TocilizumabV1, Main, Exploration, bibRecord, 001489

Assessments of the unmet need in the management of patients with rheumatoid arthritis: analyses from the NOR-DMARD registry

Identifieur interne : 001489 ( Main/Exploration ); précédent : 001488; suivant : 001490

Assessments of the unmet need in the management of patients with rheumatoid arthritis: analyses from the NOR-DMARD registry

Auteurs : Inge C. Olsen [Norvège] ; Elisabeth Lie [Norvège] ; Radu Vasilescu [Belgique] ; Gene Wallenstein [États-Unis] ; Sander Strengholt [Pays-Bas] ; Tore K. Kvien [Norvège]

Source :

Rheumatology (Oxford, England) [ 1462-0324 ] ; 2018.

RBID : PMC:6381770

Abstract

AbstractObjective

To describe the outcomes of MTX and biologic DMARD (bDMARD) treatment in patients with RA and assess unmet needs in patients who fail treatment, using real-world data from the Norwegian DMARD (NOR-DMARD) registry.

Methods

Data included RA treatment courses from January 2007 until July 2016. Patients received MTX monotherapy (in MTX-naïve patients), bDMARD monotherapy, bDMARDs + MTX, or bDMARDs + other conventional synthetic DMARDs (csDMARDs). DAS28-4(ESR) was used to measure remission (<2.6) and inadequate response (>3.2) across all groups at Months 6 and 12. Estimated ACR20/50/70 and EULAR good and good/moderate response rates (based on DAS28-4[ESR] score) for bDMARDs were modelled at Months 6 and 12 using logistic mixed regression. DAS28-4(ESR) scores and changes from baseline, and rates and reasons for discontinuation, were evaluated for all groups over 24 months.

Results

The 2778 treatment courses in this analysis included 714 MTX monotherapy, 396 bDMARD monotherapy, 1460 bDMARDs + MTX and 208 bDMARDs + other csDMARDs. Of patients with DAS28-4(ESR) data at Months 6 and 12 (25.0–34.1%), 33.9–47.2% did not switch treatment and were inadequate-responders at Month 12. There were no significant differences in efficacy between bDMARD groups (bDMARD monotherapy, or bDMARDs + MTX or other csDMARDs). Lack of efficacy was the most common reason for stopping treatment across all groups (13.7–22.1% over 24 months).

Conclusion

An unmet treatment need exists for patients still experiencing inadequate response to MTX monotherapy and bDMARDs as monotherapy or in combination with MTX/other csDMARDs after 12 months.

Trial registration

ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT01581294.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6381770

DOI: 10.1093/rheumatology/key338
PubMed: 30508189
PubMed Central: 6381770

Affiliations:

Le document en format XML

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<front><div type="abstract" xml:lang="en"><title>Abstract</title>
<sec id="s1"><title>Objective</title>
<p>To describe the outcomes of MTX and biologic DMARD (bDMARD) treatment in patients with RA and assess unmet needs in patients who fail treatment, using real-world data from the Norwegian DMARD (NOR-DMARD) registry.</p>
</sec>
<sec id="s2"><title>Methods</title>
<p>Data included RA treatment courses from January 2007 until July 2016. Patients received MTX monotherapy (in MTX-naïve patients), bDMARD monotherapy, bDMARDs + MTX, or bDMARDs + other conventional synthetic DMARDs (csDMARDs). DAS28-4(ESR) was used to measure remission (<2.6) and inadequate response (>3.2) across all groups at Months 6 and 12. Estimated ACR20/50/70 and EULAR good and good/moderate response rates (based on DAS28-4[ESR] score) for bDMARDs were modelled at Months 6 and 12 using logistic mixed regression. DAS28-4(ESR) scores and changes from baseline, and rates and reasons for discontinuation, were evaluated for all groups over 24 months.</p>
</sec>
<sec id="s3"><title>Results</title>
<p>The 2778 treatment courses in this analysis included 714 MTX monotherapy, 396 bDMARD monotherapy, 1460 bDMARDs + MTX and 208 bDMARDs + other csDMARDs. Of patients with DAS28-4(ESR) data at Months 6 and 12 (25.0–34.1%), 33.9–47.2% did not switch treatment and were inadequate-responders at Month 12. There were no significant differences in efficacy between bDMARD groups (bDMARD monotherapy, or bDMARDs + MTX or other csDMARDs). Lack of efficacy was the most common reason for stopping treatment across all groups (13.7–22.1% over 24 months).</p>
</sec>
<sec id="s4"><title>Conclusion</title>
<p>An unmet treatment need exists for patients still experiencing inadequate response to MTX monotherapy and bDMARDs as monotherapy or in combination with MTX/other csDMARDs after 12 months.</p>
</sec>
<sec id="s5"><title>Trial registration</title>
<p>ClinicalTrials.gov, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT01581294">https://clinicaltrials.gov/ct2/show/NCT01581294</ext-link>
.</p>
</sec>
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Assessments of the unmet need in the management of patients with rheumatoid arthritis: analyses from the NOR-DMARD registry

Assessments of the unmet need in the management of patients with rheumatoid arthritis: analyses from the NOR-DMARD registry

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