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Growth Hormone Deficiency PowerPoint Presentation

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Description : Check out this medical PowerPoint presentation titled "Growth Hormone Deficiency" by Annenberg Center for Health Sciences.

This medical PowerPoint presentation talks about growth hormone deficiency (GHD), a medical condition that occurs when the pituitary gland fails to produce enough growth hormone. Growth hormone is essential for normal growth and development in children, and it also plays a role in regulating metabolism and body composition in adults.

In children, growth hormone deficiency can lead to a range of symptoms, including slow growth, delayed puberty, and an abnormally short stature. Other potential symptoms may include a higher-than-normal body fat percentage, decreased muscle mass, and weaker bones. In some cases, children with GHD may also experience low energy levels, reduced strength and endurance, and difficulty concentrating.

In adults, growth hormone deficiency can cause a range of symptoms as well, including decreased muscle mass, increased body fat, and reduced bone density. Other potential symptoms may include decreased energy levels, impaired cognitive function, and a reduced sense of well-being. Adults with GHD may also be at an increased risk of developing cardiovascular disease and other health problems.

Treatment for growth hormone deficiency typically involves hormone replacement therapy, which involves regular injections of synthetic growth hormone. This treatment can help improve growth and development in children, and it can also improve body composition, bone density, and overall health in adults with GHD.

Tags : growth hormone deficiency, pituitary gland, slow growth, delayed puberty, endocrinology, endocrinology PowerPoint presentation

Published on : Apr 18, 2023 | Views : 2342 | Downloads : 3

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Epidemiology, Burden, Unmet Needs in Children and Adolescents
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Physiology of Growth Hormone/IGF-I Axis
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Growth Hormone Deficiency: Overview Underrecognized and underdiagnosed Characterized by inadequate physiological growth hormone (GH) secretion from the anterior pituitary gland GH deficiency (GHD) in children: Growth rate consistently below the 3-5% for age Likely not underweight; if anything, ‘pudgy’ Prevalence of GHD in the general population is about one in 4,000 – 10,0001,2 Consequences: growth retardation, short stature, maturation delays GHD may not persist after achievement of adult height; about 50,000 adults have GHD and about 6000 new cases are diagnosed each year.3 Cook DM, et al. Endocr Pract. 2009;15(suppl 2):1-2. 2. Stanley D. Curr Opin Endocrinol Diabetes Obes. 2012;19(1):47-52. 3. Brod M, et al. J Clin Endocrinol Metab. 2014;99(4):1204-1212.
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Onset and Etiologies of GHD Childhood/peripubertal1 Idiopathic isolated GHD: 80% Organic: 20% Isolated GHD or multiple pituitary hormone deficiencies Genetic defects in hypothalamic-pituitary axis Congenital malformations ofhypothalamic-pituitary structures Acquired (trauma, tumor, or irradiation) Adult2,3 Tumors: 75% Surgery/cranial irradiation: 4% Trauma/vascular injury: 6% Idiopathic: 10% Other (hypophysitis, infiltrative diseases): 5% Allen DB. Pediatric Endocrinology. 4th ed. 2003 Cook DM. Growth Horm IGF Res. 1999; Abs R, et al. Clin Endocrinol. 1999.
