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Summary   Background  Significance of monitoring adalimumab trough levels and anti‐adalimumab antibodies ( AAA ) for disease outcome in Crohn's disease ( CD ) patients remained unclear.    Aim  To evaluate the association of adalimumab trough levels and  AAA  at week 26 with clinical remission at week 52, the effect of azathiopurine on  AAA  and factors influencing trough levels in  CD  patients in the  DIAMOND  trial.    Methods  We performed this study using adalimumab trough levels,  AAA  at week 26 and 6‐thioguanine nucleotide ( TGN ) in red blood cells at week 12. A multiple regression model and receiver operating analysis was performed to identify factors influencing adalimumab trough levels and  AAA , and adalimumab thresholds for predicting disease activity.    Results  There was a significant difference of adalimumab trough level at week 26 between patients with disease remission and without at week 52 (7.7 ± 3.3 μg/ mL  vs 5.4 ± 4.3 μg/ mL :  P  <.001). Adalimumab trough level of 5.0 μg/ mL  yielded optimal sensitivity and specificity for remission prediction (80.2% and 55.6%, respectively).  AAA  development at week 26 significantly affected remission at week 52 ( P  = .021), which was strongly associated with adalimumab trough levels. Female gender and increasing body weight were independently associated with low adalimumab trough levels, and female gender was associated with  AAA  development. A cut‐off 6 TGN  level of >222.5 p mol/8 ×10 8   RBC s yielded sensitivity (100%) and specificity (60.6%) for  AAA  negativity.    Conclusion  Adalimumab trough levels and  AAA  occurrence were significantly associated with clinical remission. Higher 6 TGN  affected  AAA  negativity. The combination therapy is beneficial in some relevant aspects for  CD  patients. ( UMIN  Registration No. 5146)

alimentary pharmacology and therapeutics

Significance of measurement of serum trough level and anti‐drug antibody of adalimumab as personalised pharmacokinetics in patients with Crohn's disease: a subanalysis of the  DIAMOND  trial