Table 3

Safety outcomes

IXE (n=283)ADA (n=283)
Treatment-emergent adverse events209 (73.9)194 (68.6)
 Mild95 (33.6)85 (30.0)
 Moderate105 (37.1)89 (31.4)
 Severe9 (3.2)20 (7.1)
Serious adverse events12 (4.2)35 (12.4)
Discontinuations due to adverse events12 (4.2)21 (7.4)
Adverse events of special interest
 Infections119 (42)111 (39.2)
  Serious infections5 (1.8)8 (2.8)
  Candida infections7 (2.5)3 (1.1)
 Injection site reactions30 (10.6)10 (3.5)
 Allergic/Hypersensitivity reactions11 (3.9)13 (4.6)
 Cerebrocardiovascular events*5 (1.8)7 (2.5)
 Malignancies04 (1.4)
 Depression5 (1.8)9 (3.2)
 IBD†2 (0.7)0
  Ulcerative colitis†‡1 (0.4)0
  Crohn’s disease†§1 (0.4)0
 Cytopenias9 (3.2)12 (4.2)
  • Values presented as n (%).

  • *Cerebrocardiovascular events are defined using terms from the following subcategories: cardiovascular death, MI, hospitalisation for unstable angina, hospitalisation for heart failure, hospitalisation for serious arrhythmia, hospitalisation for hypertension, resuscitated sudden, death, cardiogenic shock due to MI, coronary revascularisation procedure, neurologic stroke and peripheral vascular events.

  • †EPIMAD criteria for adjudication of suspected IBD define ‘probable’ and ‘definite’ classifications as confirmed cases. Only one case met the EPIMAD criteria of confirmed IBD.13

  • ‡The event was reported as colitis ulcerative and was adjudicated as possible ulcerative colitis, which did not meet the EPIMAD criteria as confirmed IBD.

  • §Event was reported as colitis and was adjudicated as probable Crohn’s disease and met the EPIMAD criteria as confirmed IBD.

  • ADA, adalimumab; EPIMAD, EPIdémiologie des Maladies de l’Appareil Digestif; IBD, inflammatory bowel disease; IXE, ixekizumab; MI, myocardial infarction.