Effectiveness of two different doses of rituximab for the treatment of rheumatoid arthritis in an international cohort: data from the CERERRA collaboration.
- Chatzidionysiou K Department of Medicine, Karolinska Institute, Unit for Clinical Research Therapy, Inflammatory Diseases (ClinTrid), D1:00, Karolinska Universitetssjukhustet, 171 76, Stockholm, Sweden. Aikaterini.chatzidionysiou@karolinska.se.
- Lie E Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway. Elisabeth_lie@yahoo.no.
- Nasonov E ARBITER, Institute of Rheumatology, Moscow, Russia. nasonov@irramn.ru.
- Lukina G ARBITER, Institute of Rheumatology, Moscow, Russia. gvl3@yandex.ru.
- Hetland ML DANBIO, Department of Rheumatology, Copenhagen University Hospital at Glostrup, Copenhagen, Denmark. merete.hetland@dadlnet.dk.
- Tarp U Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark. ulrik.tarp@ki.au.dk.
- Ancuta I Cantacuzino Hospital, Bucharest, Romania. iancuta@hotmail.com.
- Pavelka K Charles University, Prague, Czech Republic. pavelka@revma.cz.
- Nordström DC ROB-FIN Helsinki University Central Hospital, Helsinki, Finland. dan.nordstrom@hus.fi.
- Gabay C SCQM registry, University Hospital of Geneva, Geneva, Switzerland. Cem.Gabay@hcuge.ch.
- Canhão H Rheumatology Research Unit, Instituto de Medicina Molecular, Lisbon, Portugal. helenacanhao@gmail.com.
- Tomsic M University Medical Center, Ljubljana, Slovenia. matija.tomsic@kclj.si.
- van Riel PL Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands. p.vanriel@reuma.umcn.nl.
- Gomez-Reino J Hospital Clinico Universitet De Santiago, Santiago, Spain. Juan.Jesus.Gomez-Reino.Carnota@sergas.es.
- Kvien TK Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway. t.k.kvien@medisin.uio.no.
- van Vollenhoven RF Department of Medicine, Karolinska Institute, Unit for Clinical Research Therapy, Inflammatory Diseases (ClinTrid), D1:00, Karolinska Universitetssjukhustet, 171 76, Stockholm, Sweden. ronald.van.vollenhoven@ki.se.
- 2016-02-18
Published in:
- Arthritis research & therapy. - 2016
Adult
Aged
Antirheumatic Agents
Arthritis, Rheumatoid
Cohort Studies
Cooperative Behavior
Databases, Factual
Dose-Response Relationship, Drug
Europe
Female
Humans
Internationality
Male
Middle Aged
Registries
Rituximab
Statistics as Topic
Treatment Outcome
English
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.
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.
- Language
-
- English
- Open access status
- gold
- Identifiers
-
- DOI 10.1186/s13075-016-0951-z
- PMID 26883119
- Persistent URL
- https://roar.hep-bejune.ch/global/documents/222149
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