Ekaterina Koledova

• Doctor of Medicine, Ph.D
• Managing Director at Merck

Aims To assess the potential acceptance of digital health devices for administering pediatric growth hormone (GH) therapy and to understand how clinicians in Gulf Cooperation Council (GCC) countries perceive the evolution of health technologies. The only electronic device presently available for GH therapy in GCC countries is easypod ® . Participa...

Pediatric growth hormone deficiency (PGHD) is a chronic condition where the pituitary gland fails to produce sufficient growth hormone, leading to delayed growth and developmental challenges. Patient journey maps can provide insight into pain points and potential opportunities for new or improved interventions to enhance care. However, a patient jo...

Smart technologies and connected health are providing opportunities for improved healthcare for chronic conditions. Acceptance by healthcare professionals (HCPs) and patients is crucial for successful implementation. Evidence-based standards, technological infrastructure and regulatory processes are needed to integrate digital tools into clinical p...

Adherence to recombinant human growth hormone (r-hGH; somatropin, [Saizen®], Merck Healthcare KGaA, Darmstadt, Germany) treatment is important to achieve positive growth and other outcomes in children with growth disorders. Automated injection devices can facilitate the delivery of r-hGH, injections of which are required daily for a number of years...

Introduction To analyse the perspectives of healthcare professionals (HCPs) regarding the acceptance of digital health solutions for growth hormone (GH) deficiency care. This study identified factors impacting HCPs’ intent to use and recommend digital solutions supporting recombinant-human growth hormone (r-hGH) therapy in Italy and Korea with a us...

Introduction This study in Argentina evaluated the impact of the growzen™ buddy smartphone app on adherence to recombinant human growth hormone (r-hGH) treatment. Methods The adherence data, invitation dates with a link to the app, app activation dates, and height measurements entered were extracted from the growzen™ digital health ecosystem. Pati...

Disclosure: S. Loche: Advisory Board Member; Self; SL has received advisory board fees from the healthcare business of Merck KGaA, Darmstadt, Germany. Consulting Fee; Self; SL has received consultancy fees from the healthcare business of Merck KGaA, Darmstadt, Germany. Speaker; Self; SL has received lecture fees from the healthcare business of Merc...

Background: Digital solutions targeting children's health have become an increasingly important element in the provision of integrated health care. For the treatment of growth hormone deficiency (GHD), a unique connected device is available to facilitate the delivery of recombinant human growth hormone (r-hGH) by automating the daily injection pro...

Adherence to recombinant human growth hormone (r-hGH; somatropin, [Saizen®], Merck Healthcare KGaA, Darmstadt, Germany) treatment is fundamental to achieve positive growth outcomes in children with growth disorders and to improve quality of life and cardiometabolic risk in adult patients affected by GH deficiency. Pen injector devices are commonly...

Diagnosis and management of individuals who have differences of sex development (DSD) due to numerical or structural variations of sex chromosomes (NSVSC) remains challenging. Girls who have Turner syndrome (45X) may present with varying phenotypic features, from classical/severe to minor, and some remain undiagnosed. Boys and girls who have 45,X/4...

Background: Children with growth hormone deficiency face the prospect of long-term recombinant human growth hormone (r-hGH) treatment requiring daily injections. Adherence to treatment is important, especially at treatment initiation, to achieve positive health outcomes. Historically, telenursing services embedded in patient support programs (PSPs...

Background Growth hormone deficiency (GHD) is a rare disorder characterized by inadequate secretion of growth hormone (GH) from the anterior pituitary gland. One of the challenges in optimizing GH therapy is improving adherence. Using digital interventions may overcome barriers to optimum treatment delivery. Massive open online courses (MOOCs), fir...

Introduction The appropriate use of recombinant human growth hormone (r-hGH) treatment provides an opportunity to improve growth outcomes among pediatric patients with growth hormone deficiency (GHD). However, a major challenge in clinical practice is to adequately recognize and address factors that negatively affect treatment adherence. TUITEK® pa...

