. 2018 Dec 27;5(3):376–383. doi: 10.1001/jamaoncol.2018.5860

Table 1. Characteristics of 137 Patients Who Did or Did Not Develop irAEs During Nivolumab or Pembrolizumab Monotherapy.

Characteristic	No. (%) of Patients		P Value
Characteristic	With irAE (n = 66)	Without irAE (n = 71)	P Value
Sex, male	54 (82)	51 (72)	.24^a
Age, median (range), y	68 (36-88)	67 (31-84)	.61^b
ECOG PS
0	47	35
1	17	35
≥2	2	1
Pathologic subtype, No.
Squamous cell carcinoma	24	27	.98^a
Nonsquamous NSCLC	42	44
Smoking, never or previous/current, No.	9/57	15/56	.35^a
Past regimens, median (range), No.	1.5 (0-7)	2.0 (0-9)	.05^c
Best response
Complete response	1	1
Partial response	33	8
Stable disease	27	26
Progress disease	5	36
Objective response rate^d	34 (52)	9 (13)	<.001^a
Disease control rate^e	61 (92)	35 (49)	<.001^a
Immunoglobulin, median (range), mg/dL
IgG	1322 (481-3185)	1219 (649-3165)	.46^c
IgA	275 (54-1114)	256 (102-514)	.55^f
IgM	79 (14-251)	86 (29-370)	.90^c
IgE	78 (54-1114)	78 (5-8900)	.99^c
Preexisting antibody
Any^g	48 (73)	32 (45)	.002^a
RF^h	26 (39)	12 (17)	.006^a
ANAⁱ	29 (44)	19 (27)	.05^a
Antithyroid^j	15 (23)	10 (14)	.28^a

Abbreviations: ANA, antinuclear antibody; ECOG PS, Eastern Cooperative Oncology Group performance status; Ig, immunoglobulin; irAE, immune-related adverse event; NSCLC, non–small cell lung cancer; RF, rheumatoid factor.

SI conversion factor: To convert immunoglobulin level to milligrams per liter, multiply by 10.

^{^a}

By χ² test.

^{^b}

By t test

^{^c}

By Mann-Whitney test.

^{^d}

Proportion of patients achieving complete or partial response based on modified Response Evaluation Criteria in Solid Tumors version 1.1.

^{^e}

Proportion of patients achieving complete response, partial response, or stable disease based on modified Response Evaluation Criteria in Solid Tumors version 1.1.

^{^f}

By Welch t test.

^{^g}

A patient was considered positive if any RF, ANA, antithyroglobulin, or antithyroid peroxidase was present at pretreatment.

^{^h}

A patient was considered positive if RF was greater than 15 IU/mL at pretreatment.

^ⁱ

A patient was considered positive if ANA was 1:40 or greater at pretreatment.

^{^j}

A patient was considered positive if either antithyroglobulin or antithyroid peroxidase was present at pretreatment.