Table 2.

Safety, self- and clinician rated psychological data for patients A–C prior (T0) and at end of metreleptin treatment (T1) and serum leptin levels at T0 and during treatment.

		Patient
		A		B		C
		T0	T1	T0	T1	T0	T1
Safety data
Body weight	kg	35.8	37.0	32.9	33.6	42.9	42.7
BMI	kg/m2	13.6	14.1	12.2	12.5	15.6	15.5
Pulse (range)		52–72	61–84	68–76	72–72	52–77	57–64
Systolic/diastolic blood pressure (range)	mmHg	85/55–90/70	85/55–95/60	90/65–95/60	80/60–90/60	75/60–113/58	100/60–105/70
Body temperature (range)	oC	36.2–37.1	36.1–37.3	35.2–36.0	35.6–36.8	36.5a	35.8a
Serum glucose (range)	mmol/l	4.6–5.1	5.1–6.5	3.8–4.3	4.8–5.1	4.8–6.2	4.1–6.6
Leucocytes	/nl	4.59	6.12	2.1	3.2	3.29	4.74
Lymphocytes	/nl	0.73	0.91	0.83	1.06	0.7	1.38
Erythrocytes	/nl	3.38	3.63	3.27	3.29	4.48	4.71
Thrombocytes	/nl	235	266	231	208	247	192
GOT	U/l	25	35	38	32	22	34
GPT	U/l	13	43	60	28	44	47
Amylase	U/l	70	68	44	53	54	69
Lipase	U/l	71	72	63	86	46	64
Electrocardio-gram		Sinus rhythm; NAD	Sinus rhythm; NAD	Sinus rhythm; NAD	Sinus rhythm; NAD	Sinus bradycardia; NAD	Sinus bradycardia; NAD
Self-ratings
BDI-II		34	15	37	27	37	6
EDI-2	Percentile rank
Total score		84	87	87	87	99	80
Drive for Thinness		75	75	85	90	99	75
Bulimia		1	99	1	1	99	45
Body Dissatisfaction		45	10	55	55	95	75
Ineffectiveness		99	85	95	95	99	80
Perfectionism		75	10	70	70	90	70
Interpersonal Distrust		95	55	80	85	60	50
Interoceptive Awareness		65	99	95	90	99	85
Maturity Fears		40	90	70	80	99	99
EDE-Qb
Total score		3.11	2.48	3.62	3.53
Restraint		2.4	2.4	3.2	3.4
Eating Concern		1.2	0.6	2.4	2.4
Weight Concern		3.6	1.8	3.8	3.2
Shape Concern		5.25	5.13	4.88	5.13
Clinician ratings
HAMD-17		29	12	22	15	31	14
Leptin serum levelsc
T0	ng/ml	<0.5		<0.5		<0.1

During treatment						3 time points:
	ng/ml	72.9		4.4		6.7	55.9	80.8
Treatment day		7		13		2	4	5
Last dose	mg	10		11.3		6	9	9
Hours after sc. applicationd		7		22		22	2	4

NAD no abnormality detected, BDI-II Beck Depression Inventory-II, BMI body mass index, EDI-2 Eating Disorder Inventory-2, HAMD-17 Hamilton Depression Scale-17, s.c subcutaneous.

^aMeasured once daily only.

^bInstructions were adapted to shortened observation time.

^cLeptin assays for determination of total leptin serum concentrations: Leptin ELISA assay E07 (Mediagnost GmbH, Reutlingen, Germany; for patients A and B) and Leptin ELISA assay MD53001 (IBL International GmbH, Hamburg, Germany; patient C).

^dFor metreleptin a half-life of 3.8–4.7 h and a median t_max of 4 h (range 2–6 h) following s.c. administration was reported in patients with lipodystrophy³².