Effectiveness of Third-Class Biologic Treatment in Crohn’s Disease: A Multi-Center Retrospective Cohort Study

Albshesh, Ahmad; Taylor, Joshua F.; Savarino, Edoardo; Truyens, Marie; Armuzzi, Alessandro; Ribaldone, Davide Giuseppe; Shitrit, Ariella Bar-Gil; Fibelman, Morine; Molander, Pauliina; Liefferinckx, Claire; Nancey, Stéphane; Korani, Mohamed; Rutka, Mariann; Acosta, Manuel Barreiro‐de; Domislović, Viktor; Surís, Gerard; Eriksson, Carl; Alves, Catarina; Mpitouli, Afroditi; Jiang, Caroline Di; Tepeš, Katja; Coletta, Marina; Foteinogiannopoulou, Kalliopi; Gisbert, Javier P.; Amir-Barak, Hadar; Attauabi, Mohamed; Seidelin, Jakob Benedict; Afif, Waqqas; Marinelli, Carlo; Lobatón, Triana; Pugliese, Daniela; Maharshak, Nitsan; Cremer, Anneline; Limdi, Jimmy K.; Molnár, Tamás; Otero-Alvarin, Borja; Krznarić, Željko; Magro, Fernando; Karmiris, Konstantinos; Raine, Tim; Drobne, David; Koutroubakis, Ioannis Ε.; Chaparro, María; Yanai, Henit; Burisch, Johan; Kopylov, Uri

doi:10.3390/jcm10132914

Cited by 9 publications

(6 citation statements)

References 49 publications

(38 reference statements)

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“…Patients in either 4th or 5th line of treatment had CD more than UC (69% vs. 31%). This unbalance could be explained by the less curative role of surgery in CD, and broadly reflect a common 22 [17] Median duration of IBD 12 [11] 11 [9] 13 [12] Median duration of follow-up 9 [ In our cohort, the patients with multi-drug failure tried anti-TNF, ustekinumab and vedolizumab but still did not achieve the treatment target. The majority of patients received anti-TNF as 1st and 2nd line treatment, and ustekinumab or vedolizumab as 3rd line.…”

Section: Discussionmentioning

confidence: 94%

“…These results are broadly consistent with what was expected from the literature; in a large cohort of patients with CD, 27 patients out of the 204 (13.2%) required surgical intervention after the failure of 3rd line biological treatment. 17 In a retrospective study of 100 patients with CD who failed anti-TNF and either vedolizumab or ustekinumab at week 48, the surgery rate was 23.5%. 18 The relevance of surgery to the difficulty of treating IBD is well testified in the aforementioned survey of gastroenterologists where 69% of respondents would include the need for surgery in the definition of difficult-to-treat CD, and 64% agreed a cutoff of two or more resections at the qualifying criterion for difficult-to-treat IBD; 83% supported surgery as a criterion for difficult-to-treat UC.…”

Section: Discussionmentioning

confidence: 99%

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Difficult‐to‐treat inflammatory bowel disease: Effectiveness and safety of 4th and 5th lines of treatment

Caron,

Habert,

Bonsack

et al. 2024

UEG Journal

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BackgroundMany patients with inflammatory bowel disease (IBD) have signs or symptoms of active disease despite multiple treatment attempts. This emerging concept is defined as difficult‐to‐treat IBD.AimThe objective of this study was to investigate for the first time the treatment persistence, efficacy and safety of biologics or small molecules used in 4th or 5th line therapy.MethodsWe reviewed all consecutive patients with IBD treated at the Nancy University Hospital between July 2022 and April 2023 with the 4th or 5th line treatment for at least three months. The primary outcome was to assess the persistence rate of 4th and 5th line therapy.ResultsWe enrolled 82 patients with IBD (4th line: 44; 5th line: 38). On Kaplan–Meier analysis, the duration of risankizumab, ustekinumab or vedolizumab therapy did not differ significantly (p > 0.05) as 4th and 5th line treatment. The restricted mean survival time analysis showed that the persistence rate of risankizumab was the highest as 4th line therapy (risankizumab vs. vedolizumab: 36.0 and 29.4 weeks, respectively, p = 0.008; risankizumab vs. ustekinumab: 36.0 and 32.8 weeks, respectively, p = 0.035). In multivariate regression, Crohn's disease diagnosis (Odd ratio 4.6; 95% confidence interval 1.7–12.4) was significantly associated with treatment persistence.ConclusionIn this first real‐world setting, risankizumab could have a longer persistence rate as 4th line treatment for IBD than other agents. Persistence of biological agents was greater in Crohn's disease than in ulcerative colitis. More studies are needed to compare treatment efficacy in patients with difficult‐to‐treat IBD.

