G Calzado Gómez

1ISG-003 Cost saving in antiretroviral therapy through breaking fixed-dose combination and switch to generic formulations

Background The commercialisation of fixed-dose combination meant an improvement in antiretroviral therapy (ART). With generics we have the opportunity to maintain the therapy at a lower cost, but we complicate the dosage regimen again. Purpose To assess the effect in costs of a two-pill, generic-based regimen compared with a branded coformulated regimen, and to project the potential annual savings in the first year of a switch to generic-based ART. We replaced Triumeq® (ABC/3TC/DTG) by a combination of Tivicay® (DTG) +generic ABC/3TC, and Atripla® (TDF/FTC/EFV) by Truvada® (TDF/FTC)+generic EFV. Material and methods We selected and analysed all patients who received Atripla® (TDF/FTC/EFV) and Triumeq® (ABC/3TC/DTG) from June 2016 to September 2017. Data were collected from the medication consumption files of the institution. We analysed the records related to the treatment. The economic savings associated with the change of treatment were quantified. Results 313 patients were analysed, 108 (34.5%) initially treated with Atripla® and 205 (65%) initially treated with Triumeq®. A total of 252 (80.5%) patients were switched to a new treatment (162 patients with Triumeq® and 90 patients whith Atripla®), four (1,27%) of whom returned to initial treatment for adverse effects. A total of 61 patients were not changed. The main reason for opposing the change was the difficulty in adherence 17 (27.8%), followed by patient refusal four (6.5%) The change to Triumeq® meant a saving of €22.380/month and the change to Atripla® a saving of €10.100/month. This represents a total saving of €389.772/year. Conclusion Generics formulations in ART is an opportunity to contain pharmaceutical costs in hospitals. Changes in therapy produced a low rate of adverse reactions (1.27%) and a cost saving of €389.772/year. It requires adherence data to be able to affirm that this strategy decreases costs without prejudice to the patient. References and/or Acknowledgements All staff of our pharmacy service No conflict of interest

PP-053 Evaluation of 5 compounded formulations for the treatment of oral mucositis in cancer patients

Background Oral mucositis (OM) is a frequent complication of chemotherapy which severely affects patient quality of life. Management is generally based on topical compounded formulations. Purpose To analyse the use of our compounded formulation of Lidollanten 1% for the treatment of OM in a tertiary hospital, to describe this and four other formulations and to perform a comparative cost analysis without including professional fees. Material and methods We performed a 1 year retrospective study (January 2015–December 2015) involving all cancer patients who had used our compounded formulation during the study period. Patient data were obtained from the SAP application. Results During the study period, we dispensed 3122 Lidollanten 1% preparations for 530 patients. The cost of preparation in the hospital was €1.55/100 mL, which meant €4 823.51/year. Different formulations for the treatment of OM are shown in the table. Compounded formulation Lidollanten 1% 2 3 4 5 Components - Llanten leaves- Lidocaine- Sodium borate- Potassium chlorate- Pink honey extract- Syrup - Chlorhexidine 5%- Methylprednisolone- Mepivacaine 2%- Sodium bicarbonate- Sodium chloride- Sterile water - Mepivacaine 2%- Aluminium hydroxide- Magnesium hydroxide- Sorbitol 70%- Guar gum 1%- Nipagin- Citric acid- Peppermint oil- Sterile water - Gentamicine- Hydrocortisone- Nystatin- Lidocaine- Sodium bicarbonate- Cremophor RH 40- Xanthan gum- Sorbitol 70%- Peppermint oil- Sterile water - Sucralfate- Lidocaine- Cremophor RH 40- Sorbitol 70%- Sterile water Complexity High Low High Medium Medium Preparation time 5 hours 30 min 30 min 2 hours 30 min Storage Fridge Ambient temperature Ambient temperature Fridge Fridge Expiry time (days) 30 days 30 days 60 days 15 days 15 days Cost (100 mL) (€) 1.55 1.36 4.27 6.51 2.53 Conclusion According to our data, the least expensive formulation (from the point of view of acquisition cost) was No 2, which also happened to be that requiring the least processing time; it can be stored at room temperature, with an expiry time of 1 month. For these reasons, we believe it is the most efficient. Future studies will determine whether there are differences in effectiveness between the different formulations. References and/or acknowledgements 1. Lalla RV, Bowen J, Barasch A, et al. MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer2014;120:1453–61. No conflict of interest

