Therapeutic monitoring of adalimumab at non-trough levels in patients with inflammatory bowel disease.
Adalimumab (ADA) trough level and anti-ADA antibody (AAA) positivity influence mucosal healing and loss of response in patients with inflammatory bowel disease (IBD). In this study, we clarified the correlation between ADA monitoring, including non-trough level, and real-world IBD clinical outcomes....
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2021
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oai:doaj.org-article:7bcc3f90536f46b3bb7962457b2aa47e2021-12-02T20:15:30ZTherapeutic monitoring of adalimumab at non-trough levels in patients with inflammatory bowel disease.1932-620310.1371/journal.pone.0254548https://doaj.org/article/7bcc3f90536f46b3bb7962457b2aa47e2021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0254548https://doaj.org/toc/1932-6203Adalimumab (ADA) trough level and anti-ADA antibody (AAA) positivity influence mucosal healing and loss of response in patients with inflammatory bowel disease (IBD). In this study, we clarified the correlation between ADA monitoring, including non-trough level, and real-world IBD clinical outcomes. This retrospective, observational, single-center study involved patients with ulcerative colitis (19) and Crohn's disease (33) treated with ADA from January 2007 to August 2018. Serum ADA and AAA levels were measured 4‒14 days after ADA administration. The AAA positivity rate was 23.1% (12/52). ADA continuity was higher in AAA-negative patients than in AAA-positive patients (P = 0.223). Receiver operating characteristic (ROC) analysis revealed that a serum AAA cut-off of 9.2 μg/mL was associated with ADA continuity. The ADA level was significantly higher in the endoscopic remission group than in the non-remission group (P = 0.02). Based on the ROC curve analysis results of serum ADA level and endoscopic remission, the cut-off value of the serum ADA level was set to 11.1 μg/mL. Under the combined use of ADA with immunomodulators and AAA positivity, ADA continuity was significantly higher when the serum AAA level at 4-14 days after ADA administration was ≥9.2 μg/mL. Furthermore, endoscopic remission can be expected with a serum ADA level of ≥11.1 μg/mL. Overall, to predict clinical outcomes, it would be useful to measure the blood level of ADA regardless of the timing of the trough.Masaichi KatoKen SugimotoKentaro IkeyaRyosuke TakanoAi MatsuuraTakahiro MiyazuNatsuki IshidaSatoshi TamuraShinya TaniMihoko YamadeYasushi HamayaMoriya IwaizumiSatoshi OsawaTakahisa FurutaHiroyuki HanaiPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 7, p e0254548 (2021) |
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Medicine R Science Q |
| spellingShingle |
Medicine R Science Q Masaichi Kato Ken Sugimoto Kentaro Ikeya Ryosuke Takano Ai Matsuura Takahiro Miyazu Natsuki Ishida Satoshi Tamura Shinya Tani Mihoko Yamade Yasushi Hamaya Moriya Iwaizumi Satoshi Osawa Takahisa Furuta Hiroyuki Hanai Therapeutic monitoring of adalimumab at non-trough levels in patients with inflammatory bowel disease. |
| description |
Adalimumab (ADA) trough level and anti-ADA antibody (AAA) positivity influence mucosal healing and loss of response in patients with inflammatory bowel disease (IBD). In this study, we clarified the correlation between ADA monitoring, including non-trough level, and real-world IBD clinical outcomes. This retrospective, observational, single-center study involved patients with ulcerative colitis (19) and Crohn's disease (33) treated with ADA from January 2007 to August 2018. Serum ADA and AAA levels were measured 4‒14 days after ADA administration. The AAA positivity rate was 23.1% (12/52). ADA continuity was higher in AAA-negative patients than in AAA-positive patients (P = 0.223). Receiver operating characteristic (ROC) analysis revealed that a serum AAA cut-off of 9.2 μg/mL was associated with ADA continuity. The ADA level was significantly higher in the endoscopic remission group than in the non-remission group (P = 0.02). Based on the ROC curve analysis results of serum ADA level and endoscopic remission, the cut-off value of the serum ADA level was set to 11.1 μg/mL. Under the combined use of ADA with immunomodulators and AAA positivity, ADA continuity was significantly higher when the serum AAA level at 4-14 days after ADA administration was ≥9.2 μg/mL. Furthermore, endoscopic remission can be expected with a serum ADA level of ≥11.1 μg/mL. Overall, to predict clinical outcomes, it would be useful to measure the blood level of ADA regardless of the timing of the trough. |
| format |
article |
| author |
Masaichi Kato Ken Sugimoto Kentaro Ikeya Ryosuke Takano Ai Matsuura Takahiro Miyazu Natsuki Ishida Satoshi Tamura Shinya Tani Mihoko Yamade Yasushi Hamaya Moriya Iwaizumi Satoshi Osawa Takahisa Furuta Hiroyuki Hanai |
| author_facet |
Masaichi Kato Ken Sugimoto Kentaro Ikeya Ryosuke Takano Ai Matsuura Takahiro Miyazu Natsuki Ishida Satoshi Tamura Shinya Tani Mihoko Yamade Yasushi Hamaya Moriya Iwaizumi Satoshi Osawa Takahisa Furuta Hiroyuki Hanai |
| author_sort |
Masaichi Kato |
| title |
Therapeutic monitoring of adalimumab at non-trough levels in patients with inflammatory bowel disease. |
| title_short |
Therapeutic monitoring of adalimumab at non-trough levels in patients with inflammatory bowel disease. |
| title_full |
Therapeutic monitoring of adalimumab at non-trough levels in patients with inflammatory bowel disease. |
| title_fullStr |
Therapeutic monitoring of adalimumab at non-trough levels in patients with inflammatory bowel disease. |
| title_full_unstemmed |
Therapeutic monitoring of adalimumab at non-trough levels in patients with inflammatory bowel disease. |
| title_sort |
therapeutic monitoring of adalimumab at non-trough levels in patients with inflammatory bowel disease. |
| publisher |
Public Library of Science (PLoS) |
| publishDate |
2021 |
| url |
https://doaj.org/article/7bcc3f90536f46b3bb7962457b2aa47e |
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