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Table 4 Overview and general characteristics of identified reviewed randomized controlled trials performed in 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) Study timec Population N Age criteria Agea Background Primary outcome/endpoint Main conclusion
CD80/86 inhibitor abatacept 10 mg/kg q4w dIM101–033, NCT00095173
(III) [48,49,50,51]b 		26 PJIA, SJIA (without systemic features), extended OJIA 190 6 to 17 12.4 MTX, corticosteroids Disease flare Effective
IL-1 inhibitor anakinra 1 mg/kg/d e,b990758–990779, NCT00037648 (II) [52, 53] 16 PJIA 86 2 to 17 12 MTX Safety Efficacy is inconclusive
2 mg/kg/d ANAJIS, NCT00339157
(II/III) [53, 54] 		4.33 SJIA 24 2 to 20 8.5 NSAID, corticosteroids Modified ACR Pedi 30 Effective
canakinumab 4 mg/kg single dose fβ-SPECIFIC 1, NCT00886769 (III) [55,56,57] 4.33 SJIA 84 2 to 19 8a MTX, NSAID, corticosteroids ACR Pedi 30 Effective
4 mg/kg q4w gβ-SPECIFIC 2, NCT00889863 (III) [55,56,57]b 120 SJIA 177 2 to 19 8a MTX, NSAID, corticosteroids Disease flare Effective
rilonacept 2.2 mg/kg qw RAPPORT, NCT00534495
(II) [58, 59] 		24 SJIA 71 1 to 19 10 NA Modified ACR Pedi 30 Effective
2.2 mg/kg qw, 4.4 mg/kg qw IL1T-AI-0504, NCT01803321
(II) [60] 		104 SJIA 24 4 to 20 12.6 MTX, NSAID, corticosteroids ACR Pedi 30 Not effective
IL-6 inhibitor tocilizumab 8 mg/kg q4w, 10 mg/kg q4w hCHERISH, NCT00988221
(III) [61,62,63,64,65]b 		104 PJIA, extended OJIA 188 2 to 17 11 MTX, corticosteroids Disease flare Effective
8 mg/kg q2w, 12 mg/kg q2w iTENDER, NCT00642460
(III) [63,64,65,66,67] 		260 SJIA 112 2 to 17 9.7 MTX, corticosteroids Modified ACR Pedi 30 Effective
8 mg/kg q2w MRA316JP, NCT00144599
(III) [68]b 		18 SJIA 56 2 to 19 8.3 corticosteroids ACR Pedi 30 Effective
TNF inhibitor adalimumab 24 mg/m2 q2w jM11–328, NCT01166282
(III) [69,70,71] 		12 ERA 46 6 to 17 12.9 MTX or SSZ, NSAID Joints with active arthritis Effective
40 mg q2w Horneff 2012, EudraCT 2007–003358-27(III) [72] 12 ERA 32 12 to 17 15.3 NSAID, corticosteroids ASAS40 Effective
24 mg/m2 q2w k,bDE038, NCT00048542
(III) [73, 74] 		48 PJIA 171 4 to 17 11.2 MTX, NSAID, corticosteroids Disease flare Effective
20 mg q2w, 40 mg q2w SYCAMORE, EudraCT 2010–021141-41 (NA) [75, 76] 78 JIA-associated uveitis 90 2 to 18 8.9 MTX Treatment failure Effective
24 mg/m2 q2w, 40 mg q2w lADJUVITE, NCT01385826 (II/III) [77] 52 JIA-associated uveitis 32 > = 4 9.5a MTX, corticosteroids (oral and topical) LFP improvement > = 30% and no worsening on slit lamp Effective
etanercept 0.8 mg/kg/qw Horneff 2015, EudraCT 2010–020423-51 (III) [78] b 48 ERA 38 6 to 17 13.3 SSZ, NSAID, corticosteroids Disease flare Effective
0.8 mg/kg/qw o16.0016 (NA) [79, 80] 30.33 PJIA 69 4 to 17 NA NSAID, corticosteroids Disease flare Effective
0.8 mg/kg/qw o20021616, NCT03780959 (II/III) [81]b 30.33 PJIA 69 4 to 18 10.5 NSAID Disease flare Effective
  0.8 mg/kg/qw 20021628, NCT03781375
(III) [82] 		52 PJIA 25 NA 10.1 MTX ACR Pedi 30 NA
0.8 mg/kg/qw TREAT, NCT00443430
(IV) [83, 84] 		52 PJIA 85 2 to 17 10.5 MTX Clinical inactive disease Not effective
0.8 mg/kg/qw, 1.6 mg/kg/qw b20021631, NCT00078806
(III) [85] 		39 SJIA 19 2 to 18 9.1 MTX, NSAID, corticosteroids Disease flare NA
0.8 mg/kg/qw BeSt for Kids, NTR1574 (NA) [86, 87] 12 PJIA,RF−; OJIA, JPsA 94 2 to 16 8.8a MTX Unclear Effective
golimumab 30 mg/m2 q4w mGO KIDS, NCT01230827 (III) [88, 89]b 48 PJIA, SJIA (without systemic features), PsA 154 2 to 17 11.1 MTX, corticosteroids Disease flare Not effective
infliximab 3 mg/kg,
6 mg/kg 		CR004774, NCT00036374 (III) [90] 58 PJIA 122 4 to 17 11.2 MTX, NSAID, corticosteroids ACR Pedi 30 Not effective
3–5 mg/kg ACUTE-JIA, NCT01015547 (III) [91] 54 PJIA 60 4 to 15 9.6 MTX, other
DMARDs 		ACR Pedi 75 Effective
JAK inhibitor tofacitinib 2–5 mg BID nA3921104, NCT02592434 (III) [92]b 44 ERA, PJIA, PsA 225 2 to 17 13a NA Disease flare Effective
  1. Abbreviations: Drug class: IL interleukin, TNF tumour necrosis factor, JAK Janus Kinase; Dose: mg milligram, kg kilogram, d per day, qw once per week, q2w once per every 2 weeks, q4w once per every 4 weeks, BID twice a day; Population: ERA enthesitis-related juvenile idiopathic arthritis, PsA psoriatic juvenile idiopathic arthritis, OJIA oligoarticular juvenile idiopathic arthritis, PJIA juvenile Polyarticular idiopathic arthritis, RF− rheumatoid factor negative, SJIA systemic juvenile idiopathic arthritis; Background: MTX methotrexate, HCQ hydroxycloroquine, NSAID non-steroidal anti-inflammatory drugs, DMARDS disease modifying antirheumatic drugs, SSZ sulfasalazine; Outcome: ACR Pedi 30 ACR Pedi 30% response criteria, ACR Pedi 75 ACR Pedi 75% response criteria, LFP laser flare photometry, ASAS40 assessment in ankylosing spondylitis response criteria 40%; NA not available
  2. amedian age, otherwise mean age across all arms of the study, bwithdrawal study design instead of parallel, cduration in weeks, dAlso registered under EudraCT 2005–000443-28; eAlso registered under EudraCT 2015–002466-22; fAlso registered under EudraCT 2008–005476-27; gAlso registered under EudraCT 2008–005479-82; hAlso registered under EudraCT 2009–011593-15; iAlso registered under EudraCT 2007–00872-18; jAlso registered under EudraCT 2009–017938-46; kAlso registered under EudraCT 2011–001661-40; lAlso registered under EudraCT 2010–019441-26; mAlso registered under EudraCT 2009–015019-42; nAlso registered under EudraCT 2015–001438-46; osame study
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Pediatric Rheumatology

ISSN: 1546-0096