Clinical outcome after anti‐tumour necrosis factor therapy discontinuation in 1000 patients with inflammatory bowel disease: the EVODIS long‐term study

Casanova, M J; Chaparro, María; Nantes, Óscar; Benítez, José Manuel; Rojas‐Feria, María; Castro‐Poceiro, Jesús; Huguet, José María; Martín‐Cardona, Albert; Aicart-Ramos, M.; Cuquerella, J.; Martín‐Rodríguez, María del Mar; González‐Muñoza, Carlos; Mañosa, Míriam; Leo-Carnerero, Eduardo; Lamuela‐Calvo, Luis Javier; Pérez‐Martínez, Isabel; Bujanda, Luís; Hinojosa, Joaquín; Pajares, Ramón; Argüelles‐Arias, Federico; Pérez-Calle, J.L.; Rodríguez‐González, Gloria Esther; Guardiola, Jordi; Acosta, Manuel Barreiro‐de; Gisbert, Javier P.; Bermejo, Fernando; Barrio, Jesús; Beltrán, Belén; Gomollón, Fernando; Lorente, Rufo; Gutiérrez, Ana; Domínguez-Cajal, Manuel; Dueñas, Carmen; Ponferrada-Díaz, Ángel; Domselaar, Manuel Van; Piscina, P Ramírez-de la; Ramos, Laura; Almela, Pedro; Navarro-Llavat, M; Botella, Belén; Castaño-Milla, C.; Rodrı́guez, Cristina; Iglesias-Flores, Eva; Serrano‐Muñoz, M. J.; Ricart, Elena; Monzó, Ana; Esteve, María; Garrido, Elena; Mínguez, Miguel; Cabello-Tapia, María José; Garcia-Planella, E.; Domènech, Eugeni; Núñez-Ortiz, Andrea; García-López, Santiago

doi:10.1111/apt.16361

Cited by 18 publications

(15 citation statements)

References 25 publications

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“…There is a substantial heterogeneity among these studies. The majority of these studies examined relapse rates in patients with clinical remission [ 9 , 10 , 17 , 18 , 20 , 25 – 27 ]. However, the applied definitions of clinical remission vary strongly.…”

Section: Discussionmentioning

confidence: 99%

Relapse rates after withdrawal versus maintaining biologic therapy in IBD patients with prolonged remission

et al. 2023

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Biologic treatment withdrawal in inflammatory bowel disease patients with prolonged remission may lead to benefits but also increases the risk of getting a relapse. The risk of relapse after biologic withdrawal according to the Dutch STOP-criteria is still unknown. The aim of this study was to compare the cumulative incidence of relapse in inflammatory bowel disease patients that discontinued biologic therapy after applying the STOP-criteria with patients who maintained biologic therapy. We performed a mono-centre, observational, retrospective study by evaluating relapse risk of patients treated with biologic agents who discontinued this treatment according to the STOP-criteria (STOP-group) compared to patients who were in remission for more than 3 years before withdrawal (LATERSTOP-group) and patients who continued their biologic (MAINTAIN-group). The cumulative risk was calculated at 12 and 36 months using the log-rank test to compare Kaplan–Meier curves. Eighty-three of 398 patients that used biologics between 1 January 2010 and 1 January 2020 were included. The cumulative relapse incidences in the STOP-group and the LATERSTOP-group were, respectively, 29% and 42% at 12 months and 47% versus 58% at 36 months. Patients in the MAINTAIN-group showed a lower ( p = 0.03) cumulative relapse incidence of 10% at 12 months and 18% at 36 months. Patients who discontinued their biologic therapy according to the STOP-criteria had significantly more relapses at 12 and 36 months than patients who maintained biologic treatment.

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Section: Discussionmentioning

confidence: 99%

Relapse rates after withdrawal versus maintaining biologic therapy in IBD patients with prolonged remission

et al. 2023

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“…A systematic review and meta-analysis of previous observational studies demonstrated that 28% of UC and 36% of CD patients relapsed at 12 months following discontinuation of anti-TNF agents [ 8 ]. In addition, a recent large retrospective observational study evaluated >1,000 IBD patients who discontinued IFX or ADA and revealed that 12% of patients relapsed annually, with a cumulative relapse rate of 48% in 5 years after discontinuation [ 31 ].…”

Section: Discontinuation Of Tnfimentioning

confidence: 99%

Evidence-Based Approach to the Discontinuation of Immunomodulators or Biologics in Inflammatory Bowel Disease

