Infliximab and Adalimumab Monitoring versus Clinical Control during Maintenance Therapy in Patients with Inflammatory Bowel Disease

Introduction & Aims Although the serum levels of infliximab (IFX) and adalimumab (ADA) are correlated with the clinical response in patients with inflammatory bowel disease (IBD), the optimal management strategy during maintenance therapy remains controversial. We performed a randomized trial to determine whether proactive monitoring drug in patients with inflammatory bowel disease is better than control clinical to keep clinical remission Methods We conducted a randomized, prospective, multicenter trial involving 209 patients with Crohn's disease (CD) or ulcerative colitis (UC) who had been in clinical remission for at least 12 weeks. Patients were randomized into two groups: 104 in the TDM group and 105 in the clinical practice (CP) group. In the TDM group, the dosing and intervals of IFX and ADA were adjusted at each visit to maintain optimal serum concentrations (3–7 μg/mL for IFX and 5–8 μg/mL for ADA). The primary endpoint was the proportion of patients who remained in clinical remission at 12 months of follow-up. The secondary endpoints included the number of disease flares, duration of clinical remission, rate of hospital admissions related to IBD, and quality of life Results The primary endpoint of remission was achieved in 94 patients (90.3%) in the TDM group and 86 patients (81.9%) in the CP group, with a difference of 8.4% between the groups (p = 0.079; 95% CI: –17.70.91). The mean duration of remission over the 12-month follow-up was significantly longer in the TDM group [48.04 ± 10.76 weeks] than in the CP group [45.69 ± 14.21 weeks] (p = 0.03). The number of disease flares was lower in the TDM group (15 flares) than inthe CP group (24 flares). At baseline, optimal IFX levels were present in 51 patients (48.5%), and optimal ADA levels were present in 36 patients (35.3%). Conclusions In this prospective randomized trial of patients with CD or UC in clinical remission receiving IFX or ADA, compared withstandard clinical management, proactive TDM did not significantly increase the overall remission rate at one year. However, patients in the TDM group remained in clinical remission for a significantly longer duration. ClinicalTrials.gov Identifier: NCT06666569