Resultados de la implementación de un programa piloto de optimización de antimicrobianos (PROA) en Atención Primaria Results of implementation of a pilot antimicrobial stewardship program (ASP) in Primary Care
BackgroundBiological agents targeting interleukin such as ustekinumab and secukinumab are strategies employed in psoriasis treatment. Ustekinumab requires double doses in patients over 100 kg, which implies an increase in costs due to the absence of a 90 mg injectable solution in our national market. Secukinumab, recently approved for psoriasis, does not require dose modification based on weight.PurposeTo describe the experience and assess the clinical response and economic impact of switching from ustekinumab to secukinumab in moderate–severe plaque psoriasis patients weighing more than 100 kg in the maintenance phase with optimal (Psoriasis Area and Severity Index (PASI) <5) or suboptimal (PASI 5–10) response.Material and methodsThis was a retrospective observational study of psoriasis patients previously treated with ustekinumab double dose, from March to October 2016. Variables were: sex, age, weight, diagnosis, previous therapy with ustekinumab 90 mg quarterly and PASI. Patients with PASI 5–10 during maintenance received secukinumab 300 mg with reduced induction (weeks 1, 3) instead of normal induction (weeks 1, 2, 3, 4), followed by monthly administration; and patients with PASI <5 had no induction (monthly). Clinical response was assessed as no change in PASI in patients with optimal response or improvement in those with suboptimal response. Economic impact was measured comparing the patient year cost of ustekinumab double dose versus secukinumab to calculate the patient year savings.Results6 patients, 83.3% men, mean age 55 years (49–67), were evaluated. 3 patients had suboptimal response with ustekinumab (mean PASI 6.8); they received secukinumab with reduced induction and 2 achieved improvement in PASI and the third has not yet been evaluated. 3 patients had optimal response with ustekinumab (mean PASI 3.1); they received secukinumab without induction, achieving improvement in PASI. Switching from ustekinumab double dose to secukinumab with reduced induction involved an economic patient year saving of €8971.68 (34%) compared with ustekinumab maintenance; while switching to secukinumab without induction gave a patient year saving of €10 218.66 (39%).ConclusionOptimisation of anti-interleukin biological agents is a strategy to manage psoriasis patients over 100 kg based on clinical activity criteria and costs in our settings. Our experience using alternative dosing of secukinumab induction depending on PASI revealed a decrease in costs, providing direct savings for the hospital while maintaining treatment efficacy.No conflict of interest
BackgroundDolutegravir/abacavir/lamivudine (Triumeq) is a new oral drug to treat human immunodeficiency virus (HIV) offering a single pill regimen. Treatment discontinuations due to adverse events occurred in our clinical experience raising concerns about drug safety.PurposeTo determine the proportion of patients who stopped Triumeq use due to adverse events (AEs) and to analyse its causality.Material and methodsThis retrospective study included adult patients treated with Triumeq between June 2015 and June 2016. The following outcomes were collected: sex, age, HIV progression time, previous antiretroviral treatment, hepatitis C virus (HCV) or hepatitis B virus (HBV) coinfection, fibrosis stage, reasons for stopping treatment, risk factors, interventions required, results after stopping drug and length of treatment with Triumeq. Data were collected from clinical history and electronic prescribing software. The Karch–Lasagna algorithm was applied to evaluate AE causality.Results66 patients were treated with Triumeq during the study period. 12.1% of patients discontinued treatment due to AEs, representing 72.7% of the total suspensions (8/11). 75% were women and median age was 50 years. The median HIV progression time was 22.7 years and all had received previous HIV treatment. 7 patients were HCV coinfected (only one cirrhotic), and 1 had a liver transplant due to liver cancer related to HBV. AEs causing discontinuation of treatment were nausea and vomiting (3/8); daily headache (3/8); cutaneous reaction (3/8); muscle pain and sleepiness (2/8); disorientation and conduct disorder (1/8); and acute confusional syndrome (1/8). The last 2 cases occurred in patients with mental disorder secondary to illicit drug abuse and depression, respectively. Both required hospitalisation. AEs were resolved after changing antiretroviral treatment, although 3 cases required specific treatment and 1 biopsy of a cutaneous lesion was needed. Median length of treatment with Triumeq was 41 days. AEs were notified to the Pharmacovigilance Centre. The causal link between drug and the occurrence of adverse drug reaction was probable, according to the algorithm.ConclusionMore than 10% of patients suffered Triumeq related AEs which required discontinuation of treatment. Although all AEs were described in the Technical Data Sheet, serious psychiatric disorders occurred, recommending attention in patients with mental risk factors treated with Triumeq. Probable causal link strengths pharmaceutical collaboration, especially in medicines under additional monitoring.References and/or acknowledgementsInfectious Disease Department.No conflict of interest
considered to be at risk to each healthcare professional, offering them other treatment options based on efficacy, safety and cost. ResultsWe reviewed 36 patients under treatment with tofacitinib, 28 females (73%), average age 51.6 years. 32 patients had rheumatoid arthritis and 4 patients had ulcerative colitis. We identified 13 (36%) patients with an increased risk of major adverse cardiovascular events and malignances, and all of them had rheumatoid arthritis: 7 patients were aged 65+ years, 5 patients had cardiovascular risk factors, and 2 patients had a malignancy process. We sent 11 personalised reports to healthcare professionals. Conclusion and relevance One in three patients being treated with tofacitinib were affected by the security alert, and were considered to be a population at increased risk of major adverse cardiovascular events and malignances. This study allowed us to find these patients and communicate this information to healthcare professionals, providing them with an alternative treatment option based on efficacy, safety and cost.References and/or acknowledgements https://www.aemps. gob.
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