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 One (2%) patient was withdrawn from therapy due to primary failure and three (5%) had no available response data during the entire period of the study.Regarding safety, only one patient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
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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