Table 1.

Treatment characteristics, demographic and clinic-biological data of ICI-related hypophysites recorded in the French Pharmacovigilance Database (FPVD) until May 2018.

Patients	Immune Check Point Inhibitor(s) (ICI)
	ipilimumab (ipi)	nivolumab (nivo)	Pembrolizumab (pembro)	ipilimumab + nivolumab (ipi + nivo)
Number of cases	40	28	13	13
Women n (%)	21 (52·5)	12 (49·9)	7 (53·8)	9 (69·2)
Age (mean ± SD) (years)	68·4 (±15·2)	62·8 (±9·8)	65·4 (±15·8)	55·5 (±13·7)
Body Mass Index (mean ± SD) (kg/m2)	27·1 (±4·9)	23·7 (±4·42)	22·3 (±3·9)	25·37 (±3·94)
Previous immunotherapy (n)	2	1	1	0
ICI treatment (median [min-max])
Number of courses	4[1–7]	10[1–33]	7[1–19]	3[2–4]
Dose per course (mg)	235 [150–330]	242 [123–354]	136 [88–190]	ipi 7460–90 + nivo 229 [190–260]
Cumulated dose before hypophysitis (mg)	756 [495–1140]	1901 [294–8910]	616 [120–3610]	ipi 255 [146–300] + nivo 770 [438–924]
Time of onset (days)	79 [14–506]	155·5 [5–552]	184 [6–686]	119 [18–500]
Indication
Melanoma	40	7	13	11
Non small cell type lung cancer	0	17	0	1
Small cell type lung cancer	0	1	0	0
Colorectal cancer	0	1	0	0
Renal cell carcinoma	0	2	0	0
Pleural mesothelioma	0	0	0	1
Hypophysitis severity/outcome/MRI
Grade 1	0	0	0	0
Grade 2	9	4	4	4
Grade 3	17	22	9	9
Grade 4	5	2	0	0
Grade 5*	3	0	0	0
Recovered	1	0	1	0
MRI with pituitary enlargement	7	2	1	6
Management
Levothyroxine supplementation	15	1	1	3
Hydrocortisone supplementation	32	28	13	12
Other supplementation	1	0	0	0
Immunotherapy continuation	4	14	8	9

Qualitative data are expressed as number and rates, and qualitative ones as mean (±SD) or median with [minimal and maximal values]. Gradation of severity is detailed in the Methods section. MRI: magnetic resonance imaging.

*Without enough evidence to exclude disease progression fatality.