BackgroundThe introduction of biosimilar drugs into clinical practice allows us to maintain the effectiveness and safety of treatments, taking greater advantage of health resourcesPurposeThe objective of the study was to evaluate the safety and effectiviness of infliximab biosimilar (IFXb) in patients previously treated with original infliximab (IFXo) in digestive and rheumatology pathology in a third-level hospital.Second, we calculated the savings that this measure has made.Material and methodsA retrospective, 11 month retrospective study (April 2016 to March 2017) in which all patients treated with IFXo were switched to IFXb.The following variables were recorded: sex, age, pathology, weeks of treatment with IFXo, weeks of treatment with IFXb, dose increases of IFXb, decreased dose interval, increased dose of immunomodulatory drugs, change of treatment and reactions to adverse effects. Data were obtained from the medical records using the computer application SAP.ResultsA total of 48 patients were switched to IFXb. 38 patients had Crohn’s disease, eight ulcerative colitis, one ankylosing spondylitis and one rheumatoid arthritis.The change to IFXb was only performed in those situations where a stabilisation of the disease had been achieved in a sustained manner.Only one patient required treatment intensification and a total of four patients required an increased dose of immunomodulatory drugs.Adverse reactions of interest different from those usually described with IFXo were not identified.The cost per IFXo vial (100 mg) was €357 while IFXo (100 mg) cost €251. The total amount spent until the change to IFXb was €1,562,400.If all patients had been treated with IFXo, the cost would be €2 22 084. The real cost of the change to iFXb was €149,847, so the estimated saving with this measure was €72 237 (33%)Currently, the change to IFXb has been made in 68 patients.ConclusionThe data shown leads to increasing evidence that guarantees the switch in a safe way for patients. These types of measures also prove to be efficient due to the lower cost of biosimilars.References and/or Acknowledgements1. Danese S, Gomollon F. ECCO position statement: the use of biosimilar medicines in the treatment of Inflammatory Bowel Disease (IBD). Journal of Crohn’s and Colitis2013;7:586–9.No conflict of interest
La gestión hospitalaria centrada en el pacienteThe patient-centered hospital management
treatment was temporarily suspended due to decreased haemoglobin and three (37.5%) had adverse effects (nausea, vomiting, stomach pain) without interruption of treatment.Niraparib: four (36.4%) patients started with 300 mg and seven (63.6%) 200 mg. Five (45.5%) patients needed dose reduction, two with initial dose 300 mg and three 200 mg: three of them continued (one of 300 mg and two of 200 mg initial dose). In five (45.5%) patients, treatment was discontinued, two (40%) due to adverse effects (neutropaenia, thrombocytopaenia and increased creatinine respectively) and three due to progression (60%), in addition temporarily suspending it due to neutropaenia. Six continued (three with 200 mg and three with 100 mg) and three of them had to temporarily interrupt it due to thrombocytopaenia. Conclusion In both treatments, the haematological adverse effects are more severe, frequent and worse tolerated in the case of Niraparib than Olaparib. In addition, greater discontinuity of treatment is observed in patients with Niraparib.
flushes (7.7%); four thrombocytopaenia, three cases grade 1 (11.5%) and one case grade 3 (3.8%); and two alopecia grade 1 (7.7%); Of all of them, there were a total of seven temporary treatment suspensions (26.9%) and four dose reductions (15.3%). Conclusion With the results of our study, we wanted to show the safety profile of these new drugs, although the reflected data do not allow comparisons with clinical trials due to the small sample size. Future studies will allow to make these comparisons, because the advantages that these drugs bring in effectiveness will lead to considerable increases in their use.
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