Real-world effectiveness of select biologic and DMARD monotherapy and combination therapy in the treatment of rheumatoid arthritis: results from the RADIUS observational registry

Weaver, Arthur L.; Lautzenheiser, Richard L; Schiff, Michael; Gibofsky, Allan; Perruquet, James L.; Luetkemeyer, John; Paulus, Harold E.; Xia, H. Amy; Leff, Jonathan A.; Investigators, Radius

doi:10.1185/030079905x65510

Cited by 61 publications

(48 citation statements)

References 21 publications

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“…Failure to suppress the CRP is a predictor of a poor response to TNF inhibitors. 18 However, the ESR and CRP are not sufficient to determine treatment responses. Despite improvement of acute phase reactants, some patients will have progression of joint damage.…”

Section: Biomarkers For Ra Disease Activitymentioning

confidence: 99%

“…Many instruments have been validated that can be incorporated into routine clinical practice to aid in treatment decisions with the goal of optimizing clinical responses and reducing joint damage from RA. 18 In randomized clinical trials, all of these agents have been shown to be effective in reducing clinical signs of inflammation in RA patients who have failed synthetic DMARDs. Multiple studies have demonstrated significant benefits of early treatment with TNF-alpha inhibitors combined with methotrexate.…”

Section: ■■ Conclusionmentioning

confidence: 99%

“…Two nonrandomized prospective cohort studies 17,18 and 1 open-label effectiveness trial 19 compared the tissue necrosis factor (TNF)-alpha inhibitors etanercept and infliximab. Based on ACR20 and ACR50 response rates, there were no differences in efficacy outcomes between treatment groups; the strength of evidence in these 3 studies was judged as moderate.…”

Section: Comparisons Of Biologic Agents Used As Monotherapymentioning

confidence: 99%

“…In randomized clinical trials RCTs, all of these agents have been shown to be effective in reducing clinical signs of inflammation in RA patients who have failed therapy with synthetic disease-modifying agents by measures such as ACR20 and DAS28. [18][19][20][21][22][23][24][25] Impressively, a significant number of patients in these RCTs also achieve ACR50 and ACR70 responses, and in some cases can achieve remission. Furthermore, TNF inhibitors are effective in reducing radiographic progression.…”

Section: Pathophysiology Of Joint Inflammation In Rheumatoid Arthritismentioning

confidence: 99%

“…Treatment with synthetic DMARDs (sulfasalazine, methotrexate, or leflunomide) is not only effective in treating joint inflammation, [15][16][17][18][19][20] but also in slowing radiographic progression. 19,21 Furthermore, it has been shown that biologics are also effective in decreasing clinical symptoms of RA and reducing radiographic progression.…”

Section: Benefits Of Aggressive Treatment In Early Ramentioning

confidence: 99%

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Managed Care Strategies for Improving Patient Outcomes in Rheumatoid Arthritis

Agarwal¹,

Farheen²,

Oderda³

et al. 2011

JMCP

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Section: Biomarkers For Ra Disease Activitymentioning

confidence: 99%

Section: ■■ Conclusionmentioning

confidence: 99%

Section: Comparisons Of Biologic Agents Used As Monotherapymentioning

confidence: 99%

Section: Pathophysiology Of Joint Inflammation In Rheumatoid Arthritismentioning

confidence: 99%

Section: Benefits Of Aggressive Treatment In Early Ramentioning

confidence: 99%

See 3 more Smart Citations

Managed Care Strategies for Improving Patient Outcomes in Rheumatoid Arthritis

Agarwal¹,

Farheen²,

Oderda³

et al. 2011

JMCP

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Research Misconduct Identified by the US Food and Drug Administration

