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Table 5 Overview and general characteristics of identified reviewed randomized controlled trials performed in non-JIA patients (July 2020)

From: Biologic disease modifying antirheumatic drugs and Janus kinase inhibitors in paediatric rheumatology – what we know and what we do not know from randomized controlled trials

Drug class Drug Dose Study (phase) Studytimec Population N Age criteria Agea Primary outcome/endpoint Main conclusion
IL-12/23 inhibitor ustekinumab 0.75 mg/kg, 22.5/45/ 90 mg dCADMUS, NCT01090427
(III) [93]b
60 Plaque psoriasis 110 12 to 17 15.2 PGA ≤1 Effective
IL-17 inhibitor ixekizumab 20 mg BW < 25 kg q4w,
40 mg BW 25–50 kg q4w,
80 mg BW > 50 kg q4w
eIXORA-PEDS, NCT03073200 (III) [94] b 12 Plaque psoriasis 201 6 to 17 13.5 PASI75, PGA ≤1 Effective
TNF inhibitor adalimumab 0.4 mg/kg q2w,
0.8 mg/kg q2w
fM04–717, NCT01251614
[95,96,97,98] b
52 Plaque psoriasis 114 4 to 17 13 PASI75, PGA ≤1 Effective
etanercept 0.8 mg/kg/qw EATAK, NCT00841789
(II) [99] b
6 KD 205 0 to 18 3.7 Fever Not effective
0.8 mg/kg/qw 20,030,211, NCT00078819
(III) [100,101,102,103,104] b
48 Plaque psoriasis 211 4 to 17 13a PASI75 Effective
infliximab 5 mg/kg single dose Han 2018 (NA) [105] b 0.571 KD 154 0 to 4 2.2a Unclear Effective
5 mg/kg single dose TA-650-22, NCT01596335
(III) [106] b
8 KD 31 1 to 10 3a Defervescence Effective
5 mg/kg single dose Tremoulet 2014, NCT00760435 (III) [107, 108] b 5 KD 196 0 to 17 3a Fever Effective
5 mg/kg, 10 mg/kg q4w Pro00000057, NCT00589628 (IV) [109] b 39 Non-infectious uveitis 13 4 to 18 NA Uveitis disease activity NA
BAFF inhibitor belimumab 10 mg/kg qm gPLUTO, NCT01649765
(II) [110, 111] b
52 SLE 93 5 to 17 14 SRI4 Effective
  1. Abbreviations: Drug class: IL interleukin, TNF tumour necrosis factor; Dose: mg milligram, kg kilogram, qw once per week, q2w once per every 2 weeks, q4w once per every 4 weeks, qm once every month; Population: KD Kawasaki disease, SLE systemic lupus erythematosus; Outcome: PASI psoriasis area and severity index, PGA Physician global assessment, SRI4 systemic lupus erythematosus response index 4, NA not applicable
  2. amedian age, otherwise mean age across all arms of the study, bparallel study design, cduration in weeks; dAlso registered under EudraCT 2009–014368-20, eAlso registered under EudraCT 2016–003331-38;fAlso registered under EudraCT 2009–013072-52; gAlso registered under EudraCT 2011–000368-88
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