BackgroundTreatments for ulcerative colitis (UC) and Crohn’s disease (CD) include conventional agents and tumour necrosis factor-alpha inhibitors (anti-TNFα). A substantial proportion of patients do not respond, are intolerant to both therapies or these drugs are contraindicated. Vedolizumab, a monoclonal antibody directed against α4β7-integrin that inhibits lymphocyte recruitment to the gastrointestinal tract, provides another therapeutic option.PurposeTo assess the efficacy, safety and economic impact of vedolizumab treatment in UC and CD patients in clinical practice.Material and methodsRetrospective, observational study of patients treated with intravenous vedolizumab from September 2015 to September 2017. Variables: age, sex, diagnosis, previous anti-TNFα therapy, duration, dose variation and analytical parameters: haemoglobin (Hb), C-reactive protein (CRP) and faecal calprotectine (FCP). Clinical response was measured by haemoglobin and CRP variation during induction and maintenance, and FCP reduction. Safety was assessed by reported treatment-emergent adverse events, and economic impact by drug patient-year cost.ResultsForty-one patients, 63% men, mean age 46.6 years (19–76), were included. Indications: 16 patients (39%) UC and 19 (61%) CD. Most of the patients had previously been treated with anti-TNFα therapies (85%), mostly infliximab (88%), while 15% had never had biotherapy. Mean duration was 10.4 (1–30) months. Fourteen patients (34%) required a maintenance dose modification every 4 to 6 weeks instead of every 8 weeks. Mean Hb and CRP levels before vedolizumab administration were 13.3 mg/dl and 18.5 mg/L respectively, improving at the end of the induction in 0.2 mg/dl and 6.4 mg/L, and 0.3 mg/dl and 7.7 mg/L in the maintenance phase. Average FCP reduction was 22.4% from baseline levels to values at the end of the study. With regard to adverse events, 16 patients (39%) reported gastrointestinal events and seven (17%) arthralgias. Treatment was discontinued in two patients due to lack of efficacy. Estimated patient-year cost in our hospital was €18 259 the first year, and €14 202 the following year.ConclusionVedolizumab provides an additional therapy for patients with an inadequate response or were intolerant to anti-TNFα. Effectiveness outcomes in our clinical setting were within the percentages presented in clinical trials either in induction or maintenance, showing a similar safety profile to other biological treatments and to that described in clinical trials.References and/or AcknowledgementsVedolizumab: EPAR-Summary for the public. EMA.No conflict of interest

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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