Table 4:

Multivariable Logistic Regression Analysis of Risk Factors for Developing Colitis

	Discovery Cohort (N = 213)			Validation Cohort (N = 169)
	Odds Ratio	95% CI	P value	Odds Ratio	95% CI	P value
Immune Checkpoint Inhibitor Class
Ipi + Nivo vs. Pembrolizumab	3.34	1.1 – 9.8	0.001	3.37	1.4 – 8.1	0.009
Nivolumab vs. Pembrolizumab	1.04	0.1 – 9.3		1.25	0.3 – 5.3
Ipilimumab vs. Pembrolizumab	7.48	2.6 – 21.8		2.68	1.5 – 4.9
Ipi + Nivo vs. Ipilimumab	0.45	0.2 – 1.0		1.26	0.5 – 2.9
Neutrophil-to-Lymphocyte Ratio
≥ 5 vs. < 5	0.34	0.1 – 0.9	0.046	0.61	0.3 – 1.3	0.38
Vitamin D Intake
Yes vs. No	0.35	0.1 – 0.9	0.01	0.46	0.2 – 0.9	0.03

Characteristics with a univariate Fisher’s exact P-value of 0.30 or less were incorporated into a multivariable logistic regression. The model demonstrated higher odds of developing colitis in patients treated with combination (ipilimumab + nivolumab) or ipilimumab monotherapy compared to those treated with pembrolizumab monotherapy. Furthermore, NLR ≥ 5 and pre-treatment vitamin D supplementation were associated with decreased odds of colitis. The validation cohort confirmed the relationship between colitis and vitamin D intake.