Table 4.
Summary of retrospective/registry-based studies on biological DMARDs in ERA
| Reference no./country/year | No. of patients with ERA/no. of patients (% ERA) | Drug | Outcomes | Major safety signals |
|---|---|---|---|---|
| 81/Finland/2006 | 2/71 (2.8) | 43 ETAN, 28 IFX | Improvement in growth velocity was noted in those patients who had retarded growth prior to initiating anti-TNF agent. At 2 years, number of joints involved and inflammatory markers showed improvement; ~50% attained remission | No SAE |
| 82/The Netherlands/2009 | 5/146 (3.4) | ETAN | At 3 months, four of five children attained ACR Pedi 30, 50, and 70 response. At further time points, incomplete data available | Nine SAE overall in the group over 312 patient-years (4 infective) |
| 83/The Netherlands/2011 | 22/22 (100) | 20 ETAN, 2 ADA, 2 IFX (including drug switches) | By 3 months, significant improvements in patient/parent/physician VAS, quality of life, inflammatory markers, ACR Pedi 30 and 70. No separate data on enthesitis/IBA | No SAE |
| 84/USA/2011 | 125/53 (42.4) | 104 ETAN, 7 IFX, 14 ADA (at first visit) | 24% had inactive disease at 1 year; 43% had inactive disease ever. Overall, presence of ERA was a predictor for failure to attain inactive disease. No information on enthesitis | NA |
| 85/Germany/2015 | 238/1,678 (14.2) | ETAN | In ERA group – significant improvement in JADAS-10 from baseline at 3 months, maintained till 24 months. Occurrence of uveitis flare 2.7 per 100 PY. New-onset I BD 0.49 per 100 PY | Two serious infections, two malignancies infections |
| 86/USA/2016 | 5/5 (100) | Ustekinumab | Clinical improvement in enthesitis, back pain, and active arthritis in four of five over 7–12 months. One withdrawal at 1 month due to inefficacy | None |
Abbreviations: ACR Pedi 30, 50, 70, 90, and 100, American College of Rheumatology Pediatric 30, 50, 70, 90, and 100 Response; ADA, adalimumab; DMARDs, disease-modifying antirheumatic drugs; ERA, enthesitis-related arthritis; ETAN, etanercept; IBA, inflammatory backache; IBD, inflammatory bowel disease; IFX, infliximab; JADAS-10, Juvenile Arthritis Disease Activity Score 10; NA, not available; SAE, serious adverse events; PY, patient years; TNF, tumor necrosis factor.