Background Asthma is an inflammatory disease of the airways with symptoms that vary over time and intensity, sometimes leading to disability or even death. Eosinophilic asthma accounts for 25% of cases of severe asthma. It is mediated by eosinophils regulated by interleukin-5 (IL-5), the target of mepolizumab, which has been recently licensed as an add-on treatment of severe refractory eosinophilic asthma. The aim of this study was to evaluate the effectiveness and safety of mepolizumab in clinical practice. Methods A multicentre, retrospective, and descriptive study covering a year was conducted in a province of Spain with more than 500,000 inhabitants. Every patient prescribed with mepolizumab since its introduction into the hospital was included in the study. Clinical parameters were collected from the pharmacists’ counselling reports from electronic prescription software and electronic patient records. Effectiveness was assessed as a decrease in the exacerbation frequency and/or a reduction in the use of oral corticosteroids (OCS) compared to the previous year. Results A total of 25 patients were studied, but only 23 could be evaluated by the cut-off date. A decrease in the exacerbation frequency was observed in 19 (82.6%) patients, 11 of them without any exacerbation during the treatment. A relative reduction of 87% in the exacerbation rate per year was obtained. A total of 15 patients were on regular OCS – 9 patients (60%) reduced their average dose, whilst 4 (26.7%) patients completely abandoned OCS. Safety was evaluated based on reported adverse effects. Adverse events were observed in 12 patients, the most common being headache, arthralgia, and dizziness/nausea. Conclusion Mepolizumab has been shown to be effective based on the high decrease in the exacerbation frequency and reduced use of OCS. Reported adverse effects were mostly mild and appeared in half of the patients; some of the adverse events had not been previously described in pivotal trials.

BackgroundAbiraterone and enzalutamide are expensive drugs used in hospitals for metastatic prostate cancer and it is necessary to evaluate health outcomes from its use to establish whether it is cost effectivePurposeTo analyse the effectiveness and cost of abitarerone and enzalutamide in asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer patients (mCRPC) to whom chemotherapy is not clinically indicated and in those whose disease has progressed after docetaxel chemotherapy regimen-based.Material and methodsA retrospective descriptive study covering the period from January 2013 to June 2017 of mCRPC patients starting treatment with abiraterone or enzalutamide between January 2013 and June 2016 was performed. Parameters collected were: age, sex, drug, previous chemotherapy, progression-free survival (PFS) and economic spending. Data were collected from the Electronic Prescription Software Prisma® and the program of electronic patient records Diraya® and afterwards, organised in an Excel® base design for this study.ResultsA total of 74 patients with a median age of 76 years, 53 chemotherapy-naive and 21 chemotherapy-treated, were included. Fifty-nine patients were treated with abiraterone and 15 with enzalutamide. The mean PFS was 12.3 months with 49.2% of 1 year PFS. However, in the group of chemotherapy-naive patients it was 15 months, with 56% of 1 year PFS and 9.6 months (28% of 1 year PFS) in chemotherapy-treated patients. No difference was found between abiraterone group (12.4 PFS) and the enzalutamide group (12 PFS) nor in the age of the groups where PFS was 13 months in patients younger than 75 years and 12 months in those older than 75. The cost of treatment/patient was €35 559 and the total expenditure was €2,631,366 (2% of the total pharmacy service budget).ConclusionThe results of the effectiveness regarding PFS are lower than the ones obtained in the pivotal studies ‘301 and 302’ (abiraterone) and ‘PREVAIL and AFFIRM (enzalutamide). Chemoterapy-naïve patients have better PFS than chemotherapy-treated and there is no difference between the abiraterone group and the enzalutamide group. The cost of abiraterone and enzalutamida per life-year gained were less than €30 000.References and/or AcknowledgementsPivotal study 301 & 302 Pivotal study PREVAIl & AFFIRMNo conflict of interest

Pembrolizumab is a mAb against the programmed cell death protein-1 (PD-1). It has been approved for the treatment of advanced melanoma (unresectable or metastatic) in adults. Side effects associated with the use of anti-PD-1 are usually considered well tolerated; nevertheless, there are immune-related adverse events that may require treatment discontinuation. A 79-year-old man diagnosed with stage IV right scapular melanoma experienced unspecific symptoms and alterations of the hypothalamus-hypophysis axis after six cycles with pembrolizumab. The case was compatible with immune-related hypophysitis. Autoimmune thyroiditis and primary hypophysitis were excluded and toxicity due to pembrolizumab was considered the cause of hypophysitis. Pembrolizumab was discontinued and toxicity was managed with corticosteroids and hormonal replacement therapy (HRT). After 7 months of follow-up, symptoms were controlled with HRT but thyrotropin and corticotropin hormones had not recovered. It was decided not to reintroduce immunotherapy. Although endocrine disorders are common with the use of anti-PD-1, hypophysitis is very rare. However, clinical signs and symptoms can be nonspecific, therefore, it has probably been underdiagnosed. Monitoring hormones before and during the treatment is important for an early diagnosis and also to replace the alterations with HRT to control the symptoms. Hormonal function does not always recover, but it does not mean immunotherapy cannot be restarted and it should be evaluated in every case.

Introduction The treatment of non-small cell lung cancer (NSCLC) has profoundly changed on account of the arrival of new therapies, like immunotherapy. Within this group of drugs, those aimed at the programmed cell death-1 or programmed cell death ligand-1(PD1/PDL-1) are very relevant, for example, Pembrolizumab. Although its adverse reactions are generally mild and well tolerated, it has been associated with certain immune-related adverse events (IrAEs) than can be serious and affect any organ. Case report A 62-year-old woman diagnosed with stage IV NSCLC with a single bone metastasis and PD-L1 expression of 60% started treatment with cisplatin-pemetrexed-pembrolizumab, and maintenance with pembrolizumab. Management and outcome The patient attended the ER with pericardial effusion that was assumed to be a Pembrolizumab IrAE and was managed with corticosteroids. The patient fully recovered but immunotherapy was not reintroduced due to the severity of the AE. Discussion The cardiovascular system is among the least affected organs by immunotoxicity, with an incidence between 0.09–0.6%. However, some authors suspect the incidence is underestimated. Median time to onset is highly variable, ranging from 6 weeks since the first dose to 2 years after discontinuation of the treatment. There are not guidelines on the most effective management of the IrAEs, but according to the pharmaceutical reference, corticosteroids should be initiated followed by a progressive reduction. If no response is obtained, another immunosuppressive agent should be added. The determination to restart immunotherapy depends on the severity of the adverse reaction, the availability of other alternative treatments, and the cancer response.

Introduction Pembrolizumab is a monoclonal antibody approved for adult patients with advanced non–small-cell lung cancer (NSCLC). Although immune related adverse events are considered to be well tolerated, complications may occur and discontinuation of the treatment could be required. Case report A 62-year old patient diagnosed with advanced non-small cell lung cancer experienced a decline in the renal function after seven cycles with pembrolizumab. Management & outcome: After ruling out other common causes of interstitial nephritis, pembrolizumab was attributed as a cause of interstitial nephritis. At first, toxicity was managed with corticosteroids and closely monitoring the patient, but finally pembrolizumab had to be discontinued due to the kidney function did not recover. Discussion Renal and urinary disorders were reported in <3% of patients treated with pembrolizumab, being interstitial nephritis the most reported toxicity. The kidney damage can be a complication to consider in patients receiving pembrolizumab. Early identification of an increase in serum creatinine levels may help with prevention by establishing an effective treatment, although it may not mean a total recovery of kidney function.