J González García

GRP-078 Guideline For Albumin Use: Effect on Cost Saving

Background Albumin has been widely used in clinical practise. While some of these indications are supported by the results of randomised studies, others are based only on clinical experience and have not been proved in prospective studies. Efforts should be made to define the indications for albumin use, so that patients gain the maximum benefit from its administration. Purpose To evaluate the cost saving obtained by the implementation of a guideline for albumin use in a 737-bed hospital. Materials and Methods Retrospective study that compared albumin use in two periods: July–September 2012 vs. July–September 2011. In June 2012 the guideline for albumin use was distributed to the medical staff. Physicians were requested to complete a form for each albumin order indicating the type and amount of albumin, the clinical service, and the indication for use. Albumin use data and costs were obtained from pharmacy service management system (SAP®) and were tabulated using the Excel® software. Results The total amount of albumin ordered during the study period was 29.360 g (€63,246) vs. 53.195 g (€108,617) for the same period during 2011, which means a reduction of 45%. In terms of cost, the saving obtained amounted to €45,371 (58%). The albumin use by specialty had also changed; a major decrease in use of albumin was observed for Anaesthesiology 4,000 g (75%), General Surgery 3,080 g (65%), Nephrology 4,900 g (64%), Internal Medicine 3,860 g (56%), Haematology 1,410 g (53%) and Digestive 1,400 g (30%). On the other hand, Haemodialysis significantly increased its use of albumin to 2,805 g (65%), although within the approved indication of plasmapheresis. Conclusions An albumin use guideline with restrictions focused on albumin prescriptions had suficient efficacy to reduce consumption and save cost. In our hospital guideline the cost of implementation decreased a 58% (€181,484 per year). No conflict of interest.

4CPS-212 Relationship between ugt1a1*28 and serum bilirubin levels

Background UGT1A1 polymorphisms have been relatated to interindividual variability effectiveness and toxicity in many drugs. In addition, the presence of mutated alleles in this gene has also been identified historically as Gilbert’s disease which exhibits high levels of unconjugated bilirubin. Purpose Analysing the relationship between total serum bilirubin levels and rs8175347 (*28) polymorphism in the UGT1A1 gene. Material and methods Observational, retrospective and unicentre study of 2 years was carried out. Patients with colorectal cancer who have been tested for gDNA determination of UGT1A1 genotype for clinical practice were included. Clinical data were obtained using the application SAP®. A high level of total-bilirrubine was considered as at least a 90% determination, with total-bilirubin higher than 1 mg/dL. Polymorphism *28 of UGT1A1 was established by analysing the genomic DNA of a peripheral blood sample. Genetic characterisation was carried out using the LightClycler® 480 platform and specific allele HybProbe fluorescent probes. The relationship between the UGT1A1 genotype and levels of total serum bilirrubine were determined by univariable statistical analysis. Patients were requested to sign an informed consent form prior to the inclusion. Results One hundred and seventy-three patients were included in the study, with a median age of 62 years (81–27) and 62.3% were males. 46,2% of participants had WT genotype: 21.2% (n=17) of them showed high levels of total serum bilirubin. On the other hand, 53.7% of patients had mutant alleles (*1/*28. *28/28), of which 36.5% (n=34) showed high levels of bilirubin (p=0.003). Conclusion Our results show that the presence of *28 allele in UGT1A1 is associated with high levels of serum bilirubin. With these results, we feel that this finding could provide the clinician with a tool to detect patients with high risk of drug toxicity such as irinotecan or pazopanib, among others. No conflict of interest

4CPS-146 Ustekinumab and adalimumab for psoriasis patients who are no-responders to etanercept: a comparative effectiveness study

