Publications (8)31.48 Total impact
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Article: Consensus treatment plans for induction therapy of newly diagnosed proliferative lupus nephritis in juvenile systemic lupus erythematosus.
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ABSTRACT: To formulate consensus treatment plans (CTPs) for induction therapy of newly diagnosed proliferative lupus nephritis (LN) in juvenile systemic lupus erythematosus (SLE). A structured consensus formation process was employed by the members of the Childhood Arthritis and Rheumatology Research Alliance after considering the existing medical evidence and current treatment approaches. After an initial Delphi survey (response rate = 70%), a 2-day consensus conference, and 2 followup Delphi surveys (response rates = 63-79%), consensus was achieved for a limited set of CTPs addressing the induction therapy of proliferative LN. These CTPs were developed for prototypical patients defined by eligibility characteristics, and included immunosuppressive therapy with either mycophenolic acid orally twice per day, or intravenous cyclophosphamide once per month at standardized dosages for 6 months. Additionally, the CTPs describe 3 options for standardized use of glucocorticoids, including a primarily oral, a mixed oral/intravenous, and a primarily intravenous regimen. There was consensus on measures of effectiveness and safety of the CTPs. The CTPs were well accepted by the pediatric rheumatology providers treating children with LN, and up to 300 children per year in North America are expected to be candidates for the treatment with the CTPs. CTPs for induction therapy of proliferative LN in juvenile SLE based on the available scientific evidence and pediatric rheumatology group experience have been developed. Consistent use of the CTPs may improve the prognosis of proliferative LN, and support the conduct of comparative effectiveness studies aimed at optimizing therapeutic strategies for proliferative LN in juvenile SLE.Arthritis care & research. 12/2011; 64(3):375-83. -
Article: Reply to Connelly, et al., Letter to Editor, "Pain as a quality care measure in juvenile idiopathic arthritis - one step forward, but is it the best foot?", Manuscript ID: ACR-11-0193.
Arthritis care & research. 06/2011; -
Article: Measuring process of arthritis care: a proposed set of quality measures for the process of care in juvenile idiopathic arthritis.
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ABSTRACT: The ability to assess quality of care is a necessary component of continuous quality improvement. The assessment typically is accomplished by determination of compliance with a defined set of quality measures (QMs). The objective of this effort was to establish a set of QMs for the assessment of the process of care in juvenile idiopathic arthritis (JIA). A 12-member working group composed of representatives from the American College of Rheumatology, American Academy of Pediatrics, American Board of Pediatrics, and Association of Rheumatology Health Professionals was assembled to guide the project. Delphi questionnaires were sent to 237 health professionals involved in the care of children with JIA. A total of 471 items in 23 domains were identified. The working group met via 4 live e-meetings during which results from the Delphi questionnaires were distilled to a reduced draft set. Each working group member selected a proposed QM to investigate and present evidence from the literature as to its attributes and appropriateness for inclusion into the set. Nominal group technique was used to come to consensus on a proposed set of QMs. The proposed set contains 12 QMs within 4 health care domains. Each QM consists of a statement of 1) the assessment to be completed, 2) when the first assessment should be completed and a suggested frequency of assessment during followup, 3) recommendations of appropriate tools or methods of assessment, and 4) initial performance goals. Implementation of the proposed QM set will improve the process of care, facilitate continuous quality improvement, and eventuate in improved health outcomes of children with JIA.Arthritis care & research. 01/2011; 63(1):10-6. -
Article: Long-term efficacy and safety of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis: findings from an open-label treatment extension.