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Clinical Manifestations Children with GHD are usually normal size at birth May become hypoglycemic; males may have micropenis May have delayed rates of development of facial bones, slow tooth eruptions, delayed lengthening of long bones, fine hair, poor nail growth May have truncal obesity, high pitched voice, delayed closure of the sutures of the skull – and thus delayed closure of the fontanelles NOTE: many of these clinical features not apparent in children with idiopathic GHD Growth rate consistently < 5% for age
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Isolated GH Deficiency – Burden of Disease and Therapy Quality of Life – is being short a burden? Controversial Yes – Peds QoL lower in children with shorter stature No - Cumulative Pediatric and Adult data do not support beliefs that shorter stature associated with lower psychosocial functioning as children or adults. Avail QOL studies have high degree of bias. Development of QoLISSY- Quality of Life in Short Stature Youth Questionnaire Does GH improve quality of life? Yes – Using QoLISSY - Upon one year of therapy Burden of therapy: Daily injections, frequent medical visits and blood draws, multiyear therapy, variable outcomes between patients. Many adolescent patients (and their parents) asking when can they discontinue GH Bullinger et al. HormResPaediatr. 2009 72:74, Giesler et al. HormResPaediatr.. 2012 78:94 Sandberg DE PedClinNAmer. 2015 – 62: 963 Bullinger et al. Health Qual Life Outcomes Briceno et al. JCEM. 2019 104: 2103
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Safety considerations with GH Treatment Safety issues with GH Treatment for GHD Intracranial hypertension Slipped capital femoral epiphysis (SCFE) Scoliosis progression Monitor for glucose metabolism Risk of neoplasia – controversial Arthralgias and edema are common in young adults/adults especially when higher doses are used
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Diagnosis
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Typical Growth Patterns First 6 months of life: 16-17 cm Second 6 months of life: ~8 cm Second year of life: >10 cm Third year of life: 8 cm Fourth year: 7 cm Years 4-10: average of 5-6 cm/year A growth velocity of <5% for age (aka <4 cm/year in the 4-10 year old) should prompt evaluation. Constitutional Delay of Growth and Puberty
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Growth Attenuation/Arrest (growth velocity < 4 cm/year) Endocrine disorders directly affecting GH/IGF secretion Pituitary diseases causing GH deficiency Endocrine disorders indirectly affecting GH secretion Hypothyroidism Prolonged excess cortisol Endogenous – Cushing syndrome Exogenous – Corticosteroid treatment for inflammatory diseases Non-Endocrine disorders indirectly affecting GH secretion Malnutrition Low calorie intake/Starvation Malabsorption Celiac disease Inflammatory bowel disease Chronic disease Other disease causes of short stature Skeletal Disorders (eg, achondroplasia) Genetic Syndromes (eg, Trisomy 21) Chromosomal Abnormality (Turner Syndrome) IUGRSGA Lab Eval Differential Diagnosis IGF-1, prolactin, free T4, morning cortisol TSH, free T4 Salivary cortisol Celiac panel CMP with albumin ESR/CRP Bone age = Chronological Age Consider skeletal Survey Karyotype
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Who should be evaluated for GH deficiency? Pediatric Endocrine Society Guidelines Establish diagnosis of GHD without GH provocative testing if patient meets all 3 criteria: Auxological criteria Hypothalamic-pituitary defect (eg, major congenital malformation, tumor, irradiation) Deficiency of at least 1 additional pituitary hormone Do not rely on GH provocative testing as sole diagnostic criteria NOTE: very low peak GH levels on provocative testing are consistent with severe GHD– however, threshold that distinguishes between ‘normal’ and partial GHD that would respond to GH treatment – not well established. Owing to large discrepancies between labs, recommend that laboratories use somatropin standard IRP IS 98/574, 22k rhGH isoform Grimberg A, et al; Pediatric Endocrine Society. Horm Res Paediatr. 2016;86:361-397. 13
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GH deficiency diagnosis Growth Rate < 4 cm/year with IGF-1 z-score < -2, other causes excluded Assess other pituitary hormones (thyroxine, prolactin, cortisol) MRI Growth Hormone Stimulation testing abnormal normal Tumor –appropriate management Pituitary Structural abnormality – hormone replacement, including Growth Hormone abnormal normal Prepubertal with Age > 10 female or > 11 male no Sex steroid priming prior to stimulation testing GH levels < 5 GH levels >5, < upper limits of normal GH levels >5, > upper limits of normal, <10 ng/mL GH levels >upper limits of normal, > 10 ng/mL GH deficiency Probable GH deficiency Possible GH deficiency No GH deficiency
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Summary: Pearls and Pitfalls Differential diagnosis of attenuated growth is broad and includes hormone and non-hormone causes It can be difficult to distinguish between constitutional delay of growth and puberty and isolated partial (probable or possible) growth hormone deficiency Cut-offs for GH deficiency using the GH stimulation test are open to interpretation 15
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Pediatric Treatment Recommendations
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Indications and Patient Selection All daily somatropin products are FDA-approved for GH deficiency. Significant variability in indications for non-GH deficient diagnoses among agents Variabilities in dosing and dosing frequencies Somatropin products not generally considered bioequivalent with one another (lack of head-to-head studies) NOTE: selection of somatropin product is dictated by the insurance provider/payer, not the family or the physician 17
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Treatment considerations: Efficacy for GH Deficiency Growth hormone treatment with daily growth hormone injections generally leads to increase in height for persons who are GH deficient and whose growth plates have not fused Efficacy of daily GH injections With treatment, achieved adult height SDS – Midparental Height (MPH) score is -0.8 to -0.4 SD depending upon study. Even with GH, children rarely achieve an adult height higher than MPH Those with a higher achieved adult height had a higher midparental height, height gain in first year of therapy, more years on GH, lower GH peak on diagnostic stimulation testing.
