TABLE 2.
Summary of main characteristics of the selected clinical trials.
| Author/Study Acronim | Study design | Patient Eligibility | Dose | Number of Patients | Duration | Primary Endpoints | Statistical Analysis | Quality of Evidence (GRADE) |
|---|---|---|---|---|---|---|---|---|
| Paller (Paller et al., 2008) | Multicentre, double-blind | PASI≥12 | ⁃Etanercept 0.8 mg/kg (max 50 mg) | 106 | 12 weeks | PASI 75 | Intention to treat | ⊕⊕ high |
| PGA≥3 | ⁃Placebo | 105 | ||||||
| BSA≥10% | ||||||||
| Papp (Papp et al., 2017) | Multicentre, double-blind, multiperiod, phase 3 trial | PASI≥20 or ≥10 and at least one of active psoriatic arthritis unresponsive to non-steroidal anti-inflammatory drugs | ⁃Adalimumab 0.8 mg/kg (max 40 mg) | 38 | 16 weeks | PASI 75 | Intention to treat | ⊕⊕ high |
| PGA≥4 | ⁃Adalimumab 0.4 mg/kg (max 20 mg) | 39 | PGA 0/1 | |||||
| BSA>20% or ≥10% with very thick lesions | ⁃Methotrexate 0.1–0.4 mg/kg (max 25 mg per week total dose) | 37 | ||||||
| CDLQI≥10 or clinically relevant facial, genital, or hand or foot involvement | ||||||||
| Landells/CADMUS (Landells et al., 2015) | Multicentre, double-blind, phase 3 trial | PASI≥12 | ⁃Ustekinumab Standard Dose 0.75 mg/kg | 36 | 12 weeks | PGA 0/1 | Non responder imputation | ⊕⊕ high |
| PGA≥3 | ⁃Ustekinumab Half-Standard Dose 0.375 mg/kg | 37 | ||||||
| BSA≥10% | ⁃Placebo | 37 | ||||||
| Bodemer (Bodemer et al., 2021) | Multicentre, double-blind, placebo- and active controlled | PASI≥20 | ⁃Secukinumab low dose (LD) 150 mg | 40 | 12 weeks | PASI 75 | Non responder imputation | ⊕⊕ high |
| IGA≥4 | ⁃Secukinumab high dose (HD) 300 mg | 40 | IGA 0/1 | |||||
| BSA≥10 | ⁃Etanercept | 41 | ||||||
| ⁃Placebo | 41 | |||||||
| Paller/IXORA Ped (Paller et al., 2020) | Multicentre, double-blind, phase 3 trial | PASI ≥20 sPGA ≥4 | ⁃Ixekizumab1 | 115 | 12 weeks | PASI 75 sPGA 0/1 | Non responder imputation | ⊕⊕ high |
| ⁃Placebo | 56 |
According to body weight, dosing was as follows: subjects >50 kg received a starting dose of 160 mg, then 80 mg every 4 weeks (Q4W) thereafter; subjects 25–50 kg received a starting dose of 80 mg, then 40 mg Q4W thereafter; subjects <25 kg received a starting dose of 40 mg, then 20 mg Q4W thereafter).