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 One (2%) patient was withdrawn from therapy due to primary failure and three (5%) had no available response data during the entire period of the study.Regarding safety, only one patient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
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
Background Prasugrel and ticagrelor are new antiplatelet agents developed for patients with Acute Coronary Syndrome (ACS) and high risk of thrombosis. Their benefits in terms of mortality and major cardiovascular events have been well established, but some concerns remain regarding their safety. Purpose To analyse antiplatelet prescriptions focusing on new drugs and with a subgroup analysis (diabetes, renal function, age, weight, risk of haemorrhage). Materials and methods A retrospective observational study was carried out in our healthcare area from January to June 2013. Patients included had ACS and required antiplatelet therapy. Demographic and clinical data were obtained from electronic medical records (Historia de Salud, PowerChart-Millennium and Intensive Care Unit programme). The CRUSADE scale was used to calculate the bleeding risk. Results 379 patients were included (72.8% male, mean age 64.9 ± 12.8 years, 134 patients diagnosed with ST-Segment Elevation Myocardial Infarction and 245 with Non-ST Elevation Myocardial Infarction). During hospitalisation, 350 patients received clopidogrel and only 52 were treated with new drugs (29 with prasugrel and 23 ticagrelor); 37 of these received clopidogrel initially and then switched to a new drug. 9 deaths occurred during hospitalisation. At discharge, 280 patients continued with dual antiplatelet therapy (239 with clopidogrel and aspirin (AAS), 27 with prasugrel-AAS and 15 with ticagrelor-AAS), 81 with single treatment (64 with AAS and 17 with clopidogrel) and 9 interrupted the treatment. See Subgroup analysis on patients with dual therapy in Table 1. Abstract CP-115 Table 1 Clopidogrel Prasugrel Ticagrelor Diabetic (n = 98) 79 16 3 ClCr <60 ml/min at admission (n = 46) 44 2 0 Age >75 years (n = 60) 58 0 2 Weight <60 kg (n = 25) 25 0 0 Risk of haemorrhage: •High (CRUSADE ≥41 points) (n = 35) 33 2 0 •Low/moderate (CRUSADE ≤30 points) (n = 212) 172 25 15 Conclusions Use of new antiplatelet drugs in our healthcare area is still moderate. They are prescribed only in selected cases with low bleeding risk. The results show only a disposition towards prescribing prasugrel for diabetic patients according to the clinical trials results, but not in other subgroups that can benefit from new drugs. No conflict of interest.
closure integrity, impurities, charge variants, oxidation, endotoxin, particulates and biological activity. Results A total of 132 syringes underwent three freeze-thaw cycles, exposing each syringe for a total of 144 hours to 30°C and 144 hours to À5°C. Following exposure, 66 syringes were used for the analysis and 66 were retained. The effects of this thermal cycling on the critical quality attributes of SB5 from baseline is shown in table 1. Conclusion and relevance SB5 was stable in the immediate pack when exposed to multiple freeze-thaw cycles. These results may help hospital pharmacists assess the impact of temperature excursions during shipment or storage on product quality of SB5. REFERENCES AND/OR ACKNOWLEDGEMENTS Conflict of interest Corporate sponsored research or other substantive relationships: HE is an employee of, and holds stock in Biogen, responsible for the commercialisation of SB5. JK, JY, DP, SJH and SJP are employees of Samsung Bioepis, the marketing authorisation holder of SB5.
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