Efficacy, Safety and Mucosal Healing of Methotrexate in a Large Longitudinal Cohort of Inflammatory Bowel Disease Patients

Rouiller-Braunschweig, Carole; Fournier, Nicolas; Pittet, Valérie; Michetti, Pierre

doi:10.1159/000482007

Cited by 6 publications

(7 citation statements)

References 22 publications

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“…Furthermore, the largest study to assess the efficacy of MTX in patients with IBD showed 59.9% and 40% efficacy for CD and UC, respectively, with rates comparable to smaller studies on this issue [11]. In our experience, the only patient who received MTX in combination with an anti-TNF agent had no improvement of their psoriatic lesions.…”

Section: Discussionsupporting

confidence: 60%

Paradoxical cutaneous manifestations induced by TNF inhibitors in patients with inflammatory bowel disease

Alaou¹,

Alami²,

Lagdali³

et al. 2023

Our Dermatol Online

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Background: Anti-TNF drugs have revolutionized the management of numerous inflammatory diseases, yet they may produce paradoxical effects. Materials and Methods: A descriptive study was conducted on patients with chronic inflammatory bowel disease (IBD) on anti-TNF therapy who had developed paradoxical psoriasis. Results: Out of a total of 218 patients followed for IBD on TNF inhibitors, five presented with paradoxical psoriasis. In four patients, a specific treatment for psoriasis was associated with anti-TNF treatment. In one patient, a swap to ustekinumab was decided. Good progress was noted in four patients. In one, there was no improvement of the psoriasis on methotrexate, which was switched to another anti-TNF agent. Conclusion: In our experience, TNF inhibitor-induced psoriasis is relatively rare (prevalence of 2.3%). The choice of treatment is reached by assessing the benefit-risk balance. Key words: Paradoxical cutaneous manifestations; TNF inhibitors; Cutaneous manifestations; Inflammatory bowel disease

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Section: Discussionsupporting

confidence: 60%

Paradoxical cutaneous manifestations induced by TNF inhibitors in patients with inflammatory bowel disease

Alaou¹,

Alami²,

Lagdali³

et al. 2023

Our Dermatol Online

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“…Other therapies currently approved for CD include methotrexate, ustekinumab and vedolizumab 54‐56 . However, patients with symptomatic strictures were excluded from pivotal phase III studies.…”

Section: Discussionmentioning

confidence: 99%

“…Other therapies currently approved for CD include methotrexate, ustekinumab and vedolizumab. [54][55][56] one paediatric 33 ) compared intralesional steroids to saline in patients who had failed medical therapy. In adult patients, quadrantic triamcinolone injection after endoscopic balloon dilation of CD ileocolonic anastomotic strictures was compared to placebo.…”

Section: (A Crohn's Disease Clinical Trial Evaluating Infliximab In A...mentioning

confidence: 99%

Systematic review: medical therapy for fibrostenosing Crohn’s disease

Lu¹,

Baraty²,

Robertson³

et al. 2020

Aliment Pharmacol Ther

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Background: Medical therapy and/or endoscopic balloon dilation with intralesional therapies are options for the treatment of small bowel fibrostenotic Crohn's disease (CD). Aim: To perform a systematic review summarising evidence for efficacy of systemic and endoscopic intralesional medical therapy in established small bowel strictures in adult CD patients. Methods: A systematic search of MEDLINE, EMBASE, CENTRAL and Scopus was conducted. Primary outcomes were rates of surgical resection and repeat endoscopic dilation. Pooled event rates from random effects models across studies with 95% confidence intervals were reported.Results: Ten studies describing systemic medical therapy and eight studies of intralesional injection were included. One randomised controlled trial each for systemic therapy and intrastricture injection were identified. Only observational studies were found for systemic biologic therapies, which exclusively included tumour necrosis factor (TNF) antagonists, while intralesional therapies all involved corticosteroids except for one study that evaluated infliximab. Pooled event rates for surgical resection after systemic and intralesional therapy were 28.3% (95% CI: 18.2%-41.3%) and 18.5% (95% CI: 8.3%-36.2%), respectively over a median follow-up of 23 months (range 5.5-105.8), and 21.8 months (range 5-47). Risk of repeat endoscopic balloon dilation in those with intralesional therapy was 58.3% (95% CI: 36.6%-77.3%) over a median follow-up of 21.8 months (range 5-47). Conclusions:There are no favoured therapies for patients with stricturing small bowel CD. Data are lacking for ustekinumab and vedolizumab. No endoscopic intralesional medications provided a clear benefit for prevention of repeat EBD or surgery.

