Table 3.
Study | Patients, N | ≥1 AEs | SAEs | Most Common AEs | AEs of Special Interest |
---|---|---|---|---|---|
Papp et al25 Phase IIb |
355 split in a 1:2:2:2:1 ratio | tildrakizumab 5 mg: 71% tildrakizumab 25 mg: 61% tildrakizumab 100 mg: 65% tildrakizumab 200 mg: 63% placebo: 69% |
tildrakizumab 5 mg: 0% tildrakizumab 25 mg: 1% tildrakizumab 100 mg: 1% tildrakizumab 200 mg: 2% placebo: 0% |
Nasopharyngitis Headache |
1) Severe infections tildrakizumab 5 mg: 0% tildrakizumab 25 mg: 0% tildrakizumab 100 mg: 1% tildrakizumab 200 mg: 0% placebo: 0% 2) Drug-related injection site reaction tildrakizumab 5 mg: 0% tildrakizumab 25 mg: 1% tildrakizumab 100 mg: 0% tildrakizumab 200 mg: 0% placebo: 1% |
Reich et al26 Phase III reSURFACE 1 |
772 split in a 2:2:1 ratio | tildrakizumab 200 mg: 42% tildrakizumab 100 mg; 47% placebo: 48% |
tildrakizumab 200 mg: 3% tildrakizumab 100 mg; 2% placebo: 1% |
1)Nasopharyngitis tildrakizumab 200 mg: 6% tildrakizumab 100 mg; 8% placebo: 5% 2) Upper respiratory tract infection tildrakizumab 200 mg 5% tildrakizumab 100 mg; 3% placebo: 6% |
1) Severe infections tildrakizumab 200 mg: <1% tildrakizumab 100 mg; <1% placebo: 0% 2)Cardiovascular events tildrakizumab 200 mg: 0% tildrakizumab 100 mg: <1% placebo: 0% 3) Drug-related hypersensitivity reactions tildrakizumab 200 mg: <1% tildrakizumab 100 mg: 0% placebo: 0% |
Reich et al26 Phase III reSURFACE 2 |
1090 split in a 2:2:1:2 ratio | tildrakizumab 200 mg: 49% tildrakizumab 100 mg: 44% placebo: 55% etanercept 50 mg: 54% |
tildrakizumab 200 mg: 2% tildrakizumab 100 mg: 1% placebo: 3% etanercept 50 mg: 2% |
1) Nasopharyngitis tildrakizumab 200 mg: 11% tildrakizumab 100 mg: 13% placebo: 8% etanercept 50 mg: 12% 2) Injection site erythema tildrakizumab 200 mg: 1% tildrakizumab 100 mg: 1% placebo: 1% etanercept 50 mg: 9% |
1) Severe infections tildrakizumab 200 mg: <1% tildrakizumab 100 mg; 0% placebo: 1% etanercept: 0% 2) Malignancies tildrakizumab 200 mg: <1% tildrakizumab 100 mg; <1% placebo: 0% etanercept: <1% 3) Drug-related hypersensitivity reactions tildrakizumab 200 mg: 0% tildrakizumab 100 mg; <1% placebo: 1% etanercept: 0 |
Abbreviations: AEs, adverse events; SAEs, serious adverse events.