Outcome After Discontinuation of TNFα-blocking Therapy in Patients with Inflammatory Bowel Disease in Deep Remission

Molander, Pauliina; Färkkilä, Martti; Salminen, Kimmo; Kemppainen, Helena; Blomster, Timo; Koskela, Ritva; Jussila, Airi; Rautiainen, Henna; Nissinen, Markku; Haapamäki, Johanna; Arkkila, Perttu; Nieminen, U; Kuisma, Juha; Punkkinen, Jari; Kolho, Kaija‐Leena; Mustonen, Harri; Sipponen, Taina

doi:10.1097/mib.0000000000000052

Cited by 53 publications

(57 citation statements)

References 30 publications

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“…All achieved clinical remission within 14 weeks. This is consistent with other studies, which reported 93-96 % remission rates in CD patients and a 71 % remission rate in UC patients within 14 weeks of infl iximab retreatment (13,20,24).…”

Section: Effectiveness Of Retreatmentsupporting

confidence: 82%

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Relapse rates of inflammatory bowel disease patients in deep and clinical remission after discontinuing anti-tumor necrosis factor alpha therapy

Hlavatý¹,

Krajčovičová²,

Letkovsky³

et al. 2016

BLL

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BACKGROUND AND AIMS: Relapse rates after discontinuing anti-tumor necrosis factor-α (TNFα) therapy of infl ammatory bowel disease (IBD) patients in deep remission are poorly understood. This prospective singlecenter open-label study evaluated the relapse rates of IBD patients after stopping anti-TNFα therapy. METHODS: All IBD patients who were in clinical remission and stopped anti-TNFα therapy in 2011-2013 and were followed up for at least 12 months were enrolled. The "Ultradeep" patients were in calprotectin-negative (<50 ng/g) deep remission for at least six months and ceased anti-TNFα therapy on physician recommendations. The "clinical" patients were in clinical but not deep remission and ceased anti-TNFα therapy for other reasons. Relapse rates were assessed and relapse risk factors identifi ed. RESULTS: One year after stopping, 27 % and 27 % of the Ultradeep (n = 11) and Clinical (n = 11) patients relapsed, respectively. Two years after stopping, 57 % and 62 % relapsed, respectively (p = 0.89). All relapsed patients who underwent retreatment with anti-TNFα therap y re-entered remission. Male sex was a signifi cant risk factor for relapse (p = 0.03). CONCLUSION: Our study showed that even highly selected IBD patients who lack clinical, endoscopic or laboratory signs of disease activity have a relatively high relapse rate in the follow-up period after ceasing anti-TNFα therapy (Tab. 2, Fig. 3, Ref. 24). Text in PDF www.elis.sk.

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Section: Effectiveness Of Retreatmentsupporting

confidence: 82%

“…These include three retrospective and six prospective studies (11)(12)(13)(19)(20)(21)(22)(23)(24). All nine studies included rather few patients (14 to 121), all but two included only infl iximab stoppers, and only three studies included UC patients.…”

Section: Relapse Rates In Other Studiesmentioning

confidence: 99%

Relapse rates of inflammatory bowel disease patients in deep and clinical remission after discontinuing anti-tumor necrosis factor alpha therapy

Hlavatý¹,

Krajčovičová²,

Letkovsky³

et al. 2016

BLL

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“…The median time to relapse was between 4.8 and 16.4 months across the studies reporting this outcome. 38,47,49,53,55,[57][58][59][60][61] Five studies 39,57,[62][63][64] included patients withdrawn from therapy while in both clinical and endoscopic remission. Radiological healing as assessed by magnetic resonance imaging was also shown in one study.…”

Section: De-escalation Of Anti-tnf In CDmentioning

confidence: 99%

Systematic Review of Effects of Withdrawal of Immunomodulators or Biologic Agents From Patients With Inflammatory Bowel Disease

