BackgroundBiological agents are used to treat rheumatic diseases. Patients are initially treated at the recommended dose according to the results of clinical trials but there is no current consensus on what attitude to take following remission. The practice of dose optimisation (DO) is spreading among professionals, resulting in an effective strategy.PurposeTo evaluate the impact of etanercept DO in patients with chronic rheumatic diseases, in a real world setting.Material and methodsDescriptive, cross-sectional study between January and July 2015. Data were collected by reviewing patient’s clinical records. DO was defined as a treatment regimen with a reduced amount of drug than recommended in the product labelling, either by using lower doses or by spacing the intervals of administration. Measured parameters were: Disease Activity Score of 28 joints (DAS28) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) before and after DO, therapeutic regimens and reasons for withdrawal.Results193 patients received treatment with etanercept. Optimisation was started in 53 (27.5%) patients by spacing the dose interval: rheumatoid arthritis (43%), psoriatic arthritis (32%) and ankylosing spondylitis (25%).55% were women, and mean age was 49 years.At the standard dose, average values for DAS28 and BASDAI were 2.1 and 2.1, respectively, versus 2.0 and 2.6 at DO. In 11 patients, data were not available.30% of patients showed a reduction in clinical parameters considered (54% of DAS28 and BASDAI 10%), 22% presented no differences (8% DAS28 and BASDAI 40%) and 48% showed an increase (46% of DAS28 and BASDAI 50%) although they were not clinically relevant.The most common therapeutic regimens used were: 25 mg/week (70%), 25 mg/2 weeks (11%) and 25 mg/10 days (7%).3 (5.6%) returned to the recommended label dose, having good disease control to date.ConclusionIn our clinical practice, 27.5% of chronic rheumatic patients received DO of etanercept, showing a risk of relapse in 5.6% of cases but reinstatement of the recommended label dose seemed to reinstate disease control. Optimisation of biological treatment in rheumatic diseases could be effective resulting in less exposure. However, well designed studies are needed to establish the best optimisation strategy.No conflict of interest.
BackgroundSecond-generation tyrosine kinase inhibitors(2G-TKI) have increased considerably over the past few years. Despite good and maintained results with imatinib, 2G-TKI have shown a growing trend in their use due to their quick and deep response. However, there is no clear positioning between nilotinib and dasatinib.PurposeTo analyse differences in the response according to the 2G-TKI used in front-line therapy in chronic myeloid leukaemia (CML) patients.Material and methodsDescriptive retrospective observational study conducted in a tertiary hospital. Patients with front-line therapy with nilotinib or dasatinib from June 2011 until April 2016 were included.Study variables were: sociodemographic (sex, age), clinical (time from diagnosis, p210 rearrangement, hydroxiurea cytoreduction, 2G-TKI, dosage regimen, time with TKI).Response was assessed in terms of molecular response and classified according to European Leukaemia Net (ELN) 2013 criteria.Degree of response at 3, 6 and 12 months according to 2G-TKI employed was analysed using the Mann–Witney U test.Timing to major molecular response (MMR) and major cytogenetic response (MCR), according to 2G-TKI were also tested using the Chi square test. Data were analysed with SPSS 19 software.ResultsTwenty-two patients received front-line 2G-TKI. Seventy seven per cent (n=17) were males, and mean age was 56.5 (±14.3). Median time since diagnosis was 33 months (2–57). p210 rearrangement was present in 18 of our patients (four had no available data). All of them received hydroxiurea.2G-TKI among our population were: 59% (n=13) nilotinib and 41% (n=9) dasatinib. Three patients required dose adjustment (one nilotinib, two dasatinib). Median time receiving TKI was 28.5 months (3–57).No significant differences were found in terms of degree and time to MMR or MCR between nilotinib and dasatinib in any point of the study (p>0.05).ConclusionOur results suggest that both 2G-ITK are reasonable options in front-line therapy, with fast and deep responses obtained. No significant differences were found between them among our population.Consequently, treatment choice should be done according to toxicity, comorbidities, clinician experience and dosage-regimen.No conflict of interest
