Understanding Anti-TNF Treatment Failure: A Prospective Multi-Centre Study of Biologic Naive Patients with Active Luminal Crohn's Disease

Kennedy, Nicholas A.; Heap, Graham A.; Green, Harry; Hamilton, Benjamin; Bewshea, Claire; Walker, Gareth; Thomas, Amanda; Nice, Rachel; Perry, Mandy H; Bouri, Sonia; Chanchlani, Neil; Heerasing, Neel; Hendy, Peter; Lin, Simeng; Gaya, Daniel R.; Cummings, JR Fraser; Lees, Charlie W.; Hart, Ailsa; Parkes, Miles; Sebastian, Shaji; Mansfield, John C.; Irving, Peter M.; Lindsay, James O.; Russell, Richard K.; McDonald, Timothy J.; McGovern, Dermot P.; Goodhand, James; Ahmad, Tariq

doi:10.2139/ssrn.3263653

Cited by 69 publications

(150 citation statements)

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“…Our study found 14 (7.1%) patients who developed de novo antibodies; none of them underwent three switches. This triple switch group may represent a selected cohort of patients on relatively long term IFX with a low immunogenicity risk 27 . A previous French study observed that antidrug antibody formation was similar in patients with one switch or two IFX biosimilar switches 28 .…”

Section: Discussionmentioning

confidence: 99%

Multiple infliximab biosimilar switches appear to be safe and effective in a real‐world inflammatory bowel disease cohort

et al. 2023

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Background Switching from originator infliximab (IFX) to biosimilar IFX is effective and safe. However, data on multiple switching are scarce. The Edinburgh inflammatory bowel disease (IBD) unit has undertaken three switch programmes: (1) Remicade to CT‐P13 (2016), (2) CT‐P13 to SB2 (2020), and (3) SB2 to CT‐P13 (2021). Objective The primary endpoint of this study was to assess CT‐P13 persistence following switch from SB2. Secondary endpoints included persistence stratified by the number of biosimilar switches (single, double and triple), effectiveness and safety. Methods We performed a prospective, observational, cohort study. All adult IBD patients on IFX biosimilar SB2 underwent an elective switch to CT‐P13. Patients were reviewed in a virtual biologic clinic with protocol driven collection of clinical disease activity, C‐reactive protein (CRP), faecal calprotectin (FC), IFX trough/antibody levels, and drug survival. Results 297 patients (CD n = 196 [66%], ulcerative colitis/inflammatory bowel disease unclassified n = 101, [34%]) were switched (followed‐up: 7.5 months [6.8–8.1]). This was the third, second and first IFX switch for 67/297 (22.5%), 138/297 (46.5%) and 92/297 (31%) of the cohort respectively. 90.6% of patients remained on IFX during follow‐up. The number of switches was not independently associated with IFX persistence after adjusting for confounders. Clinical (p = 0.77), biochemical (CRP ≤5 mg/ml; p = 0.75) and faecal biomarker (FC<250 µg/g; p = 0.63) remission were comparable at baseline, week 12 and week 24. Conclusion Multiple successive switches from IFX originator to biosimilars are effective and safe in patients with IBD, irrespective of the number of IFX switches.

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Section: Discussionmentioning

confidence: 99%

Multiple infliximab biosimilar switches appear to be safe and effective in a real‐world inflammatory bowel disease cohort

et al. 2023

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“…In einer multivariaten Analyse waren niedrige Infliximab-Serumspiegel in Woche 14 assoziiert mit dem Primärversagen in Woche 14 (OR 0,35, 95 %-KI: 0,20–0,62, p = 0,00 038). Hierbei zeigte sich ein Wert von > 7 µg/ml in Woche 14 als die optimale Serumkonzentration für die Prädiktion einer Remission in Woche 54 287 . Insbesondere für die TNF-α-Antikörper ist die Ausbildung von Anti-Drug-Antikörpern (ADA) oft limitierend.…”

Section: Crohn – Leitlinie Ag 02 Akuter Schubunclassified

Aktualisierte S3-Leitlinie „Diagnostik und Therapie des Morbus Crohn“ der Deutschen Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS) – August 2021 – AWMF-Registernummer: 021-004

Sturm

Atreya

Bettenworth³

et al. 2022

Z Gastroenterol

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Kinder und Jugendliche Fertilität Medikamente in der Schwangerschaft und Stillzeit Entbindung Impfungen des Neugeborenen Der*die ältere CED-Patient*in M. Crohn -Leitlinie AG 07 Ernährung Ernährung Ernährung als Krankheitsauslöser beim M. Crohn Ernährung als ein den Krankheitsverlauf modulierender Faktor Ernährung als therapeutischer Ansatz bei Patient*innen mit M. Crohn Ernährung zur Behandlung von Defiziten bzw. Mangelzuständen

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“…ADA to IFX or adalimumab monotherapy at 1 year occur in 62 and 28% of patients, respectively. 30 31 The HLA-DQA1*05 haplotype was recently found to be present in 40% of a European IBD cohort and is associated with increased immunogenicity to anti-TNFs. 30 31 More studies are underway to understand its clinical applicability in screening and preemptive combination therapy strategies.…”

Section: Available Therapies For Uc In the Outpatient Settingmentioning

confidence: 99%

“…34 Therapeutic drug monitoring has been best studied with anti-TNF class of biologics, with data showing an association between high drug level and clinical remission. 31 The frequency and the dose of anti-TNF can be increased to optimize anti-TNF trough level, when there is partial response or loss of response to anti-TNF because of low drug levels and/or low ADA levels. In situation of no or loss of response to anti-TNF despite adequate drug levels, it is best to switch to therapy with a different mechanism of action.…”

Section: Available Therapies For Uc In the Outpatient Settingmentioning

confidence: 99%

“…30 31 The HLA-DQA1*05 haplotype was recently found to be present in 40% of a European IBD cohort and is associated with increased immunogenicity to anti-TNFs. 30 31 More studies are underway to understand its clinical applicability in screening and preemptive combination therapy strategies. 30 32 The concomitant use of immunomodulators (thiopurine, methotrexate) with anti-TNF can decrease drug clearance, limit (or reverse) ADA formation, and increase anti-TNF drug level.…”

Section: Available Therapies For Uc In the Outpatient Settingmentioning

confidence: 99%

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Medical Treatment Options for Ulcerative Colitis

Sleiman

Bassi

Tsipotis

et al. 2022

Clin Colon Rectal Surg

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The landscape of management of ulcerative colitis, a type of inflammatory bowel disease, continues to change with advancement in pharmaceutical options as well as clinical treatment targets. Ulcerative colitis primarily involves the superficial layers of the large bowel, and cause active inflammation that can affect the colon from the rectum to the cecum in a relapsing and a remitting course. In this review, we provide evidence-based guidance on the selection of appropriate medical therapies based on individual patient and disease characteristics, with a focus on biologics and small molecules. We also review the role of surgery and management of acute severe ulcerative colitis.

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Understanding Anti-TNF Treatment Failure: A Prospective Multi-Centre Study of Biologic Naive Patients with Active Luminal Crohn's Disease

Cited by 69 publications

References 0 publications

Multiple infliximab biosimilar switches appear to be safe and effective in a real‐world inflammatory bowel disease cohort

Multiple infliximab biosimilar switches appear to be safe and effective in a real‐world inflammatory bowel disease cohort

Aktualisierte S3-Leitlinie „Diagnostik und Therapie des Morbus Crohn“ der Deutschen Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS) – August 2021 – AWMF-Registernummer: 021-004

Medical Treatment Options for Ulcerative Colitis

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