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. 2022 Apr 5;13:847308. doi: 10.3389/fphar.2022.847308

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).