Implications for sequencing of biologic therapy and choice of second <scp>anti‐TNF</scp> in patients with inflammatory bowel disease: results from the <scp>IMmunogenicity</scp> to Second <scp>Anti‐TNF</scp> therapy (<scp>IMSAT</scp>) therapeutic drug monitoring study

Chanchlani, Neil; Lin, Simeng; Auth, Marcus; Lee, Chai Leng; Robbins, Helena; Looi, Shi Jie; Murugesan, Senthil V.; Riley, Tom; Preston, Cathryn; Stephenson, Sophie; Cardozo, Wendy; Sonwalkar, Sunil; Allah‐Ditta, Mohammed; Mansfield, Lynne; Durai, Dharmaraj; Baker, Mark R.; London, Ian; London, Emily; Gupta, Sanjay; Mambro, Alex Di; Murphy, Aisling; Gaynor, Edward; Jones, Kelsey; Claridge, Andrew; Sebastian, Shaji; Ramachandran, Sankaranarayanan; Selinger, Christian P.; Borg–Bartolo, Simon; Knight, Paul R.; Sprakes, Michael; Burton, Julie; Kane, Patricia; Lupton, Stephanie; Fletcher, Aimee; Gaya, Daniel R.; Colbert, Roghan Donohue; Seenan, John Paul; Macdonald, Jonathan; Lynch, Lucy; McLachlan, I; Shields, Stephanie; Hansen, Richard; Gervais, Lisa; Jere, Mwansa; Akhtar, Muhammad; Black, Karen; Henderson, Paul; Russell, Richard K.; Lees, Charlie W; Derikx, Lauranne; Lockett, M; Betteridge, Frederica; Silva, Aminda De; Hussenbux, Arif; Beckly, John; Bendall, Oliver; Hart, J. W.; Thomas, Amanda; Hamilton, Benjamin; Gordon, C; Chee, Desmond; McDonald, Timothy J.; Nice, Rachel; Parkinson, Marian; Gardner‐Thorpe, Helen; Butterworth, Jeff; Javed, Asima; Al‐Shakhshir, Sarah; Yadagiri, Rekha; Maher, Sebrene; Pollok, Richard; Ng, Tze Pin; Appiahene, Priscilla; Donovan, F; Lok, James B.; Chandy, R; Jagdish, Reema; Baig, Daniyal; Mahmood, Zahid; Marsh, Liane; Moss, A. H.; Abdulgader, Amin; Kitchin, Angus; Walker, Gareth; George, Becky; Lim, Yuen‐Hui; Gulliver, James; Bloom, Stuart; Theaker, Holly; Carlson, Sean; Cummings, Fraser; Livingstone, Rodney; Beale, Amanda; Carter, Josiah O.; Bell, A. S.; Coulter, Archibald; Snook, Jonathon; Stone, Helen B.; Kennedy, Nicholas A; Goodhand, James; Ahmad, Tariq

doi:10.1111/apt.17170

Cited by 12 publications

(6 citation statements)

References 43 publications

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“…87 88 For each 10-fold increase in anti-TNF antibody concentration, the probability of developing antibodies to a subsequent anti-TNF increases has been estimated at 1.73. 89 Therefore, in patients with high anti-TNF drug antibody levels, switching within drug classes would be a better option than intensification. If a second anti-TNF is eventually considered, the experts recommend proactive TDM or close clinical monitoring along with adding an IMM.…”

Section: Open Accessmentioning

confidence: 99%

Controversies in the management of anti-TNF therapy in patients with Crohn’s disease: a Delphi consensus

González-Lama,

Ricart,

Carpio

et al. 2024

BMJ Open Gastroenterol

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BackgroundDespite research, there are still controversial areas in the management of Crohn’s disease (CD).ObjectiveTo establish practical recommendations on using anti-tumour necrosis factor (TNF) drugs in patients with moderate-to-severe CD.MethodsClinical controversies in the management of CD using anti-TNF therapies were identified. A comprehensive literature review was performed, and a national survey was launched to examine current clinical practices when using anti-TNF therapies. Their results were discussed by expert gastroenterologists within a nominal group meeting, and a set of statements was proposed and tested in a Delphi process.ResultsQualitative study. The survey and Delphi process were sent to 244 CD-treating physicians (response rate: 58%). A total of 14 statements were generated. All but two achieved agreement. These statements cover: (1) use of first-line non-anti-TNF biological therapy; (2) role of HLA-DQA1*05 in daily practice; (3) attitudes in primary non-response and loss of response to anti-TNF therapy due to immunogenicity; (4) use of ustekinumab or vedolizumab if a change in action mechanism is warranted; (5) anti-TNF drug level monitoring; (6) combined therapy with an immunomodulator.ConclusionThis document sought to pull together the best evidence, experts’ opinions, and treating physicians’ attitudes when using anti-TNF therapies in patients with CD.

