The Use of Biological Disease-modifying Antirheumatic Drugs for Inflammatory Arthritis in Korea: Results of a Korean Expert Consensus

Biological disease-modifying antirheumatic drugs (bDMARDs) are highly effective agents for the treatment of inflammatory arthritis; however, they also possess a potential risk for serious infection. Recently, with the rapid expansion of the bDMARDs market in Korea, reports of serious adverse events related to the agents have also increased, necessitating guidance for the use of bDMARDs. Current work entitled, “Expert Consensus for the Use of bDMARDs Drugs for Inflammatory Arthritis in Korea,” is the first to describe the appropriate use of bDMARDs in the management of inflammatory arthritis in Korea, with an aim to provide guidance for the local medical community to improve the quality of clinical care. Twelve consensus statements regarding the use of bDMARDs for the management of rheumatoid arthritis and ankylosing spondylitis were generated. In this review, we provide detailed guidance on bDMARDs use based on expert consensus, including who should prescribe, the role of education, indications for use, and monitoring strategies for safety.

Gender Is a Risk Factor for Annual Decline in Estimated Glomerular Filtration Rate in Patients Treated with Biological DMARDs in Rheumatoid Arthritis and Ankylosing Spondylitis: a Retrospective Observational Study

BACKGROUND: This study identified the risk factors of changes in renal function in patients with rheumatoid arthritis (RA) and ankylosing spondylitis (AS) treated with biological disease-modifying anti-rheumatic drugs (bDMARDs). METHODS: We retrospectively enrolled patients with RA (n = 293) and AS (n = 125) treated with bDMARDs. The estimated glomerular filter rate (eGFR) using the Modification of Diet in Renal Disease equation was applied for assessment of annual changes in renal function between initiation and last visit after bDMARD therapy. The annual change in eGFR was used as an indicator for change in renal function. Statistical significance was assessed by Mann-Whitney test, Spearman's correlation coefficient, and multivariate linear regression analysis. RESULTS: The positive annual change in eGFR in women was significantly noted, compared to that in men (P = 0.004). The annual change in eGFR was different between men and women (P = 0.038) in RA, but not in AS patients (P = 0.126). In multivariate linear regression analysis, women patients and increased serum creatinine at baseline were closely associated with positive annual change in eGFR in both RA and AS patients. In RA patients, younger age and lower ESR level were considered risk factors of positive annual change in eGFR (P = 0.013 and P = 0.022, respectively). However, disease duration and duration of bDMARD use were not associated with annual change in eGFR. CONCLUSION: This study found that gender, especially men, might be responsible for annual decline in eGFR in RA and AS patients treated with bDMARDs.

Comparative Effectiveness of Biologic DMARDs in Rheumatoid Arthritis Patients with Inadequate Response to conventional DMARDs: Using a Bayesian Network Meta-analysis

BACKGROUND: Biologic disease-modifying antirheumatic drugs (bDMARDs) extend the treatment choices for rheumatoid arthritis patients with insufficient response or intolerance to conventional DMARDs (cDMARDs). These agents have considerable efficacy compared with conventional DMARDs, but only a few head-to-head comparisons among these agents have been performed. The objective of this systematic review and network meta-analysis (NMA) was to compare the relative efficacy of Certolizumab with conventional DMARD to licensed bDMARD with cDMARD therapy for patients who failed to prior cDMARD treatment under the condition of the reimbursement coverage criteria in Korea. METHODS: A systematic review was conducted using MEDLINE and Cochrane library. Key endpoints were the American College of Rheumatology (ACR) responses of 20/50/70 at six months. Bayesian outcomes were calculated as median of treatment effect, probability of the best, Odds Ratio (OR) and probability that OR was greater than one. RESULTS: Compared with other bDMARDs, Certolizumab were associated with higher or comparable ACR response rates; in ACR20, the OR (probability of OR>1) was 2.08 (92.6%) for Adalimumab, 1.86 (85.7%) for Etanercept, 1.89 (79.5%) for Golimumab, 2.36 (92.1%) for Infliximab, 1.79 (87.0%) for Abatacept, 1.74 (80.8%) for Rituximab and 1.82 (86.8%) for Tocilizaumab. In ACR50 and ACR70, the ORs did not present significant differences. CONCLUSION: Certolizaumab with cDMARD was more effective or comparable than other bDMARDs in patients who failed prior cDMARD treatment.