Table 5.
Overview and general characteristics of identified reviewed randomized controlled trials performed in non-JIA patients (July 2020)
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 |
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 |
20030211, NCT00078819 |
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 |
52 | SLE | 93 | 5 to 17 | 14 | SRI4 | Effective |
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 available
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