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Treatment considerations: Safety – daily GH injections Safety Intracranial Hypertension – 1 per 1000 patients Dose dependent; most likely to occur with treatment initiation or dose increases Reversible when stop GH SCFE – slipped capital femoral epiphysis – 1 per 10,000-20,000 patients Occurs on average 3 years after initiation; associated with rapid growth, obesity Scoliosis progression Increased diabetes risk in those with insulin resistance Long term risk of Cancer? Cardiovascular disease? Controversial – Some European studies suggest there is an increase in CV events for treated patients in their 30s and 40s, others no.
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Shared decision making (SDM) With patient/family – collaboration, goals, risk/benefit, ongoing support, promoting long term adherence Importance of addressing psychosocial concerns during decision-making process Means to facilitate adherence and consequences of poor adherence 20
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Shared Decision Making:AHRQ Model of Patient-Centered Care Problem Lack of patient knowledge necessary for informed decision making Available evidence conflicting/confusing (eg, QOL data on short stature/effect of GH) Many medical decisions (preventive testing, diagnostic workups, treatment options) driven more by MD attitudes preferences than scientific evidence CORE PRINCIPLE of SDM: only preference driving diagnostic/treatment variations should be made by patient Intervention: Basic Tenets Patients armed with balanced information relative to their particular situation can/will participate in the medical decision-making process by asking informed questions and expressing personal values/opinions about their conditions/treatment options Clinicians will respect patients’ goals/preferences and use them to guide recommendations and treatments AHRQ 21
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Implementing Shared Decision-Making SHARE 22 Seek your patient’s participation Communicate that a choice exists and invite to be involved in decision Help your patient explore and compare treatment options Discuss benefits and harms (and unknowns) of each option Assess your patient’s values and preferences Take into account what matters most Reach a decision with your patient Decide together on the best option and arrange for follow-up Evaluate your patient’s decision Support your patient so treatment decision has a positive impact on health outcomes
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Treatment Dosing and Monitoring Daily GH injections Dosing Starting dose 0.15-0.2 mg/kg/week (20-30 mcg/kg/day) Different GH (somatropin) brands have different recommendations for dosing 0.16-0.3 mg/kg/week Subsequent dosing to titrate IGF-1 level in the upper ½ of normal range for age Minimum twice yearly – studies of this technique analyzed 3-4X yearly Wide range of mg/kg dosing among patients to keep IGF-1 in upper ½ of normal range Every 3-6 mos IGF-1 level Height Weight Screen for side effects (headaches, knee, hip pain, polyuria) Consider screening for diabetes in those at high risk Yearly Screen for other pituitary hormone deficiencies in those at high risk (consider free T4, cortisol) Bone age
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Outcomes of Growth Hormone Therapy: Beyond Height Body composition Bone Mass Accrual occurs until early 20s GH plays role in optimal accrual Quality of life Metabolic abnormalities Lean muscle mass Lipid profile 24
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Duration of therapy Transition: when linear growth done and re-evaluation for persistent GH deficiency is recommended Male: When growth rate less than 3 cm/year and bone age 17 Female: When growth rate less than 3 cm/year and bone age 14 Retesting once these milestones achieved: Multiple pituitary hormone deficiency (>2 pituitary hormones deficiency) persistent GH deficiency is 100% chance  no repeat testing needed 2 or fewer pituitary hormones (even with abnormal pituitary structure)  persistent GH deficiency 30-70% of patients  repeat testing needed IGF-1 level 1-3 months after GH held – If IGF-1 z-score < -2  persistent GH deficiency. IF IGF-1 z-score > 0 likely not persistent GH deficiency Repeat GH stimulation testing (using adult protocols) recommended if IGF-1 level indeterminate 25
