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Posted by on Sep 22, 2014 in Rheumatoid Arthritis | 0 comments

In a nutshell

This paper studied the effectiveness of Leining in treatment of patients with rheumatoid arthritis.

Some background

Methotrexate (Trexall, Rheumatrex) is used to treat rheumatoid arthritis. However, not all patients have an optimal response to methotrexateAbatacept (Orencia) is an effective and safe alternative. Leining, a drug similar to abatacept, is suggested to have similar therapeutic effects.

Methods & findings

The authors evaluated the effectiveness and safety of Leining in patients who did not fully respond to methotrexate treatment.  Patients with active adult-onset rheumatoid arthritis were included in the study. Patients had been treated with methotrexate for 3 months or longer prior to the study. During the study, patients’ swollen and tender joint count was assessed. Patient disease activity (measures how active rheumatoid arthritis is) was also evaluated. All patients continued the methotrexate treatment throughout the study.

440 patients were included in the analysis, with 330 patients randomly assigned to receive Leining and 110 patients randomly assigned to receive placebo. At the end of 24 weeks of the study, 70.61% of patients receiving Leining had a >20% improvement in the number of swollen and tender joints compared with 46.36% of patients receiving placebo.  15.4% of patients receiving Leining had low disease activity compared with 2.73% in patients receiving placebo. 12.4% of patients receiving Leining achieved disease remission (a decrease in or disappearance of signs and symptoms of the disease) compared to 2.73% of those receiving placebo. The percentage of patients who had a meaningful improvement was 54.85% of patients receiving Leining compared with 29.09% of patients receiving placebo.

The overall incidence of adverse events (unfavorable symptoms or disease that may or may not be considered related to the medical treatment) was similar for patients receiving both Leining (40%) and placebo (36.36%). The most frequently reported adverse events were upper respiratory tract (airway) infection, abnormal liver function test or urinary tract (the channel that passes urine from the body) infection.

The bottom line

The authors concluded that Leining is effective and safe in treatment of patients with active rheumatoid arthritis despite receiving methotrexate.

The fine print

This study included Chinese patients only, and may need to be repeated in other groups of patients.

Published By :

Rheumatology International

Date :

Apr 10, 2014

Original Title :

A randomized, double-blind, and placebo-controlled multicenter clinical trial of a novel cytotoxic T-lymphocyte antigen-4 fusion protein, Leining, in Chinese active rheumatoid arthritis patients with an inadequate response to methotrexate.

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