Background Adalimumab and ustekinumab have demonstrated high effectiveness in the treatment of moderate-severe psoriasis in randomised controlled trials. There is, however, limited data available on the comparative effectiveness of ustekinumab and adalimumab in psoriasis patients unsuccessfully treated with a first biologic line with etanercept. Purpose To evaluate the comparative effectiveness of adalimumab and ustekinumab in patients previously treated with etanercept using PASI 90 score. Material and methods A single-centre, retrospective, observational, comparative study was carried out from 1 November 2011 to 31 November 2015. Participants were patients with moderate-severe psoriasis that, after unsuccessful etanercept therapy, were treated with adalimumab or ustekinumab. An unblinded revision of each patient’s clinical history was carried out to assess clinical data. The primary analysis compared the percentages of patients in each treatment group who achieved ≥90% improvement from baseline PASI score (PASI 90) at week 12. Secondary endpoints included percentages of patients with PASI 90 at week 96. Statistical analysis was performed with the SPSS 22.0 software. Results Thirty-four psoriasis patients were included in the study: 15 (44.1%) patients received adalimumab and 19 (55.9%) received ustekinumab as a second-line therapy. The median age in adalimumab and ustekinumab group were 58 (SD 6.7) and 50 years (SD 17.3) (p=0.08). After 12 weeks of study treatment, 68.4% of ustekinumab-treated patients (13/19) achieved a PASI 90 response against 46.6% (7/15) in the adalimumab group (p=0.2). At week 96, more patients had a PASI 90 in the ustekinumab group compared with the adalimumab group, but the difference was not statistically significant (68.4% versus 46.6%; p=0,2). Conclusion Previously studies have shown that adalimumab and ustekinumab are effective after anti-TNF inhibitors’ therapy. However, to our knowledge, the present study is the first to evaluate the comparative effectiveness measured as PASI 90 of ustekinumab and adalimumab in psoriasis patients that failed with etanercetp. Our results suggests that there is no significant difference in the efficacy of ustekinumab between ustekinumab and adalidumab in the percentage of patients achieving PASI90. Of course, these results need to be evaluated with randomised and prospective clinical trials. References and/or Acknowledgements 1. J Dermatolog Treat2015;26(3):217–22. 2. J Eur Acad Dermatol Venereol2011;25(9):1037–40. No conflict of interest

OHP-005 Carbapenem restriction and its long term effectivness in an intensive care unit

This abstract was published in error and withdrawn at the author’s request.

DI-067 Analysis of the use of teriflunomide in a tertiary hospital

Background Teriflunomide is an immunomodulatory agent with anti-inflammatory properties that inhibits the mitochondrial enzyme dehidroorotato-dehydrogenase (DHO-DH), which is required for the synthesis of pyrimidine, blocking the proliferation of activated B and T lymphocytes. It is believed that the therapeutic effect is related to the reduction in the number of lymphocytes. It is indicated for the treatment of adult patients with relapsing-remitting multiple sclerosis with the advantage of oral administration. Purpose To analyse the use of teriflunomide in patients diagnosed with multiple sclerosis. Material and methods A retrospective observational study from January 2013 to May 2015. We used the SAP program to evaluate the clinical history and dispensations of patients treated with teriflunomide. The following data were recorded: sex, age, EDSS, previous treatments, control of liver enzymes, kidney function, blood pressure and pregnancy test. Results 18 patients, 17 women and 1 man, were evaluated, with an average age of 41.11 years (range 23–79). Mean EDSS was 1.85 (1–5). All patients had recorded blood pressure, blood count, and kidney and liver function approximately every 2 weeks. Teriflunomide was prescribed as the firstline treatment in 5 patients (27.77%), as secondline in 3 patients (16.66%), as the third treatment in 8 patients (44.44%), and as the fourth and fifth treatments, respectively, in 1 patient (5.55%). Two patients began it before marketing. The immediately preceding treatment was glatiramer acetate in 5 patients, dimethyl fumarate in 1, interferon beta 1a 44 µg in 5 and interferon beta-1a 30 µg in 2 patients. The reasons for the change were cutaneous adverse effects on local reaction at the injection site in all cases except for dimethyl fumarate (digestive intolerance). The average duration of treatment with teriflunomide was 3.77 months (1–20), without any abandonment of treatment by that time. Conclusion While reports of teriflunomide therapeutic positioning is indicated at the forefront of relapsing-remitting multiple sclerosis, only 29.41% of our patients were prescribed this as the first choice. In the future, more patients may start teriflunomide as the firstline treatment given the comfort of the route of administration and good tolerance. Due to the short time to market, a longer term review is needed to verify the response to the drug. References and/or Acknowledgements http://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/IPT-teriflunomida-aubagio.pdf No conflict of interest.

