Ten-year safety and clinical benefit from open-label etanercept treatment in children and young adults with juvenile idiopathic arthritis.

OBJECTIVES: CLIPPER2 was an 8-year, open-label extension of the phase 3b, 2-year CLIPPER study on the safety and efficacy of etanercept in patients with JIA, categorized as extended oligoarticular arthritis (eoJIA), enthesitis-related arthritis (ERA) or PsA. METHODS: Participants with eoJIA (2-17 years old), ERA or PsA (each 12-17 years old) who received ≥1 etanercept dose (0.8 mg/kg weekly; maximum 50 mg) in CLIPPER could enter CLIPPER2. Primary end point was occurrence of malignancy. Efficacy assessments included proportions achieving JIA ACR 30/50/70/90/100 criteria and ACR inactive disease criteria, and clinical remission (ACR criteria) or Juvenile Arthritis DAS (JADAS) ≤1. RESULTS: Overall, 109/127 (86%) CLIPPER participants entered CLIPPER2 [n = 55 eoJIA, n = 31 ERA, n = 23 PsA; 99 (78%) on active treatment]; 84 (66%) completed 120 months' follow-up [32 (25%) on active treatment]. One malignancy (Hodgkin's disease in 18-year-old patient with eoJIA treated with methotrexate for 8 years) was reported; there were no cases of active tuberculosis or deaths. Numbers and incidence rates (events per 100 patient-years) of TEAEs (excluding infections/ISRs) decreased from 193 (173.81) in Year 1 to 9 (27.15) in Year 10; TE infections and serious infections also decreased. Over 45% of participants (n = 127) achieved JIA ACR50 responses from Month 2 onwards; 42 (33%) and 34 (27%) participants achieved JADAS and ACR clinical remission, respectively. CONCLUSIONS: Etanercept treatment up to 10 years was well tolerated, consistent with the known safety profile, with durable response in the participants still on active treatment. The benefit-risk assessment of etanercept in these JIA categories remains favourable. TRIAL REGISTRATION: ClinicalTrials.gov IDs: CLIPPER (NCT00962741); CLIPPER2 (NCT01421069).

Three-level lumbar Ponte osteotomies with less invasive pelvic fixation improve spinal balance, quality of life and decrease disability in adult and elderly women with moderate adult spinal deformity.

PURPOSE: To report on quality of life and radiological changes of Ponte osteotomies (POs) with long fixation for primary and revision surgery, in elderly women with adult spinal deformity (ASD). METHODS: Sixty-seven (67) women, aged 69 ± 7 years, received 3 POs, spinopelvic fixation plus TLIFs. Forty-nine (73%) patients received primary and 18 (27%) revision surgery. Survivorship analysis was made for unplanned revision surgery for broken rods (BR); proximal junction failure (PJF); and deep wound infection (DWI). ODI and SF-36 were used for disability (ODI) and quality of life (SF-36) evaluation. RESULTS: In total, 201 lumbar POs were made and 9.55 ± 3 levels fused. All patients were available 49 ± 11 months postoperatively. Postoperatively, SVA, CSVL, PI-LL, scoliosis, PT and T9-spinopelvic inclination were reduced, while LL and SS were increased significantly. At the final visit, PI-LL ≤ 10° was achieved in 26 (39.4%) patients; ≤ 15° in 51 (76%) patients, while all 67 patients showed a PI-LL ≤ 20°. Unplanned reoperation was performed in 11 (16.4%) patients: for BR in 5 (7.5%); for PJF in 3 (4.5%) and for DWI in 3 (4.5%) patients, respectively. With end point the reoperation for any reason the survival ± SE was 67.8% ± 0.1; for PJF 89.6 ± 0.065; and for BR 76% ± 0.1 in the final evaluation. There was no difference in survival between the primary and revision surgery groups (P = 0.568). ODI and SF-36 scores were improved postoperatively. CONCLUSIONS: Three-segment lumbar POs offered and maintained sufficient improvement of lumbar lordosis along with restoration of the sagittal and coronal spinal alignment, improvement of quality of life and disability of female adult and elderly population after primary and revision surgery for ASD.