CT-P13 (Inflectra™, Remsima™) monitoring in patients with inflammatory bowel disease

Schulze, Kornelius; Koppka, Nadine; Lutter, Frederik; Brandhorst, Gunnar; Schreiber, Stefan; Helwig, Ulf

doi:10.1016/j.biologicals.2016.06.011

Cited by 14 publications

(15 citation statements)

References 15 publications

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“…It is unlikely that the difference in IFX TLs could be explained by the ELISA test used. It has been shown in a recent real-life study, that the ELISA tests used for measuring originator IFX TLs and ADAs are feasible also for biosimilar IFX measurements [33].…”

Section: Discussionmentioning

confidence: 99%

Switching maintenance infliximab therapy to biosimilar infliximab in inflammatory bowel disease patients

Eberl

Huoponen

Pahikkala

et al. 2017

Scandinavian Journal of Gastroenterology

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Section: Discussionmentioning

confidence: 99%

Switching maintenance infliximab therapy to biosimilar infliximab in inflammatory bowel disease patients

Eberl

Huoponen

Pahikkala

et al. 2017

Scandinavian Journal of Gastroenterology

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“…Current data suggest that infliximab enzyme-linked immunosorbent assays (ELISAs) for evaluating either drug concentrations or antibodies to infliximab (ATI) are suitable for monitoring the infliximab biosimilars SB2 and CT-P13. [114][115][116][117] 14. The threshold drug concentration may vary depending on disease phenotype and desired therapeutic outcome.…”

Section: Assays Drug Concentrations and Anti-drug Antibodiesmentioning

confidence: 99%

Appropriate Therapeutic Drug Monitoring of Biologic Agents for Patients With Inflammatory Bowel Diseases

Papamichael

Cheifetz

Melmed

et al. 2019

Clinical Gastroenterology and Hepatology

240

248

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BACKGROUND & AIMS: Therapeutic drug monitoring (TDM) is widely available for biologic therapies in patients with inflammatory bowel disease (IBD). We reviewed current data and provided expert opinion regarding the clinical utility of TDM for biologic therapies in IBD. METHODS: We used a modified Delphi method to establish consensus. A comprehensive literature review was performed regarding the use of TDM of biologic therapy in IBD and presented to international IBD specialists. Subsequently, 28 statements on the application of TDM in clinical practice were rated on a scale of 1 to 10 (1 [ strongly disagree and 10 [ strongly agree) by each of the panellists. Statements were accepted if 80% or more of the participants agreed with a score ‡7. The remaining statements were discussed and revised based on the available evidence followed by a second round of voting. RESULTS: The panel agreed on 24 (86%) statements. For anti-tumor necrosis factor (anti-TNF) therapies, proactive TDM was found to be appropriate after induction and at least once during maintenance therapy, but this was not the case for the other biologics. Reactive TDM was appropriate for all agents both for primary non-response and secondary loss of response. The panellists also agreed on several statements regarding TDM and appropriate drug and anti-drug antibody (ADA) concentration thresholds for biologics in specific clinical scenarios. CONCLUSION: Consensus was achieved towards the utility of TDM of biologics in IBD, particularly anti-TNF therapies. More data are needed especially on non-anti-TNF biologics to further define optimal drug concentration and ADA thresholds as these can vary depending on the therapeutic outcomes assessed.

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“…235 236 Similarly, existing assays seem to be capable of monitoring biosimilar drug levels. 237 The main incentive for the development of biosimilars, as with generics, is economic; the potential savings are considerable. 238 But, as the development of biosimilars is still in its infancy, gastroenterologists worldwide are just beginning to understand its implications.…”

Section: Malignancy and Infectionmentioning

confidence: 99%

Update on anti-tumor necrosis factor agents and other new drugs for inflammatory bowel disease

Cohen

Sachar

2017

BMJ

114

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The treatment of inflammatory bowel disease (IBD)-ulcerative colitis (UC) and Crohn's disease (CD)-has evolved beyond surgery with the introduction of biologic agents, primarily antibodies against mediators of inflammation and cell attraction. Anti-tumor necrosis factor (TNF) agents have been the first line treatment for moderate to severe ulcerative colitis and Crohn's disease for more than 15 years. During that time much has been learnt about how best to use these agents. This review will assess the evidence on how to optimize the use of anti-TNF agents; when and how to start treatment; how to monitor treatment and when to de-escalate it; and the potential adverse effects of these drugs. New and emerging treatments such as anti-attractants, anti-interleukins, and Janus kinase (JAK) inhibitors will also be discussed.

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CT-P13 (Inflectra™, Remsima™) monitoring in patients with inflammatory bowel disease

Cited by 14 publications

References 15 publications

Switching maintenance infliximab therapy to biosimilar infliximab in inflammatory bowel disease patients

Switching maintenance infliximab therapy to biosimilar infliximab in inflammatory bowel disease patients

Appropriate Therapeutic Drug Monitoring of Biologic Agents for Patients With Inflammatory Bowel Diseases

Update on anti-tumor necrosis factor agents and other new drugs for inflammatory bowel disease

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