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Yuen KCJ, et al. Growth Horm IGF Res. 2021;56:101375. What Are the Common Challenges to Transitioning a Patient? Pediatric Endocrinologist Lack of education and/or communication with patients Lack of effective model for transferring patients Peds endos unwilling to “hand over” patients to adult endos Patient/Caregivers Lack of disease education/awareness Lack of expectations/preparation for managing disease as an adult Lack of treatment adherence No other treatment options besides injections High cost of treatment Patients may not be directed to the appropriate clinicians/pituitary centers to take over care Payers may not cover or dictate where patients will go for their testing Parental trust issues with adult endos Adult Endocrinologist Lack of education/awareness on the importance of treating adults with GHD Lack of long-term benefit data for GH replacement therapy Lack of knowledge of how to manage transition patients with certain conditions (eg, childhood cancer) Some pediatric and/or adult endocrinologists may not offer retesting after attainment of final height
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Communication between pediatric endocrinologist and primary care Expectation management Diagnosis/evaluation process Reasonable yearly gains (cm gained/year) Achievable height outcomes GH may be needed after height achieved 27
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The ideal transition of childhood-onset GHD from pediatric to adult services Yuen KCJ, et al. Growth Horm IGF Res. 2021;56:101375.
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Summary: Pearls and Pitfalls Daily growth hormone has a proven record for efficacy and safety in GHD patients For optimal outcomes, GH treatment requires multiple years of therapy Response to therapy varies among patients so discussions about outcomes is nuanced and can change upon response to therapy Ensuring appropriate confirmatory testing and providing seamless GH replacement therapy for patients with persistent GHD is a challenge A clearly structured transition protocol is vital to provide useful, practical guidance to clinicians and establish best practices when transitioning adolescents with persistent CO-GHD to adult care 29
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Review of Available Recombinant Growth Hormone (somatropin) Treatments
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Overview of Options What factors to consider for treatment selection between approved products? Indications Frequency of administration Tolerability/Safety 31
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Somatropin Products Available in the United States for Pediatric Growth Hormone Deficiency GHD, growth hormone deficiency; TS, Turner syndrome; ISS, idiopathic short stature; PWS, Prader-Willi syndrome; SHOX, short stature homeobox-containing gene; SGA, small for gestational age; NS, Noonan syndrome
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Issues with daily GH injections Inconvenient, painful and distressing Lack of information/perceived effects Nonadherence Hypothesis: By decreasing injection frequency, LAGH preparations may improve quality of life and adherence, and thereby potentially improve clinical outcomes Why consider LAGH preparations?
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What would make an “ideal” LAGH preparation? Mode of delivery Ideal frequency of injection (weekly, biweekly…?) Small-bore needle Entire dose in a small-volume single injection User-friendly pen device to capture each dose administration Efficacy Not inferior to daily GH therapy Safety Side effect profile similar to daily GH Maintains IGF-I in the physiologic range No injection site reactions, lipodystrophy or pain Does not induce neutralizing anti-GH antibodies Does not cause iatrogenic acromegaly or other idiosyncratic side effects Cost Less costly or at least comparable to daily GH therapy
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Lonapegsomatropin (TransCon ACP-001) Indication: Growth Hormone deficiency in children Dosed weekly (0.24 mg/kg/week) Long-acting prodrug form of somatropin Human growth hormone indicated for the treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH).
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Lonapegsomatropin Thornton PS, et al. J Clin Endocrinol Metab. 2021 Jul 17;dgab529. Online ahead of print.
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Phase 3 heiGHt trial in CGHD Thornton PS, et al. J Clin Endocrinol Metab. 2021 Jul 17;dgab529. Online ahead of print.
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Near-Term Long-Acting Growth Hormone Treatments Review of Safety and Efficacy Data from Pivotal Trials
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How do we make an injection of GH last longer? Delay absorption from the subcutaneous space Incorporation into microspheres Slow clearance from circulation Polyethylene glycol Permanent pegylation Reversible pegylation Fusion proteins Synthetic polypeptides Naturally occurring proteins Human chorionic gonadotropin (hCG) Albumin Immunoglobulin chains Modify binding to serum proteins Change binding to albumin Prodrug PEGylation Depot GH fusion proteins Noncovalent albumin binding Yuen KCJ, et al. Front Endocrinol (Lausanne). 2021 Feb 24;12:637209.
