| Variables | Trial baseline | End of trial (24 weeks) | Follow-up (median 9 years) | |||
| PLAC group n = 29 | SSZ group n = 32 | PLAC group n = 29 | SSZ group n = 32 | PLAC group n = 29 | SSZ group n = 32 | |
| Active joints (range 0 to 71) | 6 (3 to 11) | 5 (2 to 11) | 4 (1 to 11) | 1*** (0 to 5) | 4 (1 to 7) | 2** (0 to 3) |
| Limited joints (range 0 to 67) | 4 (1 to 8) | 3 (1 to 6) | 3.5 (1 to 6) | 2 (1 to 4) | 7 (3 to 13) | 4 (1 to 12) |
| PGAS (range 0 to 5) | 4 (3 to 4) | 3 (2 to 4) | 3 (2 to 3.5) | 1**** (0 to 2) | 2 (1 to 3) | 1.5 (0 to 2) |
| Erythrocyte sedimentation rate mm/h | 35 (11 to 54) | 25 (12 to 38) | 14 (8 to 29) | 9 (6 to 15) | 10 (7 to 26) | 6 (4 to 18) |
| Physician’s VAS disease activity (range 0 to 100) | NA | NA | NA | NA | 18 (3 to 31) | 7 (0 to 16) |
| Patient’s VAS overall well-being (range 0 to 100) | NA | NA | NA | NA | 13 (2 to 55) | 2** (1 to 28) |
| C-HAQ score (range 0 to 3) | NA | NA | NA | NA | 0.25 (0 to 2) | 0.25 (0 to 1.8) |
| No. (%) of patients improved according to ACR Pediatric 30 definition‡ | NA | NA | 6 (21) | 18 (56)†**** | 5 (17) | 15 (47)** |
| No. (%) of patients in remission at follow-up§ | NA | NA | NA | NA | 1 (3) | 8 (25)** |
| No. (%) of patients with episodes of remission between SSZ trial inclusion and follow-up | NA | NA | NA | NA | 4 (14) | 13 (41)** |
| Duration of episodes of remission in years | NA | NA | NA | NA | 3.5 (2.3 to 6.3) | 5.0** (3.5 to 7.0) |
*Values are median and interquartile range (IQR), unless otherwise indicated. PLAC, placebo; SSZ, sulfasalazine; NA, not applicable; C-HAQ, CHAQ and HAQ results combined. PGAS: 0 = none; 1+ = very low; 2+ = low; 3+ = moderate; 4+ = active; 5+ = very active; Physicians’ visual analogue scale (VAS) disease activity (anchoring words 0 = inactive, 100 = severe) and patients’ VAS overall-well-being (anchoring words 0 = very well; 100 = very poor); †of the 18 SSZ patients who were improved according to the ACR Pedi 30 at the end of the trial, 11 (73%) remained “improved’ at follow-up; of the 6 PLAC patients who were improved at the end of the trial, none remained improved at follow-up (p<0.001); ‡improvement according to the ACR Paediatric 30 (ACR Pedi 30) definition.25 Variables included were: (1) number of active joints, (2) number of limited joints, (3) physicians’ global assessment of disease activity, and (4) erythrocyte sedimentation rate. Patients were classified as improved when they showed at least 30% improvement in 3 of 4 aforementioned variables, and not one of the variables could be worsened by more than 30%; §remission was defined as clinical remission off anti-arthritis and anti-uveitis medication for at least 12 months;24 episodes of remission were defined as the presence of episodes of disease remission off medication during the disease course between trial inclusion and follow-up.
**, ***, ****p values of <0.05, <0.01 and <0.001 for the differences in outcome scores between the treatment groups.