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. 2020 Sep 24;16:903–916. doi: 10.2147/TCRM.S227880

Table 3.

Summary of Adverse Events in Phase II and III Trials During Week 0–12/16

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.