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Somapacitan NNC0195-0092 Single-point mutation in GH, with albumin binding moiety attached (non-covalent albumin-binding properties) Approved by the FDA in August 2020 with dosing every 7 days for use in AGHD; not yet marketed
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Somapacitan vs Norditropin: REAL 3 study Savendahl L, et al. J Clin Endocrinol Metab. 2020;105(4):e1847-e1861.
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Measuring IGF-I levels using linear models while on LAGH preparations: it’s all about timing! Juul Kildemoes R, et al. J Clin Endocrinol Metab. 2021;106(2):567-576.
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Somatrogon (MOD 4023) Long-acting recombinant human growth hormone: amino acid sequence of human growth hormone + 3 copies of carboxy-terminal peptide (CTP) of HCG. Being developed as once-weekly treatment 43 https://clinicaltrials.gov/ct2/show/results/NCT02968004 https://clinicaltrials.gov/ct2/show/NCT03831880
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Somatrogon: Phase 2 and 3 trials 12-month phase 2 trial: once weekly somatrogon (0.66 mg/kg/wk) vs daily genotropin (0.24 mg/kg/wk) 5-year open label extension Phase 3 trials: n=224 Ss randomized 1:1 to somatrogon (0.66 mg/kg/wk; n=109) or qd genotropin (0.24 mg/kg/wk; n=115) X 12 months Results: mean HV was 10.10 cm/yr somatrogon group vs 9.78 cm/yr in genotropin group. Somatrogon was not inferior to genotropin Well tolerated https://clinicaltrials.gov/ct2/show/results/NCT02968004. https://clinicaltrials.gov/ct2/show/NCT03831880. Deal CL, et al. JESOCI. 2020;4(Supplement):A648-A649.
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Somatrogon: Phase 3 trial Phase 3 trial: compared somatrogon (0.66 mg/kg/wk) administered once/week vs genotropin (0.025 mg/kg/day) administered subcutaneously once/day in 44 Japanese pGHD patients (aged 3-11 years) X 12 months.[Horikawa 2021] LSM of Height velocity (HV) at 12 months: 9.65 cm/year in somatrogon group (n=22) vs 7.87 cm/year in genotropin group (n=22); Point estimate treatment difference =1.79 cm/year (95A% CI 0.97, 2.60) Met primary endpoint; somatrogon not inferior to daily genotropin Well tolerated Horikawa R, et al. J Endocrine Soc. 2021;5(Suppl 1):A682-A683.
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Biomarkers of daily vs LAGH preparations: what are the differences? Neither daily nor LAGH preparations mirror the “physiological” GH secretion Daily vs LAGH preparations: Duration of GH exposure (hours per day vs days per week) Duration of exposure to high (peak) and low (trough) IGF-I levels Relationship between GH and IGF-I levels Tissue distribution of GH (if GH molecule is modified)
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So which patients would benefit most from LAGH preparations? Naïve-patients that are likely to be non-adherent - patients already on many “other” injections - patients unable to self-inject but willing to start or remain on GH treatment Patients already on daily GH injections but are non-adherent
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Unanswered Questions with LAGH Products How to start and adjust LAGH dosing? When is the best time to measure IGF-I levels and is it the same for all LAGH preparations? Would LAGH cause tachyphylaxis and/or downregulation of GH receptors? Will the effects of LAGH preparations be durable with long-term use? Can LAGH preparations penetrate all tissues equally? Will there be long-term metabolic consequences? Are LAGH cost-effective? Will LAGH improve adherence and outcomes? Will the safety profile of LAGH be different to daily GH?
