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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