ESPE2023 Poster Category 1 Growth and Syndromes (75 abstracts)
Comparison of long-term height outcomes in pediatric patients with growth hormone deficiency receiving once weekly somatrogon with those of matched patients treated with once-daily somatropin in the Kabi/Pfizer International Growth Study (KIGS)
Yuvika Paliwal 1 , Martin Carlsson 2 , Richard Zhang 2 , Peter Lee 2 , Joan Korth-Bradley 1 , Carrie Taylor 2 & Jose Cara 2
1Pfizer Inc, Collegeville, USA. 2Pfizer Inc, New York, USA
Objectives: Somatrogon is a long-acting recombinant human growth hormone (GH) approved in the EU and other countries for once-weekly treatment of pediatric patients with GH deficiency (GHD). In this analysis, height outcomes of somatrogon-treated patients in a phase 3 trial (CP-4-006) were compared with historical data from matched somatropin-treated patients enrolled in KIGS.
Methods: In trial CP-4-006, patients were randomized to once weekly somatrogon (0.66 mg/kg/week) or once-daily somatropin (0.24 mg/kg/week) for the first 12 months. After the main study period, patients were enrolled in an open-label extension where they received somatrogon at their current dose or somatrogon at 0.66 mg/kg/week. Somatrogon-treated patients in the CP-4-006 study were matched with patients enrolled in KIGS who received somatropin (0.20–0.30 mg/kg/week), using propensity score matching according to geographic region, gender, age, peak GH levels and height standard deviation score (SDS) (i.e., peak GH levels and height SDS at study entry). All patients in CP-4-006 and KIGS were hGH therapy-naïve. 155 patients were one-to-one matched in the somatrogon-treated and KIGS groups.
Results: Somatrogon-treated patients and matched somatropin-treated patients in KIGS demonstrated similar mean annualized height velocity (HV) throughout 3 years of treatment (Table). Similarly, changes in mean height SDS from baseline to Years 1-3 were comparable between somatrogon-treated patients and the matched somatropin patients in KIGS (Table). Being ADA+ in study CP-4-006 did not negatively impact mean annualized HV or mean height SDS.
| Somatrogon CP-4-006 study (n=155) | Somatropin-treated matched KIGS cohort (n=155) | ||||
| All matched patients | ADA+ | ADA– | All matched patients | Matched to ADA+ patients | |
| Annualized HV (cm/year), mean (SD) | |||||
| Year 1 | 10.03 (2.37) n=81 | 10.09 (2.50) n=70 | 9.66 (1.28) n=11 | 9.57 (2.11) n=81 | 9.61 (2.13) n=70 |
| Year 2 | 7.70 (1.82) n=125 | 7.63 (1.75) n=89 | 7.86 (2.01) n=36 | 7.33 (1.80) n=125 | 7.34 (1.91) n=89 |
| Year 3 | 7.15 (1.80) n=47 | 7.24 (1.78) n=35 | 6.87 (1.91) n=12 | 6.56 (1.44) n=47 | 6.69 (1.48) n=35 |
| Height SDS change from baseline, mean (SD) | |||||
| Year 1 | 0.92 (0.54) n=81 | 0.95 (0.57) n=70 | 0.76 (0.25) n=11 | 0.86 (0.45) n=81 | 0.86 (0.45) n=70 |
| Year 2 | 1.69 (0.79) n=125 | 1.75 (0.85) n=89 | 1.53 (0.59) n=36 | 1.20 (0.71) n=125 | 1.20 (0.75) n=89 |
| Year 3 | 2.00 (0.81) n=47 | 2.13 (0.88) n=35 | 1.63 (0.41) n=12 | 1.32 (0.80) n=47 | 1.34 (0.81) n=35 |
Conclusions: Somatrogon-treated pediatric patients in trial CP-4-006 had similar height outcomes to matched somatropin-treated patients in KIGS, irrespective of the presence of ADAs. Clinicaltrials.gov:NCT02968004;EudraCT:2016-003874-42
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