Table 4

Selected adverse events of interest

Integrated IXE PsA
N=1401
n (%)EAIR95% CI
Injection site reactions (broad term)260 (18.6)11.610.2 to 13.1
 Mild207 (14.8)9.28.0 to 10.6
 Moderate48 (3.4)2.11.6 to 2.8
 Severe5 (0.4)0.20.1 to 0.5
Allergic reactions/hypersensitivity102 (7.3)4.53.7 to 5.5
Malignancies15 (1.1)0.70.4 to 1.1
 NMSC9 (0.6)0.40.2 to 0.8
 Malignancies excluding NMSC7 (0.5)0.30.1 to 0.7
Inflammatory bowel disease*3 (0.2)0.10.0 to 0.4
 Crohn’s disease2 (0.1)0.10.0 to 0.4
 Ulcerative colitis1 (0.1)0.00.0 to 0.3
Depression†37 (2.6)1.61.2 to 2.3
Suicidal behaviour/self-injury1 (0.1)0.00.0 to 0.3
MACE‡12 (0.9)0.50.3 to 0.9
Cytopaenia§56 (4.0)2.51.9 to 3.2
Asthma10 (0.7)0.40.2 to 0.8
Uveitis0 (0.0)0.00.0 to 0.4
  • *Data represent cases classified as ‘definite’ and ‘probable’ per external adjudication. EAIR was calculated as the total of ‘definite’ and ‘probable’ cases/total patient-years, then multiplied by 100. One patient had reported event of anal abscess and anal fistula and this event was considered consistent with inflammatory bowel disease but was not adjudicated as Crohn’s disease or ulcerative colitis due to insufficient information. Three patients had events of inflammatory bowel disease confirmed by adjudication. One patient had more than one event.

  • †Broad, according to SMQ or sub-SMQ classification.

  • ‡Data represent adjudicated cases.

  • §Broad, according to SMQ classification.

  • EAIR, exposure-adjusted incidence rate per 100 patient-years; IXE, ixekizumab; MACE, major adverse cerebro-cardiovascular event; n, number of patients in each category; N, number of patients in the analysis population; NMSC, non-melanoma skin cancer; PsA, psoriatic arthritis; SMQ, Standardised MedDRA Queries.