P408 Anti-Drug Antibodies Detected in the Presence of Adequate Infliximab Drug Levels In IBD Patients in Clinical Remission have Limited Clinical Significance

Abstract Background Immunogenicity, with the development of antibodies-to-infliximab (ATI) increases drug clearance and can lead to loss of infliximab (IFX) response in inflammatory bowel disease(IBD). Reporting of ATI is variable between commercial assays with some assays having high sensitivity for low-titre antibodies. Uniform thresholds for clinically relevant antibody titres are lacking. It is unclear how ATI affect treatment outcome when adequate trough IFX concentrations are present and ATI are detected. Methods We aimed to assess the impact of ATI detected in the presence of adequate IFX levels on the outcome of IFX therapy in IBD patients in clinical remission. A proactive therapeutic drug monitoring(TDM) strategy was utilized in our unit with IFX and ATI levels, assessed at trough, in all IBD patients receiving IFX. Baseline demographics were collected. Patients were grouped based on disease activity. An adequate trough IFX level was a concentration &amp;gt; 3 µg/mL, with low levels defined as &amp;lt; 3 µg/mL. ATI positivity was defined as a concentration &amp;gt; 10 AU/mL. Receiver operating characteristic analysis was performed to evaluate the classifying performance of ATI concentration for low IFX levels. Survival analysis was performed to determine IFX persistence in patients with adequate IFX levels and positive ATI. Follow up TDM assessments, where available, were documented to determine changes in ATI concentration over time in patients with adequate IFX levels. Results 108 patients were included. Median age 36years. 46% were female. 36% had ulcerative colitis, 60% Crohn’s disease. 35% were receiving concomitant immunomodulators. 56% of patients were in remission at the time of TDM assessment. 44%, 30% and 26% of patients had IFX levels &amp;lt; 3 µg/mL, 3 – 7 µg/mL and &amp;gt; 7 µg/mL. Median [range] ATI concentration was 11 AU/mL [0 – 800]. ATI positivity occurred in 25%, 19% and 8% of IFX groups with levels &amp;lt; 3 µg/mL, 3 – 7 µg/mL and &amp;gt; 7 µg/mL. There was a weak inverse correlation between trough ATI and IFX concentration (p=0.01)(Figure 1). ATI concentration performed poorly as a classifier of low IFX levels (AUC 0.568)(p=0.39). 83%(15/18) of IBD patients in remission with adequate IFX levels and positive ATI remained on IFX for the duration of follow up with a mean cumulative time on IFX of 111.2 weeks (95% CI 105.1 – 117.3)(Figure 2). In this group, there was no significant change in ATI titre comparing index with follow up TDM assessments (p=0.14)(Figure 3). Conclusion ATI positivity in the presence of adequate IFX levels is common with proactive TDM. For patients in clinical remission ATI positivity in the presence of adequate IFX levels has limited clinical significance. Care should be taken to avoid unnecessary therapy alterations in this patient subgroup. </jats:sec

P449 Cost Effectiveness of a Proactive Therapeutic Drug Monitoring Strategy in Patients with Inflammatory Bowel Disease Receiving Infliximab

