What is the clinical relevance of erosions and joint space narrowing in RA?

Lillegraven, Siri; Heijde, Desirée van der; Uhlig, Till; Kvien, Tore K; Haavardsholm, Espen A

doi:10.1038/nrrheum.2011.202

Cited by 49 publications

(49 citation statements)

References 27 publications

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“…The mean change from baseline in the SHS at week 52 was significantly less in the sarilumab 150 mg and 200 mg groups (mean change 0.9 and 0.25, respectively) as compared with the placebo group (mean change 2.78). The sarilumab doses of 150 mg and 200 mg had significant effects both on the erosion scores and on the joint space narrowing scores (32). Sensitivity analyses that included radiographic data from patients who received rescue therapy (and thus were receiving active treatment at the time of the radiographic measurements) yielded results that were consistent with those in the primary analysis, and analyses that used only as-observed data rather than extrapolated data also yielded results consistent with those of the primary analysis.…”

Section: Discussionsupporting

confidence: 77%

Sarilumab Plus Methotrexate in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate: Results of a Phase III Study

Genovese

Fleischmann

Kivitz

et al. 2015

Arthritis & Rheumatology

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210

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Objective To evaluate the efficacy and safety of sarilumab in combination with methotrexate (MTX) for the treatment of rheumatoid arthritis (RA). Methods Adults with moderate‐to‐severe RA and an inadequate response to MTX were randomized (1:1:1) to receive sarilumab (doses of 150 mg or 200 mg) or placebo every 2 weeks in conjunction with weekly MTX for 52 weeks. Co–primary end points were the proportion of patients achieving American College of Rheumatology 20% (ACR20) improvement responses at week 24, change from baseline in the Health Assessment Questionnaire (HAQ) disability index (DI) at week 16, and change from baseline in the modified Sharp/van der Heijde score (SHS) of radiographic damage at week 52. Results Baseline characteristics were similar among the groups. For all 3 co–primary end points, the sarilumab 150 mg and 200 mg groups demonstrated statistically significant improvements as compared with the placebo group (ACR20 response rate at week 24, 58.0%, 66.4%, and 33.4%, respectively [P < 0.0001]; least squares mean change in HAQ DI at week 16, −0.53, −0.55, and −0.29, respectively [P < 0.0001]; and mean change in SHS at week 52, 0.90, 0.25, and 2.78, respectively [P < 0.0001]). The most common treatment‐emergent adverse event was infection. In the sarilumab 150 mg, sarilumab 200 mg, and placebo groups, the incidence of serious infections was 2.6%, 4.0%, and 2.3%, respectively. Elevations in alanine aminotransferase levels >3‐fold the upper limit of normal occurred in 9.5%, 8.0%, and 2.1% of patients, respectively; in 24 patients, this led to discontinuation of treatment. Elevated total cholesterol levels were observed in 36.8%, 43.0%, and 18.3% of patients, respectively. In patients receiving 150 mg and 200 mg sarilumab, neutrophil counts of 0.5 to <1.0 × 109/liter were observed in 5.1% and 7.8% of patients, respectively, while neutrophil counts of <0.5 × 109/liter were observed in 0.9% and 0.7% of patients, respectively; none of the patients receiving placebo experienced changes in neutrophil counts. Conclusion In RA patients treated with sarilumab (150 mg or 200 mg every 2 weeks) in combination with MTX, both doses provided sustained clinical efficacy, as shown by significant improvements in symptomatic, functional, and radiographic outcomes. Sarilumab was generally well tolerated. The adverse events observed in this study were consistent with the effects of interleukin‐6 signaling blockade.

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Section: Discussionsupporting

confidence: 77%

Sarilumab Plus Methotrexate in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate: Results of a Phase III Study

Genovese

Fleischmann

Kivitz

et al. 2015

Arthritis & Rheumatology

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210

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“…Radiographic damage is associated to level of physical function, particularly in established disease,48 and baseline MHAQ score also improved during the decade.…”

Section: Discussionmentioning

confidence: 99%

Time trends in disease activity, response and remission rates in rheumatoid arthritis during the past decade: results from the NOR-DMARD study 2000–2010

et al. 2013

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“…We acknowledge there is still a large amount of research required to optimise the use of imaging tools in routine clinical practice, in particular which joints should be used for disease assessment and monitoring and consideration of the feasibility, costs and appropriate training required to use ultrasound and MRI in clinical practice. In view of a lack of literature at the time of the review, these recommendations have not focused on detecting joint space narrowing, which is important to consider in view of the impact on functional status 134. We have made specific reference to this in our proposed future research agenda.…”

Section: Discussionmentioning

confidence: 99%

EULAR recommendations for the use of imaging of the joints in the clinical management of rheumatoid arthritis

et al. 2013

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Objective To develop evidence-based recommendations on the use of imaging of the joints in the clinical management of rheumatoid arthritis (RA). Methods The task force comprised an expert group of rheumatologists, radiologists, methodologists and experienced rheumatology practitioners from 13 countries. Thirteen key questions on the role of imaging in RA were generated using a process of discussion and consensus. Imaging modalities included were conventional radiography, ultrasound, MRI, CT, dualemission x-ray absorptiometry, digital x-ray radiogrammetry, scintigraphy and positron emission tomography. Research evidence was searched systematically for each question using MEDLINE, EMBASE and Cochrane CENTRAL. The experts used the evidence obtained from the relevant studies to develop a set of 10 recommendations. The strength of recommendation was assessed using a visual analogue scale. Results A total of 6888 references was identified from the search process, from which 199 studies were included in the systematic review. Ten recommendations were produced encompassing the role of imaging in making a diagnosis of RA, detecting inflammation and damage, predicting outcome and response to treatment, monitoring disease activity, progression and remission. The strength of recommendation for each proposition varied according to both the research evidence and expert opinion. Conclusions Ten key recommendations for the role of imaging in the management of RA were developed using research-based evidence and expert opinion.

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What is the clinical relevance of erosions and joint space narrowing in RA?

Cited by 49 publications

References 27 publications

Sarilumab Plus Methotrexate in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate: Results of a Phase III Study

Sarilumab Plus Methotrexate in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate: Results of a Phase III Study

Time trends in disease activity, response and remission rates in rheumatoid arthritis during the past decade: results from the NOR-DMARD study 2000–2010

EULAR recommendations for the use of imaging of the joints in the clinical management of rheumatoid arthritis

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