Worldwide regulations during COVID-19 positively and negatively impacted self-management in paediatric patients with chronic medical conditions. We investigated the impact of regulations on adherence to recombinant human growth hormone (r-hGH) therapy in paediatric patients with growth disorders, using real-world adherence data extracted March 2019...

BACKGROUND Digital solutions targeting children’s health have become an increasingly important element in the provision of integrated health care. For the treatment of growth hormone deficiency (GHD), a unique connected device is available to facilitate the delivery of recombinant human growth hormone (r-hGH) by automating the daily injection proce...

BACKGROUND Children with growth hormone deficiency face the prospect of long-term recombinant human growth hormone (r-hGH) treatment requiring daily injections. Adherence to treatment is important, especially at treatment initiation, to achieve positive health outcomes. Historically, telenursing services embedded in patient support programs (PSPs)...

Curve matching may be used to predict growth outcomes using data of patients whose growth curves resemble those of a new patient with growth hormone deficiency (GHD) and those born small for gestational age (SGA). We aimed to investigate the validity of curve matching to predict growth in patients with GHD and those born SGA receiving recombinant h...

Pediatric growth hormone (GH) deficiency is a licensed indication for replacement therapy with recombinant human growth hormone (r-hGH). Treatment, consisting of daily subcutaneous injections, extends from the time of diagnosis until cessation of linear growth at completion of puberty. Suboptimal adherence to r-hGH therapy is common and has been we...

Background Our aim was to develop a machine learning model, using real-world data captured from a connected auto-injector device and from early indicators from the first 3 months of treatment, to predict sub-optimal adherence to recombinant human growth hormone (r-hGH) in patients with growth disorders. Methods Adherence to r-hGH treatment was ass...

We explored whether a multi-component approach – using a digital health device, the easypod™ auto-injector, the ‘MySupport’ patient support programme (PSP) and a Patient Activation Measure® (PAM®) – could improve adherence in patients receiving recombinant human growth hormone (r-hGH). A 13-item PAM was used to assess caregiver self-reported knowle...

Purpose Poor adherence to recombinant human growth hormone (r-hGH) treatment presents a significant barrier to achieving optimal growth outcomes. It is important to identify and address the treatment adherence-related needs of children prescribed r-hGH treatment, and develop new approaches to improve adherence. We aimed to measure the impact of the...

Background Recombinant human growth hormone (rhGH) therapy is an effective treatment for children with growth disorders. However, poor outcomes are often associated with suboptimal adherence to treatment. Objective The easypod connected injection device records and transmits injection settings and dose data from patients receiving rhGH. In this stu...

Recombinant human growth hormone (r-hGH) is an established therapy for growth hormone deficiency (GHD); yet, some patients fail to achieve their full height potential, with poor adherence and persistence with the prescribed regimen often a contributing factor. A data-driven clinical decision support system based on “traffic light” visualizations fo...

Recombinant human growth hormone (r-hGH) is used as a therapeutic agent for disorders of growth including growth hormone deficiency (GHD) and Turner syndrome (TS). Treatment is costly and current methods to model response are inexact. GHD (n = 71) and TS patients (n = 43) were recruited to study response to r-hGH over 5 years. Analysis was performe...

BACKGROUND Recombinant human growth hormone (rhGH) therapy is an effective treatment for children with growth disorders. However, poor outcomes are often associated with suboptimal adherence to treatment. OBJECTIVE The easypod connected injection device records and transmits injection settings and dose data from patients receiving rhGH. In this st...

Digitalization of healthcare delivery is rapidly fostering development of precision medicine. Multiple digital technologies, known as telehealth or eHealth tools, are guiding individualized diagnosis and treatment for patients, and can contribute significantly to the objectives of precision medicine. From a basis of “one-size-fits-all” healthcare,...

