Patient group characteristics and characteristics of responders and nonresponders. Values are mean (SD) unless otherwise specified.
| Characteristics | Patient Group | Nonresponders | Responders | p |
|---|---|---|---|---|
| Patients, n (%)* | 119 | 30 (25.8) | 86 (74.1) | † |
| Female, n (%) | 91 (76.5) | 23 (76.7) | 66 (76.7) | 1 |
| Age at baseline, yrs | 6.9 (4.1) | 6.3 (4.4) | 7.1 (3.9) | 0.303 |
| Disease duration until start of MTX therapy, mos | 13 (23) | 7.2 (10) | 15.6 (26) | 0.076 |
| ESR at baseline, mm/h | 36 (28) | 35 (27.5) | 36 (28.7) | 0.958 |
| No. active joints at baseline | 9 (8.6) | 9.5 (10.6) | 9 (7.9) | 0.770 |
| PGA at baseline | 5.3 (1.9) | 5.3 (1.9) | 5.3 (1.8) | 0.607 |
| PGE at baseline | 7.1 (2.1) | 7.4 (1.8) | 7 (2.2) | 0.333 |
| JADAS-71 at baseline | 23.4 (11.2) | 23.6 (12.7) | 23.3 (10.6) | |
| JIA subtype, n (%) | 0.181 | |||
| Systemic | 10 (8.4) | 1 (3.3) | 9 (10.5) | |
| Persistent oligoarticular | 24 (20.2) | 8 (26.7) | 16 (18.6) | |
| Extended oligoarticular | 24 (20.2) | 8 (26.7) | 15 (17.4) | |
| Polyarticular RF-negative | 41 (34.5) | 9 (30) | 32 (37.2) | |
| Polyarticular RF-positive | 5 (4.2) | 0 (0) | 5 (5.8) | |
| Psoriatic | 11 (9.2) | 2 (6.7) | 8 (9.3) | |
| Enthesitis-related | 2 (1.7) | 2 (6.7) | 0 (0) | |
| Undetermined | 2 (1.7) | 0 (0) | 2 (2.3) | |
| Inactive disease, n (%) | 82 (70.1) | 9 (30.0) | 73 (84.9) | 0.0013 |
| Median time to inactive disease, mos | 5.9 | 14.5 | 5 | NR |
| Concomitant oral steroids upon reaching inactive disease, n (%)** | 29 (35.4) | 3 (33.3) | 26 (35.6) | NR |
| Flare after reaching inactive disease, n (%)** | 59 (72.0) | 7 (77.8) | 52 (60.5) | NR |
| Median time to flare after reaching inactive disease, mos | 9.1 | 3.8 | 9.8 | NR |
| MTX dose to reach inactive disease, mg/m2/week | 11.5 (2.1) | 11.6 (2.0) | 11.5 (2.1) | NR |
| Remission on therapy, n (%) | 54 (46.6) | 3 (10.0) | 51 (59.3) | 0.151 |
| Median time to remission on therapy, mos | 21.9 | 28.8 | 14.9 | NR |
| Remission without therapy, n (%) | 20 (17.2) | 1 (3.3) | 19 (22.1) | 0.684 |
| Median time to remission without therapy, mos | 76.5 | NR | 76.5 | NR |
| Remission without therapy at last followup, n (%) | 16 (13.7) | 1 (3.3) | 15 (17.4) | NR |
| No. flares | 1.45 (1.5) | 1.3 (1.1) | 1.5 (1.5) | NR |
| Medication | ||||
| Starting dose of MTX, mg/m2/week | 10.2 (1.4) | 10.3 (1.2) | 10.2 (1.4) | 0.792 |
| Switched to higher dose of MTX, n (%)*** | 77 (66.3) | 25 (83.3) | 53 (60.4) | < 0.0001 |
| Subcutaneous MTX, n (%) | 42 (35.3) | 9 (30.0) | 33 (38.3) | 0.345 |
| Switched to biologic therapy, n (%) | 55 (47.2) | 26 (86.7) | 29 (33.7) | < 0.0001 |
| Median time to biologic therapy, mos | 44.0 | 5.9 | 65.3 | NR |
| Switched to biologic therapy in the first yr of treatment, n (%) | 31 (26.5) | 22 (73.3) | 9 (10.5) | NR |
↵* Three patients were excluded from the efficacy study.
↵** Analyses performed only in the patients who reached inactive disease.
↵*** Higher dose is > 12.5 mg/m2/week.
↵† p value comparing responders and nonresponders. ESR: erythrocyte sedimentation rate; PGA: physician’s global assessment; PGE: parent’s general evaluation of well-being; JADAS-71: Juvenile Arthritis Disease Activity Score including 71 joints; JIA: juvenile idiopathic arthritis; RF: rheumatoid factor; MTX: methotrexate; NR: not reported.