Higher body mass index and anti-drug antibodies predict the discontinuation of anti-TNF agents in Korean patients with axial spondyloarthritis

Hwang, Jiwon; Kim, Hye‐Mi; Jeong, Hyemin; Lee, Jaejoon; Ahn, Joong Kyong; Koh, Eun‐Mi; Kang, Eun‐Suk; Cha, Hoon‐Suk

doi:10.1016/j.rbre.2016.11.009

Cited by 6 publications

(9 citation statements)

References 34 publications

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“…Amongst the potential biomarkers, baseline serum levels of matrix metalloproteinase-3 (MMP-3) [67,68], serum type I collagen C-telopeptide (sCTX) [69], complement fraction C3 [70], serum amyloid A (SAA) [71], anti-drug antibodies (ADAbs) [72], and IL-6 [73] have been reported to predict treatment response in individual studies. Moreover, two well-designed sub-studies of RCTs evaluated the predictivity of a large pool of soluble biomarkers in AS and PsA [74,75].…”

Section: Although Data Available On Biomarkers For Predicting Therapementioning

confidence: 99%

Guidelines for biomarkers in autoimmune rheumatic diseases - evidence based analysis

Giacomelli

Afeltra

Alunno

et al. 2019

Autoimmunity Reviews

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Autoimmune rheumatic diseases are characterised by an abnormal immune system response, complement activation, cytokines dysregulation and inflammation. In last years, despite many progresses in managing these patients, it has been shown that clinical remission is reached in less than 50% of patients and a personalised and tailored therapeutic approach is still lacking resulting in a significant gap between guidelines and real-world practice. In this context, the need for biomarkers facilitating early diagnosis and profiling those individuals at the highest risk for a poor outcome has become of crucial interest. A biomarker generally refers to a measured characteristic which may be used as an indicator of some biological state or condition. Three different types of medical biomarkers has been suggested: i. mechanistic markers; ii. clinical disease markers; iii. therapeutic markers. A combination of biomarkers from these different groups could be used for an ideal more accurate diagnosis and treatment. However, although a growing body of evidence is focused on improving biomarkers, a significant amount of this information is not integrated on standard clinical care. The overarching aim of this work was to clarify the meaning of specific biomarkers during autoimmune diseases; their possible role in confirming diagnosis, predicting outcome and suggesting specific treatments.

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Section: Although Data Available On Biomarkers For Predicting Therapementioning

confidence: 99%

Guidelines for biomarkers in autoimmune rheumatic diseases - evidence based analysis

Giacomelli

Afeltra

Alunno

et al. 2019

Autoimmunity Reviews

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“…Obesity is related to a poor response to tumor necrosis factor inhibitor (TNFi) in patients with AS [28]. Obesity is also associated with TNFi discontinuation related with anti-drug antibody formation [29]. We previously investigated the effect of estrogen on the disease activity of SpA using a zymosan-induced SKG mice model, and we found that estrogen significantly reduced the disease activity of SpA [30].…”

Section: Discussionmentioning

confidence: 99%

The Effects of Sex and Estrogen on Radiographic Progression of Ankylosing Spondylitis in Korean Patients

et al. 2021

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Objective. Ankylosing spondylitis (AS) is a chronic inflammatory disease with obvious male preponderance. Males show more severe radiographic manifestations compared with females. This study aimed to evaluate the effects of sex and estrogen on the radiographic progression of AS. Methods. A total of 101 patients with AS were included in this study. All of the radiographs were scored using the modified Stoke AS Spine Score (mSASSS). Serum levels of 17β-estradiol (E2), dickkopf-1 (Dkk1), and leptin were detected by enzyme-linked immunosorbent assay. The generalized estimating equations model was used to evaluate factors associated with spinal radiographic progression. Results. The mean age at disease onset was 27.3±10.7 years, and 16 patients (15.8%) were female. In the multivariable analysis, body mass index (β-coefficient=0.12; p=0.047) and levels of Dkk1 (β-coefficient=−0.11; p＜0.001), and female (β-coefficient=−1.40; p=0.001) were associated with radiographic progression. Among male patients with AS, baseline C-reactive protein (β=0.11; p=0.005) and mSASSS (β=0.21; p=0.030) were also associated with radiographic progression. E2 and leptin levels were not significantly related to the radiographic progression. Conclusion. Although female patients were associated with less radiographic progression in AS, there was no significant relationship between serum estrogen level and radiographic progression. Results of current study suggests that genetic factors or other environmental factors associated with female may influence radiographic progression in patients with AS.

