Table 2.
Treatment Emergent Adverse Events with Ixekizumab or Adalimumab Through 24 Weeks in People with Biologic-Naïve Psoriatic Arthritis (SPIRIT-H2H)7,31
| Safety Outcomes | 24 Weeks7 | 52 Weeks31 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Treatment | IXE* | ADA | p-value | IXE | ADA | p-value | ||||
| N=283 | N=283 | N=283 | N=283 | |||||||
| N, % | n | % | n | % | n | % | n | % | ||
| Any TEAEs | 197 | 69.6 | 173 | 61.1 | 0.04 | 209 | 73.9 | 194 | 68.6 | 0.19 |
| Serious AEs | 10 | 3.5 | 24 | 8.5 | 0.02 | 12 | 4.2 | 35 | 12.4 | <0.01 |
| Discontinuation due to AEs | 7 | 2.5 | 13 | 4.6 | 0.26 | 12 | 4.2 | 21 | 7.4 | 0.15 |
| Infections | 102 | 36.0 | 87 | 30.7 | 0.21 | 119 | 42.0 | 111 | 39.2 | 0.55 |
| Serious infections | 4 | 1.4 | 8 | 2.8 | 0.38 | 5 | 1.8 | 8 | 2.8 | 0.58 |
| Candida infections | 7 | 2.5 | 2 | 0.7 | 0.18 | 7 | 2.5 | 3 | 1.1 | 0.34 |
| Injection site reactions | 27 | 9.5 | 9 | 3.2 | <0.01 | 30 | 10.6 | 10 | 3.5 | <0.01 |
| Allergic/hypersensitivity reactions | 7 | 2.5 | 11 | 3.9 | 0.47 | 11 | 3.9 | 13 | 4.6 | 0.84 |
| Cerebrocardiovascular events | 3 | 1.1 | 5 | 1.8 | 0.73 | 5 | 1.8 | 7 | 2.5 | 0.77 |
| Malignancies | 0 | 0 | 3 | 1.1 | - | 0 | 0 | 4 | 1.4 | - |
| Depression | 3 | 1.1 | 7 | 2.5 | 0.34 | 5 | 1.8 | 9 | 3.2 | 0.42 |
| IBD | 2 | 0.7 | 0 | 0 | - | 2 | 0.7 | 0 | 0 | - |
| Crohn disease | 1 | 0.4 | 0 | 0 | - | 1 | 0.4 | 0 | 0 | - |
| Ulcerative colitis | 1 | 0.4 | 0 | 0 | - | 1 | 0.4 | 0 | 0 | - |
| Cytopenias | 5 | 1.8 | 11 | 3.9 | 0.20 | 9 | 3.2 | 12 | 4.2 | 0.66 |
Notes: All ixekizumab-treated participants received 160 mg loading dose upfront; 17% had moderate to severe psoriasis and received ixekizumab 80 mg every 2 weeks up to week 12 and ixekizumab 80 mg every 4 weeks thereafter; 83% without at least moderate psoriasis received ixekizumab 80 mg every 4 weeks after the initial loading dose (dosing regimens consistent with the label). Up to 24 weeks, there were no deaths, no occurrences of major cardiovascular adverse events, no inflammatory bowel disease, and no active or latent TB. P-values between adalimumab and ixekizumab were calculated using the two-sided Fisher exact test. Significant p-values (<0.05) are in bolded font.
Abbreviations: TEAEs, treatment emergent adverse events; NMSC, non-melanoma skin cancer; IXE, ixekizumab; IXEQ4W/IXEQ2W, ixekizumab 80 mg every 4 or every 2 weeks; ADA, adalimumab.