CP-018 Effectiveness of omalizumab in asthmatic patients

Background Omalizumab is a humanised monoclonal antibody manufactured by recombinant DNA technology. It is indicated as an add-on therapy to improve asthma control in patients with severe persistent allergic asthma with forced expiratory volume in 1 s(FEV1) <80%. Purpose To evaluate the effectiveness of omalizumab (Xolair) in asthmatic patients treated with this drug in a tertiary hospital during 2015. Material and methods This was an observational retrospective study of patients treated for asthma with omalizumab during 2015 in a tertiary hospital. Data were obtained by Farmatools and Drago AE programmes. All patients treated with omalizumab for at less 1 year were included. Clinical variables collected were: FEV1(RD >80%), serum total level of IgE (RD <100 UI/mL) and omalizumab dose. Effectiveness was evaluated by number of emergency department visits for asthma. Results 66 patients were included in the study with a mean age of 37 years (40 women, 26 men). 94% of patients did not require emergency visits for asthma. At the start of the study, they presented mean serum levels of IgE of 1702 UI/mL; during this period, a mean decreased of 47% was observed. However, at the end of the study period, we observed increased serum levels of IgE in all patients. For FEV1, at the end of study, we found that: 17% of patients had FEV1 <60%, 57% had FEV1 60–80% and FEV1 was >80% for the rest of the patients. As omalizumab is indicated in patients diagnosed with persistent allergic asthma, we should consider discontinuing treatment in patients with FEV1 <80% . Conclusion Omalizumab was highly effective in this study, similar or even better than the effectiveness showed in clinical trials. We observed that lower baseline total IgE was associated with less effective treatment. References and/or acknowledgements Technical data for omalizumab. No conflict of interest

CP-022 Safety profile of glatiramer acetate 40 mg

Background Glatiramer acetate (GA) is a firstline therapy approved for the treatment of relapsing remitting multiple sclerosis (RRMS). GA 20 mg/mL (GA20) administered once daily by subcutaneous injection has been used since 2009. In 2014, modified treatment regimens–alternative dosages and low frequency administration schedules were introduced—GA 40 mg/mL (GA40) three times weekly. Purpose To analyse injection related adverse events (IRAEs) reported for GA20 and GA40 in our clinical practice. Material and methods This was a retrospective observational study of patients diagnosed with RRMS, receiving treatment with GA for at least for 6 months (January—June 2016). We studied all patients who started on GA40 three times weekly, as well as those converting from GA20 once daily to GA40, including naive and further lines of treatment. We excluded patients who wanted to get pregnant. The IRAEs analysed according to the System Organ Class were general disorders and administration site conditions, including local injection site reactions (ISRs), and symptoms or events related to immediate post-injection reactions (IPIRs). Results 52 patients were included: 23 patients (14 women, 9 men; mean age 43 years) were receiving treatment with GA40, 15 (7 women, 8 men) had converted from GA 20 and 10 patients were naive for GA. Five moderate/severe IRAEs related to ISRs and IPIRs were reported (21.7%), 2 of which were in patients who had converted from GA20. 29 patients (19 women, 10 men; mean age 46 years) were receiving treatment with GA20 for at least 6 months. One moderate IRAE associated with IPIR (3.4%) was reported in this group. Conclusion To our knowledge, post hoc analyses showed that patients receiving GA40 demonstrated a 60% reduction in the annualised event rate of moderate/severe IRAEs compared with GA20. In our study, from the total number of ISRs and IPIRs reported, GA40 had a significantly increased rate compared with GA20 (p<0.04). These outcomes suggest that moderate or severe reactions related to general disorders and administration site conditions were less frequent in GA20 treated patients. Due to the size of group, these results should be interpreted with caution; future analysis in clinical practice is necessary. References and/or acknowledgements Wolinsky JS, et al. Mult Scler Relat Disord2015;4:370–6. Available at http://dx.doi.org/10.1016/j.msard.2015.06.005 No conflict of interest

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.

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.