Сравнительная оценка эффективности базисных препаратов при лечениидетей и подростков с различными вариантами ювенильного идиопатического артрита

Objective. To specify the diagnosis of juvenile idiopathic arthritis (JIA) and to define the significance of pathogenetic changes, the authors have studied cellular and humoral immunological parameters, which are of the greatest informative value in this pathology: CD4+, CD4+/CD8+, CD8+, CD16+, CD95+ in the serum, as well as a spectrum of interleukins (IL): tumor necrosis factor-а, IL-6, IL-1, and IL-4. Subjects and methods. An optimal basic drug was selected for a specific form of JIA. Preference is given to cyclosporine and methorexate (MT) in its polyarticular form with the high activity of an inflammatory process, to MT, cyclosporine A, and auranofin in the disseminated form of oligoarthritis, and to auranofin and sulfasalazine in the persistent form. Results. None of the basic drugs is superior while individually choosing a treatment and this or that drug has to be very frequently chosen empiricallyЦель исследования. Для уточнения диагноза ювенильного идиопатического артрита (ЮИА) и определения значения патогенетических изменений исследовали показатели клеточного и гуморального иммунитета, наиболее информативные при данной патологии: CD4+, CD4+/CD8+, CD8+, CD16+, CD95+ в сыворотке крови, а также спектр интерлейкинов (ИЛ): ФНО а, ИЛ 6, ИЛ 1, ИЛ 4. Материал и методы. Для конкретной формы ЮИА подбирали оптимальный базисный препарат. При полиартикулярной форме с высокой степенью активности воспалительного процесса предпочтение отдавали циклоспорину и метотрексату (МТ); при распространяющемся варианте олигоартрита - МТ, циклоспорину А (ЦсА), ауранофину, при персистирующем варианте - ауранофину, сульфасалазину. Результаты исследования. Ни один из базисных препаратов не являлся исключительным при индивидуальном подборе лечения, и очень часто в ходе лечения приходилось эмпирически подбирать тот или иной препарат

Proceedings of the 24th Paediatric Rheumatology European Society Congress: Part three

From Springer Nature via Jisc Publications Router.Publication status: PublishedHistory: collection 2017-09, epub 2017-09-0

American College of Rheumatology Provisional Criteria for Clinically Relevant Improvement in Children and Adolescents With Childhood-Onset Systemic Lupus Erythematosus

10.1002/acr.23834ARTHRITIS CARE & RESEARCH715579-59

COMPARATIVE EVALUATION OF THE EFFICIENCY OF BASIC DRUGS IN THE TREATMENT OF CHILDREN AND ADOLESCENTS WITH DIFFERENT TYPES OF JUVENILE IDIOPATHIC ARTHRITIS

Objective. To specify the diagnosis of juvenile idiopathic arthritis (JIA) and to define the significance of pathogenetic changes, the authors have studied cellular and humoral immunological parameters, which are of the greatest informative value in this pathology: CD4+, CD4+/CD8+, CD8+, CD16+, CD95+ in the serum, as well as a spectrum of interleukins (IL): tumor necrosis factor-а, IL-6, IL-1, and IL-4. Subjects and methods. An optimal basic drug was selected for a specific form of JIA. Preference is given to cyclosporine and methorexate (MT) in its polyarticular form with the high activity of an inflammatory process, to MT, cyclosporine A, and auranofin in the disseminated form of oligoarthritis, and to auranofin and sulfasalazine in the persistent form. Results. None of the basic drugs is superior while individually choosing a treatment and this or that drug has to be very frequently chosen empiricall

Efficacy and safety of tocilizumab in patients with polyarticular-course juvenile idiopathic arthritis : results from a phase 3, randomised, double-blind withdrawal trial

Objective To evaluate the interleukin-6 receptor inhibitor tocilizumab for the treatment of patients with polyarticular-course juvenile idiopathic arthritis ( pcJIA). Methods This three-part, randomised, placebocontrolled, double-blind withdrawal study (NCT00988221) included patients who had active pcJIA for ≥6 months and inadequate responses to methotrexate. During part 1, patients received open-label tocilizumab every 4 weeks (8 or 10 mg/kg for body weight (BW) <30 kg; 8 mg/kg for BW ≥30 kg). At week 16, patients with ≥JIA-American College of Rheumatology (ACR) 30 improvement entered the 24- week, double-blind part 2 after randomisation 1:1 to placebo or tocilizumab (stratified by methotrexate and steroid background therapy) for evaluation of the primary end point: JIA flare, compared with week 16. Patients flaring or completing part 2 received open-label tocilizumab. Results In part 1, 188 patients received tocilizumab (<30 kg: 10 mg/kg (n=35) or 8 mg/kg (n=34); ≥30 kg: n=119). In part 2, 163 patients received tocilizumab (n=82) or placebo (n=81). JIA flare occurred in 48.1% of patients on placebo versus 25.6% continuing tocilizumab (difference in means adjusted for stratification: −0.21; 95% CI −0.35 to −0.08; p=0.0024). At the end of part 2, 64.6% and 45.1% of patients receiving tocilizumab had JIA-ACR70 and JIAACR90 responses, respectively. Rates/100 patient-years (PY) of adverse events (AEs) and serious AEs (SAEs) were 480 and 12.5, respectively; infections were the most common SAE (4.9/100 PY). Conclusions Tocilizumab treatment results in significant improvement, maintained over time, of pcJIA signs and symptoms and has a safety profile consistent with that for adults with rheumatoid arthritis

