 (0.4) [0.2]
 Cholecystectomy001 (0.4) [0.2]
 Hypertension001 (0.4) [0.2]
  • *Of the serious TEAEs reported during the study, those noted here were deemed to be related to CZP by the study investigators.

  • †Tuberculosis incidences were obtained from the ‘tuberculosis’ high level term and includes one incidence reported as pulmonary tuberculosis.

  • CZP, certolizumab pegol; EAIR, exposure-adjusted incidence rate per 100 patient years; Q2W, every 2 weeks; SFE, safety follow-up extension; TEAE, treatment-emergent adverse event.