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Summary Numerous LAGH preparations have been or are being developed but they all have different characteristics Short-term studies demonstrate some LAGH preparations are noninferior to daily GH in efficacy and comparable safety profile More “convenient” than daily GH injections Although LAGH preparations has the promise to improve adherence and long-term outcomes, this still needs to be proven in large prospective clinical trials
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Case Studies: Putting It All Together
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Case 1: 8-year old boy 8-year old boy on GH of 0.3 mg/kg/week (42 mcg/kg/day) Parents recently divorced, with shared custody so supply must be transferred between households Parent may forget to resupply/transfer GH pen between households, so often 2-3 days of GH missed every 2 weeks Growth velocity has dropped from the 70% to the 20th percentile with corresponding height z-score drop from -2.3SD to -2.6SD 51
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Case 1, continued Both parents and child at clinic visit state desire to continue GH, but realities of coordinating delivery and care between households has limitations His IGF-1 level fell from +1.7Sd to -0.4 SD once he had to move between household. Goals of treatment: Switching products:
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Case 2: 11-year old girl 11-year old girl treated with GH at a dose of 0.25 mg/kg/week (35 mcg/kg/day). Her growth velocity fell from the 80th percentile to 40% from her last clinic visit 6 months ago with corresponding height z-score fell from -1.4 to -1.9 SD She is tanner 3 puberty, premenarchal. Her IGF-1 z-score fell from +1.8SD to -0.7 SD. 53
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Case 2, continued At her last clinic visit, she triumphantly told you that she was doing injections herself. She prefers to do injections herself as they hurt less than when her parents do them. She reports no missed doses. However: growth data and IGF-1 level suggest she is not getting the medicine Parents think they have to call for refills as often as before but can’t recall exactly. Assessing treatment response Shared decision making Adherence barriers
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Treated with GH since age 6 Presentation: - Delayed bone age < 3rd percentile for age - Height and growth velocity < 3rd percentile - MRI normal pituitary gland Case 3: 15-year old female with idiopathic isolated GH deficiency
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Course: - Puberty at 12.5 yrs of age - Progressed normally - 8 months ago, growth velocity decreased to 3.5 cm/yr Currently: - GH dose 0.033 mg/kg/day - Height: 170 cm (mid-parental height: 175 cm) - Growth velocity: 2.2 cm/yr - Body weight: 68 kg (BMI: 23 kg/m2) - Bone age 15 yrs Case 3, continued
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Psychosocial adaptation to Short Stature Factors potentially affecting psychosocial adaptation among those with short stature Male gender The presence of a younger but taller sibling Being perceived and treated as younger than chronological age Lower intelligence Lower family socioeconomic status Acceptance into some peer group activities Bullinger M, et al. Horm Res. 2009;72:74–81
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Emotional burdens of GHD in children Social Well-Being Domain* Emotional Well-Being Domain* Brod M, et al. Qual Life Res. 2017;26:1673.
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Dealing with short stature as an adolescent Treatment burden, adherence and persistence Transition to child self-administering medication (without supervision) Injection fatigue Continued reassessment of expectations particularly as child approaches normal adult height range Challenges of adherence of adolescents as they seek independence and become more active (school sports, school trips, after school activities, etc)
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Nonadherence is more common in adolescents Rosenfeld RG, Bakker B. Endocrine Pract 2008;14:143–54 60 Teens(age 13–17) Parents of children(age 5–12)
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Patient + Parent: Following Through With Treatment Years of daily injections Temperature-sensitive storage Child autonomy Adherence Brand switches from formulary preference changes Treatment monitoring Visits to pediatric endocrinologist at least every 6 months Monitoring blood work (especially IGF-I) Serial bone age x-rays Grimberg A, et al. Endocr Pract. 2012;18:307-316.
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CONCLUSIONS and KEY TAKEAWAYS Daily growth hormone has a proven record for efficacy and safety in GHD patients There may be multiple barriers to daily GH therapy Nonadherence with daily GH therapy can contribute to poor growth and possible long-term bone and cardiovascular health Long-acting GH preparations holds the promise of improving treatment adherence and outcomes 62
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Identifying Potentially Modifiable Factors Associated with Treatment Nonadherence in Pediatric Growth Hormone Deficiency: A Systematic Review Included 6 observational studies of children treated with GH Children had any indication for GH Adherence measured by either self-report or returned/unused vials on a specific device Rates of nonadherence: 7% to 70% Identified 22 different factors that contribute to nonadherence. Physical capability Uncomfortableness with the injection or pain on the injection Concerns about inadequate training on injection, Discomfort, dissatisfaction with efficacy so want to discontinue injections Lifestyle disruptions Graham S, Weinman J, Auyeung V. Horm Res Paediatr. 2018;90:221-227.