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.
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.
Background Haematological toxicity (HT) is a well-known side effect of chemotherapy. Neutropenia and thrombocytopenia are common reasons for dose reductions and treatment delays in chemotherapy treatment. Correct management of chemotherapy-induced HT is essential to achieve optimal treatment outcomes. Purpose To assess the incidence and review the management of HT in ambulatory patients with gastrointestinal cancer receiving intravenous chemotherapy. Material and methods Haematological parameters which had been measured before the application of chemotherapy were retrospectively collected for 121 patients treated in 2012. In patients with HT (defined as leukopenia, neutropenia, thrombocytopenia or anaemia) dose reductions and treatment delays were reviewed and compared to available international guidelines for the management of HT. Results HT occurred in 73 (60.3%) patients. 41 (33.9%) patients presented with leukopenia, 33 (27.3%) with neutropenia, 25 (20.6%) with thrombocytopenia and 52 (42.9%) with anaemia. According to international guidelines, treatment adjustments were required in 24 patients (19.8%) and altogether in 64 chemotherapy cycles. Dose reductions were required in 18/64 (28.1%) cycles, and treatment delays in 58/64 (90.6%) cycles. Actual dose reductions were lower than stated in the guidelines in 7 (38.9%) cycles; treatment dates were not rescheduled in 21 (36.2%) out of 58 cycles in which treatment delays were required. Overall, treatment adjustments were not suitable in 9/24 (37.5%) patients. Higher dose reductions or longer treatment delays than stated in the guidelines were not considered inappropriate, since these may have occurred due to other conditions, not related to HT. Conclusion Incidence of thrombocytopenia and anaemia in gastrointestinal cancer patients was comparable, while incidence of neutropenia was lower than in similar previous studies. The high number of incorrectly adjusted treatments demonstrated the necessity for a clinical pharmacist to review chemotherapy prescriptions together with laboratory parameters and to create hospital guidelines for the management of HT. References and/or Acknowledgements No conflict of interest.
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