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www.medscape.c
Highest Clinical Efficacy of Rituximab in Autoantibody-Positive
Patients With Rheumatoid
Arthritis and in Those for Whom No More Than One Previous TNF
Antagonist Has Failed: Poole
Data From 10 European Registries
Chatzidionysiou K, Lie E, Nasonov E, et al
Ann Rheum Dis. 2011;70:1575-1580.
Background
Rituximab is a B-cell-depleting therapy that has been widely
used over the past several years for the treatment of
rheumatoid arthritis (RA). Typically, rituximab is used for RA
after another biologic disease-modifying antirheumatic drug
(DMARD) such as an anti-tumor necrosis factor agent has failed
to control RA; however, it is still not clear what the
optimal treatment strategy for rituximab should be. These
authors used a large-scale pooled database of patients with R
in Europe that were treated with rituximab to investigate the
real-world predictors of efficacy of this agent.
Study Summary
The authors identified 2019 patients from 10 European countries
treated with rituximab at a dose of 2 1000 mg infusions
given 2 weeks apart. They evaluated the 3- and 6-month
efficacies of this treatment measured by the 28-joint count
Disease Activity Score (DAS28).
The mean age of these subjects at the time of rituximab
treatment was 54-years-old, 80% were female, the mean durati
of RA was approximately 12 years, approximately 86% were
rheumatoid factor positive, and approximately 77% were
cyclic citrullinated peptide antibody (CCP) positive (although
not all patients had CCP assessed). At the time of first use
rituximab, the mean DAS28 at baseline was 5.8, approximately 77%
were on concomitant DMARDs, and from data on
1844 patients, 63% had failed at least 1 biologic agent.
Overall, the DAS28 improved in most patients after they received
rituximab, and by 6 months, the number of patients wi
high disease activity (DAS28 > 5.1) had decreased from 73% to
26% (but there were substantial numbers of subjects
without available data at the 6-month mark). In multivariate
analyses, the predictors of a good EULAR response (DAS
improved by > 1.2, and an overall score of! 3.2[1]) before
initiation of rituximab were: (a) use of! 1 biologic DMARD, (b
lower baseline DAS28 level, and (c) and anti-CCP positivity. The
authors also found that there was a trend for patients
using concomitant oral DMARDs to have improved DAS28 scores at 3
and 6 months when compared with those not tak
DMARDs.
The authors conclude that rituximab was most effective in
seropositive patients when used as the first biologic agent, or
before the failure of > 1 anti-tumor necrosis factor
agent.
Viewpoint
Controlled clinical trials can provide only limited amounts of
information about drug efficacy; therefore, the approach the
authors used to evaluate the "real-world" efficacy of rituximab
for RA is to be applauded. Take-home points from their
study are that certain patient groups may have better responses
to rituximab therapy, including those treated with
rituximab as a first-line biologic or before the use of multiple
anti-tumor necrosis factor agents, those taking concomitant
DMARDs, and those with CCP positivity (supporting findings of
other studies[2,3]; although the improvement seen in this
study in patients that were sero-negative suggests that
rituximab is still effective even in absence of rheumatoid
factor/CCP positivity). However, because this is not a
controlled trial, these findings should be interpreted with
some
Real-World Predictors of Success of Rituximab in RAKevin Deane,
MD
Posted: 08/30/2011
7/31/2019 Rituximab in RA (Printer-friendly)
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caution because there may other factors not accounted for that
influence these findings, although this study should help
set the stage for additional studies that can provide more
specific guidance for the use of rituximab in RA.
Abstract
Medscape Rheumatology 2011 WebMD, LLC
References
1. Fransen J, van Riel PL. The disease activity score and the
EULAR response criteria. Clin Exp Rheumatol.
2005;23:S93-S99.
2. Cohen SB, Emery P, Greenwald MW, et al. Rituximab for
rheumatoid arthritis refractory to anti-tumor necrosisfactor
therapy: results of a multicenter, randomized, double-blind,
placebo-controlled, phase III trial evaluating
primary efficacy and safety at twenty-four weeks. Arthritis
Rheum. 2006;54:2793-2806.
3. Quartuccio L, Fabris M, Salvin S, et al. Rheumatoid factor
positivity rather than anti-CCP positivity, a lower disab
and a lower number of anti-TNF agents failed are associated with
response to rituximab in rheumatoid arthritis.
Rheumatology (Oxford). 2009;48:1557-1559.
