Ten years with biosimilar rhGH in clinical practice in Sweden – experience from the prospective PATRO children and adult studies

Table 2 PATRO Adult effectiveness parameters by pre-treatment status

Visit (years)	Mean (SD) IGF-I SDS (EFF)		Mean (SD) waist (cm) (EFF)		Mean (SD) BMI (kg/m²) (EFF)		Mean (SD) HDL/LDL ratio (SAF)		Mean (SD) rhGH dose (mg/day) (EFF)
Visit (years)	Naïve	Pre-treated	Naïve	Pre-treated	Naïve	Pre-treated	Naïve	Pre-treated	Naïve	Pre-treated
Baseline	−3.0 (1.4) n = 10	−0.1 (1.6) n = 35	100.6 (13.6) n = 85	96.9 (13.3) n = 107	29.1 (5.6) n = 111	28.1 (5.4) n = 130	3.1 (1.4) n = 18	2.3 (1.1) n = 83	0.1 (0.1) n = 120	0.4 (0.3) n = 146
1	−1.2 (2.0) n = 9	0.5 (1.2) n = 8	98.9 (12.9) n = 35	96.0 (11.8) n = 64	29.4 (5.0) n = 56	27.8 (4.7) n = 77	2.6 (1.1) n = 25	2.3 (1.1) n = 62	0.3 (0.2)^a n = 114	0.4 (0.2)^a n = 142
2	−0.8 (1.6) n = 7	1.8 (1.3) n = 2	99.4 (13.0) n = 23	94.5 (11.3) n = 66	29.1 (5.5) n = 32	27.2 (4.4) n = 76	2.5 (0.5) n = 11	2.2 (0.9) n = 46	0.3 (0.2)^b n = 98	0.4 (0.2)^b n = 133
3	0.0 (2.4) n = 2	1.8 (1.0) n = 3	98.2 (15.0) n = 15	95.3 (12.0) n = 51	28.8 (6.7) n = 22	27.8 (6.0) n = 57	2.3 (0.6) n = 10	2.2 (1.0) n = 38	0.3 (0.2)^c n = 72	0.4 (0.2)^c n = 117
4	−0.8 (1.7) n = 6	−0.2 (3.6) n = 2	102.3 (11.7) n = 15	97.6 (17.0) n = 34	30.0 (7.6) n = 23	28.0 (5.3) n = 40	2.2 (0.6) n = 11	2.1 (0.8) n = 25	0.3 (0.2)^d n = 58	0.3 (0.2)^d n = 96

n Number of patients with available data
BMI Body mass index, EFF Effectiveness analysis set, IGF-I Insulin-like growth factor, HDL High-density lipoprotein, LDL Low-density lipoprotein, PATRO Patients TReated with Omnitrope®, rhGH Recombinant human growth hormone, SAF Safety analysis set, SD(S) Standard deviation (score)
^aDaily dose at years 1–1.5; ^bDaily dose at years 2–2.5; ^cDaily dose at years 3–3.5; ^dDaily dose at years 4–4.5

ISSN: 1472-6823