TABLE 2.
Treatment‐emergent adverse events reported during the 26‐week treatment period and the 52‐week study
| Treatment‐emergent AE n (%) | 26‐week treatment period a , n = 22 | 52‐week study b , n = 22 |
|---|---|---|
| Any AE | 18 (81.8) | 18 (81.8) |
| Severe AE | 2 (9.1) | 2 (9.1) |
| Serious AE | 4 (18.2) | 4 (18.2) |
| AE leading to discontinuation of study drug | 4 (18.2) | 4 (18.2) |
| Serious AE leading to discontinuation of study drug | 0 | 0 |
| AE possibly related to study drug | 9 (40.9) | 9 (40.9) |
| Serious AE possibly related to study drug | 2 (9.1) | 2 (9.1) |
| AE of special interest | ||
| Infection | 11 (50.0) | 12 (54.5) |
| Serious infection | 1 (4.5) | 1 (4.5) |
| Opportunistic infections | 0 | 0 |
| Oral candidiasis | 0 | 0 |
| Tuberculosis | 0 | 0 |
| Malignancy | 0 | 0 |
| Allergic reaction (including angioedema/anaphylaxis) | 2 (9.1) | 2 (9.1) |
| Injection‐site reaction | 1 (4.5) | 1 (4.5) |
| Deaths | 0 | 0 |
Abbreviations: AE, adverse event.
a
Data cutoff date 20 August 2019.
b
Data cutoff date 24 June 2020.