Methotrexate Is Not Superior to Placebo for Inducing Steroid-Free Remission, but Induces Steroid-Free Clinical Remission in a Larger Proportion of Patients With Ulcerative Colitis

Carbonnel, Franck; Colombel, Jean Fréd́eric; Filippi, Jérôme; Κατσάνος, Κωνσταντίνος; Peyrin–Biroulet, Laurent; Allez, Matthieu; Nachury, Maria; Novacek, Gottfried; Danese, Silvio; Abitbol, Véred; Bossa, Fabrizio; Moreau, Jacques; Bommelaer, Gilles; Bourreille, Arnaud; Fuméry, Mathurin; Roblin, Xavier; Reinisch, Walter; Bouhnik, Yoram; Brixi, Hédia; Seksik, Philippe; Malamut, Georgia; Färkkilä, Martti; Coulibaly, Baya; Dewit, Olivier; Louis, Édouard; Deplanque, Dominique; Michetti, Pierre; Sarter, Hélène; Laharie, David; Demolin, Julie; Détré, Patricia; Brillaut, Gaëlle

doi:10.1053/j.gastro.2015.10.050

Cited by 117 publications

(65 citation statements)

References 27 publications

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“…The primary endpoint achieved was steroid-free remission as defined by a Mayo score ≤ 2 with no item >1, hence including clinical as well as endoscopic features, and complete withdrawal of steroids at week 16. In this trial, methotrexate was not superior to placebo in terms of the primary endpoint of the study [14] . Notably, one secondary endpoint was attained, namely, methotrexate-induced clinical remission without steroids at week 16.…”

Section: Recent Developmentsmentioning

confidence: 60%

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Ulcerative Colitis

Sonnenberg

Siegmund

2016

Digestion

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Background: Ulcerative colitis (UC) is a chronic inflammatory bowel disease that is chronically present in patients throughout their lives. Hence, the chronic nature of the disease invariably requires continuous medical treatment. Advances in medical therapy over the last decades and current developments offer increasing options and are closely associated with a better life quality in patients. Summary: Recent developments in understanding the pathogenesis of UC are discussed. The current standard therapeutic regimens are outlined and recent developments and upcoming strategies introduced. Key Points: (1) Environmental factors that are yet to be defined contribute to the pathogenesis of UC. (2) An accelerated step-up therapy represents the current standard in UC. (3) Anti-integrins represent the most recently introduced pharmacological class in the therapy of UC. (4) Novel strategies including Janus kinase inhibitors are in the near future.

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Section: Recent Developmentsmentioning

confidence: 60%

“…The recent METEOR trial by the GETAID group fills this gap [14] . Here, patients with steroiddependent UC were randomly assigned to receive either placebo or methotrexate (25 mg/weekly) for 24 weeks.…”

Section: Recent Developmentsmentioning

confidence: 99%

Ulcerative Colitis

Sonnenberg

Siegmund

2016

Digestion

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“…A total of 32 studies were included (23 induction trials and nine combined induction and maintenance trials) . The PRISMA flow diagram is presented in Figure S1 and baseline trial characteristics are summarised in Table and Table S1.…”

Section: Resultsmentioning

confidence: 99%

Systematic review with meta‐analysis: high prevalence and cost of continued aminosalicylate use in patients with ulcerative colitis escalated to immunosuppressive and biological therapies

Guizzetti

Cipriano

et al. 2018

Aliment Pharmacol Ther

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Summary Background Aminosalicylates are the most frequently prescribed treatment for ulcerative colitis (UC). In the absence of empirical evidence, clinicians are uncertain whether to continue aminosalicylates in patients with UC after escalating therapy. Aims To quantify concomitant aminosalicylate use in UC randomised clinical trials (RCTs), identify factors associated with their use, and estimate treatment costs of concomitant aminosalicylate therapy. Methods MEDLINE, Embase, and CENTRAL were searched from inception to 1 March 2017 for placebo‐controlled RCTs of immunosuppressants, biologics, or oral small molecules in adults with UC. The proportion of patients prescribed concomitant aminosalicylates at trial entry was pooled using a random‐effects model. Meta‐regression was performed to assess trial‐level factors associated with aminosalicylate use. Treatment costs were estimated using 2018 formulary data from five Canadian provinces. Results Thirty‐two trials were included (23 induction only, nine induction, and maintenance trials). The pooled proportion of patients co‐prescribed aminosalicylates was 80.7% (95% CI 75.5%‐85.1%), with considerable observed heterogeneity (I2 = 95%). In univariable meta‐regression, aminosalicylate use was not associated with trial design, setting, year of publication, disease severity, disease duration, or drug class. The estimated direct annual treatment cost of concomitant aminosalicylates is ~$20 million for the Canadian UC population, assuming conservative estimates of UC prevalence, aminosalicylate use and dose, and the lowest cost formulation. Conclusions Approximately 80% of UC patients entering clinical trials of immunosuppressants, biologics, or oral small molecules continue to use aminosalicylates. An RCT is needed to inform the benefits and harms of continuing vs stopping aminosalicylates in patients escalating therapy.

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“…In a larger study comparing the effects of azathioprine monotherapy against infliximab monotherapy or the combination of both, mucosal healing rates after 4 months of therapy were 37, 55, and 63%, respectively [21]. Regarding methotrexate, a recent trial also indicated that endoscopic healing without steroids at week 16 was obtained in 21 of 60 (35.0%) patients randomized to the methotrexate arm in comparison to 13 of 51 (25.5%) patients randomized to the placebo arm in a cohort of steroid-dependent ulcerative colitis patients (p = 0.28), where clinical efficacy could not be proven on a statistically significant level [22].…”

Section: Immunomodulatorsmentioning

confidence: 99%

Current and Future Targets for Mucosal Healing in Inflammatory Bowel Disease

Atreya

Neurath

2017

Visc Med

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The induction and subsequent maintenance of mucosal healing has emerged as one of the central therapeutic goals in the management of patients with inflammatory bowel disease (IBD) (Crohn's disease and ulcerative colitis). Current and novel treatment options are assessed regarding their therapeutic efficacy on the basis of their ability to induce mucosal healing. However, there is still substantial debate about the precise definition of mucosal healing. Here, we will give an overview regarding the definitions of mucosal healing as well as its probable effects on long-term disease behavior and finally focus on current and potential therapeutic targets to achieve this therapeutic goal in IBD patients.

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Methotrexate Is Not Superior to Placebo for Inducing Steroid-Free Remission, but Induces Steroid-Free Clinical Remission in a Larger Proportion of Patients With Ulcerative Colitis

Cited by 117 publications

References 27 publications

Ulcerative Colitis

Ulcerative Colitis

Systematic review with meta‐analysis: high prevalence and cost of continued aminosalicylate use in patients with ulcerative colitis escalated to immunosuppressive and biological therapies

Current and Future Targets for Mucosal Healing in Inflammatory Bowel Disease

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