The problem of consistent therapy adherence is a current challenge for health informatics, and its solution can increase the success rate of treatments. Here we show a methodology to predict, at individual-level, future therapy adherence for patients receiving daily injections of growth hormone (GH) therapy for GH deficiency. Our proposed model is...

The early adoption of digital health solutions in the treatment of growth disorders has enabled the collection and analysis of more than 10 years of real-world data using the easypod™ connect platform. Using this rich dataset, we were able to study the impact of engagement on three key treatment-related outcomes: adherence, persistence of use, and...

Growth hormone administration is approved for use in a number of growth failure conditions in children. Optimal growth outcome requires continuous daily injections over many years, leading to problems of persistence and adherence with therapy. The easypod™ connect ecosystem enables electronic monitoring of injection and dose history, transmitted to...

Children born small for gestational age (SGA) comprise a heterogeneous group due to the varied nature of the cause. Approximately 85–90% have catch-up growth within the first 4 postnatal years, while the remainder remain short. In later life, children born SGA have an increased risk to develop metabolic abnormalities, including visceral adiposity,...

Background The use of technology to support health and health care has grown rapidly in the last decade across all ages and medical specialties. Newly developed eHealth tools are being implemented in long-term management of growth failure in children, a low prevalence pediatric endocrine disorder. Objective Our objective was to create a framework t...

Background: A range of factors can reduce the effectiveness of treatment prescribed for the long-term management of chronic health conditions, such as growth disorders. In particular, prescription medications may not achieve the positive outcomes expected because approximately half of patients adhere poorly to the prescribed treatment regimen. Me...

BACKGROUND The use of technology to support health and healthcare has grown rapidly in the last decade, across all ages and medical specialties. Newly-developed eHealth tools are being implemented in long-term management of growth failure in children, a low prevalence pediatric endocrine disorder. OBJECTIVE Our objective was to create a framework...

Assessment and management of children with growth failure has improved greatly over recent years. However, there remains a strong potential for further improvements by use of novel digital techniques. A panel of experts discussed developments in digitalization of a number of important tools used by pediatric endocrinologists at the third 360° Europ...

Background: Poor adherence to long-term recombinant human growth hormone (r-hGH) treatment can lead to suboptimal clinical outcomes; consequently, supporting and monitoring adherence is a crucial part of patient management. We assessed adherence to r-hGH treatment in children with growth disorders over 48 months using a connected monitoring device...

Background The easypod™ injection device allows automatic recording and transmission of adherence data from patients receiving recombinant human growth hormone (rhGH [Saizen®]) to treat growth disorders. This analysis aimed to evaluate the adherence of Saizen® administered via easypod™ in a cohort of Greek patients from the easypod™ connect observa...

Background Assessing adherence to growth hormone (GH) is challenging. The Easypod™ connect device delivers pre-set doses of recombinant human GH (r-hGH) and stores a digital record of adherence that can be shared with healthcare provider. We assessed adherence to r-hGH delivered with Easypod™ according to the approved pediatric indications for r-hG...

Background The use of mobile apps for health is growing. This rapid growth in the number of health apps can make it hard to assess their quality and features. The increased demand for and availability of mobile health apps highlights the importance of regular publication of reviews to identify potential areas of unmet needs and concern. The focus o...

No. 335 • Poor adherence to long-term treatment with growth hormone (GH) is known to affect final growth and other clinical outcomes. 1 • Adherence to GH treatment has always been difficult to monitor and is usually assessed by patient testimony or prescription records. 2 • The easypod™ electromechanical injection device, in combination with the ea...

It is over sixty years since the first administration of human growth hormone (GH) to children with GH deficiency, and over thirty years since recombinant human GH has been available for treatment of GH deficiency and a wider range of non-GH deficiency disorders. From a diagnostic perspective, genetic analysis, using single gene or Sanger sequencin...