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ABSTRACT: To assess the long-term efficacy and safety of infliximab plus methotrexate in juvenile rheumatoid arthritis (JRA). Patients eligible for the open-label extension (OLE, weeks 52-204) received infliximab 3-6 mg/kg every 8 weeks plus methotrexate. Of the 78/122 (64%) children entering the OLE, 42 discontinued infliximab, most commonly due to consent withdrawal (11 patients), lack of efficacy (eight patients) or patient/physician/sponsor requirement (eight patients). Infliximab (mean dose 4.4 mg/kg per infusion) was generally well tolerated. Infusion reactions occurred in 32% (25/78) of patients, with a higher incidence in patients positive for antibodies to infliximab (58%, 15/26). At week 204, the proportions of patients achieving ACR-Pedi-30/50/70/90 response criteria and inactive disease status were 44%, 40%, 33%, 24% and 13%, respectively. In the limited population of JRA patients remaining in the study at 4 years, infliximab was safe and effective but associated with a high patient discontinuation rate.Annals of the rheumatic diseases 04/2010; 69(4):718-22. · 8.11 Impact Factor -
Article: Long-Term Efficacy and Safety of Infliximab plus Methotrexate for The Treatment of Polyarticular Course Juvenile Rheumatoid Arthritis: Findings from an Open-Label Treatment Extension.
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ABSTRACT: OBJECTIVE: Assess long-term efficacy and safety of infliximab plus methotrexate (MTX) in juvenile rheumatoid arthritis (JRA). METHODS: Patients eligible for the open-label extension (OLE, weeks 52-204) received infliximab 3-6 mg/kg q8wks plus MTX. RESULTS: Of the 78/122 (64%) children entering the OLE, 42 discontinued infliximab, most commonly due to consent withdrawal (11 patients), lack of efficacy (8 patients) or patient/physician/sponsor requirement (8 patients). Infliximab (mean dose=4.4 mg/kg/infusion) was generally well tolerated. Infusion reactions occurred in 32% (25/78) of patients, with a higher incidence in patients positive for antibodies to infliximab (58%, 15/26). At week 204, the proportions of patients achieving ACR-Pedi-30/50/70/90 response criteria and inactive disease status were 44%, 40%, 33%, 24%, and 13%, respectively. CONCLUSIONS: In the limited population of JRA patients remaining in the study through 4 years, infliximab was safe and effective but associated with a high patient discontinuation rate.Annals of the rheumatic diseases 05/2009; · 8.11 Impact Factor -
Article: A randomized, placebo-controlled trial of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis.
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ABSTRACT: To evaluate the safety and efficacy of infliximab in the treatment of juvenile rheumatoid arthritis (JRA). This was an international, multicenter, randomized, placebo-controlled, double-blind study. One hundred twenty-two children with persistent polyarticular JRA despite prior methotrexate (MTX) therapy were randomized to receive infliximab or placebo for 14 weeks, after which all children received infliximab through week 44. Patients received MTX plus infliximab 3 mg/kg through week 44, or MTX plus placebo for 14 weeks followed by MTX plus infliximab 6 mg/kg through week 44. Although a higher proportion of patients in the 3 mg/kg infliximab group than in the placebo group had achieved responses according to the American College of Rheumatology (ACR) Pediatric 30 (Pedi 30) criteria for improvement at week 14 (63.8% and 49.2%, respectively), the between-group difference in this primary efficacy end point was not statistically significant (P = 0.12). By week 16, after the crossover from placebo to infliximab 6 mg/kg when all patients were receiving infliximab, an ACR Pedi 30 response was achieved in 73.2% of all patients. By week 52, ACR Pedi 50 and ACR Pedi 70 responses had been reached in 69.6% and 51.8%, respectively, of patients. Infliximab was generally well tolerated, but the safety profile of infliximab 3 mg/kg appeared less favorable than that of infliximab 6 mg/kg, with more frequent occurrences of serious adverse events, infusion reactions, antibodies to infliximab, and newly induced antinuclear antibodies and antibodies to double-stranded DNA observed with the 3 mg/kg dose. While infliximab at 3 mg/kg and 6 mg/kg showed durable efficacy at 1 year, achievement of the primary efficacy end point at 3 months did not differ significantly between infliximab-treated and placebo-treated patients. Safety data indicated that the 6-mg/kg dose may provide a more favorable risk/benefit profile. These results warrant further investigation in children with JRA.Arthritis & Rheumatism 10/2007; 56(9):3096-106. · 7.87 Impact Factor -
Article: Etanercept treatment in patients with refractory systemic onset juvenile rheumatoid arthritis.
