Bibliographic Details
| Title: |
Association of early therapeutic drug monitoring of adalimumab with biologic remission and drug survival in Crohn's Disease. |
| Authors: |
Rueda García, José Luis, Suárez-Ferrer, Cristina, Amiama Roig, Clara, García Ramírez, Laura, García Rojas, Cristina, Martín-Arranz, Eduardo, Poza Cordón, Joaquín, Sánchez Azofra, María, Noci, Jesús, Cubillo García, Cristina, Martín-Arranz, María Dolores |
| Source: |
Therapeutic Advances in Gastroenterology; 3/19/2025, p1-14, 14p |
| Subject Terms: |
CROHN'S disease, DRUG monitoring, DRUG dosage, RECEIVER operating characteristic curves, C-reactive protein |
| Abstract: |
Background: Therapeutic drug monitoring of adalimumab (ADA) is still controversial. Objectives: To study the association between ADA trough levels in the early stages of treatment with biological remission (BR) and drug survival in Crohn's disease (CD). Design: Retrospective cohort study. Methods: Patients treated with ADA with available trough levels at weeks 2 and 6 (after the first induction and maintenance dose, respectively) were included. Fecal calprotectin (Fcal) and C-reactive protein (CRP) were registered at baseline, week 24, and week 52. BR was defined as Fcal <200 µg/g and CRP <5 mg/dl. Treatment survival and the need for dose escalation were assessed at week 52. Receiver operating characteristic (ROC) curves were constructed to assess the diagnostic accuracy of ADA cutoff levels for BR. Quartile-specific comparisons were performed to evaluate differences in the proportion of patients achieving BR at weeks 24 and 52, drug survival, and dose escalation. Results: In all, 112 patients were included. ADA trough levels at week 6 were higher in patients achieving BR at week 24 (12.32 μg/ml vs 10.3 μg/ml, p = 0.0008), week 52 (12.3 μg/ml vs 10.8 μg/ml, p = 0.035), and in patients with 1-year treatment persistence (12.17 μg/ml vs 9.7 μg/ml, p = 0.03), but lower in patients requiring maintenance intensification (9.7 μg/ml vs 12.2 µg/ml, p < 0.0001). ADA week 6 trough levels >12.27 μg/ml predicted BR at week 24 with 79.7% specificity and 79.5% positive predictive value. Patients in the third quartile (Q3) and fourth quartile (Q4) of ADA levels at week 6 exhibited higher rates of BR at week 24, BR at week 52, 1-year drug survival, and less need for dose escalation (all p -values <0.05). In logistic regression, Q3 and Q4 of week 6 levels were significantly associated with BR at week 24 (p = 0.02 and p = 0.001); and week 6 Q4 with BR at week 52 (p = 0.02), treatment persistence (p = 0.03), and lower dose escalation (p = 0.004). ADA trough levels at week 2 did not show similar associations. Conclusion: ADA trough levels at week 6 are associated with BR at weeks 24 and 52, drug survival, and need for dose escalation in CD. However, ADA concentrations at week 2 failed to yield similar results. Plain language summary: Early monitoring of adalimumab levels improves outcomes in Crohn's disease This study investigated whether early monitoring of adalimumab (ADA) levels in patients with Crohn's disease (CD) could predict remission and improve treatment success. We aimed to identify the best timepoint and threshold for ADA monitoring, hypothesizing that early induction (week 2) and early maintenance levels (week 6) would correlate with long-term remission. CD is a chronic condition causing significant health issues, including inflammation and complications requiring surgery. Biological remission, measured through biomarkers like fecal calprotectin and C-reactive protein, is a key treatment goal. Understanding how ADA levels predict remission could improve treatment strategies and benefit a wide range of patients. We analyzed data from 112 CD patients treated with ADA. ADA levels were measured at weeks 2 and 6, and remission was assessed at weeks 24 and 52. We examined the association between ADA levels and treatment outcomes, such as dose adjustments and treatment persistence. We found that ADA levels at week 6 were significantly associated with achieving remission at weeks 24 and 52. Patients with ADA levels above 12.27 μg/ml at week 6 were more likely to remain in remission, avoid dose escalation, and continue treatment successfully. However, ADA levels at week 2 did not predict these outcomes. This research highlights the importance of early ADA monitoring during maintenance rather than induction. By identifying an optimal time and threshold for monitoring, this study offers a potential strategy to personalize treatments, reduce complications, and improve long-term outcomes for CD patients. These findings emphasize the need for further research to refine therapeutic monitoring guidelines. [ABSTRACT FROM AUTHOR] |
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| Database: |
Complementary Index |
