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Table 2 Summary of most commonly reported adverse events (incidence rates per 100 PY)

From: Safety results of ixekizumab with 1822.2 patient-years of exposure: an integrated analysis of 3 clinical trials in adult patients with psoriatic arthritis

Event typeDouble-blind period
(weeks 0–24)
All-IXE treatment periods (N = 1822.2)
IR (95% CI)
Placebo
N = 224
n (IR)
IXE80Q4W
(N = 229)
n (IR)
IXE80Q2W
(N = 225)
n (IR)
Patients with ≥ 1 TEAE127 (148.2)153 (155.6)156 (163.4)50.0 (46.9, 53.4)
 Milda60 (70.0)91 (92.6)81 (84.8)20.4 (18.4, 22.5)
 Moderatea63 (73.5)54 (54.9)61 (63.9)24.3 (22.1, 26.6)
 Severea4 (4.7)8 (8.1)14 (14.7)5.4 (4.5, 6.6)
Patients discontinuing from study drug due to AEs8 (9.3)7 (7.1)12 (12.6)5.3 (4.3, 6.4)
Patients with ≥ 1 SAEs6 (7.0)9 (9.2)11 (11.5)6.4 (5.3, 7.6)
Deaths0 (0)0 (0)0 (0)0.3 (0.1, 0.7)
Patients with ≥ 1 most frequent TEAEs (preferred term)
 Upper respiratory tract infection16 (18.7)16 (16.3)15 (15.7)8.8 (7.6, 10.3)
 Nasopharyngitis9 (10.5)15 (15.3)7 (7.3)8.2 (7.0, 9.7)
 Injection-site reaction1 (1.2)22 (22.4)32 (33.5)7.8 (6.6, 9.2)
 Bronchitis7 (8.2)4 (4.1)7 (7.3)4.4 (3.6, 5.5)
 Sinusitis5 (5.8)9 (9.2)6 (6.3)3.7 (2.9, 4.7)
 Urinary tract infection5 (5.8)8 (8.1)4 (4.2)3.2 (2.5, 4.1)
 Injection-site erythema0 (0.0)9 (9.2)17 (17.8)2.9 (2.2, 3.7)
Patients with ≥ 1 AESIs
 Cytopenias2 (2.3)2 (2.0)4 (4.2)2.5 (1.9, 3.4)
 Hepatic10 (11.7)7 (7.1)11 (11.5)4.9 (4.0, 6.0)
 Infection62 (72.3)77 (78.3)72 (75.4)34.2 (31.6, 37.0)
 Serious infections0 (0)1 (1.0)5 (5.2)1.3 (0.8, 1.9)
 Candida infections1 (1.2)4 (4.1)8 (8.4)2.1 (1.6, 2.9)
 Esophageal candidiasis0 (0)0 (0)1 (1.0)0.1 (0.0, 0.4)
 Active tuberculosis0 (0)0 (0)0 (0)0 (0.0, 0.0)
 Latent tuberculosis0 (0)0 (0)0 (0)0.7 (0.4, 1.2)
 Injection-site reactions10 (11.7)40 (40.7)57 (59.7)12.7 (11.2, 14.5)
 Allergic reactions/hypersensitivities4 (4.7)10 (10.2)14 (14.7)4.8 (3.9, 6.0)
 Confirmed cerebro-cardiovascular events2 (2.3)0 (0)0 (0)1.2 (0.8, 1.8)
 Confirmed MACE events0 (0)0 (0)0 (0)0.6 (0.3, 1.1)
 Malignancies0 (0)2 (2.0)0 (0)0.7 (0.4, 1.2)
 Depression3 (3.5)4 (4.1)4 (4.2)1.6 (1.2, 2.4)
 Adjudicated inflammatory bowel disease (narrow and broad terms)0 (0)0 (0)0 (0)0.1 (0.0, 0.4)b
 Adjudicated Crohn’s disease0 (0)0 (0)0 (0)0.1 (0.0, 0.4)
 Adjudicated ulcerative colitis0 (0)0 (0)0 (0)0.1 (0.0, 0.4)
  1. All-IXE treatment period defined as all patients who received ≥ 1 dose of IXE
  2. aPatients with multiple occurrences of the same event are counted under the highest severity
  3. AEs are listed according to the preferred term in MedDRA, and AEs occurred in ≥ 3.0% of the patients in the combined (total) ixekizumab group
  4. bThe data presented is for All-IXE treatment period
  5. AEs adverse events, AESIs adverse events of special interest, CI confidence interval, IR incidence rate, IXE ixekizumab, MACE major adverse cardiac events, MedDRA Medical Dictionary for Regulatory Activities, N population size, n number in group, PsA psoriatic arthritis, PY patient-years, Q2W every 2 weeks, Q4W every 4 weeks, SAE serious adverse event, TEAE treatment-emergent adverse event