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ABSTRACT: . To assess the efficacy and safety of etanercept in a large cohort of children with refractory systemic onset juvenile rheumatoid arthritis (SOJRA). Standardized questionnaires were sent to US pediatric rheumatologists about patients with SOJRA treated with etanercept. Data were collected at baseline and at the last visit on etanercept. Response to treatment was assessed and compared to baseline as the mean percentage reduction in the following: acute phase reactants, prednisone dose, active joint count, and physician global assessment of disease activity. Response was defined as poor if the mean reduction was < 30%, fair if 30% to < 50%, good if 50% to < 70%, and excellent if > 70%. We analyzed data obtained by survey of 82 SOJRA patients treated with etanercept for a mean of 25 months. Poor response to treatment was observed in 45% of the children, fair response in 9%, good in 13%, and excellent in 33%. Baseline steroid therapy could be discontinued in 27/59 (46%) patients. One or more disease flares occurred in 45% of all patients. Twenty-nine patients (35%) discontinued therapy, mostly due to lack of response or flare. There were 32 adverse event reports, most not considered serious, except for 2 cases of macrophage activation syndrome. In this cohort of children with SOJRA, 46% had a good or excellent response, and most were able to reduce concomitant corticosteroid doses. The response to etanercept was fair or poor in more than half our study population, and disease flares were common. Due to the unique cytokine profile of SOJRA, tumor necrosis factor blockade may not be the optimal therapeutic approach for children with treatment-resistant SOJRA.The Journal of Rheumatology 05/2005; 32(5):935-42. · 3.69 Impact Factor -
Article: Prolonged efficacy of etanercept in refractory enthesitis-related arthritis.
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ABSTRACT: For many children enthesitis-related arthritis (ERA) causes substantial morbidity, and conventional treatments frequently offer limited efficacy. Tumor necrosis factor-alpha (TNF-alpha) has been found to play a central role in the spondyloarthritides. We investigated the longterm efficacy of the TNF fusion protein etanercept in the treatment of patients with ERA refractory to disease modifying antirheumatic drug (DMARD) therapy. Eight patients with active, inflammatory ERA were treated in an open-label pilot trial of twice weekly subcutaneous injections (dosing range of 25 to 37.5 mg twice weekly, 0.2-0.8 mg/kg/dose) of etanercept for 2 years. Outcome measures included duration of morning stiffness, active joint count, hemoglobin, and erythrocyte sedimentation rate (ESR). Patients were permitted concomitant nonsteroidal antiinflammatory drugs (NSAID) and DMARD at stable doses. Treatment with etanercept resulted in significant improvement in active joint count, hemoglobin, and ESR in all 8 patients within 2 months. Additionally, all patients noted increased mobility and overall well being. Improvement in morning stiffness did not achieve statistical significance. One patient was lost to followup after completing one year of the study. The remaining 7 patients had sustained statistically significant efficacy for active joint count, hemoglobin, and ESR throughout the entire 2-year trial. All patients tolerated etanercept with no side effects. Despite limited power, these results indicate that etanercept provided a rapid clinical response in our cohort of patients with refractory ERA, who achieved sustained efficacy over a 2-year period.The Journal of Rheumatology 11/2004; 31(10):2055-61. · 3.69 Impact Factor
Top Journals
Institutions
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2011
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Cincinnati Children's Hospital Medical Center
Cincinnati, OH, USA
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2007–2009
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IRCCS Istituto G. Gaslini
Genova, Liguria, Italy
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2004
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Children's Hospital Central California
Madera, CA, USA
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