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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).
Assuntos
Antirreumáticos , Artrite Juvenil , Artrite Psoriásica , Neoplasias , Criança , Humanos , Adulto Jovem , Pré-Escolar , Adolescente , Etanercepte/efeitos adversos , Artrite Juvenil/tratamento farmacológico , Antirreumáticos/efeitos adversos , Artrite Psoriásica/tratamento farmacológico , Resultado do Tratamento , Neoplasias/tratamento farmacológicoRESUMO
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.
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Qualidade de Vida , Fusão Vertebral , Idoso , Feminino , Humanos , Pessoa de Meia-Idade , Osteotomia , Ponte , Complicações Pós-Operatórias , Estudos RetrospectivosRESUMO
BACKGROUND: No previous studies have characterized a patient's experience of rheumatoid arthritis (RA) management in Greece and unmet needs may exist despite a broad range of available treatments. Therefore, we assessed quality of life (QoL), functional ability, and healthcare resource utilization in patients with established RA and receiving treatment in a tertiary care setting in Greece. METHODS: This was a prospective, observational cohort of patients aged ≥18 years, receiving any type of treatment for RA, and followed for 12 months at 7 rheumatology referral centers across mainland Greece (NCT01001182). Patient data were collected at the initial visit and 3, 6, and 9 months. QoL was evaluated using the Euro Quality of Life-5 dimensions questionnaire (EQ-5D) and functional ability was evaluated using the Health Assessment Questionnaire (HAQ). RESULTS: A total of 210 patients with RA were enrolled (76.7% women, mean ± standard deviation [SD] age: 59.1 ± 12.6 years, median [interquartile range] disease duration: 11.9 [5.0-16.0] years). Baseline mean ± SD EQ-5D and HAQ scores were 0.57 ± 0.32 and 0.75 ± 0.63, respectively, and remained largely unchanged throughout the study. Post-hoc comparison showed that patients receiving non-biologic disease-modifying antirheumatic drugs (non-bDMARDs) had significantly higher EQ-5D and lower HAQ-DI scores compared with those receiving biologic DMARDs. A majority of patients reported having difficulty doing housework or other duties (61.4 and 61.9%, respectively), and 55.2% reported needing external support for these tasks. Positive correlation was observed between QoL and functional ability. Hospitalization at least once during the study occurred in 9.5% of the patients, and 12.5% of these cases were due to exacerbation of RA. At baseline, 52.4% of the patients were retired, with 38.5% of retirees having retired early due to RA. Among the patients who were retired at baseline, the mean ± SD period from actual retirement to expected retirement age was 12.1 ± 8.1 years. CONCLUSION: QoL and functional ability were positively correlated in patients with long-standing RA, with a large proportion showing impairments in both. Timely, target-oriented treatment initiated as soon as possible after diagnosis may help to improve patient-reported outcomes and limit the burden of RA. TRIAL REGISTRATION: ClinicalTrials.gov NCT01001182 . Registered 23 October 2009.
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Atividades Cotidianas , Artrite Reumatoide/psicologia , Necessidades e Demandas de Serviços de Saúde , Qualidade de Vida , Idoso , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Feminino , Grécia , Inquéritos Epidemiológicos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Aposentadoria/estatística & dados numéricos , Atenção Terciária à Saúde/estatística & dados numéricosRESUMO
Objectives: To examine determinants of tofacitinib discontinuation due to voluntary (i.e. patient-driven) or involuntary reasons (i.e. protocol mandated) in long-term extension (LTE) studies of patients with RA to inform clinical practice, clinical study execution and data capture. Methods: This post hoc analysis used pooled data from patients receiving tofacitinib 5 or 10 mg twice daily (BID) in LTE studies. Outcomes included time to voluntary/involuntary discontinuation (and baseline predictors), including by geographic region. Exposure-adjusted event rates (EAERs) were calculated for adverse events (AEs), serious AEs (SAEs) and discontinuations due to AEs/SAEs. Results: Of 4967 patients, 2463 (49.6%) discontinued [1552/4967 (31.2%) voluntarily, 911/4967 (18.3%) involuntarily] and 55 (1.1%) died over the course of 9.5 years. When involuntary discontinuation was present as a competing risk for voluntary discontinuation, patients who stayed on combination therapy and with higher patient-assessed pain were significantly more likely to discontinue for voluntary reasons (P < 0.05). Older patients, those enrolled in Asia, Europe or Latin America (vs USA or Canada) or with RF+/anti-CCP+ status were significantly less likely to discontinue for voluntary reasons (P < 0.05). Small numeric differences in disease activity were observed between geographic regions in patients who discontinued or completed the studies. EAERs were generally higher for tofacitinib 10 vs 5 mg BID, irrespective of discontinuation reason. Conclusion: The factors associated with voluntary/involuntary discontinuation of tofacitinib suggest that treatment persistence in RA studies is partly predictable, which may be reflected in clinical practice. Applying these results may improve our understanding of attrition and inform future study design/execution. Trial registrations: ClinicalTrials.gov (http://clinicaltrials.gov): NCT00413699 and NCT00661661.
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OBJECTIVE: RE-EMBARK investigated etanercept (ETN) withdrawal and retreatment in patients with nonradiographic axial spondyloarthritis (nr-axSpA) achieving inactive disease. METHODS: Patients received ETN and a background nonsteroidal antiinflammatory drug for 24 weeks in period 1 (P1); those achieving inactive disease (Ankylosing Spondylitis Disease Activity Score [ASDAS] with C-reactive protein [CRP] < 1.3) discontinued ETN for 40 weeks or less (period 2 [P2]). Patients who flared (ASDAS with erythrocyte sedimentation rate [ESR] ≥ 2.1) were retreated for 12 weeks in period 3 (P3). The primary endpoint was the proportion of patients with inactive disease who flared within 40 weeks of ETN withdrawal. Baseline characteristics were analyzed post hoc as predictors of maintenance and regaining of inactive disease, respectively, using univariate logistic and stepwise multivariable logistic regression models. RESULTS: The proportion of patients experiencing flare following ETN withdrawal (P2) increased from 22.3% (25/112) after 4 weeks to 67% (77/115) after 40 weeks; 74.8% (86/115) experienced flare at any time during P2. Median time to flare was 16.1 weeks. Most patients (54/87, 62.1%) who were retreated with ETN in P3 reachieved inactive disease. Absence of both sacroiliitis detected on magnetic resonance imaging (MRI) and high-sensitivity CRP (hs-CRP) > 3 mg/L at baseline predicted inactive disease maintenance in P2 following ETN withdrawal in multivariable analysis; male sex and age younger than 40 years predicted regaining of inactive disease in P3 after flare/retreatment. There were no unexpected safety signals. CONCLUSION: Approximately 25% of patients maintained inactive disease for 40 weeks after discontinuing ETN. Absence of both MRI sacroiliitis and high hs-CRP at baseline predicted response maintenance after ETN withdrawal. (ClinicalTrials.gov: NCT02509026).