Dataset Information

Efficacy and safety of tocilizumab in Korean patients with active rheumatoid arthritis.

ABSTRACT:

Background/aims

To investigate the efficacy and safety of tocilizumab (TCZ) humanized anti-interleukin-6 receptor monoclonal antibody, in Korean patients with active rheumatoid arthritis (RA) refractory to conventional disease modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX).

Methods

The main study was a 24-week, randomized, double-blind, controlled trial that was followed by a 48-week, open-labeled, extension phase. TCZ (8 mg/kg) or placebo was intravenously administered every 4 weeks.

Results

Those treated with TCZ showed more favorable outcomes in terms of 20% according to the American College of Rheumatology response criteria (ACR20) and ACR50 responses, individual parameters of ACR core set, disease activity score in 28 joints (DAS28) remission, and European League Against Rheumatism (EULAR) response at week 24. These improvements were maintained or increased during the extension period. DAS28 remission at week 72 was associated with EULAR good response at week 12. The patients who experienced any adverse event (AE) were more frequent in the TCZ group compared to the placebo group. Most AEs were mild or moderate in intensity, although TCZ therapy had possible AEs including serious infection, abnormal liver function, and atherogenic lipid profile.

Conclusion

TCZ infusion add-on is highly efficacious and well-tolerated in Korean patients with active RA refractory to conventional DMARDs including MTX. EULAR good response at week 12 could predict DAS28 remission at week 72.

SUBMITTER: Baek HJ

PROVIDER: S-EPMC6610180 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Publications

Efficacy and safety of tocilizumab in Korean patients with active rheumatoid arthritis.

Baek Han Joo HJ Lim Mie Jin MJ Park Won W Park Sung Hwan SH Shim Seung-Cheol SC Yoo Dae-Hyun DH Kim Hyun Ah HA Lee Soo Kon SK Lee Yun Jong YJ Park Young Eun YE Cha Hoon-Suk HS Song Yeong-Wook YW

The Korean journal of internal medicine 20180117 4

<h4>Background/aims</h4>To investigate the efficacy and safety of tocilizumab (TCZ) humanized anti-interleukin-6 receptor monoclonal antibody, in Korean patients with active rheumatoid arthritis (RA) refractory to conventional disease modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX).<h4>Methods</h4>The main study was a 24-week, randomized, double-blind, controlled trial that was followed by a 48-week, open-labeled, extension phase. TCZ (8 mg/kg) or placebo was intravenously a ...[more]

PMID: 29334721

Similar Datasets

Project description:BackgroundTocilizumab (TCZ) is a humanized anti-human IL-6R antibody, a novel therapy for rheumatoid arthritis (RA) patients who fail treatment with disease modifying anti-rheumatic drugs (DMARDs) or anti-tumor necrosis factor (anti-TNFs).ObjectiveTo assess the safety and efficacy of TCZ monotherapy or in combination with non-biologic DMARDs or anti-TNFs in moderate to severe active RA.DesignProspective, phase III, multi-center, open-label, single arm, 24-week trial.SettingThree centers in Saudi Arabia.Patients and methodsThe study included consecutive RA patients infused with TCZ (8 mg/kg) over 60 minutes every 4 weeks (up to 6 times), either alone or with non-biologic DMARDs. Patients were followed for 24 weeks. Patients with good/moderate European League Against Rheumatism responses, continued on TCZ as long as commerically available or for 1 year.Main outcome measure(s)Disease activity measured by DAS28 score.ResultsOf 28 patients enrolled from 2 November 2011 to 12 May 2013 (18 months), 21 completed (77.8%) and 7 (25%) discontinued TCZ therapy. One patient was excluded from the intent-to-treat analysis. Efficacy analysis showed a significant difference (P < .0001) in the Disease Activity Score based on 28 joints and on swollen and tender joint counts. Three (10.7%) patients experienced at least one AE that was considered related to study drug (one probably and two possibly). Only one (3.6%) patient reported a severe adverse event (neutropenia and thrombocytopenia). No adverse events led to dose modification or death.ConclusionTCZ monotherapy or in combination with non-biologic DMARDs resulted in a significant effect on the endpoints in moderate to severe RA in Saudi Arabia, which is consistent with other published reports.LimitationsNo information on tapering of steroid therapy, lack of follow-up data of all 28 patients, lack of data on long-term effects of TCZ on lipid levels and the need for statins. (ClinicalTrials.gov identifier: NCT01326962).

Dataset Information

Efficacy and safety of tocilizumab in Korean patients with active rheumatoid arthritis.

Background/aims

Methods

Results

Conclusion

Publications

Efficacy and safety of tocilizumab in Korean patients with active rheumatoid arthritis.

Similar Datasets

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