Table 4.

Comparison of pre and post-RTX CT scan score and PFT measurements comparing averages at baseline and 1 year with the average individual change (p-value) in subjects with repeat RTX dosing vs. subjects with a one-time RTX dose. Mean ± SD presented.

	Repeat RTX Dosing n=17		One-Time RTX Dosing n=8
	Baseline	1 Year Follow-up	Baseline	1 Year Follow-up
CT Scan	n=5		n=3
Average score	171 ± 42	152 ± 40	211± 79	244 ± 39
Paired average Δ (p-value)*	−22.9 (0.31)		32.8 (0.50)
Improved/Stable** Failure**	N=2/3 (100%) N=0 (0%)		N=0/2 (67%) N=1(33%)
FVC	n=14		n=5
FVC Percent Predicted	54 ± 14	63 ± 20	64 ± 15	52 ± 17
Paired average Δ (p-value)	+9.3 (0.0077)		−11.8 (0.13)
Improved/Stable Failure	N=8/5 (93%) N=1 (7%)		N=0/2 (40%) N=3 (60%)
TLC	n=6		n=1
TLC Percent Predicted	53 ± 13	62 ± 14	70	77
Paired average Δ (p-value)	+8.5 (0.031)		N/A
DLCO	n=12		n=5
DLCO Percent Predicted	38 ± 12	39 ± 18	43 ± 16	29 ± 8
Paired average Δ (p-value)	+1.2 (0.59)		−14.2 (0.13)

^*Paired average Δ represents difference in the mean of paired observations with the p-value as calculated using the Wilcoxon signed rank test. A p-value of <0.05 was considered significant.

^**Improved is defined by >10% decrease in CT score or >10 improvement in FVC%. Stable is defined by <10% increase in CT score or <10 decline in FVC% (Pioped criteria). Failure is defined by a ≥10% increase in CT score or a ≥10% decline in FVC%. Values are compared to baseline time point.

Abbreviations: RTX – Rituximab, CT – Computed tomography, PFTs - Pulmonary function tests, SD – Standard deviation, FVC% - Forced vital capacity (% predicted), TLC% - Total lung capacity (% predicted), DLCO% - Diffusion capacity of carbon monoxide (% predicted)