Needle-Free and Needle-Based Growth Hormone Therapy in Children: A Pooled Analysis of Three Long-Term Observational Studies

Rohrer, Tilman; Ceplis-Kastner, S.; Jorch, Norbert; Müller, Hermann L.; Pfäffle, Roland; Reinehr, Thomas; Richter‐Unruh, Annette; Weissenbacher, Claudia; Holterhus, Paul‐Martin

doi:10.1159/000496614

Cited by 8 publications

(4 citation statements)

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“…The efficacy of rhGH was shown in our analysis by positive prepubertal gains in height-SDS after 1 year of treatment in all diagnostic groups. These results are consistent with previous KIGS analyses of patients treated for GHD, TS, SGA, and PWS ( 42 , 43 ), and are also in line with findings from postmarketing studies of other pediatric rhGH therapies ( 12 , 13 , 26 , 44 ). Patients with extracranial malignancy had the smallest height-SDS gain at year 1, which could be at least partially related to the later initiation of rhGH vs other groups.…”

Section: Discussionsupporting

confidence: 92%

Safety and Efficacy of Pediatric Growth Hormone Therapy: Results From the Full KIGS Cohort

Maghnie

Ranke

Geffner

et al. 2022

The Journal of Clinical Endocrinology &Amp; Metabolism

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Context KIGS is a large, international database (1987-2012) of children treated with recombinant human growth hormone (rhGH) in real-world settings. Objective To evaluate the safety and efficacy of rhGH from the full KIGS cohort Design, Patients, Setting, and Intervention Data were collected by investigators from children with growth disorders treated with rhGH (Genotropin® [somatropin]; Pfizer, NY). Safety was evaluated in all treated patients, and efficacy in those treated for ≥1 year. A subgroup included patients treated for ≥5 years (≥2 years prepubertal) who had reached near-adult height (NAH). Main Outcomes Adverse events (AEs), serious AEs (SAEs), and height growth. Results The full KIGS cohort (N = 83,803 [58% male]) was treated for idiopathic GH deficiency (IGHD; 46.9%), organic GHD (10.0%), small for gestational age (SGA; 9.5%), Turner syndrome (TS; 9.2%), idiopathic short stature (ISS; 8.2%), and others (16.2%). Median rhGH treatment duration was 2.7 years and observation 3.1 years. SAEs occurred in 3.7% of patients and death in 0.4%. The most common SAEs were recurrence of craniopharyngioma (n = 151), neoplasm (n = 99), and cancer (n = 91); and scoliosis (n = 91). Median first-year delta height-SDS (Prader) in prepubertal patients was 0.66 (IGHD), 0.55 (ISS), 0.58 (TS), 0.71 (SGA). Median gains in NAH-SDS were 1.79 (IGHD), 1.37 (ISS), and 1.34 (SGA) for boys, and 2.07 (IGHD), 1.62 (ISS), 1.07 (TS), and 1.57 (SGA) for girls. Conclusion Data from KIGS, the largest and longest running international database of rhGH-treated children, show that rhGH is safe and increases short-term height gain and adult height across GHD and non-GHD conditions.

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Section: Discussionsupporting

confidence: 92%

Safety and Efficacy of Pediatric Growth Hormone Therapy: Results From the Full KIGS Cohort

Maghnie

Ranke

Geffner

et al. 2022

The Journal of Clinical Endocrinology &Amp; Metabolism

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“…Moreover, an important factor influencing the achievement of the target SDS in ISS patients is medication adherence. Parents of ISS children may feel sadness, guilt, and frustration for administering drugs to their children with a needle syringe, so the appropriate device type may help increase dosing compliance ( 27 , 32 , 43 , 44 ). Treatment devices with improved dosing convenience and reduced pain, such as automatic pen and electronic device, can be helpful toward reaching the target SDS ( 12 , 18 ).…”

