The OPTION trial: inhibition of the interleukin-6 receptor with tocilizumab in patients with rheumatoid arthritis

Ramos-Remus, César; Muriel-Vizcaino, Rodolfo

doi:10.2217/17460816.3.5.429

Cited by 2 publications

(3 citation statements)

References 6 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Furthermore, the golimumab [33,34] and tocilizumab [43,44] studies provided rescue therapy for patients who did not achieve at least 20% improvement in both Tender Joint Count (TJC) and Swollen Joint Count (SJC) by week 16. The TEMPO trial [30,31] did not meet the inclusion criteria defined for the network meta-analyses; the study population was not comprised solely of patients diagnosed with RA showing an inadequate response to MTX.…”

Section: Resultsmentioning

confidence: 99%

“…As presented in Table 1 , most studies were generally comparable in design, although differences were identified regarding patients not responding to treatment; the adalimumab studies included an early escape for non-responders [ 24 ] while the certolizumab pegol studies specifically withdrew patients who did not show an ACR20 response at weeks 12 and 14 [ 26 - 29 ]. Furthermore, the golimumab [ 33 , 34 ] and tocilizumab [ 43 , 44 ] studies provided rescue therapy for patients who did not achieve at least 20% improvement in both Tender Joint Count (TJC) and Swollen Joint Count (SJC) by week 16. The TEMPO trial [ 30 , 31 ] did not meet the inclusion criteria defined for the network meta-analyses; the study population was not comprised solely of patients diagnosed with RA showing an inadequate response to MTX.…”

Section: Resultsmentioning

confidence: 99%

“…The adalimumab studies included an early escape for non-responders [ 24 ] while the certolizumab pegol studies specifically withdrew patients who did not show an ACR20 response at weeks 12 and 14 [ 26 - 29 ]. Furthermore, the golimumab [ 33 , 34 ] and tocilizumab [ 43 , 44 ] studies provided rescue therapy for patients who did not achieve at least 20% improvement in both Tender Joint Count and Swollen Joint Count by week 16. The impact associated with the adalimumab, golimumab and certolizumab pegol studies was not explored in scenario analyses, as excluding these studies would have removed the treatments from the analysis and this would not have provided additional information.…”

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

Abatacept with methotrexate versus other biologic agents in treatment of patients with active rheumatoid arthritis despite methotrexate: a network meta-analysis

Guyot¹,

Taylor²,

Christensen

et al. 2011

Arthritis Res Ther

View full text Add to dashboard Cite

IntroductionThe goal of this study was to compare the efficacy in terms of Health Assessment Questionnaire change from baseline (HAQ CFB), 50% improvement in American College of Rheumatology criterion (ACR-50) and Disease Activity Score in 28 joints (DAS28) defined remission (< 2.6) between abatacept and other biologic disease modifying anti-rheumatic drugs (DMARDs) in patients with rheumatoid arthritis (RA) who have inadequate response to methotrexate (MTX-IR).MethodsA systematic literature review identified controlled trials investigating the efficacy of abatacept (three studies), etanercept (two studies), infliximab (two), adalimumab (two), certolizumab pegol (two) ritixumab (three), and tocilizumab (two) in MTX-IR patients with RA. The clinical trials included in this analysis were similar with respect to trial design, baseline patient characteristics and background therapy (MTX). The key clinical endpoints of interest were HAQ CFB, ACR-50 and DAS28 < 2.6 measured at 24 and 52 weeks. The results were analysed using network meta-analysis methods that enabled calculation of an estimate for expected relative effect of comparative treatments. Analysis results were expressed as the difference in HAQ CFB score and odds ratio (OR) of achieving an ACR-50 and DAS28 response and associated 95% credible intervals (CrI).ResultsThe analysis of HAQ CFB at 24 weeks and 52 weeks showed that abatacept in combination with MTX is expected to be more efficacious than MTX monotherapy and is expected to show a comparable efficacy relative to other biologic DMARDs in combination with MTX. Further, abatacept showed comparable ACR-50 and DAS28 < 2.6 response rates with other biologic DMARDs at 24 and 52 weeks, except for ACR-50 compared to certolizumab pegol at 52 weeks and for DAS28 < 2.6 compared to tocilizumab at 24 weeks. Sensitivity analyses confirmed the robustness of the findings.ConclusionsAbatacept in combination with MTX is expected to result in a comparable change from baseline in HAQ score and comparable ACR-50 and DAS28 < 2.6 response rates in MTX-IR patients compared to other approved biologic agents.

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Abatacept with methotrexate versus other biologic agents in treatment of patients with active rheumatoid arthritis despite methotrexate: a network meta-analysis

Guyot¹,

Taylor²,

Christensen

et al. 2011

Arthritis Res Ther

View full text Add to dashboard Cite

show abstract

Adverse effects of biologics: a network meta-analysis and Cochrane overview

Singh

Wells

Christensen

et al. 2011

Cochrane Database of Systematic Reviews

486

197

View full text Add to dashboard Cite

To compare the potential adverse e ects of tumor necrosis factor inhibitor (adalimumab, certolizumab, etanercept, golimumab, infliximab), interleukin (IL)-1 antagonist (anakinra), IL-6 antagonist (tocilizumab), anti-CD28 (abatacept), and anti-B cell (rituximab) therapy in patients with any disease condition except human immunodeficiency disease (HIV/AIDS). Methods Randomized controlled trials (RCTs), controlled clinical trials (CCTs) and open-label extension (OLE) studies that studied one of the nine biologics for use in any indication (with the exception of HIV/AIDS) and that reported our pre-specified adverse outcomes (serious adverse events (SAEs), withdrawals due to adverse events (AEs), total AEs, serious infections; specific AEs, namely, tuberculosis (TB) reactivation, lymphoma and congestive heart failure) were considered for inclusion. We searched The Cochrane Library, MEDLINE, and EMBASE (to January 2010). Identifying search results and data extraction were performed independently and in duplicate. For the network metaanalysis, we performed both Bayesian mixed-treatment comparison models and arm-based generalized linear mixed models. Main results We included 160 RCTs with 48,676 participants and 46 extension studies with 11,954 participants. The median duration of RCTs was six months and 13 months for OLEs. Data were limited for TB reactivation, lymphoma, and congestive heart failure. Using standard dose, compared with control, biologics as a group were associated with a statistically significant higher rate of total AEs (odds ratio (OR) 1.28, 95% credible interval (CI) 1.09 to 1.50; number needed to treat to harm (NNTH) = 22, 95% confidence interval (CI) 14 to 60), withdrawals due to AEs (

show abstract

The OPTION trial: inhibition of the interleukin-6 receptor with tocilizumab in patients with rheumatoid arthritis

Cited by 2 publications

References 6 publications

Abatacept with methotrexate versus other biologic agents in treatment of patients with active rheumatoid arthritis despite methotrexate: a network meta-analysis

Abatacept with methotrexate versus other biologic agents in treatment of patients with active rheumatoid arthritis despite methotrexate: a network meta-analysis

Adverse effects of biologics: a network meta-analysis and Cochrane overview

Contact Info

Product

Resources

About