Monitoring TNF-⍺ monoclonal antibody via sweat cytokine profiling using the IBD AWARE®: A non-invasive approach to assess therapeutic response

Tumor necrosis factor-alpha (TNF-α) is very important in autoimmune and chronic inflammatory diseases, and therapeutic antibodies like adalimumab only work if TNF-α is kept neutralized. Current monitoring techniques depend on invasive, sporadic tests that do not give real-time information about drug bioavailability or how well a treatment works. This paper shows a non-invasive electrochemical biosensor that is part of the IBD AWARE® device and can continuously find free TNF-α monoclonal antibodies (TNF-α mAb) and adalimumab in sweat. The ZnO-based sensor with TNF-α secondary antibodies added was very stable and specific and didn't pick up on common sweat biomarkers very often. The dose-response analysis showed that TNF-α mAb and adalimumab could be measured in a linear way in the physiologically relevant range (0.1–25.6 ng/mL). The detection limits were 1.55 ng/mL and 1.75 ng/mL, respectively, and the equilibrium dissociation constants were 0.046 nM and 0.044 nM, respectively. The %CVs for intra- and inter-assays stayed below 20 % for all concentrations and storage conditions, proving that the tests could be repeated, reproduced, and stable for two weeks. This platform offers swift, real-time evaluation of therapeutic antibody concentrations in sweat, connecting molecular pharmacodynamics with clinical results. Our results underscore the translational potential of non-invasive monitoring for the personalized management of TNF-α–mediated diseases. • Developed IBD AWARE® SENSOR for continuous sweat detection of TNF-α mAb and adalimumab. • Achieved high sensitivity (0.1–25.6 ng/mL) with LODs of 1.55 ng/mL and 1.75 ng/mL. • Validated via dose–response, recovery, and stability studies; %CV remained below 20%. • Enabled real-time monitoring of antibody levels for personalized therapeutic control. • Supports digital health integration and predictive precision medicine applications.