Section: Discussionmentioning

confidence: 99%

Height outcomes in Korean children with idiopathic short stature receiving growth hormone treatment

et al. 2022

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ObjectivesGrowth hormone (GH) therapy’s capacity to increase height velocity and height at the end of the study in children with idiopathic short stature (ISS) is controversial. We aimed to investigate the height standard deviation score (SDS) and height velocity of patients with ISS in Korea who received GH treatment.MethodsWe retrospectively reviewed and performed linear mixed model and survival analyses on data from 12 tertiary hospitals in Korea, including subjects diagnosed with ISS from January 2009 to September 2019, treated with GH therapy for more than 6 months, and who were at a pre-pubertal state at the time of diagnosis.ResultsWe included 578 children (330 boys and 248 girls). The mean daily dose of GH in this study was 0.051 mg/kg, which was lower than the approved dose in Korea of 0.062 - 0.067 mg/kg. Height SDS was higher in patients who started treatment before the age of 6 years. The probability of reaching the target SDS (-1 SDS) from the beginning of treatment to 2–3 years after its start was higher in children starting treatment before the age of 6 years. The hazard ratio to reach the target SDS (-1 SDS) when using automatic pen or electronic devices was 1.727 times higher than that when using the needle and syringe device.ConclusionISS patients should start GH treatment at an early age, and even lower-than-recommended drug doses may be effective. The selection of automatic pen or electronic device can have a positive effect on reaching the target height SDS.

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“…The high-speed jet stream delivers rapid penetration into the skin at the lowest sensitivity [22] [23] [29]. That makes the treatments easily tolerable to maintain patient's adherence and guarantee its outcome [54] [55]. Although we did not purposely select the patients with known trypanophobia, the treatment compliance was maintained through the trial and all patients finished the treatment course.…”

Section: Tolerability and Safetymentioning

confidence: 99%

Re-Densification Effect of Pressure-Injected Peptide-Hyaluronic Acid Combination on Male Androgenic Alopecia

Naranjo

2024

JCDSA

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Introduction: Mechanism of male androgenic alopecia (MAGA) is complex and leads to an excessive hair shedding and decreased hair density. Oral, topical, and injectable autologous treatments demonstrate ability to stimulate hair re-growth, but the response is suboptimal or plateaus off. Synthetic combination of the peptide complex and hyaluronic acid (P-HA) demonstrated hair regrowth in alopecia patients. Electronically-operated pneumatic injections (EPI) generate micro-trauma in the dermis and under wound-healing conditions may enhance regeneration effect of P-HA. Methods: Subjects seeking improvement of their male pattern hair loss (Hamilton-Norwood type 2 -4) received the P-HA treatments through EPI. The course included 4 treatments every two weeks over the 8-week period. In 6 months, the hair growth was assessed comparative to baseline by global clinical photography and digital phototrichograms. The treatment safety and tolerability were documented through the whole study period. Results: Twelve men (30 -45 years old) completed the treatment course with high tolerability and without adverse events. Post-treatment assessment of the previously bald areas showed improved coverage on the clinical photographs. The phototrichograms demonstrated statistically significant increase in terminal hair density by 36%, cumulative hair thickness by 37%, and follicular units by 20%; all contributing to a 38% increase in cumulated hair density (all p < 0.05). Conclusion: Electronic pneumatic injections are well tolerated and can be safely used for the needle-free administration of the peptide-hyaluronic acid combination in MAGA therapy. We achieved significant hair re-densification in the balding scalp. The exact role of the EPI-induced impact in the hair re-growth mechanism remains to be ascertained.

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Needle-Free and Needle-Based Growth Hormone Therapy in Children: A Pooled Analysis of Three Long-Term Observational Studies

Cited by 8 publications

References 50 publications

Safety and Efficacy of Pediatric Growth Hormone Therapy: Results From the Full KIGS Cohort

Safety and Efficacy of Pediatric Growth Hormone Therapy: Results From the Full KIGS Cohort

Height outcomes in Korean children with idiopathic short stature receiving growth hormone treatment

Re-Densification Effect of Pressure-Injected Peptide-Hyaluronic Acid Combination on Male Androgenic Alopecia

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