ESPE2024 Poster Category 2 GH and IGFs (22 abstracts)
Dosage of recombinant human growth hormone across geographic regions at enrolment into the Kabi/Pfizer International Growth Study (KIGS)
Mitchell Geffner 1 , Marc Thomas 2 , Wayne Cutfield 3 , Roy Gomez 4 , Toshiaki Tanaka 5 , Martin Carlsson 6 & Michael Wajnrajch 6,7
1The Saban Research Institute, Children’s Hospital Los Angeles, Keck School of Medicine of the University of Southern California, Los Angeles, USA. 2Pfizer Ltd, Tadworth, United Kingdom. 3University of Auckland, Auckland, New Zealand. 4Pfizer Pte Ltd, Singapore, Singapore. 5Tanaka Growth Clinic, Tokyo, Japan. 6Pfizer Inc, New York, USA. 7New York University, Grossman School of Medicine, New York, USA
Objectives: The Kabi/Pfizer International Growth Study (KIGS) was the largest and longest running international database of pediatric patients receiving recombinant human growth hormone (rhGH). The objective of the current analysis is to describe the dosage of rhGH at enrolment into KIGS according to diagnosis and geographical region.
Methods: Between 1987-2012, 83,803 pediatric patients were enrolled into KIGS if they received rhGH (Genotropin) treatment as prescribed by their physician or based on approved indications. Patients who initiated treatment with a different rhGH brand, but switched to Genotropin, were also eligible. The treating physician diagnosed the specific growth disorder and determined the dose and schedule of rhGH treatment. Data from patients enrolled into KIGS in 2010-2012 were used in this analysis.
Results: Overall, the mean rhGH doses received for GH deficiency (GHD), born small for gestational age (SGA), idiopathic short stature (ISS), and Turner syndrome (TS) were 0.23, 0.28, 0.30, and 0.31 mg/kg/wk, respectively (Table). In the EU, Japan, and the USA, doses varied from 28% lower to 29% higher than the locally approved doses (Table). The mean rhGH dose for most growth disorders was highest in the USA and lowest in Japan; similarly, the approved dose for GHD in Japan was lower than other regions (Table).
| GHD | SGA | ISS | TS | |||||
| GH dose (mg/kg/wk) | KIGS | Approved dose | KIGS | Approved dose | KIGS | Approved dose | KIGS | Approved dose |
| Overall | ||||||||
| N | 2794 | 1085 | 651 | 327 | ||||
| Mean (SD) | 0.23 (0.07) | 0.28 (0.08) | 0.30 (0.07) | 0.31 (0.07) | ||||
| Europe (EU) | ||||||||
| n | 1692 | 738 | 148 | 176 | ||||
| Mean (SD) | 0.21 (0.05) | 0.175-0.245 | 0.26 (0.06) | 0.245 | 0.28 (0.07) | 0.30 (0.06) | 0.315-0.35 | |
| Europe (non-EU) | ||||||||
| n | 249 | 55 | 22 | 32 | ||||
| Mean (SD) | 0.23 (0.05) | 0.27 (0.08) | 0.25 (0.10) | 0.30 (0.08) | ||||
| Japan | ||||||||
| n | 163 | 58 | 1 | 5 | ||||
| Mean (SD) | 0.19 (0.03) | 0.175 | 0.25 (0.03) | 0.23-0.47 | 0.17 (-) | 0.33 (0.04) | 0.35 | |
| USA | ||||||||
| n | 474 | 138 | 238 | 71 | ||||
| Mean (SD) | 0.31 (0.08) | 0.16-0.24 | 0.37 (0.10) | Up to 0.48 | 0.34 (0.07) | Up to 0.47 | 0.33 (0.08) | 0.33 |
| Rest of the world | ||||||||
| n | 216 | 96 | 242 | 43 | ||||
| Mean (SD) | 0.26 (0.08) | 0.32 (0.09) | 0.29 (0.06) | 0.34 (0.08) | ||||
| EU: European Union | ||||||||
Conclusion: There was substantial variation in the mean weekly doses of rhGH by both diagnosis and geographic region. Overall, the mean rhGH dose used was higher for children with non-GHD indications. For most GH disorders, patients in the USA received the highest mean rhGH doses while those in Japan received the lowest doses.
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