Comparison of outcomes using the rituximab originator MabThera with the biosimilar Truxima in patients with ANCA-associated vasculitis

Figures & data

Table 1. Comparison of characteristics of a two-centre patient cohort that received rituximab (RTX) therapy with either MabThera or Truxima for the induction and maintenance of remission of anti-neutrophil cytoplasm antibody-associated vasculitis

	Unadjusted analysis
	Remission induction			Remission maintenance
	MabThera	Truxima	p	MabThera	Truxima	p
	(n = 70)	(n = 67)		(n = 57)	(n = 63)
GPA	44 (62.9)	22 (32.8)	< 0.001*	30 (52.6)	35 (55.6)	0.85
MPA	21 (38.5)	23 (34.3)	0.37	19 (33.3)	13 (20.6)	0.14
EGPA	1 (1.4)	3 (4.5)	0.37	3 (5.3)	1 (1.6)	0.34
Age (years)	62 (51.8–72)	66 (54–76)	0.10	56 (40.8–68)	65 (52–74)	0.03*
Female	40 (57.1)	40 (59.7)	0.86	31 (54.4)	36 (57.1)	0.85
Follow-up (months)	41(29–58)	8 (4–12)	< 0.001*	46 (31.5–75)	19 (16–21)	< 0.001*
Cyclophosphamide use or steroid increase in year before RTX therapy	26 (37.1)	7 (10.4)	< 0.001*	19 (33.3)	3 (4.8)	< 0.001*
Remission achieved at 3 months	60 (85.7)	62 (92.5)	0.28
Hospitalization with infection	13 (18.6)	14 (20.9)	0.83	8 (14.0)	21 (33.3)	0.02*
Relapse	4 (5.7)	1 (1.5)	0.36	14 (24.6)	2 (3.1)	< 0.001*

Data are shown as n (%) or median (interquartile range).

GPA, granulomatosis with polyangiitis; MPA, microscopic polyangiitis; EGPA, eosinophilic granulomatosis with polyangiitis.

*Significant difference between groups (p < 0.05).

Table 2. Factors associated with remission at 3 months, relapse, and hospitalization with infection in patients treated with MabThera or Truxima for the induction and maintenance of remission of anti-neutrophil cytoplasm antibody-associated vasculitis

	Multivariate analysis for induction of remission
	Remission at 3 months			Relapse			Hospitalization with infection
	OR	95% CI	p	OR	95% CI	p	OR	95% CI	p
Age at presentation	0.96	0.90–1.0	0.22	0.98	0.92–1.05	0.48	1.01	0.98–1.04	0.53
Female	1.48	0.36–7.54	0.59	0.81	0.09–5.32	0.82	0.92	0.38–2.18	0.85
Follow-up duration	0.97	0.93–1.0	0.12	1.03	0.98–1.10	0.21	1.02	0.99–1.06	0.14
GPA	0.54	0.09–2.89	0.48	2.44	0.25–55.9	0.48	1.47	0.55–4.02	0.45
Cyclophosphamide use or steroid increase in year before RTX therapy	0.96	0.19–5.94	0.96	3.67	0.48–34.3	0.21	1.1	0.35–3.1	0.89
MabThera	1.78	0.18–22.9	0.63	0.78	0.02–29.24	0.89	0.34	0.07–1.36	0.15
Truxima	0.56	0.04–5.4	0.63	1.24	0.03–52.45	0.90	2.94	0.73–13.97	0.15
					Multivariate analysis for maintenance of remission
				Relapse			Hospitalization with infection
				OR	95% CI	p	OR	95% CI	p
Age at presentation				0.98	0.94–1.0	0.33	1.00	0.97–1.03	0.91
Female				1.04	0.28–3.59	0.96	0.40	0.14–1.02	0.06
Follow-up duration				1.03	1.00–1.06	0.02*	0.98	0.95–1.02	0.33
GPA				0.77	0.18–3.07	0.70	2.32	0.85–6.83	0.11
Cyclophosphamide use or steroid increase in year before RTX therapy				2.65	0.71–10.14	0.15	2.22	0.56–8.69	0.24
MabThera				1.96	0.26–17.72	0.52	0.38	0.08–1.51	0.19
Truxima				0.51	0.06–3.89	0.52	2.65	0.66–12.93	0.20

OR, odds ratio; CI, confidence interval; GPA, granulomatosis with polyangiitis; RTX,rituximab.

*p < 0.05.

Table 3. Subpopulation comparison of a single-centre patient cohort with anti-neutrophil cytoplasm antibody (ANCA)-associated vasculitis that received rituximab (RTX) therapy with MabThera or Truxima

	MabThera (n = 111)	Truxima (n = 29)	p
GPA	62 (55.9)	13 (44.8)	0.3
MPA	38 (34.2)	4 (48.3)	0.28
ANCA-negative glomerulonephritis	11 (9.9)	2 (6.9)	> 0.9
Age (years)	54 (42–67)	62 (38–73)	0.33
Male	43 (38.7)	11 (38)	> 0.9
Follow-up (years)	3.4 (2.5–51)	0.4 (0.25–0.98)	< 0.001*
eGFR at LTFU (mL/min/1.73 m^2)	66.5 (45.8–85.5)	58 (21–83)	0.05
RTX cumulative dose (g)	2 (1.65–3)	2 (1.5–2)	0.2
Cyclophosphamide treatment year before RTX therapy	37 (33.3)	7 (24.1)	0.37
CD19 depletion	81 (82.7)	20 (90.9)	0.52
Immunoglobulin levels at LTFU
IgA < 0.7 g/L	6 (6.5)	2 (8)	0.68
IgG < 7 g/L	21 (22.8)	9 (36)	0.2
IgM < 0.4 g/L	32 (34.8)	7 (28)	0.63
Infusion reactions			> 0.99
Shortness of breath	2 (1.8)	1 (3.4)
Myalgia	1 (0.9)	0 (0)

Data are shown as n (%) or median (interquartile range).

GPA, granulomatosis with polyangiitis; MPA, microscopic polyangiitis; eGFR, estimated glomerular filtration rate; LTFU, last follow-up; Ig, immunoglobulin.

*p < 0.05.

Figure 1. Urine protein:creatinine ratio (uPCR) before administration of (A) MabThera and (B) Truxima, and at last follow-up (LTFU) in patients with anti-neutrophil cytoplasm antibody-associated vasculitis.