A Clinical Trial and Extension Study of Infliximab in Korean Patients with Active Rheumatoid Arthritis despite Methotrexate Treatment

Abstract

Currently, infliximab is given for disease control for active rheumatoid arthritis (RA) patients despite methotrexate treatment. However, the efficacy and safety of infliximab in Korean patients has not been assessed appropriately. Therefore, we performed placebo-controlled, double-blind, randomized study and extension study. One-hundred forty-three patients with active RA were randomized to receive placebo or infliximab 3 mg/kg intravenously at week 0, 2, 6, 14, and 22 with methotrexate maintenance. Primary endpoint was American College of Rheumatology 20% improvement criteria (ACR20) at 30 week. After the clinical trial, patients on placebo (Group 1) and patients on infliximab who showed ACR20 response (Group 2) were treated with infliximab through another 84 week for evaluation of safety. During clinical trial, patients in infliximab group showed higher ACR20 at week 30 than patients in placebo group (50.1% vs 30.6%, P=0.014). A total of 92 patients participated in the extension study. The maintenance rate of infliximab was 62.0% at 84 weeks of extension study. The overall rate of adverse events was not different between Group 1 and Group 2. In Korean patients with active RA despite methotrexate treatment, infliximab in combination with methotrexate is effective and the long-term treatment with infliximab is well tolerated. (ClinicalTrials.gov No. NCT00202852, NCT00732875)

Systematic review and network meta-analysis of the efficacy and safety of tumour necrosis factor inhibitor–methotrexate combination therapy versus triple therapy in rheumatoid arthritis

“…A few considerations were given to certain studies to ensure that only approved doses were included or that study populations at all time points considered for the analysis represented the true randomised population; these are shown in the online supplementary table S9. In three trials,37 92 104 participants were allowed to switch treatments or add additional DMARDs. These studies were not analysed beyond the time point when >20% of participants no longer maintained randomisation.…”

Comparative efficacy and safety of biosimilar‐infliximab and originator‐infliximab in combination with methotrexate in patients with active rheumatoid arthritis: a meta‐analysis of randomized controlled trials

“…was not included, because the study did not provide data on ACR response as the efficacy outcome. Thus, seven RCTs that included 2606 patients (1316 events for efficacy and 262 events for safety) met the inclusion criteria (Table ). All the RCTs provided data on efficacy and safety.…”

“…A study by Abe et al 27 was excluded, because the follow-up period of RCT was too short to be included in this meta-analysis and the study by Maini et al 26 was not included, because the study did not provide data on ACR response as the efficacy outcome. Thus, seven RCTs that included 2606 patients (1316 events for efficacy and 262 events for safety) met the inclusion criteria [6][7][8][9][10][11][12] ( Table 1). All the RCTs provided data on efficacy and safety.…”

“…Because of the growing availability of biosimilars, it is important to combine the available data and to provide objective quantitative estimates of the efficacy and safety of biosimilars. Several clinical trials have attempted to evaluate the efficacy and safety of biosimilar + MTX versus infliximab + MTX and infliximab + MTX versus placebo + MTX in patients with active RA who have experienced an incomplete response to MTX . However, to our knowledge, no previous studies have directly compared biosimilar + MTX and placebo + MTX.…”

“…Several clinical trials have attempted to evaluate the efficacy and safety of biosimilar + MTX versus infliximab + MTX and infliximab + MTX versus placebo + MTX in patients with active RA who have experienced an incomplete response to MTX. [6][7][8][9][10][11][12] However, to our knowledge, no previous studies have directly compared biosimilar + MTX and placebo + MTX. Network meta-analyses enable an assessment of the comparative effectiveness of multiple interventions and combine evidence across a network of randomized controlled trials (RCTs), even in the absence of head-to-head comparisons.…”