Golimumab trough levels, antidrug antibodies and clinical response in patients with rheumatoid arthritis treated in daily clinical practice

Immunogenicity, drug trough levels and therapeutic response in patients with rheumatoid arthritis or ankylosing spondylitis after 24-week golimumab treatment

“…Also in consistence with other studies,5 6 8 serum golimumab levels were significantly associated with therapeutic response (figure 1C, D) and clinical improvement (ΔDAS28) (r=0.594, p<0.001) in patients with RA. Serum golimumab levels were also associated with therapeutic response (BASDAI50) and ASDAS status in patients with AS (figure 1E, F).…”

“…As in other reports,5 6 8 9 our patients with ADAb-positive RA had barely detectable golimumab levels (median=0.022 μg/mL, IQR 0.020–0.022 μg/mL) in contrast with patients who were ADAb negative (median=1.05 μg/mL, IQR 0.69–1.45 μg/mL, p<0.001). Besides, patients who were ADAb positive had significantly higher rates of poor EULAR response or persistent active disease (DAS28>3.2) after 24-week golimumab therapy compared with patients who were ADAb negative (100% vs 10.7%, p<0.001; 100% vs 39.3%, p<0.05, respectively, figure 1A, B).…”

“…Our results showed that the proportion (15.2%, 5/33) of ADAb positivity in patients with RA was higher than that (2.1%–8.1%) in other studies 1 5 7. The possible reasons for this discrepancy included the lower proportion of patients coreceiving MTX therapy, the relatively low MTX dosage, the difference in assays used and the lower sample size in this study.…”

“…As with other anti-TNF-α inhibitors, golimumab may elicit antidrug antibodies (ADAb), leading to pharmacokinetic changes 3 4. With the limited data regarding the immunogenicity of golimumab,1 2 5 we aim to evaluate the relations among ADAb, serum drug trough levels, therapeutic response and methotrexate (MTX) dosage in golimumab-treated patients.…”

Dose-Tapering Of TNF Inhibitors in Daily Rheumatology Practice Enables the Maintenance of Clinical Efficacy While Improving Cost-Effectiveness

“…TDM has been used in clinical practice to individualize the therapy of a small number of drugs, but it has been scarcely studied in the context of biological drugs. Some authors claim that the monitoring of drug and ADA levels can be extremely useful in guiding the dosage of these drugs [21][22][23]. However, other groups defend that only the clinical activity of patients under biological treatment is necessary to accurately control the amount of administered drug.…”