Subcutaneous Abatacept in Patients With Polyarticular-Course Juvenile Idiopathic Arthritis: Results From a Phase III Open-Label Study

To investigate pharmacokinetics, effectiveness, and safety of subcutaneous (SC) abatacept over 24 months (M) in patients with polyarticular-course juvenile idiopathic arthritis (pJIA).status: accepte

Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis: results of a multicentre, double-blind, randomised-withdrawal trial

OBJECTIVE: This report aims to determine the safety, pharmacokinetics (PK) and efficacy of subcutaneous golimumab in active polyarticular-course juvenile idiopathic arthritis (polyJIA). METHODS: In this three-part randomised double-blinded placebo-controlled withdrawal trial, all patients received open-label golimumab (30 mg/m2 of body surface area; maximum: 50 mg/dose) every 4 weeks together with weekly methotrexate during Part 1 (weeks 0-16). Patients with at least 30% improvement per American College of Rheumatology Criteria for JIA (JIA ACR30) in Part 1 entered the double-blinded Part 2 (weeks 16-48) after 1:1 randomisation to continue golimumab or start placebo. In Part 3, golimumab was continued or could be restarted as in Part 1. The primary outcome was JIA flares in Part 2; secondary outcomes included JIA ACR50/70/90 responses, clinical remission, PK and safety. RESULTS: Among 173 patients with polyJIA enrolled, 89.0% (154/173) had a JIA ACR30 response and 79.2%/65.9%/36.4% demonstrated JIA ACR50/70/90 responses in Part 1. At week 48, the primary endpoint was not met as treatment groups had comparable JIA flare rates (golimumab vs placebo: 32/78=41% vs 36/76=47%; p=0.41), and rates of clinical remission were comparable (golimumab vs placebo: 10/78=12.8% vs 9/76=11.8%). Adverse event and serious adverse event rates were similar in the treatment groups during Part 2. Injection site reactions occurred with <1% of all injections. PK analysis confirmed adequate golimumab dosing for polyJIA. CONCLUSION: Although the primary endpoint was not met, golimumab resulted in rapid, clinically meaningful, improvement in children with active polyJIA. Golimumab was well tolerated, and no unexpected safety events occurred. CLINICAL TRIAL REGISTRATION: NCT01230827; Results

Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee

Background To derive a list of opportunistic infections (OI) through the analysis of the juvenile idiopathic arthritis (JIA) patients in the Pharmachild registry by an independent Safety Adjudication Committee (SAC). Methods The SAC (3 pediatric rheumatologists and 2 pediatric infectious disease specialists) elaborated and approved by consensus a provisional list of OI for use in JIA. Through a 5 step-procedure, all the severe and serious infections, classified as per MedDRA dictionary and retrieved in the Pharmachild registry, were evaluated by the SAC by answering six questions and adjudicated with the agreement of 3/5 specialists. A final evidence-based list of OI resulted by matching the adjudicated infections with the provisional list of OI. Results A total of 772 infectious events in 572 eligible patients, of which 335 serious/severe/very severe non-OI and 437 OI (any intensity/severity), according to the provisional list, were retrieved. Six hundred eighty-two of 772 (88.3%) were adjudicated as infections, of them 603/682 (88.4%) as common and 119/682 (17.4%) as OI by the SAC. Matching these 119 opportunistic events with the provisional list, 106 were confirmed by the SAC as OI, and among them infections by herpes viruses were the most frequent (68%), followed by tuberculosis (27.4%). The remaining events were divided in the groups of non-OI and possible/patient and/or pathogen-related OI. Conclusions We found a significant number of OI in JIA patients on immunosuppressive therapy. The proposed list of OI, created by consensus and validated in the Pharmachild cohort, could facilitate comparison among future pharmacovigilance studies