Dosing of Intravenous Tocilizumab in a Real-World Setting of Rheumatoid Arthritis: Analyses from the Corrona Registry

Pappas, Dimitrios A.; John, Ani; Curtis, Jeffrey R.; Reed, George W.; Karki, Chitra; Magner, Robert P.; Kremer, Joel M.; Shewade, Ashwini; Greenberg, Jeffrey D.

doi:10.1007/s40744-016-0028-0

Cited by 7 publications

(5 citation statements)

References 17 publications

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“…Overall, TCZ-SC was effective and had a safety profile consistent to that observed with TCZ-IV in previous PMS studies and clinical trials [4][5][6][7][8][9][10]15,16]. No new safety signals were observed.…”

Section: Discussionsupporting

confidence: 79%

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Safety and effectiveness of subcutaneous tocilizumab in patients with rheumatoid arthritis in a real-world clinical setting

Atsumi

Fujio

Yamaoka

et al. 2018

Modern Rheumatology

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Section: Discussionsupporting

confidence: 79%

“…Subcutaneous TCZ (TCZ-SC) was also approved internationally after it demonstrated efficacy in patients with RA, with a consistent safety profile to that of TCZ-IV in clinical trials [11][12][13]. Although many studies have evaluated TCZ-IV in real-world clinical settings, the data for TCZ-SC have been limited [14][15][16].…”

Section: Introductionmentioning

confidence: 99%

Safety and effectiveness of subcutaneous tocilizumab in patients with rheumatoid arthritis in a real-world clinical setting

Atsumi

Fujio

Yamaoka

et al. 2018

Modern Rheumatology

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“…Based on the evidence provided above plus our findings, we recommend the use of this drug, especially the administration of higher doses in patients with moderate to severe RA as quickly as possible, which may play a more effective role in the treatment and recovery of patients; principally as the European registration authorities recommended administration of 8 mg TCZ straight away without using the dose of 4 mg initially [55].…”

Section: Clinical Commentsmentioning

confidence: 75%

Safety and efficacy of tocilizumab for rheumatoid arthritis: a systematic review and metaanalysis of clinical trial studies

Saki¹,

Rajaei²,

Rahim³

2021

Reumatologia

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The present systematic review and meta-analysis was conducted to assess the effect of tocilizumab (TCZ) in patients with rheumatoid arthritis (RA). We systematically searched all potential articles in the main databases, including PubMed, Scopus, EMBASE, Web of Sciences (ISI), and Cochrane Center. The search was subsequently updated in December 2020. The initial review and extraction of information were performed independently by two authors to collect the first author and publication year; sample size; mean age of the intervention and control groups; the dose of TCZ, and the follow-up duration. Outcomes of interest include the ACR20, ACR50, ACR70, total complication rate, and the occurrence of remission. Any disagreements between the reviewers were resolved by discussion and re-check of the article and consultation with a third reviewer. After reviewing and culling, 15 clinical trials comparing the clinical efficacy of TCZ and its comparators in the treatment of patients with RA entered the qualitative and quantitative synthesis. Tocilizumab 8 mg was statistically better than 4 mg or placebo for ACR responses. Significant clinical adverse events in patients with RA treated with TCZ, such as abnormal liver function tests (LFTs) and infections, were more frequent than in comparator groups. This systematic review and meta-analysis suggest that the combination therapy of TCZ with other drugs such as methotrexate and disease-modifying antirheumatic drugs has been studied for various clinical effects concerning safety and clinically significant adverse events. Although the data are promising, long-term performance and safety data need to be fully identified, as well as the risks and benefits of TCZ, especially appropriate timing, dosage, and regimen.

