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Observational Study
. 2016 Feb 16:18:50.
doi: 10.1186/s13075-016-0951-z.

Effectiveness of two different doses of rituximab for the treatment of rheumatoid arthritis in an international cohort: data from the CERERRA collaboration

Katerina Chatzidionysiou  1 , Elisabeth Lie  2 , Evgeny Nasonov  3 , Galina Lukina  4 , Merete Lund Hetland  5 , Ulrik Tarp  6 , Ioan Ancuta  7 , Karel Pavelka  8 , Dan C Nordström  9 , Cem Gabay  10 , Helene Canhão  11 , Matija Tomsic  12 , Piet L C M van Riel  13 , Juan Gomez-Reino  14 , Tore K Kvien  15 , Ronald F van Vollenhoven  16 ; Rheumatic Diseases Portuguese Register
Affiliations
Observational Study

Effectiveness of two different doses of rituximab for the treatment of rheumatoid arthritis in an international cohort: data from the CERERRA collaboration

Katerina Chatzidionysiou et al. Arthritis Res Ther. .

Erratum in

Abstract

Background: The approved dose of rituximab (RTX) in rheumatoid arthritis is 1000 mg × 2, but some data have suggested similar clinical efficacy with 500 mg × 2. The purpose of this study was to compare the effectiveness of the regular and low doses given as first treatment course.

Methods: Twelve European registries participating in the CERERRA collaboration (The European Collaborative Registries for the Evaluation of Rituximab in Rheumatoid Arthritis) submitted anonymized datasets with demographic, efficacy and treatment data for patients who had started RTX. Treatment effectiveness was assessed by DAS28 reductions and EULAR responses after 6 months.

Results: Data on RTX dose were available for 2,873 patients, of whom 2,625 (91.4 %) and 248 (8.6 %) received 1000 mg × 2 and 500 mg × 2, respectively. Patients treated with 500 mg × 2 were significantly older, had longer disease duration, higher number of prior DMARDs, but lower number of prior biologics and lower baseline DAS28 than those treated with 1000 mg × 2. Fewer patients in the low-dose group received concomitant DMARDs but more frequently received concomitant corticosteroids. Both doses led to significant clinical improvements at 6 months. DAS28 reductions at 6 months were comparable in the 2 dose regimens [mean DeltaDAS28 ± SD -2.0 ± 1.3 (high dose) vs. -1.7 ± 1.4 (low dose), p = 0.23 adjusted for baseline differences]. Similar percentages of patients achieved EULAR good response in the two dose groups, 18.4 % vs. 17.3 %, respectively (p = 0.36).

Conclusions: In this large observational cohort initial treatment with RTX at 500 mg × 2 and 1000 mg × 2 led to comparable clinical outcomes at 6 months.

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Figures

Fig. 1
Fig. 1
a Disease activity based on Disease Activity Score in 28 joints (DAS28)-erythrocyte sedimentation rate (ESR) at baseline, 3 and 6 months in the two treatment groups (rituximab (RTX) 500 mg × 2 and RTX 1000 mg × 2). No significant differences were observed: remission, DAS28 <2.6; low disease activity, 2.6≤ DAS28 ≤3.2; moderate disease activity, 3.2< DAS28 ≤5.1; high disease activity, DAS28 >5.1. b. Good, moderate or no European League Against Rheumatism (EULAR) response at 6 months for the two treatment groups (RTX 500 mg × 2 and RTX 1000 mg × 2). No significant differences were observed
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References

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