[Translated article] Knowledge of biological therapy in patients with immune-mediated diseases. BIOINFO study.

Objective: To determine the degree of knowledge about biological therapy and biosimilars in patients with immune-mediated inflammatory diseases treated in Outpatient Pharmaceutical Care Units.

Methods: Observational, prospective, and multicenter study during the period May 2020-March 2021. A survey (9 questions) was conducted before starting treatment in which the patients' level of knowledge about biological therapy and biosimilars was assessed.

High serum levels of ustekinumab are associated with better clinical outcomes during maintenance treatment for inflammatory bowel disease.

Background: Ustekinumab (UST) is an effective treatment option in Crohn's disease (CD) and ulcerative colitis (UC). However, it still remains unclear if therapeutic drug monitoring could be helpful to guide clinicians.

Objectives: The aim of our study was to analyze the relationship between UST through levels (UST) and clinical outcomes in real-world inflammatory bowel disease (IBD) patients.

Knowledge of biological therapy for patients with immune-mediated diseases. BIOINFO Study.

Objective: To determine the degree of knowledge about biological therapy and biosimilars in patients with immune-mediated inflammatory diseases treated in Outpatient Pharmaceutical Care Units.

Methods: Observational, prospective and multicenter study during the period May 2020-March 2021. A survey (9 questions) was conducted before starting treatment in which the patients' level of knowledge about biological therapy and biosimilars was assessed.

[Translated article] Physicochemical and microbiological stability study of two new preservative-free methylprednisolone eye drops.

Objective: To study the physicochemical and microbiological stability over 90 days of two preservative-free methylprednisolone sodium succinate (MTPSS) 1 and 10 mg/mL eye drops for use in ocular pathologies such as Sjögren's syndrome and dry eye syndrome.

Method: The two eye drops were prepared from injectable MTPSS (Solu-moderin® and Urbason®), water for injection and normal saline solution. In accordance with ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) guidelines, they were then stored in triplicate under refrigerated conditions (5±3 °C), at room temperature (25±2 °C), and at 40 °C (±2 °C).

Physicochemical and microbiological stability study of two new preservative-free methylprednisolone eye drops.

Objective: To study the physicochemical and microbiological stability over 90 days of two preservative-free methylprednisolone sodium succinate (MTPSS) 1 mg/ml and 10 mg/ml eye drops for use in ocular pathologies such as Sjögren's syndrome and dry eye syndrome.

Method: The two eye drops were prepared from injectable MTPSS (Solu-moderin® and Urbason®), water for injection and normal saline solution. In accordance with ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines, they were then stored in triplicate under refrigerated conditions (5 ±3 °C), at room temperature (25 ± 2 °C), and at 40 °C (±2 °C).

Evaluation of temocillin efficacy against KPC-2-producing Klebsiella pneumoniae isolates in a hollow-fibre infection model.

Background: Temocillin is an old antimicrobial that is resistant to hydrolysis by ESBLs but has variable activity against carbapenemase-producing Enterobacteriaceae. The current EUCAST susceptibility breakpoints for Enterobacterales are set at ≤16 mg/L (susceptible with increased exposure) based on a dose of 2 g q8h, but there is limited information on the efficacy of this dose against temocillin-susceptible carbapenemase-producing Klebsiella pneumoniae isolates.

Objectives: To evaluate the efficacy of this dose using a hollow-fibre infection model (HFIM) against six KPC-2-producing clinical isolates of K.

Performance of a New Rapid Point-of-Care Test for Infliximab Levels in Patients with Inflammatory Bowel Disease: A Comparison to ELISA.

Background: Therapeutic drug monitoring of infliximab levels in patients with inflammatory bowel disease (IBD) optimizes patients' treatment. The reference technique is based on enzyme-linked immunosorbent assay (ELISA) although point of care (POC) assays are being developed.

Aims: To assess the performance of a new rapid immunochromatographic POC assay (Promonitor Quick IFX) compared with ELISA technique to measure infliximab levels in patients with IBD.

Value contribution of cenobamate for the treatment of Focal-Onset Seizures (FOS) in patients with drug-resistant epilepsy (DRE) in Spain through reflective Multi-Criteria Decision Analysis (MCDA).

Introduction: Epilepsy is one of the most common neurological conditions worldwide. The main goal of its treatment is to achieve seizure freedom without intolerable adverse effects. However, despite the availability of many anti-seizure medications, including the latest options, called third-generation anti-seizure medications (ASMs), approximately 40% of people with epilepsy present drug-resistant epilepsy (DRE).

Lansoprazole Increases Inorganic Pyrophosphate in Patients with Pseudoxanthoma Elasticum: A Double-Blind, Randomized, Placebo-Controlled Crossover Trial.