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“…Steroid-dependency is the only indication for which MTX currently has evidence from RCTs in CD, all performed in the pre-biological era ( Table 1 ). 10 , 39 – 43 Many other uncontrolled studies, mostly retrospective ( Tables 2 and 3 ), 9 , 44 – 65 are also available, but they have included heterogeneous populations of both steroid-refractory and steroid-dependent patients, thus preventing a clear interpretation of the performance of the various formulations of MTX in these two distinct clinical scenarios. In particular, the efficacy of MTX in steroid-refractory patients is not analyzed in any specific study.…”

Section: Resultsmentioning

confidence: 99%

“…No controlled studies have analyzed the endoscopic and histological healing of MTX as primary endpoints in CD. The ability of MTX to induce mucosal healing in CD is reported in two prospective uncontrolled studies 1 , 70 and in four small retrospective studies, 63 , 64 , 71 , 72 ranging from 11% to 45% according to different definitions of complete endoscopic remission. The most favourable data have been described with parenteral formulations, starting with doses of 20–25 mg/week ( Table 4 ).…”

Section: Resultsmentioning

confidence: 99%

Evidence-based efficacy of methotrexate in adult Crohn’s disease in different intestinal and extraintestinal indications

Cassinotti¹,

Batticciotto²,

Parravicini³

et al. 2022

Therap Adv Gastroenterol

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Introduction: Methotrexate (MTX) is included in the therapeutic armamentarium of Crohn’s disease (CD), although its positioning is currently uncertain in an era in which many effective biological drugs are available. No systematic reviews or meta-analysis have stratified the clinical outcomes of MTX according to the specific clinical scenarios of its use. Methods: Medline, PubMed and Scopus were used to extract eligible studies, from database inception to May 2021. A total of 163 studies were included. A systematic review was performed by stratifying the outcomes of MTX according to formulation, clinical indication and criteria of efficacy. Results: The use of MTX is supported by randomized clinical trials only in steroid-dependent CD, with similar outcomes to thiopurines. The use of MTX in patients with steroid-refractoriness, failure of thiopurines or in combination with biologics is not supported by high levels of evidence. Combination therapy with biologics can optimize the immunogenic profile of the biological drug, but the impact on long-term clinical outcomes is described only in small series with anti-TNFα. Other off-label uses, such as fistulizing disease, mucosal healing, postoperative prevention and extraintestinal manifestations, are described in small uncontrolled series. The best performance in most indications was shown by parenteral MTX, favouring higher doses (25 mg/week) in the induction phase. Discussion: Evidence from high-quality studies in favour of MTX is scarce and limited to the steroid-dependent disease, in which other drugs are the leading players today. Many limitations on study design have been found, such as the prevalence of retrospective underpowered studies and the lack of stratification of outcomes according to specific types of patients and formulations of MTX. Conclusion: MTX is a valid option as steroid-sparing agent in steroid-dependent CD. Numerous other clinical scenarios require well-designed clinical studies in terms of patient profile, drug formulation and dosage, and criteria of efficacy.

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Efficacy, Safety and Mucosal Healing of Methotrexate in a Large Longitudinal Cohort of Inflammatory Bowel Disease Patients

Cited by 6 publications

References 22 publications

Paradoxical cutaneous manifestations induced by TNF inhibitors in patients with inflammatory bowel disease

Paradoxical cutaneous manifestations induced by TNF inhibitors in patients with inflammatory bowel disease

Systematic review: medical therapy for fibrostenosing Crohn’s disease

Evidence-based efficacy of methotrexate in adult Crohn’s disease in different intestinal and extraintestinal indications

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