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Section: Open Accessmentioning

confidence: 99%

Controversies in the management of anti-TNF therapy in patients with Crohn’s disease: a Delphi consensus

González-Lama,

Ricart,

Carpio

et al. 2024

BMJ Open Gastroenterol

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“…This latter approach is supported by recent evidence suggesting that patients with immunogenicity to previous anti-TNF therapy are more prone to developing antidrug antibodies against a subsequent anti-TNF agent. 40 , 41 …”

Section: New Insights For Proactive Tdm Of Biologicalsmentioning

confidence: 99%

Challenges in Therapeutic Drug Monitoring: Optimizing Biological Treatments in Patients With Inflammatory Bowel Disease and Other Immune-Mediated Inflammatory Diseases

Papamichael

Stocco

Agua

2023

Therapeutic Drug Monitoring

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Background: Therapeutic drug monitoring (TDM) is a decision-making tool for optimizing the use of certain therapies. In this article, the authors review the role of proactive TDM of biological agents in patients with inflammatory bowel disease (IBD) and other immune-mediated inflammatory diseases (IMID). They also discuss the future of TDM as a component of personalized medicine from the clinical laboratory perspective. Methods: This narrative review originated from proceedings of the fifth biannual Challenges in Therapeutic Drug Monitoring seminar and was supplemented by additional literature identified at various stages of critical review. Results: Proactive TDM aims to achieve adequate concentrations of biological drugs, such that patients attain and maintain an optimal treatment response. Proactive TDM may also have a role in de-escalating anti–tumor necrosis factor therapy in patients in clinical remission and in optimizing infliximab monotherapy as an alternative to combination therapy with an immunomodulator. A major proactive TDM application is in pediatric patients with IBD. Achieving mucosal healing in children with IBD requires that infliximab or adalimumab concentrations are monitored early during induction therapy, with dose modifications guided by the timing (week) of measurement. Recent innovations in biological therapy include international standards for infliximab and adalimumab for the global harmonization of bioactivity and monotest devices with an accuracy equivalent to that of conventional enzyme-linked immunosorbent assays and quicker turnaround times. Conclusions: Despite several knowledge gaps regarding proactive TDM of anti–tumor necrosis factor therapy in patients with IMID, growing evidence suggests that it is associated with better outcomes than empiric optimization and/or reactive TDM in IBD. Enhanced pharmacokinetic modeling to predict drug exposure and patient genotyping for the precise application of proactive TDM are considered key elements to optimize biological therapy in the future.

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“…Moreover, a systematic review reported that switching to a second anti-TNF agent led to successful induction of remission in 46% of patients with IBD who had failed the first anti-TNF agent[ 155 ]. Of note, the previous generation of anti-TNF antibodies increases the risk of the generation of a second anti-TNF antibody in IBD[ 156 ]. Therefore, when switching to another anti-TNF agent, a combination of immunosuppressive agents is appropriate[ 136 , 157 ].…”

Section: Optimal Management Of Anti-tnf Nonresponsementioning

confidence: 99%

Predictors and optimal management of tumor necrosis factor antagonist nonresponse in inflammatory bowel disease: A literature review

Wang¹,

Chen²,

He³

et al. 2023

World J Gastroenterol

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Tumor necrosis factor-α (TNF-α) antagonists, the first biologics approved for treating patients with inflammatory bowel disease (IBD), are effective for the induction and maintenance of remission and significantly improving prognosis. However, up to one-third of treated patients show primary nonresponse (PNR) to anti-TNF-α therapies, and 23%-50% of IBD patients experience loss of response (LOR) to these biologics during subsequent treatment. There is still no recognized predictor for evaluating the efficacy of anti-TNF drugs. This review summarizes the existing predictors of PNR and LOR to anti-TNF in IBD patients. Most predictors remain controversial, and only previous surgical history, disease manifestations, drug concentrations, antidrug antibodies, serum albumin, some biologic markers, and some genetic markers may be potentially predictive. In addition, we also discuss the next steps of treatment for patients with PNR or LOR to TNF antagonists. Therapeutic drug monitoring plays an important role in treatment selection. Dose escalation, combination therapy, switching to a different anti-TNF drug, or switching to a biologic with a different mechanism of action can be selected based on the concentration of the drug and/or antidrug antibodies.

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Implications for sequencing of biologic therapy and choice of second anti‐TNF in patients with inflammatory bowel disease: results from the IMmunogenicity to Second Anti‐TNF therapy (IMSAT) therapeutic drug monitoring study

Cited by 12 publications

References 43 publications

Controversies in the management of anti-TNF therapy in patients with Crohn’s disease: a Delphi consensus

Controversies in the management of anti-TNF therapy in patients with Crohn’s disease: a Delphi consensus

Challenges in Therapeutic Drug Monitoring: Optimizing Biological Treatments in Patients With Inflammatory Bowel Disease and Other Immune-Mediated Inflammatory Diseases

Predictors and optimal management of tumor necrosis factor antagonist nonresponse in inflammatory bowel disease: A literature review

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