SP0191 Measuring Quality of Life in Young Adults with Jia in Clinical Practice

Abstract

BackgroundChildren and adolescents with Juvenile Idiopathic Arthritis (JIA) are at risk for the development of psychosocial problems and a lowered Health Related Quality of Life (HRQOL). These problems are not always identified during consultations with a rheumatologist. Therefore, adequate screening, monitoring and providing tailored interventions is necessary. The goal of the KLIK program is therefore to monitor the HRQOL and psychosocial functioning of children and young adults with chronic illnesses over extended periods of time and to facilitate communication between patient and practitioner. Children (0-18 years) or their parents complete questionnaires on before a consultation. The basis of KLIK is a generic HRQOL questionnaire. The decision of disease-specific HRQOL and psychosocial questionnaires is based on focus groups with practitioners. The answers on the questionnaires (Patient Reported Outcomes) are converted into a KLIK ePROfile. The KLIK ePROfile consists of a literal representation of the answers and a graphic presentation. The KLIK ePROfiles are available prior to a consultation. The practitioner retrieves the ePROfile from the website and discusses this with the patient and parents. The KLIK program is effective in increasing discussion about emotional and psychosocial functioning in pediatric care. However, young adults can also benefit from the use of KLIK in adult care. The aim of this project is to adapt the KLIK program for young adults and facilitate transition.MethodsTo adapt the website for young adults (16-30 years) we will conduct focus groups in order to select the most important themes. To know where their major problems in psychosocial functioning and HRQOL are and to select the most suitable questionnaires for feedback in the KLIK program, we will conduct a cross-sectional study. After this we will change the lay-out of the website to make it more usable for young adults.ResultsSince implementation began in pediatric care in 2011, 31 patient groups, (including children with JIA) over 300 professionals in 8 different hospitals and around 3000 pediatric patients have started using KLIK in the Netherlands. The first steps in adapting KLIK for young adults are taken by conducting the first focus groups and by adding transition-specific questionnaires to the KLIK website.ConclusionsThe implementation of KLIK appears to be feasible and workable in pediatric care, and with information from focus groups, cross-sectional research and adaption of the website for young adults we will explore if the program is also feasible in adult care.Disclosure of InterestNone declared

Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review

“…Of the 23 clinical, non-medical switching studies (Table 1) [53, 55, 56, 60, 61, 69, 70, 73–75, 81, 82, 84–86, 91–99, 101–104], 22 reported data on main efficacy parameters in switched versus non-switched or pre-switch versus post-switch groups. The originator biologics/biosimilars assessed were infliximab (six studies [53, 55, 56, 61, 69, 70, 73]), erythropoietin-stimulating agents (ESAs) (four studies [74, 75, 81, 82]), filgrastim [93–95] (three studies), insulin [84–86], adalimumab [96–98], rituximab [60, 99] and etanercept [101–103] (two studies each), and genotropin [83, 92] and follicle stimulating hormone [104] (one study each).…”

“…The originator biologics/biosimilars assessed were infliximab (six studies [53, 55, 56, 61, 69, 70, 73]), erythropoietin-stimulating agents (ESAs) (four studies [74, 75, 81, 82]), filgrastim [93–95] (three studies), insulin [84–86], adalimumab [96–98], rituximab [60, 99] and etanercept [101–103] (two studies each), and genotropin [83, 92] and follicle stimulating hormone [104] (one study each).…”

“…The NOR-SWITCH infliximab trial was conducted across six indications and used a non-inferiority margin of 15% (adapted from rheumatoid arthritis studies), with results suggesting no loss of efficacy and no unexpected treatment-emergent adverse events (TEAEs) [53]. Eight studies reported similar outcomes between groups, but failed to provide a formal statistical analysis of between-group comparisons [55, 56, 69, 70, 75, 98, 102–104]. …”

“…The relative frequency of ADAs in biologic originator and biosimilars was reported in 27 studies, of which 18 were clinical studies [53, 55, 56, 60, 61, 69, 70, 73, 81, 82, 84–86, 91, 92, 95–99, 101–104] and nine were observational [46–48, 52, 57, 63, 67, 68, 71, 105]. In 26 studies (17 clinical: follow-up 12–52 weeks [53, 55, 56, 60, 61, 69, 70, 73, 81, 82, 84, 85, 91, 92, 95–99, 101–103]; nine observational: follow-up 6–13 months [46–48, 52, 57, 63, 67, 68, 71, 105]), there were either no cases of ADAs, or the incidence of ADAs was similar in both groups.…”

“…Remission: 61% in each group; adjusted rate difference: 0.6% (95% CI − 7.5% to 8.8%)INX RP vs CT-P13: ≥ 1 TEAE: 70 vs 68%; infusion reactions: 4 vs 2%; serious TEAEs 10 vs 9%; discontinuation because of AE: 4 vs 3%. No deathsAt any time point, INX RP vs CT-P13: 11% vs 13%Kay et al 2015 (abstracts and poster) [55, 56]Rheumatoid arthritis ( N  = 189)53INX RP (Remicade ® ), 16 weeks (study also included patients on BOW015 throughout, with no switch)BOW015, 38 weeksINX RP/BOW015 vs BOW015/BOW015: similar disease activity and disability scores (shown as graph; statistical analysis NR)INX RP/BOW015 vs BOW015/BOW015, patients with ≥ 1 TEAE: 53 vs 48%; SAE: 6 vs 7%; infusion reaction: 2 vs 4%; discontinuation due to TEAE: 0 vs 1%INX RP/BOW015 vs BOW015/BOW015, week 30: 47 vs 42%; at week 58: 66 vs 65%Park et al 2017 [61]AS ( N  = 174) (PLANETAS open-label extension)86INX RP, 54 weeks (study also included patients on CT-P13 throughout, with no switch)CT-P13, 48 weeksClinical response maintained at similar levels before and after switch, and similar in switch and non-switch groups (all P NS)INX RP/CT-P13 vs CT-P13/CT-P13, proportion of patients with ≥ 1 TEAE during extension study: 71 vs 49%; considered related to study drug: 39 vs 22%INX RP/CT-P13 vs CT-P13/CT-P13, proportion of patients with ADAs at week 102: 27 vs 23% ( P NS) (all patients with ADAs also had nADAs)Smolen et al 2016 (abstract) [69]Rheumatoid arthritis ( N  = 396)94INX RP, 54 weeks (study also included patients on INX RP or SB2 throughout, with no switch)SB2, 24 weeksResponse rates were maintained and similar between groups (shown on graph)Incidence of AEs and infusion-related reactions, INX RP/INX RP: 36 and 2%; SB2/SB2: 40 and 4%; INX RP/SB2: 36 and 3%Newly developed ADAs, INX RP/INX RP: 15%; SB2/SB2: 14%; INX RP/SB2: 15%Tanaka et al 2017 [70]With rheumatoid arthritis ( N  = 104)33INX RP, duration 54 weeksCT-P13, duration 105 weeksMean DAS28 at end of follow-up, maintenance vs switch group: 3.2 vs 4.0; P NR); discontinuation because of lack of efficacy: 3 vs 3%≥1 AE, maintenance vs switch group: 90 vs 88%; discontinuation because of AE: 11 vs 24%Maintenance vs switch group at end of follow-up: 16 vs 17%. New ADA post switch: 3 vs 3%Yoo et al 2017 [73]Rheumatoid arthritis ( N  = 302) (PLANETRA open...…”