Recombinant human growth hormone (r-hGH) is used as a therapeutic agent for disorders of growth including growth hormone deficiency (GHD) and Turner syndrome (TS). Treatment is costly and current methods to model response can only account for up to 60% of the variance. The aim of this work was to take a novel genomic approach to growth prediction....

Background: The ECOS observational study was a long term, multicentre, observational study that looked at assessing the level of adherence to paediatric patients’ prescribed recombinant GH (r-hGH) Saizen (somatropin) via the Easypod® electromechanical auto-injector device, and to then further analyse possible clinical and socioeconomic factors that...

Background: Various prediction models for the growth response to recombinant human growth hormone (rhGH) have been published, but none of these have been able to incorporate data on adherence to rhGH treatment. Previous studies have shown that suboptimal adherence negatively affects the growth response in the first two years of rhGH treatment. The...

Background Quantifying the association between adherence and the growth response to growth hormone (GH) treatment is hampered by suboptimal methods of measuring adherence, confounders associated with the growth response, and restriction of the outcome parameters to yearly growth velocities. Aim To investigate the effect of adherence on the two-yea...

Objective: The easypod™ connect observational study (ECOS) assessed treatment adherence among paediatric patients receiving growth hormone (GH) via the easypod electronic injection device. Design: ECOS was an open-label, observational, longitudinal study conducted in 24 countries between 2010 and 2016, enrolling children treated with GH. Method...

The growth hormone (GH)–insulin-like growth factor (IGF)-I axis is a key endocrine mechanism regulating linear growth in children. While paediatricians have a good knowledge of GH secretion and assessment, understanding and use of measurements of the components of the IGF system are less current in clinical practice. The physiological function of t...

Background: The effect of gene expression data on diagnosis remains limited. Here, we show how diagnosis and classification of growth hormone deficiency (GHD) can be achieved from a single blood sample using a combination of transcriptomics and random forest analysis. Methods: Prepubertal treatment-naive children with GHD (n = 98) were enrolled...

The “360° GH in Europe” meeting, which examined various aspects of GH diseases, was held in Lisbon, Portugal, in June 2016. The Merck KGaA (Germany) funded meeting comprised three sessions entitled “Short Stature Diagnosis and Referral,” “Optimizing Patient Management,” and “Managing Transition.” Each session had three speaker presentations, follow...

Growth hormone (GH) promotes growth in children, but is also essential for bone strength, body composition, metabolic factors, such as lipid profile, and maintenance of quality of life. The Merck KGaA (Germany) funded “360° GH in Europe” meeting, held in Lisbon, Portugal, in June 2016, comprised three sessions entitled “Short Stature Diagnosis and...

Objective Single-nucleotide polymorphisms (SNPs) associated with the response to recombinant human growth hormone (r-hGH) have previously been identified in growth hormone deficiency (GHD) and Turner syndrome (TS) children in the PREDICT long-term follow-up (LTFU) study (Nbib699855). Here, we describe the PREDICT validation (VAL) study (Nbib1419249...

Objectif L’objectif principal de ECOS est d’évaluer le niveau d’observance des patients recevant rhGH via easypod™ ; les objectifs secondaires sont d’évaluer l’impact de l’observance sur les résultats cliniques et les concentrations de IGF1. Méthode Les données démographiques, auxologiques et diagnostiques sont obtenus des dossiers médicaux, les d...

Diagnosis and management of growth disorders comprises an important area of pediatric practice. Current procedures in the different stages of the identification, referral, investigation and treatment of growth disorders in the GCC countries have been summarized. Evidence-based procedures, relating specifically to height screening for identification...

Early diagnosis is a key objective in clinical medicine, and early detection of pathological short stature has tangible benefits for growth prognosis and the well-being of the child. Despite late diagnosis being common in growth disorders, programmes of height screening in primary care are not universal in developed countries and may be random or n...

