Rituximab use in everyday clinical practice as a first-line biologic therapy for the treatment of DMARD-resistant rheumatoid arthritis

McGonagle, Dennis; Tan, Ai Lyn; Madden, Julie; Taylor, L.H.; Emery, Paul

doi:10.1093/rheumatology/ken103

Cited by 32 publications

(16 citation statements)

References 15 publications

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“…RTX treatment has also been tried in patients with early RA, even in those previously unexposed to anti-TNF␣ treatment. Some brief reports (McGonagle et al, 2008;Renato, 2009) have demonstrated that RTX might be useful as firstline biological therapy for the treatment of severe seropositive RA. The efficacy of RTX in daily clinical practice as a first-line biological therapy was evaluated in 39 patients with RA.…”

Section: Targeting B Cellsmentioning

confidence: 99%

Therapeutic Targeting of B Cells for Rheumatic Autoimmune Diseases

et al. 2011

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Section: Targeting B Cellsmentioning

confidence: 99%

Therapeutic Targeting of B Cells for Rheumatic Autoimmune Diseases

et al. 2011

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“…The use of rituximab as a first line biologic agent has recently gained acceptance [10] and it is now a licensed indication for rheumatoid arthritis [10, 11]. Rituximab is effective in both methotrexate non-responders [12] as well TNFi non-responders [13] and has the advantage of needing only two infusions for a long lasting remission.…”

Section: Introductionmentioning

confidence: 99%

Leflunomide is equally efficacious and safe compared to low dose rituximab in refractory rheumatoid arthritis given in combination with methotrexate: results from a randomized double blind controlled clinical trial

Wijesinghe

Galappatthy

Silva

et al. 2017

BMC Musculoskelet Disord

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BackgroundThe standard dose of rituximab used in rheumatoid arthritis (RA) is 1000 mg but recent studies have shown that low dose (500 mg) is also effective. Efficacy of low dose rituximab in rheumatoid arthritis (RA) refractory to first-line non-biologic Disease Modifying Anti Rheumatic Drugs (DMARDs), compared to leflunomide is unknown. In a tertiary care referral setting, we conducted a randomized, double blind controlled clinical trial comparing the efficacy and safety of low-dose rituximab-methotrexate combination with leflunomide-methotrexate combination.MethodsPatients on methotrexate (10-20 mg/week) with a Disease Activity Score (DAS) > 3.2 were randomly assigned to rituximab (500 mg on days 1 and 15) or leflunomide (10-20 mg/day). The primary end-point was ACR20 at 24 weeks. Sample of 40 had 70% power to detect a 30% difference. ACR50, ACR70, DAS, EULAR good response, CD3 + (T cell), CD19 + (B cell) and CD19 + CD27+ (memory B cell) counts, tetanus and pneumococcal antibody levels were secondary end points.ResultsBaseline characteristics were comparable in the two groups. At week 24, ACR20 was 85% vs 84% (p = 0.93), ACR50 was 60% vs. 64% (p = 0.79) and ACR70 was 35% vs 32% (P = 0.84), in rituximab and in leflunomide groups respectively. Serious adverse events were similar.With rituximab there was significant reduction in B cells (p < 0.001), memory B cells (p < 0.001) and pneumococcal antibody levels (P < 0.05) without significant changes in T cells (p = 0.835) and tetanus antibody levels (p = 0.424) at 24 weeks. With leflunomide, significant reduction in memory B cells (p < 0.01) and pneumococcal antibody levels (p < 0.01) occurred without significant changes in B cells (P > 0.05), T cells (P > 0.05) or tetanus antibody levels (P > 0.05).ConclusionsLeflunomide-methotrexate combination is as efficacious as low-dose rituximab-methotrexate combination at 24 weeks, in RA patient’s refractory to initial DMARDs. The high responses seen in both groups have favorable cost implications for patients in developing countries. Changes in immune parameters with leflunomide are novel and need further characterization.Trial registrationThe trial was registered with the Sri Lanka Clinical Trials Registry (SLCTR), a publicly accessible primary registry linked to the registry network of the International Clinical Trials Registry Platform of the WHO (WHO-ICTRP) (registration number: SLCTR/2008/008 dated 16th May 2008).

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“…To date, few observational studies have reported on the effectiveness of RTX in anti-TNF-naive patients 10,11,12 . Several observational studies have reported on the effective-…”

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confidence: 99%

Effectiveness of Rituximab in Patients with Rheumatoid Arthritis: Observational Study from the British Society for Rheumatology Biologics Register

Soliman

Hyrich²,

Lunt³

et al. 2011

J Rheumatol

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ABSTRACT. Objective. To assess the effectiveness of rituximab (RTX) in patients with rheumatoid arthritis (RA) in routine clinical practice, and to identify predictors of 6-month response to RTX in patients for whom at least 1 anti-tumor necrosis factor-α (anti-TNF) therapy has failed. Method. The analysis involved 646 patients with RA registered with the British Society for Rheumatology Biologics Register (BSRBR) who were starting RTX and were followed for at least 6 months. Change in the 28-joint Disease Activity Score (DAS28), European League Against Rheumatism (EULAR) response, and proportions of patients achieving disease remission were used to assess the clinical response 6 months after starting RTX. Regression analyses were used to identify factors associated with the response in the patients for whom anti-TNF therapy had not worked. The models included baseline demographics, disease characteristics, baseline Health Assessment Questionnaire (HAQ), and drug history including biologic history.Results. The mean DAS28 at baseline was 6.2 (95% CI 6.1, 6.3), which decreased significantly to 4.8 (95% CI 4.7, 4.9) at the 6-month followup. Seventeen percent of the patients were EULAR good responders and 43% were moderate responders. Eight percent of the patients achieved disease remission. Subjects with higher baseline DAS28 score and those with positive rheumatoid factor (RF) status were significantly associated with a decrease in their DAS28 score (improvement), while women and patients with higher baseline HAQ score were less likely to improve. Conclusion. RTX has proven to be effective in routine clinical practice. When anti-TNF therapy fails, response to RTX was influenced by baseline DAS28 score, RF status, baseline HAQ score, and sex.

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Rituximab use in everyday clinical practice as a first-line biologic therapy for the treatment of DMARD-resistant rheumatoid arthritis

Abstract: Rituximab is well tolerated in everyday clinical practice and may represent a good short-term treatment option where anti-TNF therapy is either unavailable or relatively contraindicated.

Cited by 32 publications

References 15 publications

Therapeutic Targeting of B Cells for Rheumatic Autoimmune Diseases

Therapeutic Targeting of B Cells for Rheumatic Autoimmune Diseases

Leflunomide is equally efficacious and safe compared to low dose rituximab in refractory rheumatoid arthritis given in combination with methotrexate: results from a randomized double blind controlled clinical trial

Effectiveness of Rituximab in Patients with Rheumatoid Arthritis: Observational Study from the British Society for Rheumatology Biologics Register

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