Background Alpha tumour necrosis factor inhibitors (TNF inhibitors) represent an important advance in immune-mediated inflammatory diseases. The first three drugs marketed and most used nowadays within this family are: infliximab, etanercept, and adalimumab. There is no apparent superiority between any of these drugs and it is known they often loss their efficacy over time. Therefore, it could be of interest to find out if any of them (under usual clinical conditions) has a longer period of time without loss of efficacy. Purpose To compare the different treatments with TNF inhibitors, in order to find out which has the longest average duration (in days) before loss of treatment response finally requires a change in the treatment. Materials and Methods All patients who began the treatment with TNF inhibitors between March 2007 and March 2012 and who had a change in treatment were analysed retrospectively with pharmacotherapy management software. Patients who had stopped the treatment after presenting immediate adverse reactions in the first administration were excluded. The mean durations of treatment were compared using the Student’s t-test for unpaired data Results In total 309 patients were analysed. The three TNF inhibitor drugs most used were etanercept (Average duration 574.47 ± 461.51, N = 125), infliximab (Average duration 470.82 ± 469.64, N = 95) and adalimumab (Average duration 454.92 ± 378.89, N = 95). We found a significant difference between etanercept versus adalimumab (P.value = 0.0412), but not in the case of etanercept versus infliximab (P.valour = 0.0997). These results are coincident with Dr. Hetland’s study in 8074 patients (1). They also agree with the study presented by J.A Markenson in 2418 patients (2). However our study results do not resemble those of G. Lapadula’s study (3). Conclusions The average duration of treatment before requiring a change of drug is higher with etanercept than infliximab and adalimumab, but only is statistically significant with adalimumab. These results should be considered in the design of TNF inhibitor prescribing guidelines. No conflict of interest.
BackgroundRilpivirine is a recently authorised antiretroviral. Adherence is essential in this kind of drug.PurposeTo evaluate treatment adherence with rilpivirine/emtricitabine/tenofovir (RPV/FTC/TDF) using the SMAQ questionnaire and pharmacy dispensing records (FDR) and the correlation between these in HIV/AIDS mono-infected patients.Material and methodsProspective observational study. We included patients treated with RPV/FTC/TDF from September 2013 until September 2014 with adherence data available of at least 3 months. Demographics data and reason for treatment were collected.Adherence was calculated across the SMAQ questionnaire (qualitative and semi-quantitative) and FRD, considering the patient adherent when any of these parameters was ≥95%. The correlation between the methods was assessed using the kappa (k) index.Results33 patients started treatment with RPV/FTC/TDF during the above-mentioned period. 21 were included in the study. 71% were men (average age: 40 ± 10 years). 38% were treatment-naïve and the rest were changes of therapeutic strategy (33% adverse reactions and 29% simplification of treatment strategies).26% of patients were considered adherent from a qualitative point of view in the SMAQ questionnaire, 76% from a semi-quantitative perspective and 95% via the FRD. The results between the three analysis only coincided in 6 patients.As for the results of k index, we observed the following strength of agreement: fair between the SMAQ quantitative and qualitative questionnaires (k = 0.22) and slight between the SMAQ qualitative questionnaire and FRD (k = 0.04) and between semi-quantitative SMAQ and FRD questionnaire (k = 0.01).ConclusionOur study highlights a low adherence to treatment obtained with the SMAQ questionnaire (both qualitative and semi-quantitative). It may be due to both the inflexibility of the questions and because of the patient assessment. These results could be improved through a pharmacist intervention in the monthly clinical review.Correlation between the three methods was low, so their use in isolation may give erroneous results in predicting adherence. However, with this way, “hidden” non-adherent patients (adherent FRD and non-adherent SMAQ) and “masked” non-adherent patients (non-adherent FRD and adherent SMAQ) could be detected.References and/or acknowledgementsNo conflict of interest.
BackgroundOff-label prescription is legal and common, but often not supported by strong evidence.PurposeTo analyse off-label treatments with biological therapies, its indications and to determine its economic impact within the total cost of these drugs.Material and methodsThis observational descriptive study was conducted in a reference hospital from October 2015 to March 2016. Treatments codified in the dispensation system (Savac) according to the diagnosis ‘Treatments not included in data sheet’ and those who had a defined diagnosis but were not reflected in the data sheet were included.Drug, diagnosis and clinical service prescriber were collected from the electronic clinical record (Selene) and request reports sent to the pharmacy. The number of dispensations and spending (both off-label and total spending on biological therapy in the study period) was recorded from Savac.ResultsDuring the study period 34 off-label treatments were prescribed to 32 patients. Applicant services were: internal medicine (35.3%), allergology (26.5%), digestive (12.7%), dermatology (11.8%), ophthalmology (8.8%) and rheumatology (2.9%). 11 drugs were used in 18 different indications. The most employed was omalizumab with 26.5% (33.33% food allergy, 33.33% anaphylaxis and the rest for atopic dermatitis, allergic rhinitis and urticaria acute recurrent) followed by adalimumab with 14.7% (uveitis non-infectious), ustekinumab with 11.8% (75% Crohn’s disease and 25% atopic dermatitis), tocilizumab with 11.8% (spondyloarthritis, papilophlebitis, thyroid associated orbitopathy and uveitis), and the rest had low values. In terms of economic impact, off-label use represented 4.73% (€122 482.7) of total expenditure on biological therapies during the study period; 1.19% at the cost of omalizumab. Regarding the total cost of each drug, off-label use was 57.34% of total expenditure for tocilizumab; 11.55% for rituximab, 10.85% for omalizumab, 8.91% for ustekinumab and less than 5% for the rest.ConclusionOur study results showed that off-label use of biological agents has important economic and healthcare impact; some biologicals represented >50% of expenditure (eg, tocilizumab). A monitoring mechanism should be set up to evaluate the efficacy and safety of these treatments due to insufficient clinical experience with them.No conflict of interest
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