Background: Predicting response to r-hGH therapy will allow optimisation of dose to maximise the cost:benefit of treatment. Response to treatment over one year has previously been associated with distinct gene expression (GE) profiles(1)but the relationship of baseline GE to longer term response is unknown. Objectives:To assess the relationship of...

Background: Measurement of peak growth hormone levels during pharmacological stimulation testing remains central to the diagnosis and classification of growth hormone deficiency (GHD) despite problems with reproducibility and assay variability. The tests also require admission to hospital, fasting and are associated with adverse events. New tools t...

Meta-analysis has shown a modest improvement in first-year growth response to recombinant human growth hormone (r-hGH) for carriers of the exon 3-deleted GH receptor (GHRd3) polymorphism but with significant interstudy variability. The associations between GHRd3 and growth response to r-hGH over 3 years in relation to severity of GH deficiency (GHD...

This study examined discrepancies between the perceptions of physicians treating short children with GH deficiency (GHD) using GH replacement therapy (GHRT) and the perceptions of the parents of these children and identified the major causes of parental anxiety. Three attending pediatric endocrinologists and the parents of 31 GHD children participa...

To investigate the effects of growth hormone (GH) treatment, using a dose-adjustment regimen based on serum insulin-like growth factor (IGF)-I concentrations, in adult Japanese hypopituitary patients with GH deficiency. Japanese patients who had initially been administered GH (n = 31) or placebo (n = 28) in a 24-week double-blind study received ind...

The consequences of lifelong untreated childhood-onset GH deficiency (COGHD) on adult bone and especially fracture prevalence are largely unknown due to the lack of data on long-term outcome of untreated patients. Therefore, we studied adult Russian patients (n = 66; 28 females and 38 males) with idiopathic GH-untreated COGHD. Patients had isolated...

To evaluate the influence of factors intrinsic to the Japanese population on consequences of growth hormone deficiency (GHD) and effects of GH treatment in adult Japanese hypopituitary patients with GHD. A 24-week, randomised, placebo-controlled, double-blind study in 64 patients in Japan, with GHD onset during adulthood (AO; n=27) or childhood (CO...

The paper presents the results of treatment in 45 adult patients with somatotropic insufficiency. The study was undertaken to compare the efficiency of treatment of the patients with different doses of the human growth hormone Humatrop and to evaluate its safety. The treatment lasted 6 months. Within the first 3 months, Group 1 patients (n = 24) re...

Humalog Mix25 (Mix25) is a premixed insulin mixture of 25% insulin lispro and 75% neutral protamine lispro. The aim of this study was to quantitate the improvement in glycemic control achieved with Mix25 versus the maximum dose of glyburide (GB) in patients with type 2 diabetes inadequately controlled with GB. In this randomized, parallel, open-lab...

Современные препараты инсулина разделяют на группы в зависимости от происхождения (животные и человеческие) и длительности действия. Инсулины от животных - свиные, говяжьи и смешанные (свиной+говяжий). На протяжении 60 лет для лечения СД применяли говяжий и свиной инсулины, которые по составу отличаются от человеческого (на 3 и 1 аминокислоту соотв...

Анализ стоимости лечения сахарного диабета (СД) является частью фармакоэкономики ? нового направления в здравоохранении. Экономический анализ медицинской помощи зависит от типа затрат, типа прибыли, а также точки зрения части общества, относительно которой проводится анализ. При анализе стоимости лечения СД необходимо различать прямые и непрямые за...

The authors analyze published data on clinical variants and hormonal parameters in patients with this syndrome and present their own observations of children with this condition. Besides early sexual maturation, they describe the clinical picture of Cushing's syndrome, thyroid nodular hyperplasia. The said disorders do not depend on the tropic effe...

In some children premature sexual maturation occurs in the absence of pubertal levels of gonadotropins and gonadal hormone producing tumors. Clinical and hormonal evaluation of 7 children (3 girls and 4 boys) was performed. In all girls the onset of sexual development was seen before 3 years of age. The clinical picture was characterised with featu...