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

Katerina Chatzidionysiou, Elisabeth Lie, Evgeny Nasonov, Galina Lukina, Merete Lund Hetland, Ulrik Tarp, Ioan Ancuta, Karel Pavelka, Dan C Nordström, Cem Gabay, Helene Canhão, Matija Tomsic, Piet L. C. M. van Riel, Juan Gomez-Reino, Tore K. Kvien, Ronald F van Vollenhoven, Rheumatic Diseases Portuguese Register

Research output: Contribution to journalArticleAcademicpeer-review

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.

Original languageEnglish
Pages (from-to)50
JournalArthritis Research & Therapy
Volume18
DOIs
Publication statusPublished - 16 Feb 2016

Cite this

Chatzidionysiou, Katerina ; Lie, Elisabeth ; Nasonov, Evgeny ; Lukina, Galina ; Hetland, Merete Lund ; Tarp, Ulrik ; Ancuta, Ioan ; Pavelka, Karel ; Nordström, Dan C ; Gabay, Cem ; Canhão, Helene ; Tomsic, Matija ; van Riel, Piet L. C. M. ; Gomez-Reino, Juan ; Kvien, Tore K. ; van Vollenhoven, Ronald F ; Rheumatic Diseases Portuguese Register. / Effectiveness of two different doses of rituximab for the treatment of rheumatoid arthritis in an international cohort : data from the CERERRA collaboration. In: Arthritis Research & Therapy. 2016 ; Vol. 18. pp. 50.
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title = "Effectiveness of two different doses of rituximab for the treatment of rheumatoid arthritis in an international cohort: data from the CERERRA collaboration",
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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author = "Katerina Chatzidionysiou and Elisabeth Lie and Evgeny Nasonov and Galina Lukina and Hetland, {Merete Lund} and Ulrik Tarp and Ioan Ancuta and Karel Pavelka and Nordstr{\"o}m, {Dan C} and Cem Gabay and Helene Canh{\~a}o and Matija Tomsic and {van Riel}, {Piet L. C. M.} and Juan Gomez-Reino and Kvien, {Tore K.} and {van Vollenhoven}, {Ronald F} and {Rheumatic Diseases Portuguese Register}",
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Chatzidionysiou, K, Lie, E, Nasonov, E, Lukina, G, Hetland, ML, Tarp, U, Ancuta, I, Pavelka, K, Nordström, DC, Gabay, C, Canhão, H, Tomsic, M, van Riel, PLCM, Gomez-Reino, J, Kvien, TK, van Vollenhoven, RF & Rheumatic Diseases Portuguese Register 2016, 'Effectiveness of two different doses of rituximab for the treatment of rheumatoid arthritis in an international cohort: data from the CERERRA collaboration' Arthritis Research & Therapy, vol. 18, pp. 50. https://doi.org/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. / Chatzidionysiou, Katerina; Lie, Elisabeth; Nasonov, Evgeny; Lukina, Galina; Hetland, Merete Lund; Tarp, Ulrik; Ancuta, Ioan; Pavelka, Karel; Nordström, Dan C; Gabay, Cem; Canhão, Helene; Tomsic, Matija; van Riel, Piet L. C. M.; Gomez-Reino, Juan; Kvien, Tore K.; van Vollenhoven, Ronald F; Rheumatic Diseases Portuguese Register.

In: Arthritis Research & Therapy, Vol. 18, 16.02.2016, p. 50.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Effectiveness of two different doses of rituximab for the treatment of rheumatoid arthritis in an international cohort

T2 - data from the CERERRA collaboration

AU - Chatzidionysiou, Katerina

AU - Lie, Elisabeth

AU - Nasonov, Evgeny

AU - Lukina, Galina

AU - Hetland, Merete Lund

AU - Tarp, Ulrik

AU - Ancuta, Ioan

AU - Pavelka, Karel

AU - Nordström, Dan C

AU - Gabay, Cem

AU - Canhão, Helene

AU - Tomsic, Matija

AU - van Riel, Piet L. C. M.

AU - Gomez-Reino, Juan

AU - Kvien, Tore K.

AU - van Vollenhoven, Ronald F

AU - Rheumatic Diseases Portuguese Register

PY - 2016/2/16

Y1 - 2016/2/16

N2 - 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.

AB - 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.

KW - Adult

KW - Aged

KW - Antirheumatic Agents

KW - Arthritis, Rheumatoid

KW - Cohort Studies

KW - Cooperative Behavior

KW - Databases, Factual

KW - Dose-Response Relationship, Drug

KW - Europe

KW - Female

KW - Humans

KW - Internationality

KW - Male

KW - Middle Aged

KW - Registries

KW - Rituximab

KW - Statistics as Topic

KW - Treatment Outcome

KW - Journal Article

KW - Observational Study

U2 - 10.1186/s13075-016-0951-z

DO - 10.1186/s13075-016-0951-z

M3 - Article

VL - 18

SP - 50

JO - Arthritis Research & Therapy

JF - Arthritis Research & Therapy

SN - 1478-6354

ER -