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“…The present phase 1 trial was designed to evaluate equivalent efficacy regarding the pharmacokinetic parameters (AUC 0‐t , AUC 0‐∞ , and C max ) and also to compare safety and immunogenicity in male healthy subjects after a single injection of 40 mg of either HS016 or adalimumab. In order to ensure the homogeneity of the study population and better reflect the pharmacokinetic differences between the HS016 and adalimumab groups, we selected healthy male subjects for the study and limited the inclusion criteria, such as to a negative HAHA status and BMIs between 20 and 25 kg/m 2 11 . We used a single subcutaneous injection of 40 mg HS016 because it is the recommended therapeutic dose of adalimumab for patients with AS or RA and was an acceptable dosage for healthy subjects 6,12 …”

Section: Discussionmentioning

confidence: 99%

“…In order to ensure the homogeneity of the study population and better reflect the pharmacokinetic differences between the HS016 and adalimumab groups, we selected healthy male subjects for the study and limited the inclusion criteria, such as to a negative HAHA status and BMIs between 20 and 25 kg/m 2 . 11 We used a single subcutaneous injection of 40 mg HS016 because it is the recommended therapeutic dose of adalimumab for patients with AS or RA and was an acceptable dosage for healthy subjects. 6,12 The GMs of the pharmacokinetic parameters were all similar between the 2 groups, and the 90%CI ratios of AUC 0-t , AUC 0-∞ , and C max were fully contained within the standard prespecified criteria of 80% to 125%, which indicated subcutaneous comparability between HS016 and adalimumab.…”

Section: Discussionmentioning

confidence: 99%

A Randomized, Double‐Blind, Parallel‐Group, Phase 1 Clinical Trial Comparing the Pharmacokinetic, Safety, and Immunogenicity of the Biosimilar HS016 and the Originator Adalimumab in Chinese Healthy Male Subjects

Cao

et al. 2020

Clinical Pharm in Drug Dev

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A comparison of the immunogenicity, safety, and pharmacokinetic properties of HS016 and its originator, adalimumab, was conducted in Chinese healthy male subjects. This was a phase 1 single‐center, randomized, parallel‐group double‐blind clinical trial. Chinese healthy male subjects (1:1) allocated to HS016 and adalimumab groups were treated with single subcutaneous injections (40 mg/0.8 mL). The pharmacokinetic equivalence of HS016 and adalimumab was assessed by (1) the area under the plasma concentration‐time curve (AUC) from time 0 to the last detectable drug concentration (AUC0‐t), (2) the AUC from time 0 extrapolated to infinity (AUC0‐∞), and (3) the maximum plasma concentration (Cmax). Other pharmacokinetic parameters (time to Cmax, apparent clearance, and half‐life), safety, and immunogenicity were also evaluated. A total of 136 subjects were randomly divided into HS016 (n = 68) or adalimumab (n = 68) groups. The geometric means of AUC0‐t, AUC0‐∞, and Cmax were similar for HS016 and adalimumab. The 90%CIs of AUC0‐t (87.2% to 106.1%), AUC0‐∞ (87.4% to 108.4%), and Cmax (98.6% to 113.6%) were all within the prespecified bioequivalence criteria (80% to 125%). The incidence of treatment‐emergent adverse events (TEAEs) was similar in both groups, with most TEAEs being mild; only 3 (4.4%) subjects in the HS016 group experienced moderate TEAEs. No significant differences in the time to Cmax, apparent clearance, half‐life, and immunogenicity were detected. The pharmacokinetic profile of HS016 was equivalent to that of the originator, adalimumab, with similar safety and immunogenicity profiles. HS016 may be considered for assessment in the treatment of patients with ankylosing spondylitis.

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Higher body mass index and anti-drug antibodies predict the discontinuation of anti-TNF agents in Korean patients with axial spondyloarthritis

Abstract: Our result suggests that the presence of anti-drug antibodies against adalimumab and infliximab as well as a higher body mass index can predict subsequent drug discontinuation in axial spondyloarthritis patients.

Cited by 6 publications

References 34 publications

Guidelines for biomarkers in autoimmune rheumatic diseases - evidence based analysis

Guidelines for biomarkers in autoimmune rheumatic diseases - evidence based analysis

The Effects of Sex and Estrogen on Radiographic Progression of Ankylosing Spondylitis in Korean Patients

A Randomized, Double‐Blind, Parallel‐Group, Phase 1 Clinical Trial Comparing the Pharmacokinetic, Safety, and Immunogenicity of the Biosimilar HS016 and the Originator Adalimumab in Chinese Healthy Male Subjects

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