Abstract Background Proactive therapeutic drug monitoring (TDM) has not demonstrated improved therapy outcomes compared with clinically-based dosing strategies. While the use of proactive TDM incurs additional assay-related costs this strategy may be cost-effective due to TDM-driven therapy dose de-escalation and discontinuation. Methods We aimed to assess if proactive-TDM is cost-effective in clinical practice. A proactive TDM strategy was utilized in our unit with infliximab (IFX) and antibody-to-infliximab (ATI) levels assessed at trough in all inflammatory bowel disease(IBD) patients receiving IFX. Baseline demographics and IFX dosing schedules were documented. Patients were grouped based on disease activity status. Patients with IFX levels outside therapeutic range had dosing adjusted as appropriate. IFX dose adjustments were not protocolized and were at physicians discretion. IFX dosing regimens following proactive TDM were documented and net effect on IFX infusions number over the subsequent year extrapolated. Increase or decrease in drug-related costs on an annualized basis were estimated. Results 108 patients were included. Median age 36 years. 46% were female. 36% had ulcerative colitis, 60% Crohn’s disease. 35% were receiving concomitant immunomodulators. 56% were in remission at the time of TDM. 44%, 30% and 26% had IFX levels &amp;lt; 3 µg/mL, 3 – 7 µg/mL and &amp;gt; 7 µg/mL. IFX levels were significantly lower in patients with active disease compared with those in remission(p=0.008). Following proactive TDM assessment 37%, 11%, 36%, 13%, 2% and 1% of patients had no treatment change, therapy discontinuation, interval shortening, interval lengthening, dose increase and dose decrease respectively. Cost-effectiveness analysis focused on patients in remission (n=59). The use of proactive TDM-based IFX dosing resulted in a projected annualized reduction of 19.5 and 28.5 infusions due to IFX discontinuation and interval lengthening; the projected annualized increase in infusions was 39.1 and 4.3 due to IFX interval shortening and dose increase. This resulted in a net projected reduction of 4.7 IFX infusions per annum. Utilizing publicly available list prices for originator and biosimilar IFX and accounting for assay cost, projected cost savings resulting from proactive-TDM was 9105.0 and 6840.7 Euro per annum. Conclusion Proactive TDM in IBD patients in remission resulted in a modest reduction in the projected annualized number of infusions in our unit with consequent minor drug-related cost savings. Proactive-TDM encouraged cost-effective prescribing of IFX, however, the effect was minor. The frequency at which proactive TDM should be performed and whether subsequent rounds of proactive-TDM would continue to deliver similar cost savings is uncertain. </jats:sec

INTERAÇÕES ENTRE ENFERMEIRAS E PAIS DE CRIANÇAS HOSPITALIZADAS

With the purpose of supplying subsidies to nurses who work in pediatric wards, and using observation as method, the author attempts to analise and comment the interactions that occur between nurses and parents of hospitalized children in different, but usual situations during the hospitalization of children.Com a finalidade de oferecer subsidios às enfermeiras de unidades pediátricas e utilizando a observação como método, a autora procura analisar e comentaras interações que ocorrem entre enfermeiras e pais de crianças hospitalizadas em diferentes situações que são comuns à hospitalização de crianças

A EXPERIÊNCIA DE ACOMPANHAR UM FILHO HOSPITALIZADO: SENTIMENTOS, NECESSIDADES E EXPECTATIVAS MANIFESTADOS POR MÃES ACOMPANHANTES

This work had the finality of searching elements to improve the living-in mothers assistance in our hospitals. The population under study included accompanying mothers in two different pediatric units. The differences between the two units were with respect to room accomodations for mothers and stipulations as to the type of disease pathology being treated. The data was collected by way of interviews in which a questionnaire of open questions was used. Results showed that the rooming-in mothers of the sample felt more discomfort than confort in the hospital, due to many different aspects of the hospital situation; the principal need of the studied mothers was to be able to give care to their children, while others needs related to receiving information about their child's condition. The living-in mothers expected to have personal contact with the hospital health team while the hospital personnel would be giving assistance to the children. Many reasons were given for the varying needs and expectations of the rooming-in mothers, showing the individuality of these women and the different ways in which a living-in experience affect different mothers.Este trabalho, realizado para atender uma motivação pessoal da autora, teve como finalidade a de encontrar elementos que permitissem melhorar a assistência à mãe acompanhante em nosso meio. A população constou de mães que acompanhavam seus filhos internados em duas unidades pediátricas que apresentavam sistema de internação conjunta de características diferentes, bem como diferenças quanto ao tipo de patologia assistida. Os dados foram colhidos por meio de entrevista, utilizando-se um formulário com perguntas abertas. Verificou-se que as mães acompanhantes sentem mais mal-estar do que bem-estar no hospital e que elas justificam seu mal-estar principalmente através de uma gama de razões relacionadas à situação hospitalar; que a principal nececessidade das mães na situação estudada é dar cuidados ao filho, além de apresentarem necessidades como informações; que as mães acompanhantes esperam contatos pessoais da equidpe hospitalar e que o pessoal hospitalar dê assistência às crianças. Constatou-se também uma grande variedade de motivos determinando tanto as necessidades quanto as expectativas das mães, motivos esses que evidenciam a individualidade das mães e dos significados únicos que a experiência de acompanhar um filho hospitalizado têm para cada uma delas