hrp0095fc7.2 | Growth and Syndromes | ESPE2022

Post-hoc subgroup analysis of the pivotal phase 3 study of once-weekly somatrogon vs once-daily Genotropin: results from subjects with peak stimulated growth hormone value <6.7 ng/ml

Phillip Moshe , Deal Cheri , Silverman Lawrence , Henocque Robin , Nijher Monica , Wajnrajch Michael , Wang Ronnie , Cara Jose

Objectives: Somatrogon is a long-acting recombinant human growth hormone (GH) approved by the EMA as a once weekly treatment for children with GH deficiency (GHD). The peak stimulated GH cut-off value for diagnostic criteria for GHD varies according to country-specific guidelines. The objective of this subgroup analysis of the pivotal phase 3 somatrogon study was to evaluate the primary and secondary efficacy endpoints for subjects with a peak GH value <6.7...

hrp0095t7 | Section | ESPE2022

Efficacy and safety of once-weekly somatrogon in pediatric subjects with growth hormone deficiency: lack of impact of anti-drug antibodies

Deal Cheri , Silverman Lawrence , Korth-Bradley Joan , Roland Carl , Taylor Carrie , Cara Jose , Wajnrajch Michael

Objectives: Somatrogon, a long-acting recombinant human growth hormone (GH) consisting of the amino acid sequence of human GH (hGH) and three copies of the carboxy-terminal peptide (CTP) of human chorionic gonadotropin, is approved by the EMA for treatment of children with GH deficiency (GHD). In this phase 3 study, children with GHD received either somatrogon or Genotropin. The impact of testing positive for anti-drug antibodies to somatrogon (ADA+) on the ef...

hrp0084p1-138 | Turner &amp; Puberty | ESPE2015

Weight Gain in Turner Syndrome: Association to Puberty Induction?

Reinehr Thomas , Lindberg Anders , Toschke Christina , Cara Jose , Chrysis Dionisios , Camacho-Hubner Cecila

Background: We have recently reported a BMI-SDS increase in girls with Turner syndrome (TS) treated with growth hormone (GH) (1).Objective and hypothesis: We hypothesise that puberty induction in TS is associated with weight gain.Method: We analysed the weight changes (BMI-SDS) of 888 girls with TS in the Pfizer International Growth Database (KIGS). Overweight was defined by a BMI >90th percentile and obesity by a BMI >97th...

hrp0097p1-110 | Growth and Syndromes | ESPE2023

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)

Paliwal Yuvika , Carlsson Martin , Zhang Richard , Lee Peter , Korth-Bradley Joan , Taylor Carrie , Cara Jose

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 ran...