Table 3.
Frequency of adverse events in patients included in the placebo‐controlled data set (SPIRIT‐P1 and SPIRIT‐P2), according to treatment groupa
| Event type or category | Placebo (n = 224) | IXEQ4W (n = 229) | IXEQ2W (n = 225) | Total IXE (n = 454) |
|---|---|---|---|---|
| Patients with ≥1 TEAE | 127 (56.7) | 153 (66.8)b | 156 (69.3)b | 309 (68.1)b |
| Mildc | 60 (26.8) | 91 (39.7) | 81 (36.0) | 172 (37.9) |
| Moderatec | 63 (28.1) | 54 (23.6) | 61 (27.1) | 115 (25.3) |
| Severe | 4 (1.8) | 8 (3.5) | 14 (6.2)b | 22 (4.8) |
| Patients discontinuing study drug because of an AE | 8 (3.6) | 7 (3.1) | 12 (5.3) | 19 (4.2) |
| Patients with ≥1 SAE | 6 (2.7) | 9 (3.9) | 11 (4.9) | 20 (4.4) |
| Deaths | 0 | 0 | 0 | 0 |
| Patients with ≥1 most frequent TEAE (preferred term)d | ||||
| Injection site reaction | 1 (0.4) | 22 (9.6)b | 32 (14.2)b | 54 (11.9)b |
| Upper respiratory tract infection | 16 (7.1) | 16 (7.0) | 15 (6.7) | 31 (6.8) |
| Injection site erythema | 0 | 9 (3.9)b | 17 (7.6)b | 26 (5.7)b |
| Nasopharyngitis | 9 (4.0) | 15 (6.6) | 7 (3.1) | 22 (4.8) |
| Diarrhea | 6 (2.7) | 7 (3.1) | 10 (4.4) | 17 (3.7) |
| Headache | 4 (1.8) | 10 (4.4) | 6 (2.7) | 16 (3.5) |
| Sinusitis | 5 (2.2) | 9 (3.9) | 6 (2.7) | 15 (3.3) |
| Patients with ≥1 AE of special interest | ||||
| Hepatice | 10 (4.5) | 7 (3.1) | 11 (4.9) | 18 (4.0) |
| Infections | 62 (27.7) | 77 (33.6) | 72 (32.0) | 149 (32.8) |
| Serious infection | 0 | 1 (0.4) | 5 (2.2)b | 6 (1.3) |
| Candida infectionf | 1 (0.4) | 4 (1.7) | 8 (3.6)b | 12 (2.6) |
| Esophageal candidiasis | 0 | 0 | 1 (0.4) | 1 (0.2) |
| Active tuberculosis | 0 | 0 | 0 | 0 |
| Latent tuberculosisg | 0 | 0 | 0 | 0 |
| Injection site reactionsh | 10 (4.5) | 40 (17.5)b | 57 (25.3)i | 97 (21.4)b |
| Allergic reaction/hypersensitivity | 4 (1.8) | 10 (4.4) | 14 (6.2)b | 24 (5.3)b |
| Confirmed cerebrocardiovascular event | 2 (0.9) | 0 | 0 | 0b |
| Confirmed MACE event | 0 | 0 | 0 | 0 |
| Malignancy | 0 | 2 (0.9) | 0 | 2 (0.4) |
| Depression‐related | 3 (1.3) | 4 (1.7) | 4 (1.8) | 8 (1.8) |
| Inflammatory bowel disease (narrow and broad terms) j | 0 | 0 | 1 (0.4) | 1 (0.2) |
| Crohn's disease | 0 | 0 | 0 | 0 |
| Ulcerative colitis | 0 | 0 | 0 | 0 |
Values are the number (%). TEAE = treatment‐emergent adverse event (AE); SAE = serious AE; MACE = major adverse cardiovascular event (see Table 1 for other abbreviations).
P ≤ 0.05 vs. placebo, by Cochran‐Mantel‐Haenszel test.
Comparisons between treatment and placebo were not performed.
AEs are listed according to the preferred terms (PTs) in Medical Dictionary for Regulatory Activities (MedDRA). Shown are AEs occurring in ≥3% of patients in the combined (total) ixekizumab group.
Potentially drug‐related hepatic disorders using the MedDRA PTs contained any of the following MedDRA Queries: broad and narrow terms in the liver‐related investigations, signs and symptoms; broad and narrow terms in the cholestasis and jaundice of hepatic origin; broad and narrow terms in the hepatitis, non‐infectious; broad and narrow terms in the hepatic failure, fibrosis, cirrhosis, and other liver damage; narrow terms in the liver‐related coagulation and bleeding disturbances.
Patients with ≥1 TEAE of Candida infections (high‐level plus clinical terms). The esophageal candidiasis case was an SAE.
Two ixekizumab‐treated patients had positive results of an interferon‐γ (IFNγ) release assay. At screening, these patients had negative results using a purified protein derivative test, which later appeared to be poorly documented; this prompted the study site to perform an IFNγ release assay, which appeared to be positive (in the absence of any baseline IFNγ release assay).
Composite of several injection site reaction–related terms.
P ≤ 0.05, IXE vs. placebo and IXEQ2W vs. IXEQ4W, by Cochran‐Mantel‐Haenszel test.
Composite of inflammatory bowel disease (IBD; narrow terms) and events that can occur with IBD (broad terms).