CP-098 Is the combination daptomycin-cloxacilin associated with better prognosis in methicillin susceptible staphylococcus aureus bacteraemia compared with cloxacilin monotherapy?

Background Methicillin susceptible Staphylococcus aureus (MSSA) bacteraemia continues to be associated with high clinical failure rates. Combination therapy has been proposed as an alternative to improve outcomes but there is a lack of clinical studies. Purpose To evaluate if the combination of daptomycin plus cloxacilin achieves higher clinical success rates in the treatment of MSSA bacteraemia than cloxacilin alone. Material and methods A single centre, retrospective, observational, comparative study was performed between January 2015 and August 2015. The subjects were patients with MSSA bacteraemia who received cloxacilin as monotherapy (standard therapy group) or the combination cloxacilin plus daptomycin. A revision of the clinical history of each patient was carried out to asses clinical, laboratoy and microbiological data. The main outcome variable was 30 day all-cause mortality and 30 day all-cause hospital readmission. Secondary endpoints were: (i) percentage of patients who achieved a decrease in CRP levels to <50% of their initial value in the first 72 h of therapy; (ii) length of hospital stay (LOS); and (iii) percentage of patients with persistent bacteraemia after 72 h of initiation of therapy. Results 14 patients met the study criteria. 7 (50%) patients received cloxacilin as monotherapy and 7 (50%) received the combination cloxacilin-daptomycin. No differences in 30 day all-cause mortality were observed (14% (1/7 in the standard therapy group vs 14% (1/7) in the combination group). No statistical differences between groups were observed in all-cause readmission at 30 days (14% (1/7) in the standard group vs 0/7 in the combination group (p = 0.337)). Similarly, there were no differences in the secondary endpoints: LOS (median 32 vs 37 days, p = 0.86) and a decrease in CRP levels to <50% of their initial value in the first 72 h of therapy (42% (3/7) in the combination group vs 28% (2/7) in the standard therapy group (p = 0.611)). The rate of persistent bacteraemia did not differ between the two groups. Conclusion Our data showed a benefit of adding daptomycin to cloxacilin in patients with MSSA bacteraemia. However, studies with a large number of patients are required to define the role of combination therapy in patients with MSSA bacteraemia. References and/or Acknowledgements Emerg Infect Dis 2011;17:1099-102 No conflict of interest.

PKP-008 Long term stability of trastuzumab in serum samples

Background Immunoassays remain the primary analytical method for quantification of macromolecules such as monoclonal antibodies (mAbs). For the quantification of mAbs in serum or plasma, study samples are not immediately analysed once collected, and thus the various conditions that study samples undergo must be considered to ensure that analytical stability has not been compromised. Purpose To analyse the long term stability of the monoclonal antibody trastuzumab (Herceptin) in serum samples at -20°C. Material and methods Blood samples (1.5 mL) were stored in K2EDTA tubes (Becton Dickinson, USA). They were immediately sent to the laboratory, centrifuged (2 × 3000 g/5 min) and were divided into two aliquots. One aliquot was immediately analysed. The second aliquot was stored at −20°C for 2 months and then analysed. The immediately analysed samples were considered the baseline value. At the time of analysis, both samples were analysed at dilutions of 1/20 and 1/80 in duplicate to minimise pipetting errors and the intrinsic variation of the method. Serum trastuzumab concentrations were determined by enzyme linked immunosorbent assay (ELISA) using the automated analyser TRITURUS (Grifols). SPSS statistical (v.22.0.0.0) program was used for statistical analysis. Repeated measurements made from the same samples kept under different storage conditions were tested using the Wilcoxon test. A p value <0.05 was considered to be significant. The research protocol was approved by the local ethics committee of our institution. Results Blood samples from 4 patients a with diagnosis of HER2+ breast cancer receiving treatment with subcutaneus trastuzumab (Herceptin) were included in the study after providing written informed consent. We did not find a significant difference between the samples analysed immediately and those stored at -20°C for 60 days (p = 0.414) (table 1).Abstract PKP-008 Table 1 Patient Trastuzumab concentration day 1 (μg/mL) Trastuzumab concentration day 60 (μg/mL) Difference (%) 1 46 48 4.3 2 70 68 -2.8 3 50 50 0 4 86 82 -4.65 Conclusion In our study, we observed that serum trastuzumab (Herceptin) samples stored at -20°C were stable for at least 2 months. This was consistent with previous studies. References and/or Acknowledgements Ficha Técnica Herceptin No conflict of interest.

