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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.

Background: Perianal Crohn’s disease (PD) remains a major therapeutic challenge, with heterogeneous responses to anti-TNF therapy and limited real-world data on predictors of long-term outcomes. This study aimed to evaluate clinical and radiological response to anti-TNF therapy initiated exclusively for PD and to identify factors associated with treatment response. Methods: A retrospective study was conducted in a cohort of 65 patients with PD treated with anti-TNF. The primary endpoint was clinical response assessed at weeks 24, 52, and 60 months. It was defined as a ≥50% reduction in drainage, and remission as complete absence of drainage. Radiological response was assessed by magnetic resonance imaging at the same time points whenever feasible. Multivariate logistic regression analyses were performed to identify independent predictors of response. Results: At week 24, 84.6% of patients achieved a clinical response, while radiological response was observed in 30.8%. At week 52, clinical and radiological response rates were 80.0% and 52.3%, respectively. At 60 months, 61.5% maintained clinical response and 46.1% radiological response. Among patients who responded at week 24, 90.7% maintained response at week 52, with a secondary loss of response rate of 9.3%. Multivariate analysis identified absence of antineutrophil cytoplasmic antibodies (ANCA) as an independent predictor of clinical response at week 52 (OR 0.06, 95% CI 0.006–0.59; p = 0.01). No significant associations were observed between anti-TNF serum levels and clinical or radiological outcomes. Conclusions: In this real-world cohort of patients initiating anti-TNF exclusively for PD, early response (week 24) emerged as a potential marker of long-term outcomes, highlighting the importance of early reassessment and individualized therapeutic strategies.

Background: The rates of clinical and biochemical responses in Crohn’s disease (CD) patients treated with intravenous (IV) ustekinumab (UST) intensification are scarcely described. Methods: Patients with diagnosis of CD who were under intensified IV ustekinumab treatment (130 mg every 4 weeks) were retrospectively included, evaluating the clinical and biochemical response 12 weeks after the change in treatment regimen (switch from SC to IV), as well as the serum levels of the drug. Results: Twenty-seven patients, all of whom had transitioned to intensified intravenous ustekinumab treatment due to a secondary loss of response to the drug, were included in the retrospective analysis. At the baseline visit, prior to changing IV UST, differences in levels were observed between intensified and non-intensified patients (7216 vs. 2842 ng/mL, p = 0.00005). However, no significant differences were found between these two groups 12 weeks after IV intensification (7949 vs. 7937 ng/mL; p = 0.99). In patients with previous intensified UST SC, a decrease in fecal calprotectin was observed 12 weeks after starting IV intensification, going from a mean of 1463 ug/g to 751 ug/g, although the differences were not significant (p = 0.14). Conclusion: In our experience, intensifying treatment with IV UST leads to clinical and biochemical improvements in CD patients with a secondary loss of response to SC maintenance with this drug, and an increase in drug levels was observed 12 weeks after IV UST intensification.

BackgroundThe outbreak of COVID-19 has rapidly evolved into a pandemic that has represented a challenge to health systems worldwide. Inflammatory bowel disease (IBD) units have been forced to change their practices to address the disease and to ensure the quality of care.MethodsWe conducted a national survey among IBD gastroenterologist members of the Spanish Working Group on Crohn’s Disease and Colitis regarding changes of practice, IBD treatments, and diagnosis and treatment of COVID-19.ResultsWe received 54 answers from Spanish hospitals. One hundred percent of the IBD units rescheduled onsite visits to telematic consultation, and elective endoscopic and surgical procedures were delayed. Protective measures were also taken in the infusion units (100% of health centers) and hospital pharmacies, with 40.7% sending subcutaneous medications to patients. No switching between intravenous and subcutaneous anti-tumor necrosis factor drugs were made. We also found that 96.1% of IBD units advised their patients to maintain treatment if they were asymptomatic for COVID-19. For patients with COVID-19 symptoms, 92.6% of IBD units referred them to primary care or the emergency department. In addition, 7.5% of IBD units made a COVID-19 diagnosis through polymerase chain reaction and/or chest x-ray.Modifications in IBD treatment and treatment recommended for COVID-19 are also discussed.ConclusionsWe report a representative national survey of changes made in the structure, diagnosis of COVID-19, and modifications in IBD treatments within IBD units.Because of the COVID-19 pandemic, IBD units have been forced to adapt their practices to address the disease. A nationwide questionnaire was conducted among IBD units regarding measures taken in terms of organization, IBD treatment, and management of patients with COVID-19 symptoms.