Table 2

Summary of safety

Integrated IXE PsA
N=1401
Total patient-years of exposure2247.7
Mean exposure (days)586.4
Median exposure (days)504.5
Range of exposure (days), min–max8–1219
n (%) EAIR 95% CI
Death6 (0.4)0.30.1 to 0.6
AE leading to discontinuation (including death)115 (8.2)5.14.3 to 6.1
SAE*134 (9.6)6.05.0 to 7.1
 Injection site reactions (broad term)1 (0.1)0.00.0 to 0.3
 Allergic reactions/hypersensitivities2 (0.1)0.10.0 to 0.4
 Malignancies7 (0.5)0.30.1 to 0.7
  NMSC00.00.0 to 0.4
  Malignancies excluding NMSC7 (0.5)0.30.1 to 0.7
 Inflammatory bowel disease†2 (0.1)0.10.0 to 0.4
 Depression‡1 (0.1)0.00.0 to 0.3
 Suicidal behaviour/self-injury00.00.0 to 0.4
 MACE†12 (0.9)0.50.3 to 0.9
 Cytopaenia§00.00.0 to 0.4
TEAE¶1131 (80.7)50.347.5 to 53.3
 Mild461 (32.9)20.518.7 to 22.5
 Moderate556 (39.7)24.722.8 to 26.9
 Severe114 (8.1)5.14.2 to 6.1
Most common TEAEs**
 Nasopharyngitis202 (14.4)9.07.8 to 10.3
 Upper respiratory tract infection186 (13.3)8.37.2 to 9.6
 Injection site reaction††156 (11.1)6.95.9 to 8.1
 Bronchitis91 (6.5)4.03.3 to 5.0
 Sinusitis77 (5.5)3.42.7 to 4.3
  • *Data collection for the clinical trial database does not specify when events became serious and therefore the numbers shown may represent more serious events than what actually occurred during the treatment period.

  • †Data represent adjudicated cases.

  • ‡Broad, according to Standardised MedDRA Queries (SMQ) or sub-SMQ classification.

  • §Broad, according to SMQ classification.

  • ¶Patients with multiple occurrences of the same event are counted under the highest severity.

  • **Defined as frequency of TEAE ≥5%.

  • ††Narrow term.

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