Risk factors for severe infections in patients with rheumatoid arthritis treated with rituximab in the autoimmunity and rituximab registry

Gottenberg, Jacques-Éric; Ravaud, Philippe; Bardin, Thomas; Cacoub, Patrice; Cantagrel, A.; Combe, Bernard; Dougados, Maxime; Flipo, René‐Marc; Godeau, Bertrand; Guillevin, Loı̈c; Loët, Xavier Le; Hachulla, É.; Schaeverbeke, Thierry; Sibilia, Jean; Baron, Gabriel; Mariette, Xavier

doi:10.1002/art.27555

Cited by 275 publications

(180 citation statements)

References 18 publications

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“…Hypoimmunoglobulinemia prior to rituximab treatment has been suggested as a risk factor for development of severe infections in RA patients (9). However, none of our patients with late-onset neutropenia had low IgG values before rituximab treatment, yet most of them developed severe infections during late-onset neutropenia.…”

Section: Discussionmentioning

confidence: 56%

Late‐onset neutropenia following rituximab therapy in rheumatic diseases: Association with B lymphocyte depletion and infections

Tesfa

Ajeganova

Hägglund

et al. 2011

Arthritis & Rheumatism

134

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Objective. Late-onset neutropenia following rituximab therapy is a well-recognized side effect in lymphoma patients, but only a few cases of late-onset neutropenia have been reported in patients with autoimmune disorders. The purpose of this study was to define the incidence, clinical features, and some of the underlying mechanisms of late-onset neutropenia in relation to rituximab use in several rheumatic diseases.Methods. We conducted a retrospective analysis of a cohort of 209 consecutive patients with rheumatic diseases who had been treated with rituximab at a university hospital between June 2003 and March 2009.Results. Eleven patients with late-onset neutropenia were identified. The highest incidence was observed in granulomatosis with polyangiitis (Wegener's) and systemic lupus erythematosus patients (23% and 20%, respectively), whereas the incidence in rheumatoid arthritis patients was 3%. The median time to onset of neutropenia was 102 days (range 40-362 days) and coincided with the entire period of B lymphocyte depletion; this depletion was more pronounced in patients with late-onset neutropenia (P ‫؍‬ 0.002) than in a control group of 20 matched patients without late-onset neutropenia. Serum IgM levels decreased during the same time and to a significantly greater amount in patients with late-onset neutropenia than in controls (P ‫؍‬ 0.027). No patient with late-onset neutropenia displayed specific antineutrophil antibodies. Seven patients were hospitalized because of infections (6 with sepsis and 1 with febrile neutropenia) that required intravenous antibiotics. Six were treated with granulocyte colony-stimulating factor.Conclusion. In patients treated with rituximab for rheumatic diseases, late-onset neutropenia is a clinically significant adverse event associated with marked B lymphocyte depletion and severe infections. The incidence of late-onset neutropenia appears to vary with autoimmune disease type.

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Section: Discussionmentioning

confidence: 56%

Late‐onset neutropenia following rituximab therapy in rheumatic diseases: Association with B lymphocyte depletion and infections

Tesfa

Ajeganova

Hägglund

et al. 2011

Arthritis & Rheumatism

134

View full text Add to dashboard Cite

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“…In clinical practice, many patients initiating RTX have lower disease activity levels compared with those enrolled in anti-TNF RCT, a factor that further influences evaluations of effectiveness 12,13,14 . Most observational data examining the effectiveness of RTX in routine clinical practice have been reported from European registries 15,16,17,18,19,20,21,22 , with scant information currently available from the United States 23 . There is tremendous value in examining US cohorts of patients with RA to assess effectiveness because of the differences in treatment practices and patient characteristics.…”

Section: Rheumatologymentioning

confidence: 99%

Effectiveness of Rituximab for the Treatment of Rheumatoid Arthritis in Patients with Prior Exposure to Anti-TNF: Results from the CORRONA Registry

Harrold

Reed²,

Shewade³

et al. 2015

J Rheumatol

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Objective.To characterize the real-world effectiveness of rituximab (RTX) in patients with rheumatoid arthritis.Methods.Clinical effectiveness at 12 months was assessed in patients who were prescribed RTX based on the Clinical Disease Activity Index (CDAI). Change in CDAI was calculated (CDAI at 12 mos minus at initiation). Achievement of remission or low disease activity (LDA; CDAI ≤ 10) among those with moderate/high disease activity at the time of RTX initiation was compared based on prior anti-tumor necrosis factor agent (anti-TNF) use (1 vs ≥ 2) using logistic regression models.Results.Patients (n = 265) were followed for 12 months with a mean change in CDAI of −8.1 (95% CI −9.8 – −6.4). Of the 218 patients with moderate/high disease activity at baseline, patients with 1 prior anti-TNF (baseline CDAI 25.0) demonstrated a mean change in CDAI of −10.1 (95% CI −13.2 – −7.0); patients with ≥ 2 prior anti-TNF (baseline CDAI 30.0) demonstrated a mean change of −10.5 (95% CI −12.9 – −8.0). The unadjusted OR for achieving LDA/remission in patients with moderate/high disease activity at baseline exposed to ≥ 2 versus 1 prior anti-TNF was 0.40 (95% CI 0.22–0.73), which was robust to 4 different adjusted models (OR range 0.38–0.44).Conclusion.A good clinical response was observed in all patients; however, patients previously treated with 1 anti-TNF, who had lower baseline CDAI and a greater opportunity for clinical improvement compared with patients previously treated with ≥ 2 anti-TNF, were more likely to achieve LDA/remission.

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“…Moreover, CYC and repeated courses of rituximab may result in hypogammaglobulinemia, which may in turn predispose patients to increased risk of infections. Intravenous immunoglobulin therapy may be considered in these patients (27).…”

Section: Infectionsmentioning

confidence: 99%

Is Newer Safer? Adverse Events Associated with First-Line Therapies for ANCA-Associated Vasculitis and Lupus Nephritis

Hogan

Avasare

2014

Clinical Journal of the American Society of Nephrology

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Clinical outcomes in ANCA-associated vasculitis (AAV) and lupus nephritis have improved greatly with treatment regimens containing high-dose glucocorticoids and cyclophosphamide. However, with the use of these medications come significant adverse events, most notably infections, cytopenias, malignancies, and reproductive abnormalities. Multiple recent randomized controlled trials in AAV and lupus nephritis have compared cyclophosphamide-based regimens with agents such as rituximab, mycophenolate mofetil, and azathioprine, with the hope of providing better clinical outcomes with improved safety profiles. Although some of these newer regimens are now considered first-line treatments of these diseases, their adverse event profiles have been disappointingly similar to those of cyclophosphamide-based protocols. Physicians and patients should consider the adverse event profiles generated by these trials in the context of their extensive use in other patient populations, as well as available measures to prevent such events, when choosing the ideal regimen for an individual patient.

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Risk factors for severe infections in patients with rheumatoid arthritis treated with rituximab in the autoimmunity and rituximab registry

Cited by 275 publications

References 18 publications

Late‐onset neutropenia following rituximab therapy in rheumatic diseases: Association with B lymphocyte depletion and infections

Late‐onset neutropenia following rituximab therapy in rheumatic diseases: Association with B lymphocyte depletion and infections

Effectiveness of Rituximab for the Treatment of Rheumatoid Arthritis in Patients with Prior Exposure to Anti-TNF: Results from the CORRONA Registry

Is Newer Safer? Adverse Events Associated with First-Line Therapies for ANCA-Associated Vasculitis and Lupus Nephritis

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