et al. 2015

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Little is known about the optimal duration of therapy with an anti-tumor necrosis factor (TNF) agent and/or an immunomodulator for patients with inflammatory bowel disease (IBD). We performed a systematic search of the literature to identify studies reporting after de-escalation (drug cessation or dose reduction) of anti-TNF agents and/or immunomodulators in patients in remission from IBD. Studies were reviewed according to the type of IBD and drug. Rates of relapse, factors associated with relapse, and response to re-treatment were determined. Our search yielded 6315 unique citations; we analyzed findings from 69 studies (18 on de-escalation [drug cessation or dose reduction] of immunomodulator monotherapy, 8 on immunomodulator de-escalation from combination therapy, and 43 on de-escalation of anti-TNF agents, including 3 during pregnancy) comprising 4672 patients. Stopping immunomodulator monotherapy after a period of remission was associated with high rates of relapse in patients with Crohn's disease or ulcerative colitis (approximately 75% of patients experienced a relapse within 5 years after therapy was stopped). Most studies of patients with Crohn's disease who discontinued an immunomodulator after combination therapy found that rates of relapse did not differ from those of patients who continued taking the drug (55%-60% had disease relapse 24 months after they stopped taking the immunomodulator). The only study in patients with ulcerative colitis supported continued immunomodulator use. Approximately 50% of patients who discontinued anti-TNF agents after combination therapy maintained remission 24 months later, but the proportion in remission decreased with time. Markers of disease activity, poor prognostic factors, and complicated or relapsing disease course were associated with future relapse. In conclusion, based on a systematic review, 50% or more of patients with IBD who cease therapy have a disease relapse. Further studies are required to accurately identify subgroups of patients who are good candidates for discontinuation of treatment. The decision to withdraw a drug should be made for each individual based on patient preference, disease markers, consequences of relapse, safety, and cost.Keywords : Crohn's Disease ; Ulcerative Colitis ; Patient Management ; Cessation.Abbreviations used in this paper : anti-TNF, anti-tumor necrosis factor therapy ; CD, Crohn's disease ; CRP, C-reactive protein ; FC, fecal calprotectin ; IBD, inflammatory bowel disease ; PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses ; RCT, randomized controlled trial ; TNF, tumor necrosis factor ; UC, ulcerative colitis.Therapeutic strategies in inflammatory bowel disease (IBD) have evolved considerably in the past few decades. The acknowledgment that subclinical and undertreated inflammation can lead to poor outcomes has underpinned a shift in treatment goals from symptomatic control to sustained clinical and endoscopic remission.1 Treatment strategies have changed accordingly, including the ear...

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“…In the case of extensive small bowel disease and/or symptomatic perianal fistulas, longterm treatment with anti-TNF agents is indicated, because alternative medical therapies are limited. [96][97][98] Retreatment of patients that experience a relapse after cessation of IFX therapy is usually well tolerated and the success rate is high, ranging from 71% to 94% in different studies. [96][97][98] Nevertheless, for IFX it is known that patients have an increased risk of developing (severe) infusion reactions and delayed hypersensitivity during reintroduction with IFX.…”

Section: Discontinuation and Reintroduction Of Anti-tnf Treatmentmentioning

confidence: 99%

“…[96][97][98] Retreatment of patients that experience a relapse after cessation of IFX therapy is usually well tolerated and the success rate is high, ranging from 71% to 94% in different studies. [96][97][98] Nevertheless, for IFX it is known that patients have an increased risk of developing (severe) infusion reactions and delayed hypersensitivity during reintroduction with IFX. [18,99,100] Despite limited evidence, we do recommend to always restart IFX together with corticosteroids and a H1-receptor antagonist as pre-medication in order to reduce the chance of developing an acute infusion reaction.…”

Section: Discontinuation and Reintroduction Of Anti-tnf Treatmentmentioning

confidence: 99%

Optimization of anti-TNF therapy in patients with Inflammatory Bowel Disease

Strik

Bots

D’Haens

et al. 2016

Expert Review of Clinical Pharmacology

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After the introduction of anti-tumor necrosis factor (anti-TNF) agents, the clinical outcome of patients with Inflammatory Bowel Disease (IBD) has improved significantly. However, use of anti-TNF therapy is complicated by loss of response. In order to maintain remission, adequate serum levels are required. Hence, therapeutic drug monitoring (TDM) is important in order to optimize serum drug levels, especially in patients with loss of response to these agents. Optimization of anti-TNF therapy by applying TDM enables clinicians to regain response to TNF blockers in a significant proportion of patients. It is important to use anti-TNF agents in their most optimal way, since these therapeutic agents are expensive and the medical options after failing anti-TNF therapy are limited. Here, we will discuss how to optimize treatment with anti-TNF agents in IBD patients in order to improve treatment efficacy, prevent anti-drug antibody formation, reduce side effects, discontinue unnecessary treatment and manage costs. ARTICLE HISTORY

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Outcome After Discontinuation of TNFα-blocking Therapy in Patients with Inflammatory Bowel Disease in Deep Remission

Cited by 53 publications

References 30 publications

Relapse rates of inflammatory bowel disease patients in deep and clinical remission after discontinuing anti-tumor necrosis factor alpha therapy

Relapse rates of inflammatory bowel disease patients in deep and clinical remission after discontinuing anti-tumor necrosis factor alpha therapy

Systematic Review of Effects of Withdrawal of Immunomodulators or Biologic Agents From Patients With Inflammatory Bowel Disease

Optimization of anti-TNF therapy in patients with Inflammatory Bowel Disease

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