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Table 3 Characteristics of included studies

From: Prediction of methotrexate efficacy and adverse events in patients with juvenile idiopathic arthritis: a systematic literature review

Reference Design Country of origin N Inclusion criteria Outcomea Follow up
[18]b Prospective The Netherlands 113 JIA, starting MTX 1k, 2a, 2d, 2f 1 y
[19] Prospective UK 87 JIA, starting MTX 1b, 1j 6 mo
[17]c Retrospective and prospective The Netherlands 287 JIA, starting MTX 1c 1 y
[10] Retrospective Germany 411 JIA, starting MTX 1a, 1b, 1c, 2i 1 y
[16] (deriv) Retrospective The Netherlands 183 JIA, starting MTX 1e 1 y
[16] (rep) Prospective The Netherlands 104 JIA, starting MTX 1e 1 y
[23] (deriv)d Prospective UK 197 JIA, starting MTX 1d 6 mo
[23] (rep)d Unknown USA 210 JIA, starting MTX 1g 6 mo
[31] Cross-sectional Japan 92 JIA, at least 3 mo MTX 2e Mean 58.2 moe
[24] (deriv)d Prospective UK 197 JIA, starting MTX 1d 6 mo
[24] (rep)d Unknown USA 210 JIA, starting MTX 1g 6 mo
[20] Cross-sectional Czech Republic 69 JIA, at least 3 mo MTX 1i, 2d, 2f, 2g, 2h Median 1.3-1.4 ye
[28]f Prospective Multinational (PRINTO) 563 RF negative polyarticular course JIA, starting MTX 1a, 1c 6 mo
[26] Prospective Italy 60 JIA, ≥2 active joints in oligo persistent, ≥5 active joints in other categories 1b 1 y
[27]f Prospective Multinational (PRINTO) 521 RF negative polyarticular course JIA, starting MTX 1l 6 mo
[25] Retrospective Italy 125 Polyarticular JIA, starting MTX 1f, 1i 6 mo, 5 y
[32] Retrospective Germany 58 JIA, at least 3 mo MTX 2d, 2i Mean 48 months
[21] Retrospective Italy 80 JIA, at least 6 mo MTX 1a, 2c, 2g Efficacy: 6 mo
Toxicity: median 6–9 mo
[29] Retrospective USA 49 JRA, starting MTX 1h Mean 2.6 y (range 1.0-7.3 y)
[34]b Prospective The Netherlands 152 JIA, starting MTX 2b 1 y
[22] Retrospective and prospective Czech Republic, UK, The Netherlands 694 JIA, starting MTX 1f 6 mo
  1. Abbreviations: ACR30/50/70 American College of Rheumatology pediatric 30, 50 or 70 response criteria, respectively, AE adverse event, ALT alanine aminotransferase, AST aspartate aminotransferase, CHQ child health questionnaire, deriv derivation cohort, GI gastrointestinal, HRQOL health-related quality of life, JADAS juvenile arthritis disease activity score, JIA juvenile idiopathic arthritis, min minutes, MISS methotrexate intolerance severity score, mo months, MTX methotrexate, NR non-response, PhS physical component summary score, PsS psychosocial component summary score, RA rheumatoid arthritis, rep replication cohort, RF rheumatoid factor, ULN upper limit of normal, y years.
  2. a1a: Achievement of ACR30; 1b: Achievement of ACR50; 1c: Achievement of ACR70; 1d: Achievement of ACR70 vs. non-achievement of ACR30; 1e: Achievement of ACR70 in 2/3 visits; 1f: NR vs. ACR30 vs. ACR50 vs. ACR70; 1g: >70% improvement in joint count vs. <30%; 1h: Adapted ACR criteria for RA: morning stiffness <15 min, no fatigue, no joint swelling, no joint pain for 2 consecutive months; 1i: Clinical inactive disease on MTX monotherapy according to Wallace criteria; 1j: JADAS-10; 1k: JADAS-27; 1l: HRQOL: CHQ PhS ≥30 and PsS ≥30; 2a: MISS: intolerant (score >6); 2b: MISS: intolerant (score >6) after 6 and/or 12 months; 2c: ALT/AST > ULN; 2d: ALT/AST >2 ULN; 2e: ALT >5 ULN; 2f: Bone marrow suppression (any cytopenia); 2g: GI toxicity; 2h: Other (alopecia, headaches, behavioural changes, nodulosis); 2i: Any AE; bThis is the same cohort as the replication cohort of [16], but different outcome and/or predictors; cThis cohort is the derivation and replication cohort of [16] together, but uses a slightly different outcome and different predictors; dThese are the same cohorts, but they use different predictors; eTime after start of MTX; fThese are the same cohorts, but they use different outcome measurements.