Seife

2015

JAMA Intern Med

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IMPORTANCE Every year, the US Food and Drug Administration (FDA) inspects several hundred clinical sites performing biomedical research on human participants and occasionally finds evidence of substantial departures from good clinical practice and research misconduct. However, the FDA has no systematic method of communicating these findings to the scientific community, leaving open the possibility that research misconduct detected by a government agency goes unremarked in the peer-reviewed literature.OBJECTIVES To identify published clinical trials in which an FDA inspection found significant evidence of objectionable conditions or practices, to describe violations, and to determine whether the violations are mentioned in the peer-reviewed literature. DESIGN AND SETTINGCross-sectional analysis of publicly available documents, dated from , describing FDA inspections of clinical trial sites in which significant evidence of objectionable conditions or practices was found. MAIN OUTCOMES AND MEASURESFor each inspection document that could be linked to a specific published clinical trial, the main measure was a yes/no determination of whether there was mention in the peer-reviewed literature of problems the FDA had identified. RESULTS Fifty-seven published clinical trials were identified for which an FDA inspection of a trial site had found significant evidence of 1 or more of the following problems: falsification or submission of false information, 22 trials (39%); problems with adverse events reporting, 14 trials (25%); protocol violations, 42 trials (74%); inadequate or inaccurate recordkeeping, 35 trials (61%); failure to protect the safety of patients and/or issues with oversight or informed consent, 30 trials (53%); and violations not otherwise categorized, 20 trials (35%). Only 3 of the 78 publications (4%) that resulted from trials in which the FDA found significant violations mentioned the objectionable conditions or practices found during the inspection. No corrections, retractions, expressions of concern, or other comments acknowledging the key issues identified by the inspection were subsequently published.CONCLUSIONS AND RELEVANCE When the FDA finds significant departures from good clinical practice, those findings are seldom reflected in the peer-reviewed literature, even when there is evidence of data fabrication or other forms of research misconduct.

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Epidemiology and Treatment of New‐Onset and Established Rheumatoid Arthritis in an Insured US Population

Crane

Juneja

Allen

et al. 2015

Arthritis Care & Research

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Objective. To investigate the epidemiology and treatment of rheumatoid arthritis (RA) in a population broadly representative of employed adults in the US, using a retrospective cohort design. Methods. Incident and prevalent RA cohorts were defined from a sample of 4.66 million adults with complete followup data from the period of January 2005 through September 2008 in the Pharmetrics medical claims database. Demographics, comorbidity, and medical therapies were summarized using descriptive statistics. Results. Median duration in the database was 5.7 years. Age-and sex-adjusted incidence in 2006 was 0.71 per 1,000 persons at risk (n 5 3,992) and prevalence in 2005 was 0.63% (n 5 30,530). Within 12 months after diagnosis, 65%, 64%, and 20% of the incident cohort had been prescribed corticosteroids, nonbiologic disease-modifying antirheumatic drugs (DMARDs), and tumor necrosis factor (TNF) inhibitors, respectively. Median time to first anti-TNF prescription was 6 months; 31% switched to a second drug and 15% to a third. An aggressive subcohort (11% of incident patients) received more DMARDs (83%) and TNF inhibitors (43%), and was more likely to switch. Twenty-eight percent of incident patients received only symptomatic therapy over a minimum of 1.75 years of followup; these patients were older with more comorbidities and contraindications to methotrexate. Conclusion. In this insured population-based cohort, only two-thirds of newly diagnosed RA patients were prescribed a DMARD in year 1 and 28% received no antirheumatic therapy. Although limited by lack of clinical information and by left-censoring, administrative databases capture clinical practice and suggest that gaps exist in treatment options available to a significant number of patients.

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Real-world effectiveness of select biologic and DMARD monotherapy and combination therapy in the treatment of rheumatoid arthritis: results from the RADIUS observational registry

Abstract: These data from routine rheumatology clinical practice settings highlight the effectiveness of common biologic and DMARD therapies, and provide additional data beyond those of randomized, controlled trials.

Cited by 61 publications

References 21 publications

Managed Care Strategies for Improving Patient Outcomes in Rheumatoid Arthritis

Managed Care Strategies for Improving Patient Outcomes in Rheumatoid Arthritis

Research Misconduct Identified by the US Food and Drug Administration

Epidemiology and Treatment of New‐Onset and Established Rheumatoid Arthritis in an Insured US Population

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