CP-080 Comparative effectiveness of ustekinumab and adalimumab in psoriasis patients previously treated with etanercept

Background Adalimumab and ustekinumab have demonstrated a high level of efficacy in the treatment of moderate-severe psoriasis in randomised controlled trials. There are, however, no data available on the comparative effectiveness of ustekinumab and adalimumab in psoriasis patients switching from etanercept. Purpose To evaluate the comparative effectiveness of adalimumab and ustekinumab in patients previously treated with etanercept. Material and methods A single centre, retrospective, observational, comparative study was carried out from 1 November 2011 to 31 March 2013, with a follow-up of 2 years. Subjects were patients with moderate-severe psoriasis that after etanercept therapy were treated with adalimumab or ustekinumab. A revision of each patient’s clinical history was carried out to asses clinical data. The primary analysis compared the percentages of patients in each treatment group who achieved ≥75% improvement from baseline PASI score (PASI 75) at week 12. Secondary endpoints included the percentages of patients with PASI 75 at week 96. Statistical analysis was performed with the SPSS 22 software. Results 28 psoriasis patients were included: 11 (39.3%) patients received adalimumab and 17 (60.7%) received ustekinumab as secondline therapy. Median age in the adalimumab and ustekinumab groups were 58 (SD 6.5) years and 49 years (SD 16.3), respectively (p = 00.08). After 12 weeks of study treatment, 76.5% of ustekinumab treated patients (13/17) achieved a PASI 75 response compared with 36.4% (4/11) in the adalimumab group (p = 0.034). At week 96, more patients had a PASI 75 in the ustekinumab group compared with the adalimumab group, but the difference was not statistically significant (70.6% vs 36.4%, p = 0.07). Conclusion Previously studies have shown that adalimumab and ustekinumab are effective after anti-TNF inhibitor therapy. However, to our knowledge, the present study is the first to evaluate the comparative effectiveness of ustekinumab and adalimumab in psoriasis patients switching from etanercept. Our study suggests that ustekinumab is associated with a higher effectiveness compared with adalimumab as secondline treatment in patients previously treated with etanercept. Prospective, randomised studies with a large number of patients are required to establish the optimal treatment in psoriasis patients who have previously received etanercept. References and/or Acknowledgements J Dermatolog Treat 2015;26:217-22 J Eur Acad Dermatol Venereol 2011;25:1037-40 No conflict of interest.

