Summary of infections
| | Integrated IXE PsA N=1401 | ||
| n (%) | EAIR | 95% CI | |
| Infections | 759 (54.2) | 33.8 | 31.4 to 36.3 |
| Mild | 415 (29.6) | 18.5 | 16.8 to 20.3 |
| Moderate | 326 (23.3) | 14.5 | 13.0 to 16.2 |
| Severe | 18 (1.3) | 0.8 | 0.5 to 1.3 |
| Most common infections* | |||
| Nasopharyngitis | 202 (14.4) | 9.0 | 7.8 to 10.3 |
| Upper respiratory tract infection | 186 (13.3) | 8.3 | 7.2 to 9.6 |
| Bronchitis | 91 (6.5) | 4.0 | 3.3 to 5.0 |
| Sinusitis | 77 (5.5) | 3.4 | 2.7 to 4.3 |
| Urinary tract infection | 69 (4.9) | 3.1 | 2.4 to 3.9 |
| Pharyngitis | 54 (3.9) | 2.4 | 1.8 to 3.1 |
| Serious infections | 28 (2.0) | 1.2 | 0.9 to 1.8 |
| Opportunistic infections | 40 (2.9) | 1.8 | 1.3 to 2.4 |
| Oral candidiasis | 16 (1.1) | 0.7 | 0.4 to 1.2 |
| Oral fungal infection† | 6 (0.4) | 0.3 | 0.1 to 0.6 |
| Oesophageal candidiasis‡ | 2 (0.1) | 0.1 | 0.0 to 0.4 |
| Herpes zoster | 16 (1.1) | 0.7 | 0.4 to 1.2 |
| Hepatitis B virus reactivation | 1 (0.1) | 0.0 | 0.0 to 0.3 |
| Latent tuberculosis§ | 35 (2.5) | 1.6 | 1.1 to 2.2 |
| Candida infections | 45 (3.2) | 2.0 | 1.5 to 2.7 |
| Oral candidiasis¶ | 22 (1.6) | 1.0 | 0.6 to 1.5 |
| Vulvovaginal candidiasis** | 13 (1.8) | 1.1 | 0.7 to 2.0 |
| Skin candidiasis | 5 (0.4) | 0.2 | 0.1 to 0.5 |
| Genital candidiasis | 3 (0.2) | 0.1 | 0.0 to 0.4 |
| Oesophageal candidiasis‡ | 2 (0.1) | 0.1 | 0.0 to 0.4 |
| Nail candidiasis | 1 (0.1) | 0.0 | 0.0 to 0.3 |
| Systemic candidiasis | 0 (0.0) | 0.0 | 0.0 to 0.4 |
| Viral infections | |||
| Viral upper respiratory tract infections | 25 (1.8) | 1.1 | 0.8 to 1.6 |
| Viral respiratory tract infections | 9 (0.6) | 0.4 | 0.2 to 0.8 |
| Influenza | 38 (2.7) | 1.7 | 1.2 to 2.3 |
A patient could present more than one event.
*Defined as EAIR of TEAE >2.0.
†As reported by investigator.
‡Data included one case considered severe and one case considered moderate.
§Data include cases of latent tuberculosis, interferon-gamma release assay positive, tuberculin test positive and Mycobacterium tuberculosis complex test positive.
¶Oral candidiasis infection includes oral candidiasis and oral fungal infection.
**Denominator adjusted due to gender-specific event for women: n=722, patient-years=1142.2 (pooled IXE).
EAIR, exposure-adjusted incidence rate per 100 patient-year; IXE, ixekizumab; n, number of patients in each category; N, number of patients in the analysis population; PsA, psoriatic arthritis; TEAE, treatment-emergent adverse event.