BackgroundSecukinumab is a recently approved interleukin 17A inhibitor indicated for the treatment of patients with plaque psoriasis, psoriatic arthritis and ankylosing spondylarthritis.PurposeThe aim of the study was to assess the early effectiveness and safety of secukinumab in patients with psoriasis.Material and methodsRetrospective study performed in a third-level hospital. Patients with psoriasis who started treatment with secukinumab between December 2015 and May 2017 were included.Demographic, clinical and treatment variables (previous systemic therapies and/or phototherapy and other biological treatments) at baseline were collected. Efficacy and safety were assessed based on the overall subjective assessment of the physician after 12±4 weeks of treatment. These data were obtained from medical records (Millennium-Cerner®).Analysis was performed according to the intention-to-treat principle. The variables are presented by means and percentages.ResultsA total of 60 patients were selected, with a mean age of 51±12 years, of whom 38 (63%) were males.All patients had moderate to severe psoriasis. Fifty-six (93%) presented plaque psoriasis, six (10%) of them also have psoriatic arthritis. Fifty-six (93%) patients had received prior non-biological systemic treatment and 27 (45%) had received phototherapy. Forty-three (71%) patients had failed prior biologics.After 12 weeks of treatment 56 (93%) patients had achieved a good response according to the physician records: 33 (55%) patients achieved a completely clear skin and 23 (38%) almost clear skin. One (2%) patient was withdrawn from therapy due to primary failure and three (5%) had no available response data during the entire period of the study.Regarding safety, only one patient experienced injection-site-reaction, even though it did not lead to treatment discontinuation.ConclusionIn this short-term study, secukinumab shows high efficacy, achieving completely clear skin in more than 50% of patients at week 12, both in naive patients and in those who failed prior biologics.Secukinumab is well tolerated, with a good safety profile and without discontinuations due to adverse effects. Therefore, it can be considered as a good therapeutic option in patients with moderate to severe psoriasis who are non-responders or have contraindication or intolerance to systemic treatments or phototherapy.References and/or Acknowledgements1. European Medicines Agency. EPAR for cosentyx. http://www.ema.europa.eu/ema/index.jsp?curl=/pages/medicines/human/medicines/003729/human_med_001832.jspNo conflict of interest
optimise trt management, safety and outcomes. This innovative cancer care model could improve drug awareness of drug consumption and patient education to promptly recognise and manage AEs.
to the anaesthetist and registered into the patient's medical record. Retroactive MRs were carried out, using the same sources, after the patient's entry and after the first prescriptions.Results Over a 6-month period, 200 MRs were performed in the vascular surgery department. 100 were proactive MRs and 100 were retroactive MRs. Concerning the populations, the average age was 66 years for proactive MRs versus 69 years for retroactive MRs, with 56% and 69% of men, respectively. The average number of home treatments was 7.4 (1-14) for proactive MRs and 8 (2-18) for retroactive MRs. As regards the UMDs found, there were 26 for the proactive MRs (ie, 0.26 UMD/patient). For retroactive MRs, there were 150 UMDs (ie, 1.55 UMD/patient). Conclusion and relevanceThere are more than 5.5 times fewer UMDs when MRs are carried out proactively before the patient's entry. Carrying out MRs for PACs enables the prescription to be anticipated and the anaesthetist to obtain an exhaustive list of the patient's treatments, which also avoids forgetting to stop some of them, particularly anticoagulants. The development of prescription assistance software with a pre-prescription module would be a step forward and an added value for the reduction of medication errors.