OHP-037 Financial impact of simplifying antiretroviral therapy in hiv patients

Background In recent years, simplification of antiretroviral therapy is increasingly being recognised as an attractive therapeutic alternative for cost minimization. Currently, this kind of treatment is used in patients without a prior history of failure of protease inhibitors (PIs), with an undetectable viral load for the last 6 months and signs or symptoms of toxicity from nucleoside analogues. Purpose To describe the cost savings that have been achieved by changing triple therapy in antiretroviral treatment to monotherapy with a protease inhibitor (PI) boosted with ritonavir in HIV patients. Material and methods Cross-sectional study in which all patients who were on antiretroviral monotherapy on a particular date (1 March 2014) were included. The following variables obtained from the SAP application were recorded: the current and previous treatment, as well as the duration of each of the schemes. The prices of antiretroviral drugs used were those for which the Pharmacy Department had acquired them. Results A total of 953 patients were on antiretroviral treatment on 1 March 2014, 33 of whom were prescribed monotherapy boosted with ritonavir; 21 with darunavir/ritonavir and 12 with lopinavir/ritonavir. Median duration of treatment was 23 months (standard deviation (SD) = 18.69). The treatment simplification in these patients has meant savings of €263.000 (monthly average of €286 per patient (SD = €156)). The simplifications that showed higher rates of reduction of direct acquisition costs of the drugs were the switching of atazanavir/ritonavir+ tenofovir + abacavir for darunavir/ritonavir (−55% (€449/month/patient)), and atazanavir/ritonavir + tenofovir+ efavirenz for lopinavir/ritonavir (−52% (€446/month/patient)). Conclusion Simplification of antiretroviral therapy translates to an average monthly saving of 290 euros per patient, which has meant savings of €260,000 euros in comparison to the previous treatment these 33 patients had received. It is necessary to carry out more studies to corroborate that simplified antiretroviral therapy is, besides being financially attractive, a strategy as effective as traditional antiretroviral therapy. References and/or acknowledgements No conflict of interest.Background In recent years, simplification of antiretroviral therapy is increasingly being recognised as an attractive therapeutic alternative for cost minimization. Currently, this kind of treatment is used in patients without a prior history of failure of protease inhibitors (PIs), with an undetectable viral load for the last 6 months and signs or symptoms of toxicity from nucleoside analogues. Purpose To describe the cost savings that have been achieved by changing triple therapy in antiretroviral treatment to monotherapy with a protease inhibitor (PI) boosted with ritonavir in HIV patients. Material and methods Cross-sectional study in which all patients who were on antiretroviral monotherapy on a particular date (1 March 2014) were included. The following variables obtained from the SAP application were recorded: the current and previous treatment, as well as the duration of each of the schemes. The prices of antiretroviral drugs used were those for which the Pharmacy Department had acquired them. Results A total of 953 patients were on antiretroviral treatment on 1 March 2014, 33 of whom were prescribed monotherapy boosted with ritonavir; 21 with darunavir/ritonavir and 12 with lopinavir/ritonavir. Median duration of treatment was 23 months (standard deviation (SD) = 18.69). The treatment simplification in these patients has meant savings of €263.000 (monthly average of €286 per patient (SD = €156)). The simplifications that showed higher rates of reduction of direct acquisition costs of the drugs were the switching of atazanavir/ritonavir+ tenofovir + abacavir for darunavir/ritonavir (−55% (€449/month/patient)), and atazanavir/ritonavir + tenofovir+ efavirenz for lopinavir/ritonavir (−52% (€446/month/patient)). Conclusion Simplification of antiretroviral therapy translates to an average monthly saving of 290 euros per patient, which has meant savings of €260,000 euros in comparison to the previous treatment these 33 patients had received. It is necessary to carry out more studies to corroborate that simplified antiretroviral therapy is, besides being financially attractive, a strategy as effective as traditional antiretroviral therapy. References and/or acknowledgements No conflict of interest.

DI-089 Effectiveness of abiraterone in prostate cancer in clinical practice

Background Abiraterone is an expensive drug used in hospitals for metastatic prostate cancer and it is necessary to evaluate health outcomes from its use to establish whether it is cost-effective treatment. Purpose To analyse the effectiveness profile of abiraterone for metastatic prostate cancer in a tertiary hospital. Material and methods Retrospective observational study of three years, since abiraterone was first marketed to the present (November 2011–July 2014). All prostate cancer patients treated with abiraterone were included. Variables recorded: age, performance status (ECOG) and progression-free survival (PFS). Data were collected from patients medical records. The statistical analysis was ANOVA followed by t test. A confidence limit of p < 0.05 was set for the interpretation of results. Results 33 patients were included in the study. The median age was 72.7 (SD 9.1) years old. The PFS was 7.0 (5.2–8.8) vs. 2.9 (0.7–5.1) months for patients with ECOG 0–1 and ECOG2 respectively (p = 0.01). 5 patients were treated in first line, 3.8 months of PFS (9.1 months for ECOG0–1 patients and 1.0 months for ECOG2 patients). 28 patients in second line, 4.2 months of PFS (5.0 months for ECOG0–1 patients and 2.6 months for ECOG2 patients). Conclusion Our results indicate that ECOG 2 patients derive little clinical benefit from abiraterone. References and/or acknowledgements To the oncology service. No conflict of interest.