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The goal of this multicentre, phase 4, open-label, 48-week, biopsy-driven randomized controlled trial was to assess if tocilizumab (interleukin-6 receptor inhibitor) is superior to rituximab in terms of improving clinical outcomes in RA patients who had unsatisfactory response to anti-tumor necrosis factor (TNF) stratified for synovial B-cell status.
The histological classification of rheumatoid arthritis (RA)
synovial tissue was impervious in assessing therapeutic response, but the sequencing-based
grouping had significant connections with clinical responses. Also, low or no
B-cell lineage expression signature tocilizumab illustrated superiority than
rituximab concerning the number of patients with CDAI 50%, and other secondary
endpoints.
The
goal of this multicentre, phase 4, open-label, 48-week,
biopsy-driven randomized controlled trial was
to assess if tocilizumab (interleukin-6 receptor inhibitor) is superior
to rituximab in terms of improving clinical outcomes in RA patients who had unsatisfactory
response to anti-tumor necrosis factor (TNF) stratified for synovial B-cell
status.
In this study (rituximab vs tocilizumab in anti-TNF inadequate responder patients with rheumatoid arthritis; R4RA), 164 RA patients (aged 18 years or older) were included. The patients were labeled histologically as B-cell poor or rich after a standard synovial biopsy. Subjects were stratified into two groups: (i) Rituximab group (n=83): Participants received two 1000 mg rituximab infusions at an interval of two weeks, and (ii) Tocilizumab group (n=81): Participants received tocilizumab 8 mg/kg infusions at an interval of four weeks.
To improve the precision of the stratification of
B-cell poor and rich patients, RNA sequencing of the standard synovial biopsies
was done and again classified by B-cell molecular signature. In B-cell poor
population, tocilizumab's superiority over rituximab was evaluated at 16 weeks.
A 50% improvement in Clinical Disease Activity Index (CDAI 50%) from the
starting point was the major outcome parameter.
In patients histologically categorized as B-cell poor,
no substantial differences in CDAI 50% were witnessed between rituximab and
tocilizumab group. But, as compared to the rituximab arm, the tocilizumab arm
had a remarkably greater response rate for CDAI 50% in the synovial biopsies
categorized as B-cell poor with RNA sequencing.
No statistically significant difference was found in terms of the incidence of
adverse events and serious adverse events between both the groups, as
illustrated below:
RNA
sequencing-based stratification displayed a stronger link with clinical
responses than with histopathological classification in RA patients.
Furthermore, for patients categorized
as B-cell poor in synovial tissue
tocilizumab was more effective as compared to rituximab.
Lancet
Rituximab versus tocilizumab in anti-TNF inadequate responder patients with rheumatoid arthritis (R4RA): 16-week outcomes of a stratified, biopsy-driven, multicentre, open-label, phase 4 randomised controlled trial
Frances Humby et al.
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