The evidence is based on 3 placebo controlled RCTs with short follow-up (12-16 weeks).
| Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias «Tildrakizumab in treatment of moderate to severe plaque psoriasis: effectiveness and safety compared to placebo»1 |
|---|---|---|---|---|---|
| RCT=randomized controlled trial; MA=meta-analysis | |||||
| «Bilal J, Berlinberg A, Bhattacharjee S ym. A syste...»1 | MA | RCTs, adults (> 18 years) with moderate to severe plaque psoriasis treated with biologic
agents. n=1768 |
Tildrakizumab 200 mg or 100 mg at baseline, week 4 and every 12 weeks vs. placebo | Primary: PASI-75, PGA 0-1 at 12-16 weeks Secondary: PASI-90, safety | low |
| «Blauvelt A, Reich K, Papp KA ym. Safety of tildrak...»2 | Pooled analysis 3 RCTs | Adults (> 18 years) with moderate to severe plaque psoriasis treated with biologic
agents. n=1768 |
Tildrakizumab 200 mg or 100 mg at baseline, week 4 and every 12 weeksvs. placebo | Treatment-emergent adverse events, serious AE. | low |
Results
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Relative effect (95% CI) |
|---|---|---|---|---|---|
| I= intervention; C=comparison; CI=confidence interval | |||||
| «Bilal J, Berlinberg A, Bhattacharjee S ym. A syste...»1 | 3 RCTs 100 mg (705/355) 200 mg (708/355) |
12 weeks | 402 (57.0) 432 (61.0) |
18 (5.1) | RR 10.03 (6.45-15.59) RR 10.97 (6.44-18.69) |
| Level of evidence: moderate The quality of evidence is downgraded due to imprecision. |
|||||
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Relative effect (95% CI) |
|---|---|---|---|---|---|
| I= intervention; C=comparison; CI=confidence interval | |||||
| «Bilal J, Berlinberg A, Bhattacharjee S ym. A syste...»1 | 3 RCTs100 mg (705/355)200 mg (708/355) | 12 weeks | 280 (39,7)283 (40,0) | 7 (2,0)7 (2,0) | RR 17.27 (8.24-36.19)RR 17.97 (8.58-37.64) |
| Level of evidence: low The quality of evidence is downgraded due to indirectness(secondary outcome) and imprecision. |
|||||
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Relative effect (95% CI) |
|---|---|---|---|---|---|
| I= intervention; C=comparison; CI=confidence interval, TEAEs=treatment-emergent adverse events | |||||
| «Blauvelt A, Reich K, Papp KA ym. Safety of tildrak...»2 | 3 RCTs100 mg (705/355)200 mg (708/355) | 16 weeks | TEAEs100 mg 340 (48.2)200mg 339 (47.9)Serious AEs100 mg 10 (1.4)200 mg 16 (2.3) | 191 (53.8)6 (1.7) | NA |
| Level of evidence: low The quality of evidence is downgraded due to imprecision. |
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