Cited by 2,623Rheumatoid Arthritis Research and TherapiesAutoimmune and Inflammatory Disorders ResearchNatural Compounds in Disease Treatment

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Efficacy of B-cell-targeted therapy with rituximab in patients with rheumatoid arthritis

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Edwards, Jonathan C.W., Szczepański, Leszek, Szechiński, Jacek, Filipowicz-Sosnowska, Anna, Emery, Paul, Close, David R., Stevens, Randall M., Shaw, Tim·2004·New England Journal of Medicine

DOI 10.1056/nejmoa032534

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Abstract

BACKGROUND: An open-label study indicated that selective depletion of B cells with the use of rituximab led to sustained clinical improvements for patients with rheumatoid arthritis. To confirm these observations, we conducted a randomized, double-blind, controlled study. METHODS: We randomly assigned 161 patients who had active rheumatoid arthritis despite treatment with methotrexate to receive one of four treatments: oral methotrexate (> or =10 mg per week) (control); rituximab (1000 mg on days 1 and 15); rituximab plus cyclophosphamide (750 mg on days 3 and 17); or rituximab plus methotrexate. Responses defined according to the criteria of the American College of Rheumatology (ACR) and the European League against Rheumatism (EULAR) were assessed at week 24 (primary analyses) and week 48 (exploratory analyses). RESULTS: At week 24, the proportion of patients with 50 percent improvement in disease symptoms according to the ACR criteria, the primary end point, was significantly greater with the rituximab-methotrexate combination (43 percent, P=0.005) and the rituximab-cyclophosphamide combination (41 percent, P=0.005) than with methotrexate alone (13 percent). In all groups treated with rituximab, a significantly higher proportion of patients had a 20 percent improvement in disease symptoms according to the ACR criteria (65 to 76 percent vs. 38 percent, P< or =0.025) or had EULAR responses (83 to 85 percent vs. 50 percent, P< or =0.004). All ACR responses were maintained at week 48 in the rituximab-methotrexate group. The majority of adverse events occurred with the first rituximab infusion: at 24 weeks, serious infections occurred in one patient (2.5 percent) in the control group and in four patients (3.3 percent) in the rituximab groups. Peripheral-blood immunoglobulin concentrations remained within normal ranges. CONCLUSIONS: In patients with active rheumatoid arthritis despite methotrexate treatment, a single course of two infusions of rituximab, alone or in combination with either cyclophosphamide or continued methotrexate, provided significant improvement in disease symptoms at both weeks 24 and 48.

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Authors: Edwards, J. C. W., Szczepański, L., Szechiński, J., Filipowicz-Sosnowska, A., Emery, P., Close, D. R., Stevens, R. M., & Shaw, T.
Affiliations: University College London (GB)
University of Wrocław (PL)
Roche (United Kingdom) (GB)
ORCID: Edwards, Jonathan C.W.
Emery, Paul
Stevens, Randall M.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2004-06-17
Volume: 350
Issue: 25
Pages: 2572-2581
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa032534
OpenAlex: W2118994799
Cited by: 2,623
References: 21
Citations by year: 2026: 65 · 2025: 69 · 2024: 76 · 2023: 62 · 2022: 61 · 2021: 85 · 2020: 87 · 2019: 85 · 2018: 103 · 2017: 112 · 2016: 96 · 2015: 103 · 2014: 129 · 2013: 133 · 2012: 133
FWCI: 109.25
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
UCL Discovery (University College London) (submittedVersion)
Topics: Health Sciences › Medicine › Rheumatology › Rheumatoid Arthritis Research and Therapies
Health Sciences › Medicine › Hematology › Autoimmune and Inflammatory Disorders Research
Health Sciences › Medicine › Complementary and alternative medicine › Natural Compounds in Disease Treatment
Keywords: rheumatoid arthritis, rituximab, B-cell depletion, cyclophosphamide, methotrexate, combination therapy, adverse events, serious infections, immunoglobulin levels, treatment-resistant rheumatoid arthritis, ACR response criteria, EULAR response criteria, maintenance therapy, relapse prevention, long-term follow-up, drug efficacy
MeSH terms: Rituximab, Antibodies, Monoclonal, Arthritis, Rheumatoid, B-Lymphocytes, Bacterial Infections, Cyclophosphamide, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Immunosuppressive Agents, Male, Methotrexate, Middle Aged, Antirheumatic Agents, Antigens, CD20, Antibodies, Monoclonal, Murine-Derived

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Efficacy of B-cell-targeted therapy with rituximab in patients with rheumatoid arthritis

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