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“…The H2H trials compared the efficacy of IL-6Ri with adalimumab in b/ts-naïve RA patients while the present study included the b/ ts-experienced patients on IL-6Ri and various TNFi drugs (not limited to adalimumab). Further, the dose of IL-6Ri (tocilizumab) used in the trial [10] was higher as compared with the approved starting dose in clinical practice and the real-world studies, where tocilizumab (subcutaneous or intravenous) was initiated either at low doses or escalated over time as per the patient's disease activity [27][28][29]. Lastly, the present study included those patients who either had prior use of csDMARDs and/or were on combination therapy with csDMARDs, while the patients in H2H trials were those considered inappropriate candidates for the continued treatment with MTX.…”

Section: Discussionmentioning

confidence: 99%

Comparative effectiveness of TNF inhibitor vs IL-6 receptor inhibitor as monotherapy or combination therapy with methotrexate in biologic-experienced patients with rheumatoid arthritis: An analysis from the CorEvitas RA Registry

et al. 2023

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Objective Randomized controlled trials (RCTs) in biologic-naïve rheumatoid arthritis (RA) patients with high disease activity and inadequate response/intolerance to methotrexate have shown interleukin-6 (IL-6) receptor inhibitors (IL-6Ri) to be superior to tumor necrosis factor inhibitors (TNFi) as monotherapy. This observational study aimed to compare the effectiveness of TNFi vs IL-6Ri as mono- or combination therapy in biologic/targeted synthetic (b/ts) -experienced RA patients with moderate/high disease activity. Methods Eligible b/ts-experienced patients from the CorEvitas RA registry were categorized as TNFi and IL-6Ri initiators, with subgroups initiating as mono- or combination therapy. Mixed-effects regression models evaluated the impact of treatment on Clinical Disease Activity Index (CDAI), patient-reported outcomes, and disproportionate pain (DP). Unadjusted and covariate-adjusted effects were reported. Results Patients initiating IL-6Ri (n = 286) vs TNFi monotherapy (n = 737) were older, had a longer RA history and higher baseline CDAI, and were more likely to initiate as third-line therapy; IL-6Ri (n = 401) vs TNFi (n = 1315) combination therapy initiators had higher baseline CDAI and were more likely to initiate as third-line therapy. No significant differences were noted in the outcomes between TNFi and IL-6Ri initiators (as mono- or combination therapy). Conclusion This observational study showed no significant differences in outcomes among b/ts-experienced TNFi vs IL-6Ri initiators, as either mono- or combination therapy. These findings were in contrast with the previous RCTs in biologic-naïve patients and could be explained by the differences in the patient characteristics included in this study. Further studies are needed to help understand the reasons for this discrepancy in the real-world b/ts-experienced population. Key Points• Patients with rheumatoid arthritis (RA) often require switching between biologics or targeted synthetic (b/ts) disease-modifying anti-rheumatic drugs (DMARDs) to achieve their treatment target.• Head-to-head randomized controlled trials (RCTs) in biologic-naïve RA patients with high disease activity and inadequate response/intolerance to methotrexate have shown interleukin-6 receptor inhibitors (IL-6Ri) to be superior to tumor necrosis factor inhibitors (TNFi) as monotherapy; however, there are no RCTs comparing these therapies in a population previously treated with b/tsDMARDs (i.e., b/ts-experienced patients).• This observational study compared the effectiveness of TNFi vs IL-6Ri (as mono- or combination therapy) in b/ts-experienced RA patients with moderate or high disease activity and found no significant differences in clinical outcomes for the two treatments.• A discrepancy is noted between our study and RCTs, which have shown superiority of IL-6Ri therapy (albeit in biologic-naïve patients). Further analyses may help elucidate the reason for this discrepancy in the real-world b/ts-experienced population.

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Dosing of Intravenous Tocilizumab in a Real-World Setting of Rheumatoid Arthritis: Analyses from the Corrona Registry

Cited by 7 publications

References 17 publications

Safety and effectiveness of subcutaneous tocilizumab in patients with rheumatoid arthritis in a real-world clinical setting

Safety and effectiveness of subcutaneous tocilizumab in patients with rheumatoid arthritis in a real-world clinical setting

Safety and efficacy of tocilizumab for rheumatoid arthritis: a systematic review and metaanalysis of clinical trial studies

Comparative effectiveness of TNF inhibitor vs IL-6 receptor inhibitor as monotherapy or combination therapy with methotrexate in biologic-experienced patients with rheumatoid arthritis: An analysis from the CorEvitas RA Registry

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