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Section: Discussionmentioning

confidence: 94%

Section: Discussionmentioning

confidence: 99%

Difficult‐to‐treat inflammatory bowel disease: Effectiveness and safety of 4th and 5th lines of treatment

Caron,

Habert,

Bonsack

et al. 2024

UEG Journal

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“…Earlier studies have shown the effectiveness of UST in CD patients refractory to anti-TNFs. However, these studies do not describe the effectiveness of UST as second-line biologic after VDZ failure as a first-line therapy [ 32 , 33 , 34 , 35 ].…”

Section: Discussionmentioning

confidence: 99%

Comparison of Short- and Long-Term Effectiveness between Anti-TNF and Ustekinumab after Vedolizumab Failure as First-Line Therapy in Crohn’s Disease: A Multi-Center Retrospective Cohort Study

Albshesh

Bannon

Fischler

et al. 2023

JCM

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Background: The effectiveness of anti-TNF or ustekinumab (UST) as a second-line biologic after vedolizumab (VDZ) failure has not yet been described. Aims and Methods: In this retrospective multicenter cohort study, We aim to investigate the effectiveness of anti-TNF and UST as second-line therapy in patients with Crohn’s disease (CD) who failed VDZ as a first-line treatment. The primary outcome was clinical response at week 16–22. Secondary outcomes included the rates of clinical remission, steroid-free clinical remission, CRP normalization, and adverse events. Results: Fifty-nine patients who failed on VDZ as a first-line treatment for CD were included; 52.8% patients received anti-TNF and 47.2% UST as a second-line therapy. In initial period (Week 16–22), the clinical response and remission rate was similar between both groups: 61.2% vs. 68%, p = 0.8 and 48.3% vs. 56%, p = 0.8 on anti-TNF and UST therapy, respectively. Furthermore, in the maintenance period the rate was similar: 75% vs. 82.3%, p = 0.8 and 62.5% vs. 70.5%, p = 0.8, respectively. Of the patients, 12 out of the 59 stopped the therapy, without a significant difference between the two groups (p = 0.6). Conclusion: Second-line biological therapy after VDZ failure therapy was effective in >60% of the patients with CD. No differences in effectiveness were detected between the use of anti-TNF and UST as a second line.

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“… 32 This may reflect superior assessment of performance of UST in patients with prior anti-TNF therapy outside the stringent conditions of clinical trials, in line with other cohort studies. 38–40 …”

Section: Discussionmentioning

confidence: 99%

Biologic Therapy for Inflammatory Bowel Disease: Real-World Comparative Effectiveness and Impact of Drug Sequencing in 13 222 Patients within the UK IBD BioResource

Kapizioni,

Desoki,

Lam

et al. 2023

Journal of Crohn's and Colitis

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Background and Aims This study compares the effectiveness of different biologic therapies and sequences in patients with inflammatory bowel disease [IBD] using real-world data from a large cohort with long exposure. Methods Demographic, disease, treatment, and outcome data were retrieved for patients in the UK IBD BioResource. Effectiveness of treatment was based on persistence free of discontinuation or failure, analysed by Kaplan–Meier survival analysis with inverse probability of treatment weighting to adjust for differences between groups. Results In total, 13 222 evaluable patients received at least one biologic. In ulcerative colitis [UC] first-line vedolizumab [VDZ] demonstrated superior effectiveness over 5 years compared to anti-tumour necrosis factor [anti-TNF] agents [p = 0.006]. VDZ was superior to both infliximab [IFX] and adalimumab [ADA] after ADA and IFX failure respectively [p < 0.001 and p < 0.001]. Anti-TNF therapy showed similar effectiveness when used as first-line treatment, or after failure of VDZ. In Crohn’s disease [CD] we found significant differences between first-line treatments over 10 years [p = 0.045], with superior effectiveness of IFX compared to ADA in perianal CD. Non-anti-TNF biologics were superior to a second anti-TNF after first-line anti-TNF failure in CD [p = 0.035]. Patients with UC or CD experiencing TNF failure due to delayed loss of response or intolerance had superior outcomes when switching to a non-anti-TNF biologic, rather than a second anti-TNF. Conclusions We provide real-world evidence to guide biologic selection and sequencing in a range of common scenarios. Our findings challenge current guidelines regarding drug selection after loss of response to first anti-TNF treatment.

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Effectiveness of Third-Class Biologic Treatment in Crohn’s Disease: A Multi-Center Retrospective Cohort Study

Cited by 9 publications

References 49 publications

Difficult‐to‐treat inflammatory bowel disease: Effectiveness and safety of 4th and 5th lines of treatment

Difficult‐to‐treat inflammatory bowel disease: Effectiveness and safety of 4th and 5th lines of treatment

Comparison of Short- and Long-Term Effectiveness between Anti-TNF and Ustekinumab after Vedolizumab Failure as First-Line Therapy in Crohn’s Disease: A Multi-Center Retrospective Cohort Study

Biologic Therapy for Inflammatory Bowel Disease: Real-World Comparative Effectiveness and Impact of Drug Sequencing in 13 222 Patients within the UK IBD BioResource

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