BackgroundNatalizumab is indicated in relapsing-remitting multiple sclerosis (RRMS) that remains highly active despite treatment with interferon B and glatiramer acetate, and in rapidly evolving severe RRMS.PurposeTo analyse the effectiveness, safety and results in comparison with the reference clinical trial (CT) in natalizumab patients.Material and methodsRetrospective observational study including patients on natalizumab at the time of data collection (August 2014). Variables included: demographics, time from diagnosis, time with natalizumab, indication, previous treatments, pre/post disability (EDSS), outbreaks before/after change, JC virus antibodies, adverse reactions (ADRs), discontinuations and causes.Data were obtained from medical records and the electronic prescription software.ResultsWe analysed 24 patients. 58.3% were women. Mean age was 37.8 years, median time from diagnosis 9.3 years and time on natalizumab 36.6 months.Previous treatments received were: 13/24 interferon B 1A SC (INF), 10/24 INFB 1A IM, 10/24 glatiramer acetate (GA), 3/24 INFB 1B, 1/24 fingolimod, 1/24 azathioprine and 1 no immunomodulators.Before natalizumab, mean EDSS was 4.3. EDSS after treatment was 4.6.33.3% patients had JC + antibodies.11 patients reported ADRs: 5 infections, 4 skin disorders, 4 fatigue, 3 headaches, 2 insomnia and 1 diarrhoea.Mean flare-ups before changing were 2.1. Only 6 patients had flare-ups during treatment.ConclusionOur baseline characteristics and selected variables were not always comparable with the reference CT. Moreover, our small sample size and the daily clinical practice characteristics of our patients made an exhaustive comparison difficult. However, as in the CT, our population presented a maintained EDSS, with a decrease in outbreaks and the ADRs were consistent with the most frequent observed in the CT.With these results, and according to the published studies,1,2 we have demonstrated that natalizumab is an effective alternative to immunomodulators for non-responders.Notified ADRs in our population are consistent with the known safety profile.References and/or AcknowledgementsPolman CH, et al. NEJM 2006O’Connor P, et al. Neurology 2014No conflict of interest.
BackgroundThe arsenal of drugs available to antiretroviral therapy (ART) is extensive. It’s important to optimise HIV treatment basing on recommendations established by experts.PurposeTo analyse prescription profile, treatment changes, causes and financial impact of the changes in a first level hospital.Material and methodsObservational retrospective study from January 2013 to March 2014. The variables studied included: demographics (age, gender), clinical data (age at diagnosis, HCV/HBV co-infection, stage, HLAB5701 allele, viral load (VL) and CD4 cells before/after the change, reason for change) and financial analysis (cost per month before/after the change). Data were obtained from medical records and the electronic prescription programme.GESIDA 2014 recommendations were considered as therapeutic strategies to improve efficiency and safety.ResultsOut of the 178 patients receiving ART, 40 (22.5%) patients, who switched treatment were analysed.The average age was 44.7 (22–57), 72.5% were male, 60% co-infected with HCV. The most frequent stage was C3 (40%). The average time since diagnosis was 14.6 years.Before changing treatment 62.5% patients had undetectable VL (68% for at least six months) and the mean CD4 cell was 596.68 cells/mm3. HLAB5701 determination was available only in 15% (100% negative).Reasons for change were: 52.5% adverse reactions (ADRs) (38% renal failure), 12.5% prevention of ADRs, 10% virological failure, 10% development of resistance, 7.5% reduction in the number of tablets, 2.5% immune failure, 2.5% unknown reason and only 2.5% therapeutic simplification.These changes assumed an average cost increase of 21% per patient/month.With these data 25% of our patients could be candidates for monotherapy and 17.5% for changing the combination of NRTI (Tenofovir/Emtricitabine for Lamivudine/Abacavir).ConclusionART has a high impact on the hospital budget. It is necessary to include efficiency strategies in changes of treatment and ART initiation.We suggest developing with the infectious unit a protocol consistent with the existing recommendations, including an algorithm to support medical decision-taking in the light of safety and efficiency criteria.References and/or AcknowledgementsNo conflict of interest.
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