Eiko Koubayashi

Osaka University of Pharmaceutical Sciences

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Hideki Tawa

Osaka University of Pharmaceutical Sciences

Kazuki Kakimoto

Osaka University of Pharmaceutical Sciences

Hiroki Nishikawa

Osaka University of Pharmaceutical Sciences

Shirô Nakamura

Kansai Medical University

Toshihisa Takeuchi

Osaka University of Pharmaceutical Sciences

Yuka Kawasaki

Osaka University of Pharmaceutical Sciences

Kazuhide Higuchi

The Japanese Society of Gastroenterological Surgery

Naokuni Sakiyama

Osaka University of Pharmaceutical Sciences

Takako Miyazaki

Osaka University of Pharmaceutical Sciences

Yuki Hirata

Jichi Medical University

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Osaka University of Pharmaceutical Sciences

Osaka Medical and Pharmaceutical University

Chikamori Hospital

ProQuest (United States)

The Japanese Society of Gastroenterological Surgery

National Institute of Diabetes and Digestive and Kidney Diseases

Nara Prefecture General Medical Center

Hyogo Medical University

Takatsuki General Hospital

National Center for Global Health and Medicine

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Serum IL-13 Predicts Response to Golimumab in Bio-Naïve Ulcerative Colitis

Journal of Clinical Medicine (2022)

Naohiko Kinoshita Kazuki Kakimoto Hikaru Shimizu Kohji Nishida Keijiro Numa

A certain number of patients with ulcerative colitis (UC) are refractory to anti-TNF-α antibodies; biomarkers are thus needed to predict treatment efficacy. This study aimed to evaluate whether serum biomarkers that were reported to be associated with UC or anti-TNF-α antibody could predict the response to golimumab, a human anti-TNF-α monoclonal antibody, in bio-naïve patients with UC. We prospectively enrolled 23 consecutive patients with UC who were treated with golimumab. Serum samples were collected before the first golimumab dose. Eleven molecules were measured by electrochemiluminescence (ECL) or enzyme-linked immunosorbent assay (ELISA) and their association with efficacy after 10 weeks of golimumab treatment. Among the serum biomarkers, IL-13 levels were significantly higher in the non-remission group than in the remission group (p = 0.014). IL-15 levels were significantly lower in the non-response group than in the response group (p = 0.04). For clinical remission at week 10, the IL-13 0.20 concentration of pg/mL was associated with a sensitivity and specificity of 82.4% and 83.3%, respectively. Serum IL-13 may be a biomarker to predict golimumab efficacy in biologic-naïve patients with UC, and thus may help to tailor personalized treatment strategies.

Golimumab

10.3390/jcm11174952

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Therapeutic Drug Monitoring of Golimumab for the Prediction of Long-Term Clinical Remission in Patients with Ulcerative Colitis

Digestion (2022)

Hideki Tawa Kazuki Kakimoto Keijiro Numa Naohiko Kinoshita Yuka Kawasaki

A considerable number of patients with ulcerative colitis (UC) who initially respond to golimumab (GLM), an anti-TNF-α antibody, gradually lose clinical response. Therapeutic drug monitoring has been proposed to optimize serum anti-TNF-α antibody concentrations before the loss of response; however, little is known about ideal serum GLM concentrations. We aimed to evaluate whether the serum GLM trough levels (TLs) early after the initiation of induction therapy affect the long-term outcomes in UC and to identify the early GLM TLs that should be targeted for better long-term outcomes.Thirty-one patients were prospectively evaluated. The primary outcome was clinical remission at 54 weeks, and we measured the serum GLM TLs at weeks 6, 10, and 14. Receiver operating characteristic (ROC) curves were constructed to identify optimal GLM TL thresholds early after induction therapy that were associated with clinical remission at week 54.The GLM TL at week 14, but not at weeks 6 or 10, was significantly associated with clinical remission at week 54 (median [IQR] 1.6 [1.3-1.6] μg/mL vs. 0.9 [0.6-1.3] μg/mL; p = 0.04). The area under the ROC curve for GLM TLs at week 14 was 0.78. We identified a week-14 GLM TL of 1.1 μg/mL as the target threshold for achieving clinical remission at week 54.Our results demonstrate the value of early serum GLM TLs in predicting the long-term outcomes of GLM for patients with UC.

Golimumab

Therapeutic Drug Monitoring

10.1159/000524593

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