Miyatani

2022

Digestion

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Background: Biologics and immunomodulators are key drugs in the long-term treatment of inflammatory bowel diseases, while they may negatively impact patients’ quality of life due to concerns of adverse events, need for frequent hospital visits, and medical expenses. The basic concept of drug withdrawal should be based on the risk of relapse and the efficacy of re-treatment. Considering a number of patients may relapse even if treatment is continued, the disadvantage of discontinuation should be recognized not by all relapse after discontinuation, but by the increase in relapse. Summary: Discontinuation of immunomodulator monotherapy is associated with an increased risk of relapse. However, prolonged remission might be an indication of withdrawal, concerning the long-term adverse effect including lymphoma and nonmelanoma skin cancers. When considering discontinuation from combination therapy of anti-tumor necrosis factor (TNF) agents with immunomodulators, therapeutic drug monitoring may be useful to understand the pharmacokinetic effect. However, recent randomized controlled trials, as well as large-scale observational studies, demonstrated that discontinuation of anti-TNF agents, but not of immunomodulators, resulted in a significantly higher risk of relapse even in deep remission. Therefore, discontinuation of anti-TNF agents should be considered with caution and close monitoring combined with fecal calprotectin may be necessary. On the other hand, evidence of not only short-term relapse rate but of the true long-term influence on the patient’s quality of life should be clarified by a multidimensional approach. Key Messages: Discontinuation of treatment should be implemented based on shared decision-making with careful interpretation of evidence and the condition.

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“…39 In addition, a recent large-scale retrospective observational study of 1,000 IBD patients who discontinued infliximab or adalimumab demonstrated that 12% of patients relapsed annually, and the cumulative relapse rate at years was 48% after discontinuation. 40…”

Section: Anti-tnf-α 1) Discontinuation Of Tnfimentioning

confidence: 99%

“…38 A large-scale observational study also showed that 60% of patients who relapsed after discontinuation were treated with the same TNFi, in which 73% of patients achieved remission. 40 However, decisions on whether the same TNFi should be used were made by physicians or patients in clinical practice; therefore, the outcome might have been biased.…”

Section: Tnfimentioning

confidence: 99%

“…Younger age at diagnosis 40 Without concomitant immunomodulator 40 De-escalation without endoscopic evaluation 4 Appropriate infliximab trough level before de-escalation 41 Elevated CRP 38 Histologically active (Nancy<2) 38 Elective decision 40 Withdrawal due to AE 40 Younger age at diagnosis 40,59 Male sex 60 Ileocolonic disease 61 Without concomitant immunomodulator 40 De-escalation without endoscopic evaluation 4 Without history of operation 60 Appropriate infliximab trough level before de-escalation 41 Previous TNFi dose escalation 61 Previous TNFi treatment 61 Low hemoglobin level 60 Increased WBC 59,60 Elevated CRP/FC level [58][59][60][61] Elective decision 40 Withdrawal due to AE 40…”

Section: Tnfimentioning

confidence: 99%

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De-escalation of Therapy in Patients with Quiescent Inflammatory Bowel Disease

Miyatani

2022

Gut and Liver

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Inflammatory bowel disease is a chronic disease of unknown origin that requires long-term treatment. The optical duration of maintenance treatment once remission has been achieved remains unclear. When discussing a de-escalation strategy, not only the likelihood of relapse but also, the outcome of retreatment for relapse after de-escalation should be considered. Previous evidence has demonstrated controversial results for risk factors for relapse after de-escalation due to the various definitions of remission and relapse. In fact, endoscopic or histologic remission has been suggested as a treatment target; however, it might not always be indicative of a successful drug withdrawal. For better risk stratification of relapse after de-escalation, it may be necessary to evaluate both the current and previous treatments. Following de-escalation, biomarkers should be closely monitored. In addition to the risk of relapse, a comprehensive understanding of the overall outcome, such as the long-term safety, patient quality of life, and impact on healthcare costs, is necessary. Therefore, a shared decision-making with patients on a case-by-case basis is imperative.

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Clinical outcome after anti‐tumour necrosis factor therapy discontinuation in 1000 patients with inflammatory bowel disease: the EVODIS long‐term study

Cited by 18 publications

References 25 publications

Relapse rates after withdrawal versus maintaining biologic therapy in IBD patients with prolonged remission

Relapse rates after withdrawal versus maintaining biologic therapy in IBD patients with prolonged remission

Evidence-Based Approach to the Discontinuation of Immunomodulators or Biologics in Inflammatory Bowel Disease

De-escalation of Therapy in Patients with Quiescent Inflammatory Bowel Disease

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