Pseudoxanthoma elasticum (PXE) is characterized by low levels of inorganic pyrophosphate (PPi) and a high activity of tissue-nonspecific alkaline phosphatase (TNAP). Lansoprazole is a partial inhibitor of TNAP. The aim was to investigate whether lansoprazole increases plasma PPi levels in subjects with PXE.

[Translated article] Biological and immunosuppressive medications in pregnancy, breastfeeding and fertility in immune mediated diseases.

Objective: The objective of this review is to gather the available evidence on the different drugs used in immune-mediated inflammatory diseases in pregnancy, lactation, their influence on female and male fertility, advice on discontinuation before conception and to help in routine clinical practice for better patient advice on family planning.

Methods: A bibliographic search was carried out, where published articles (review studies, observational studies and case series) in English or Spanish until April 2020 that analyzed the management of pregnancy, lactation and/or fertility in patients on treatment in immune-mediated diseases were selected.

Results: A total of 95 references were selected and the information on each drug was synthesized in tables.

Biological and immunosuppressive medications in pregnancy, breastfeeding and fertility in immune mediated diseases.

Objective: The objective of this review is to gather the available evidence on the different drugs used in immune-mediated inflammatory diseases in pregnancy, lactation, their influence on female and male fertility, advice on discontinuation before conception and to help in routine clinical practice for better patient advice on family planning.

Methods: A bibliographic search was carried out, where published articles (review studies, observational studies and case series) in English or Spanish until April 2020 that analyzed the management of pregnancy, lactation and/or fertility in patients on treatment in immune-mediated diseases were selected.

Results: A total of 95 references were selected and the information on each drug was synthesized in tables.

Use of cyclodextrins as excipients in pharmaceutical products: why not in extemporaneous preparations?

Objective: To conduct an assessment of cyclodextrins used as excipients in  pharmaceutical formulations, considering compounding,  iopharmaceuticalpharmacokinetic, toxicological, regulatory, economic and  commercial aspects.

Methods: A literature search was performed of highly cited review and original articles. Regulatory and legislative documents and well-established pharmacopoeias were also consulted.

Effectiveness of Fosfomycin for the Treatment of Multidrug-Resistant Escherichia coli Bacteremic Urinary Tract Infections: A Randomized Clinical Trial.

Importance: The consumption of broad-spectrum drugs has increased as a consequence of the spread of multidrug-resistant (MDR) Escherichia coli. Finding alternatives for these infections is critical, for which some neglected drugs may be an option.

Objective: To determine whether fosfomycin is noninferior to ceftriaxone or meropenem in the targeted treatment of bacteremic urinary tract infections (bUTIs) due to MDR E coli.

Role of inorganic phosphate concentrations in in vitro activity of fosfomycin.

Objectives: The objective of this study was to evaluate the in vitro activity of fosfomycin under different physiological concentrations of inorganic phosphate (P).

Methods: The wild-type BW25113 strain, four isogenic mutants (ΔglpT, ΔuhpT, ΔglpT-uhpT, and ΔphoB) and six clinical isolates of Escherichia coli with different fosfomycin susceptibilities were used. EUCAST breakpoints were used.

Switch to subcutaneous infliximab during the SARS-CoV-2 pandemic: preliminary results.

A new subcutaneous formulation of the infliximab biosimilar CT-P13 has recently been developed for the treatment of inflammatory bowel disease (IBD), providing response rates similar to intravenous treatment. The use of this new formulation was requested, in an effort to limit patient attendance at intravenous infusion centers and to maintain biological treatment during the COVID-19 pandemic. The objective of this observational, retrospective and descriptive study was to assess CT-P13 efficacy and safety after switching from intravenous to a subcutaneous formulation in patients with IBD receiving maintenance therapy.

Population Pharmacokinetics of Piperacillin in Non-Critically Ill Patients with Bacteremia Caused by Enterobacteriaceae.

This study analyzes the pharmacokinetic variability of piperacillin in non-critically ill patients with Enterobacteriaceae bloodstream infections (EBSI) and explores predicted clinical outcomes and piperacillin-related neurotoxicity under different renal conditions. Hospitalized, non-critically ill patients treated with piperacillin-tazobactam for EBSI were included. Four serum samples per patient were collected and analyzed.

Formulation, long-term physicochemical and microbiological stability of 15% topical resorcinol for hidradenitis suppurativa.

Objectives: Topical resorcinol 15% is a self-treatment for painful hidradenitis suppurativa nodules and abscesses with good results in reducing pain and lesion duration. The aim of this study is to establish a 15% topical resorcinol formula, to develop a physicochemical and microbiological stability study and to further determine the compounding shelf-life in different package conditions following the European Pharmacopoeia (Ph. Eur.

Cut-off ranges of infliximab serum levels in Crohn's disease in the clinical practice.

Introduction: between 30 % and 40 % of patients treated with infliximab lose response during maintenance. Therapeutic drug monitoring could be used to optimize management in these situations. However, infliximab serum levels are not well defined.