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Ann Rheum Dis. 2014 Aug;73(8):1508-14. doi: 10.1136/annrheumdis-2013-203480. Epub 2013 May 30.

Evaluation of low-dose rituximab for the retreatment of patients with active rheumatoid arthritis: a non-inferiority randomised controlled trial.

Author information

1
Department of Rheumatology, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Paris Sud, Université Paris Sud, INSERM U1012, Le Kremlin-Bicêtre, France.
2
Roche, Boulogne Billancourt, France.
3
Service de Rhumatologie, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.
4
Department of Rheumatology, Hôpital Lapeyronie, Université Montpellier I, Montpellier, France.
5
Department of Rheumatology, Hôpital Universitaire de Rouen, Institute for Research and Innovation in Biomedicine (IRIB), Rouen University, Rouen, France.
6
Department of Rheumatology, Hôpital Lyon-sud, Pierre-Bénite, France.
7
Department of Rheumatology, Hôpital Cochin, Rene Descartes University, Paris, France.

Abstract

BACKGROUND:

The licensed dose of rituximab in rheumatoid arthritis (RA) is two doses of 1000 mg given 2 weeks apart. A lower dose has never been specifically studied in patients with an inadequate response to anti-tumour necrosis factor (TNF) agents.

OBJECTIVE:

To compare the efficacy and safety of rituximab repeat treatment with two doses (1000 mg×1 and 1000 mg×2) following initial treatment with 1000 mg×2.

METHODS:

We set up an open-label, prospective, multicentre, non-inferiority study comprising a non-controlled period (24 weeks) followed by a randomised controlled period (weeks 24-104) in patients with RA and an inadequate response to anti-TNF agents. All patients received one course of rituximab (1000 mg×2) with methotrexate. At week 24, patients achieving a EULAR response (moderate or good) were randomised to rituximab retreatment at 1000 mg×1 (Arm A) or 1000 mg×2 (Arm B). The primary objective measure was disease activity in 28 joints C-reactive protein (DAS28-CRP) area under the curve (AUC) over 104 weeks with a non-inferiority margin defined by 20% (444) of the mean DAS28-CRP AUC (mean±SD 2218±967) of the reference data.

RESULTS:

The intent-to-treat and per-protocol (PP) populations comprised 143 (A/B: 70/73) and 100 (A/B: 51/49) patients, respectively. The adjusted mean difference in DAS28-CRP AUC (PP) was 51.4 (95% CI -131.2 to 234), demonstrating non-inferiority between arms A and B. The overall rituximab safety profile was similar with both retreatment regimens.

CONCLUSIONS:

Following a clinical response to a first course of rituximab in RA at the licensed dose of 1000 mg×2, retreatment with rituximab at 1000 mg×1 results in efficacy outcomes that are non-inferior to those achieved with retreatment at 1000 mg×2.

CLINICALTRIALSGOV REGISTRATION NUMBER:

NCT01126541.

KEYWORDS:

B cells; Rheumatoid Arthritis; Treatment

PMID:
23723317
DOI:
10.1136/annrheumdis-2013-203480
[Indexed for MEDLINE]
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