The usage of biological DMARDs and clinical remission of rheumatoid arthritis in China: a real-world large scale study

Abstract

The aims of this study are to characterize the biological disease-modifying antirheumatic drug (bDMARD) usage patterns in real-life and examine the remission rate of rheumatoid arthritis (RA) patients receiving bDMARDs in routine clinical practice in China. Consenting RA patients (≥18 years) from 15 teaching hospitals and receiving marketed bDMARDs were included. In total, 802 patients (81.3 % women, 49.0 ± 13.9 years) were included; 89.5 % were receiving a combination of bDMARDs and conventional synthetic DMARDs (csDMARDS), whereas 10.5 % were receiving bDMARD monotherapy. Etanercept (including Enbrel® and local brand Yi Sai Pu® and Qiangke®), tocilizumab, adalimumab, and infliximab were used by 66.6 %, 17.0 %, 7.5 %, and 6.6 % patients, respectively. Etanercept was used at a mean weekly dose of 38.2 ± 15.6 mg for 25.5 ± 47.0 weeks and tocilizumab at 94.5 ± 21.9 mg for 4.7 ± 7.5 weeks. Overall rate of remission was 12.6 %, 5.4 % , and 3.5 % based on DAS28, CDAI, and SDAI scores, respectively. Compared with patients receiving bDMARDs for <3 months, those receiving bDMARDs for ≥3 months exhibited significantly lower DAS28 scores (p < 0.0001), and a significantly higher proportion of patients who received bDMARDs for ≥12 months achieved the treatment goal (remission or low disease activity, 62.5 % vs. 18.3 %, p < 0.0001). Patients receiving combination therapy with csDMARDs exhibited lower DAS28 scores than patients receiving bDMARD monotherapy (4.3 vs. 4.8, p = 0.011). This large-scale real-world study showed that bDMARD usage patterns in routine clinical practice in China were in accordance with international guidelines for RA management despite the short treatment duration. Longer duration of bDMARD usage and combination therapy showed a favored outcome of RA.

Tofacitinib with conventional synthetic disease‐modifying antirheumatic drugs in Chinese patients with rheumatoid arthritis: Patient‐reported outcomes from a Phase 3 randomized controlled trial

“…43 Currently, six bDMARDs are approved for RA treatment in China, and a recent large-scale, real-world study of RA patients in China reported bDMARD usage in routine clinical practice in accordance with treatment guidelines. 48 Interestingly, this study also reported that a lower proportion of patients (10.5%) were prescribed bDMARD monotherapy in China than in the USA (30%), 49 which suggests better compliance with international treatment guidelines that recommend bDMARDs in combination with csDMARDs, rather than as monotherapy. 50 A number of limitations of the current analysis are acknowledged.…”

Biological disease‐modifying drugs for rheumatoid arthritis

“…Some ‘real world’ studies have reported better outcomes than these meta‐analyses, with remission rates or remission/low disease activity (as defined by DAS28 score) as high as 44–63% 18,19 . In the British Society for Rheumatology (BSR) Biologics Registry for Rheumatoid Arthritis, remission (DAS28 <2.6) was achieved in about 15% and low disease activity (DAS28 2.6 to 3.2) in about 26% of patients treated with anti‐TNF therapy between 2001 and 2013 20 .…”

Anti‐tumor necrosis factor biosimilars and intended copies in rheumatology: Perspective from the Asia Pacific region

“…Two intended copies of etanercept are available in China: Qiangke and Yi Sai Pu . A study evaluated real‐world use of biologics for RA at 15 teaching hospitals in China and found that etanercept was used by 66.6% of patients . The breakdown of etanercept agents was Yi Sai Pu (58.1%), Enbrel (6.1%) and Qiangke (2.4%) .…”

“…A study evaluated real‐world use of biologics for RA at 15 teaching hospitals in China and found that etanercept was used by 66.6% of patients . The breakdown of etanercept agents was Yi Sai Pu (58.1%), Enbrel (6.1%) and Qiangke (2.4%) . The other biologics in use were tocilizumab (17.0%), adalimumab (7.5%) and infliximab (6.6%) …”

“…The high cost of these biologics has resulted in a demand for lower‐cost biosimilar agents . For example, rheumatoid arthritis (RA) is becoming one of the most expensive diseases in China, and one study found that drugs, particularly biologics, comprise half of the expense . Although insurance coverage varies widely in China, for many patients, biologic therapies are not covered .…”