The efficacy and safety of low-dose rituximab in the treatment of pemphigus vulgaris: a cohort study

Figures & data

Table 1. Comparison of baseline characteristics between two groups.

Indicators	Group A (n = 19)	Group B (n = 25)	p Value
Sex			0.067
male	6	16
female	13	9
Age, years	44.21 (12.59)	43.92 (13.39)	0.942
Weight, kilograms	60.47 (10.73)	55.92 (7.55)	0.106
PDAI	22.50 (32.00)	21.50 (19.25)	0.787
Disease activity			0.542
Moderate	10 (52.63%)	16 (64.00%)
Severe	9 (47.37%)	9 (36.00%)
Skin involvement			0.622
No	1 (5.26%)	3 (12.00%)
Yes	18 (94.74%)	22 (88.00%)
Mucosa involvement			0.432
No	1 (5.26%)	0 (0.00%)
Yes	18 (94.74%)	25 (100.00%)
Positivity of anti-Dsg1 antibodies			0.122
No	0 (0.00%)	4 (16.00%)
Yes	19 (100.00%)	21 (84.00%)
Positivity of anti-Dsg3 antibodies			NA
No	0 (0.00%)	0 (0.00%)
Yes	19 (100.00%)	25 (100.00%)

Group A: 500 mg RTX combined with corticosteroids; Group B: corticosteroids alone; PDAI: pemphigus disease area index; Dsg: desmoglein; age and weight are mean (SD); PDAI is median (IQR); n (%); Compared by t-test (age), rank sum test (PDAI) or Fisher’s exact test (the rest variables).

Table 2. Comparison of outcome indicators between two groups.

	Group A (n = 19)	Group B (n = 25)	p Value
CR rates	10 (52.63%)	1 (4.00%)	0.000*
Time to CR, days	243 (2)	294.00 (19.80)	NA
Doses of corticosteroids (mg prednisone equivalent)
Initial doses, mg/day	50 (20)	50.00 (12.5)	0.499
Doses at 1^st month, mg/day	40 (15)	45.00 (10)	0.971
Cumulative doses at 1^st month, mg	1500 (450)	1490 (360)	0.878
Doses at 3^rd month, mg/day	25 (10)	35.00 (10)	0.003*
Cumulative doses at 3^rd month, mg	3415 (1110)	3900.00 (865)	0.162
Doses at 6^th month, mg/day	20 (7.5)	25 (8.75)	0.002*
Cumulative doses at 6^th month, mg	5220 (1625)	6495 (1515.40)	0.047*
Doses at 12^th month, mg/day	12.5 (5)	15 (3.75)	0.005*
Cumulative doses at 12^th month, mg	8185 (2442)	9827.5 (2749.35)	0.007*

Group A: 500 mg RTX combined with corticosteroids; Group B: corticosteroids alone; data are n (%) or median (IQR); Compared by Fisher’s exact test (the CR rates) or rank sum test (the other variables).

*p < 0.05; NA: statistical test cannot be employed due to only one patient achieving CR in the corticosteroids alone group.

Figure 1. Changes in (A) doses of corticosteroids, (B) cumulative doses of corticosteroids, (C) PDAI, (D) B-cells counts between two groups.

Figure 2. Kaplan-Meier survival analysis between two groups.

Table 3. COX Proportional hazard regression analysis between two groups.

	HR	95% CI for HR
		Lower	Upper
Group	41.112	1.981	853.370
Gender	0.891	.051	15.545
Age	.990	.919	1.065
Weight	1.105	0.963	1.268
Initial PDAI score	1.135	.965	1.334
Disease activity	3.846	.065	227.616
Involvement of skin	.000	.000	.000
Positivity of anti-Dsg1 antibodies
Initial anti-Dsg1 antibodies	1.003	.979	1.027
Initial anti-Dsg3 antibodies	.982	.962	1.002
Initial prednisone doses	.952	.867	1.046

PDAI: pemphigus disease area index; Dsg: desmoglein; HR: hazrd ratio; CI: confidence interval.

Table 4. Adverse events between two groups.

	Group A (n = 12)	Group B (n = 33)
Folliculitis	2 (17%)
Steroid acne		1 (3%)
Superficial mycoses		4 (12%)
Viral infection	1 (8.3%)	4 (12%)
Verruca vulgaris		2 (6%)
Herpes simplex	1 (8.3%)	1 (3%)
Herpes zoster		1 (3%)
Pulmonary bacterial infection		3 (9%)
Encephalopyosis		1 (3%)
Hyperlipidaemia	1 (8.3%)
Hypokalemia	1 (8.3%)
Hypertension	1 (8.3%)
Diabetes mellitus	2 (17%)
Blurred vision	1 (8.3%)
Bone abnormality		11 (33.3%)
Osteoporosis		7 (21%)
Pathological fracture		3 (9%)
Osteonecrosis		1 (3%)
Digestive system abnormality	3 (25%)	7 (21%)
Elevation of liver enzyme	3 (25%)	4 (12%)
Gastritis		2 (6%)
Stress ulcer with bleeding		1 (3%)
Hypothyroidism		1 (3%)
Injury of occipital nerve		1 (3%)

Group A: 500 mg RTX combined with corticosteroids; Group B: corticosteroids alone; n: number of AEs; data are n (%).

Data availability statement

The original contributions presented in the study are included in the article/supplementary material. Further inquiries can be directed to the corresponding authors.