BackgroundIn our community, alirocumab and evolocumab, first-in-class proprotein convertase subtilisin–kexin type-9 inhibitors (PCSK9-I), have been authorised by the public health system for the treatment of patients with uncontrolled familial hypercholesterolaemia (FH) with LDL-C >130 mg/dL, uncontrolled stable atherosclerotic cardiovascular disease (ASCVD) with LDL-C >130 mg/dL or unstable ASCVD with LDL-C >100 mg/dL in combination with a statin and ezetimibe at maximum tolerated doses, and in patients who cannot tolerate or cannot be given statins with LDL-C >100 mg/dl.PurposeDescribe the efficacy and safety of PCSK9-I at a tertiary care hospital.Material and methodsRetrospective study was performed. We reviewed all cases treated with PCSK9-I from April 2016 to June 2017.Demographic, clinical, analytical and treatment variables were collected at baseline and after the first follow-up visit (cut-off date 4 October 2017). These data were obtained from medical records.Analysis was performed according to the intention-to-treat principle. The variables are presented by means and percentages. The Chi-square test was used for comparison among groups. Statistical analysis was performed using IBM® SPSS Statistics® v 22.0.ResultsUp to the cut-off date, 38 patients (20 females) received a PCSK9-I. The median age was 56 years (range 35–80). In 19 cases a PCSK9-I was indicated for ASCVD, 15 for FH and four for both indications. Fifteen were statin intolerant and 7 ezetimibe intolerant. The mean baseline LDL-C level was 180.5±49.4 mg/dL.PCSK9-I in combination with statins were prescribed in 25 patients (11 at maximum dose) and 24 with ezetimibe. Evolocumab was indicated in 27 cases and alirocumab in 11.After the first follow-up visit (mean of 14.0±8.3 weeks), the mean LDL-C was 79.4±38.8 mg/dl, mean percent change, −56%; absolute change, −102.5 mg/dL. There were no significant differences in LDL-C reduction between evolocumab and alirocumab (−58% vs −50%; p=0.334). One patient had poor compliance due to adverse events (hair loss and nail fungus), although it is not described in the European Public Assessment Report (EPAR).ConclusionLDL-C reductions obtained with PCSK9-I in clinical practice are similar to those described in clinical trials (50% to 70%).PCSK9-I were well tolerated without discontinuations due to side-effects.These new drugs bring a treatment opportunity to patients who are nowadays intolerant or non-responders to the currently available therapies.No conflict of interest
BackgroundCardiovascular (CV) toxicity is a potential complication of various anticancer therapies. Although targeted therapies are considered less toxic than classic chemotherapy agents, serious CV complications have been described and longer follow-up is needed to determine the profile and outcomes of related cardiac side-effects.PurposeTo describe the CV toxicity induced by targeted agents.Material and methodsA retrospective observational study was carried out at a tertiary care hospital. Patients who started treatment with targeted therapy between March and August 2016 were included and followed-up until January 2017.The following information was collected:Demographic and clinical data;bull; revious diagnosis of CV disease and CV risk factors.Targeted agent initiated;reatment cycle and type of CV adverse event (CVAE) presented: hypertension (HTA), thromboembolic event (TEV), left ventricular dysfunction (LVEF), oedema.The information was collected from electronic medical records (PowerChart-Millenium® and Farmis-Oncofarm®). Data were analysed using descriptive statistics.ResultsForty patients were included (65% females, mean age 59.9 years (±11.8) and 35% males, mean age 59.9 years (±11.0)). Targeted therapies prescribed were (no. of patients): bevacizumab (18), trastuzumab (five), pertuzumab/trastuzumab (four), pazopanib (four), sorafenib (three), regorafenib (two), axitinib (two), sunitinib (one) and aflibercept (one). Thirteen patients (32.5%) presented CVAE. The drugs involved were (no. of patients; CVAE): bevacizumab (three; HTA, one; HTA and TEV, one; oedema,), pazopanib (two; HTA), axitinib (one; HTA, one;TEV), trastuzumab/pertuzumab (one; LVEF), trastuzumab (one; oedema), regorafenib (one; HTA), sorafenib (one; HTA). Six of the 13 patients had a previous diagnosis of HTA and seven had at least one CV risk factor. Adjustment of CV treatment was required in nine cases, the targeted agent was temporarily discontinued in two patients and the CVAE led to discontinuation in two patients (both had TEV, one of them in the form of a severe stroke in the third cycle of axitinib). In January 2017, 18 patients were still receiving treatment.ConclusionThe incidence and type of CVAE seems to be similar to previous published data and only in one case was the effect life-threatening. Most of the effects were easily managed and toxicity was reversible.No conflict of interest
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