Longitudinal monitoring of adalimumab levels and anti-adalimumab antibodies in Chinese patients with ankylosing spondylitis: a prospective cohort study
7 affiliations
- 1Department of Pharmacy, The First Affiliated Hospital of Soochow University , ,
- 2Department of Rheumatology, The First Affiliated Hospital of Soochow University , ,
- 3Department of Pharmacy, The Second Xiangya Hospital, Central South University , ,
- 4Department of Rheumatology and Immunology, The Second Xiangya Hospital, Central South University , ,
- 5Department of Rheumatology and Immunology, The Third Affiliated Hospital of Soochow University , ,
- 6Department of Pharmacy, The Third Affiliated Hospital of Soochow University , ,
- 7Department of Rheumatology, Shanghai Guanghua Hospital, Shanghai University of Traditional Chinese Medicine , ,
Abstract
Objective: This study aimed to clarify the association between longitudinal adalimumab concentrations, anti-adalimumab antibodies (AAA) levels, and clinical response in Chinese patients with ankylosing spondylitis (AS).
Methods: A prospective multi-center, observational cohort study of AS patients receiving adalimumab therapy was conducted. Disease activity was assessed with the AS Disease Activity Score (ASDAS), and clinical responders were defined based on ASDAS improvement together with C-reactive protein normalization. Adalimumab concentrations were measured using a validated sandwich immunoassay. Measurement of AAA levels was performed with a laboratory-developed immunoassay system integrating electrochemiluminescence technology with specific immunomagnetic separation, with result reported as signal-to-noise ratio (S/N).
Results: A total of 140 patients receiving adalimumab monotherapy were included. The median follow-up period was 169 days, and 711 plasma samples were available for adalimumab concentrations and AAA levels measurements. Seven patients had pre-existing AAA, and 120 (90.2%) of the remaining 133 patients tested positive for AAA during follow-up. A total of 48 patients were excluded from the exposure–response relationship dataset owing to pre-existing AAA (n=7), lack of active disease (n=26), incomplete follow-up (n=8), and prolonged dosing intervals (n=7). Among the remaining 92 patients, a total of 58 (63%) achieved clinical response. Adalimumab concentrations were higher, and AAA levels were significantly lower, in responders compared with non-responders at multiple time points. Exposure–response relationship models also revealed a steady-state adalimumab concentration target of 5.1 μg/mL and a week-4 concentration target of 3.3 μg/mL, corresponding to an 80% probability of clinical response. Thirty-six of 92 patients (39.1%) exhibited AAA-S/N values exceeding the putative clinically meaningful threshold (AAA-S/N=10). Patients in the high-AAA group (AAA-S/N≥10) had lower drug levels (median: 1.5 μg/mL vs. 6.9 μg/mL, P< 0.0001) and poorer response rates (38.8% vs. 78.6%, P = 0.0002), relative to those in the low-AAA group (AAA-S/N<10). Furthermore, patients who were week-4 AAA-positive exhibited a 1.8-fold increased risk of non-response (relative risk, 95% confidence interval, 1.1–2.8).
Conclusions: Our results demonstrate that longitudinal profiles of adalimumab concentrations and AAA levels show a strong association with clinical responses in this Chinese AS cohort, which may inform therapeutic drug monitoring–guided adalimumab treatment strategies that remain to be further validated.
Trial registration: ClinicalTrials.gov (NCT04875299).
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BibTeX
@article{ding2026longitudinal,
title = {{Longitudinal monitoring of adalimumab levels and anti-adalimumab antibodies in Chinese patients with ankylosing spondylitis: a prospective cohort study}},
author = {Xiaoliang Ding and Ling Xue and Mingjun Wang and Shizheng Pan and Bikui Zhang and Fen Li and Yingchun Ma and Nan Hu and Dongyi He and Lin Song and Sheng Jiang and Shengxiong Zhu and Jian Wu and Liyan Miao},
journal = {Frontiers in immunology},
year = {2026},
month = oct,
doi = {10.3389/fimmu.2026.1893483},
url = {https://europepmc.org/article/PMC/PMC13668797},
note = {CC BY},
}
RIS
TY - JOUR
TI - Longitudinal monitoring of adalimumab levels and anti-adalimumab antibodies in Chinese patients with ankylosing spondylitis: a prospective cohort study
AU - Xiaoliang Ding
AU - Ling Xue
AU - Mingjun Wang
AU - Shizheng Pan
AU - Bikui Zhang
AU - Fen Li
AU - Yingchun Ma
AU - Nan Hu
AU - Dongyi He
AU - Lin Song
AU - Sheng Jiang
AU - Shengxiong Zhu
AU - Jian Wu
AU - Liyan Miao
PY - 2026
DA - 2026/10/01
JO - Frontiers in immunology
DO - 10.3389/fimmu.2026.1893483
UR - https://europepmc.org/article/PMC/PMC13668797
AB - Objective: This study aimed to clarify the association between longitudinal adalimumab concentrations, anti-adalimumab antibodies (AAA) levels, and clinical response in Chinese patients with ankylosing spondylitis (AS). Methods: A prospective multi-center, observational cohort study of AS patients receiving adalimumab therapy was conducted. Disease activity was assessed with the AS Disease Activity Score (ASDAS), and clinical responders were defined based on ASDAS improvement together with C-reactive protein normalization. Adalimumab concentrations were measured using a validated sandwich immunoassay. Measurement of AAA levels was performed with a laboratory-developed immunoassay system integrating electrochemiluminescence technology with specific immunomagnetic separation, with result reported as signal-to-noise ratio (S/N). Results: A total of 140 patients receiving adalimumab monotherapy were included. The median follow-up period was 169 days, and 711 plasma samples were available for adalimumab concentrations and AAA levels measurements. Seven patients had pre-existing AAA, and 120 (90.2%) of the remaining 133 patients tested positive for AAA during follow-up. A total of 48 patients were excluded from the exposure–response relationship dataset owing to pre-existing AAA (n=7), lack of active disease (n=26), incomplete follow-up (n=8), and prolonged dosing intervals (n=7). Among the remaining 92 patients, a total of 58 (63%) achieved clinical response. Adalimumab concentrations were higher, and AAA levels were significantly lower, in responders compared with non-responders at multiple time points. Exposure–response relationship models also revealed a steady-state adalimumab concentration target of 5.1 μg/mL and a week-4 concentration target of 3.3 μg/mL, corresponding to an 80% probability of clinical response. Thirty-six of 92 patients (39.1%) exhibited AAA-S/N values exceeding the putative clinically meaningful threshold (AAA-S/N=10). Patients in the high-AAA group (AAA-S/N≥10) had lower drug levels (median: 1.5 μg/mL vs. 6.9 μg/mL, P< 0.0001) and poorer response rates (38.8% vs. 78.6%, P = 0.0002), relative to those in the low-AAA group (AAA-S/N<10). Furthermore, patients who were week-4 AAA-positive exhibited a 1.8-fold increased risk of non-response (relative risk, 95% confidence interval, 1.1–2.8). Conclusions: Our results demonstrate that longitudinal profiles of adalimumab concentrations and AAA levels show a strong association with clinical responses in this Chinese AS cohort, which may inform therapeutic drug monitoring–guided adalimumab treatment strategies that remain to be further validated. Trial registration: ClinicalTrials.gov (NCT04875299).
SN - 1664-3224
ER -