Table 3. Summary of Harms in Patients With Moderate to Severe Psoriasis in a Phase 2b Study for Zasocitinib.
| Adverse Event | No. (%) | ||||
|---|---|---|---|---|---|
| Placebo (n = 52) | Zasocitinib, once daily | ||||
| 2 mg (n = 50) | 5 mg (n = 52) | 15 mg (n = 53) | 30 mg (n = 52) | ||
| Deaths | 0 | 0 | 0 | 0 | 0 |
| SAEs | 0 | 0 | 0 | 1 (2) | 0 |
| TEAEs | 23 (44) | 31 (62) | 28 (54) | 28 (53) | 31 (60) |
| TEAEs leading to study treatment discontinuationa | 1 (2) | 1 (2) | 1 (2) | 1 (2) | 2 (4) |
| Most frequent TEAEsb | |||||
| COVID-19c | 1 (2) | 6 (12) | 4 (8) | 6 (11) | 7 (14) |
| Acnec | 0 | 0 | 1 (2) | 3 (6) | 2 (4) |
| Acneiform dermatitisc | 0 | 0 | 1 (2) | 1 (2) | 3 (6) |
| Diarrheac | 1 (2) | 3 (6) | 1 (2) | 1 (2) | 0 |
Abbreviations: SAE, serious adverse event; TEAE, treatment-emergent adverse event.
a
TEAEs leading to drug discontinuation and early termination in 5 patients included increased creatine kinase levels (30 mg), pericardial effusion and pleural effusion (15 mg), tachycardia and syncope (5 mg), decreased lymphocyte cell counts (2 mg), and atrial fibrillation (placebo).
b
TEAEs reported by 3 or more patients in any treatment group (events elicited by laboratory testing are not included).
c
All events of COVID-19 and acneiform dermatitis were grade 1 (mild) or grade 2 (moderate) in severity and resolved by the end of the study. All events of acne and diarrhea were grade 1 (mild) in severity, and most were resolved by the end of the study.