Addition of Granulocyte/Monocyte Apheresis to Oral Prednisone for Steroid-dependent Ulcerative Colitis: A Randomized Multicentre Clinical Trial

Domènech, Eugeni; Panés, Julián; Hinojosa, Joaquín; Annese, Vito; Magro, Fernando; Sturniolo, Giacomo Carlo; Bossa, Fabrizio; Fernández, Francisco; González-Conde, Benito; García–Sánchez, Valle; Dignaß, Axel; Herrera, José Manuel Palma; Cabriada, José Luis; Guardiola, Jordi; Vecchi, Maurizio; Portela, Francisco; Ginard, Daniel

doi:10.1093/ecco-jcc/jjy023

Cited by 11 publications

(5 citation statements)

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“…Three unblinded studies were at high risk of performance bias. 19 22 25 Because of the nature of the intervention, four studies which lacked a description of the blinding process were interpreted as having a high risk of bias. 18 21 23 24 As regards assessment blinding, two unblinded studies were judged to be at high risk of bias.…”

Section: Resultsmentioning

confidence: 99%

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Granulocyte and monocyte apheresis as an adjunctive therapy to induce and maintain clinical remission in ulcerative colitis: a systematic review and meta-analysis

et al. 2021

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ObjectiveThe goal of treatment in ulcerative colitis (UC) is to induce and maintain remission. The addition of granulocyte and monocyte apheresis (GMA) to conventional therapy may be a promising therapeutic alternative. In this meta-analysis, we aimed to assess the efficacy and safety profile of GMA as an adjunctive therapy.DesignSystematic review and meta-analysis.MethodsWe searched four databases (MEDLINE, Embase, Web of Science and Cochrane Central Register of Controlled Trials) for randomised or minimised controlled trials which discussed the impact of additional GMA therapy on clinical remission induction and clinical remission maintenance compared with conventional therapy alone. Primary outcomes were clinical remission induction and maintenance, secondary outcomes were adverse events (AEs) and steroid-sparing effect. ORs with 95% CIs were calculated. Trial Sequential Analyses were performed to adjusts for the risk of random errors in meta-analyses.ResultsA total of 11 studies were eligible for meta-analysis. GMA was clearly demonstrated to induce and maintain clinical remission more effectively than conventional therapy alone (598 patients: OR: 1.93, 95% CI 1.28 to 2.91, p=0.002, I2=0.0% for induction; 71 patients: OR: 8.34, 95% CI 2.64 to 26.32, p<0.001, I2=0.0% for maintenance). There was no statistically significant difference in the number of AEs (OR: 0.27, 95% CI 0.05 to 1.50, p=0.135, I2=84.2%).ConclusionGMA appears to be more effective as an adjunctive treatment in inducing and maintaining remission in patients with UC than conventional therapy alone.PROSPERO registration numberCRD42019134050.

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Section: Resultsmentioning

confidence: 99%

“… 18 21 23 24 As regards assessment blinding, two unblinded studies were judged to be at high risk of bias. 19 25 Two studies were deemed as having a high risk of other bias; although they used ITT analysis, they considered subjects who left the study as a treatment failure that may lead to bias. 7 …”

Section: Resultsmentioning

confidence: 99%

Granulocyte and monocyte apheresis as an adjunctive therapy to induce and maintain clinical remission in ulcerative colitis: a systematic review and meta-analysis

et al. 2021

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“…Patients were excluded if they used probiotics or antibiotics within the preceding 8 weeks, were pregnant, or were unable to provide informed consent. Prednisolone (PSL) dependency was defined by the inability to withdraw corticosteroids without recurrence, or the appearance of relapse within 3 months after withdrawal of corticosteroids [22]. Donors Donors were ≥20 years old and met all conditions according to the FMT guidelines reported by Bakken et al [23].…”

Section: Recipientsmentioning

confidence: 99%

Oral Corticosteroids Impair Mucin Production and Alter the Posttransplantation Microbiota in the Gut

et al. 2022

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Introduction: Gut microbiota alterations cause inflammation in patients with ulcerative colitis (UC). Fecal microbiota transplantation (FMT) enables manipulating the microbiota’s composition, but the mechanisms underlying colonization of the posttransplantation microbiota are poorly understood. Methods: In this open-label, nonrandomized study, the FMT efficacy and changes in the gut microbiota were evaluated in 8 UC patients with mild-to-moderately active endoscopic colonic lesions. Compositional changes in the fecal and mucosal microbiotas between donors and recipients were examined via 16S rRNA-based sequencing. To investigate the effects of oral corticosteroids on microbiota colonization, FMT was performed in germ-free prednisolone (PSL)-administered mice to examine the factors determining colonization. Results: Four UC patients achieved clinical remission (CR) after FMT, and 3 also achieved endoscopic remission. The fecal microbiotas of the CR patients changed similar to those of the donors after FMT. The mucin-coding gene, MUC2, was less expressed in the colons of the PSL-dependent patients than in the PSL-free patients. In the mice, PSL treatment decreased the fecal mucin production and altered the posttransplantation fecal microbiota composition. Adding either exogenous mucin or the mucin secretagogue, rebamipide, partially alleviated the PSL-induced dysbiosis of the gut microbiota. Administering rebamipide with FMT from healthy donors relieved inflammation in mice with Enterococcus faecium-induced colitis. Conclusion: Colonic mucin controlled the gut microbiota composition, and oral corticosteroid treatment modified the gut microbiota partly by reducing the colonic mucin.

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“…In the majority of published studies, a remission rate of 39–71% has been achieved in patients with steroid-dependent or steroid-refractory UC, and the steroid-sparing effects of this treatment have been proven [ 8 , 9 , 15 , 17 , 18 ]. However, some of the reported data failed to prove the benefits of apheresis treatment [ 19 , 20 ]. Moreover, some of the studies concerning leukocytapheresis in UC patients are unblinded, with single-arm design, meaning that statistical comparisons could not be performed.…”

Section: Leukocytapheresis Efficacy In Ulcerative Colitismentioning

confidence: 99%

“…in analysis of efficacy and safety of adding GMA to oral prednisone in patients with steroid-dependent UC. The authors concluded that the addition of 7 weekly sessions of GMA to a conventional course of oral prednisone did not increase the proportion of steroid-free remissions in patients with active steroid-dependent UC, although it delayed clinical relapse [ 20 ].…”

Section: Leukocytapheresis Efficacy In Ulcerative Colitismentioning

confidence: 99%

Leukocytapheresis in patients with inflammatory bowel diseases

Woźniak¹,

Kurnatowska²,

Małecka‐Panas³

et al. 2021

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Leukocytapheresis, a blood purification therapy, exerts anti-inflammatory effects by removing activated leukocytes from the peripheral blood through extracorporeal circulation. It is a potential option of treatment for patients with inflammatory bowel diseases (IBD), especially those with ulcerative colitis (UC), who do not respond to conventional therapy. Given that it has a favourable safety profile and seems to have steroid sparing effects, its position in the treatment of UC is likely to expand. However, there is inadequate evidence to draw any conclusions about the efficacy of leukocytapheresis in patients with Crohn's disease, and it should only be used in accordance with special arrangements for consent. Considering the current level of knowledge, it is essential to conduct large, well-designed, randomized clinical trials to evaluate the effects of leukocytapheresis in the management of IBD patients.

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Addition of Granulocyte/Monocyte Apheresis to Oral Prednisone for Steroid-dependent Ulcerative Colitis: A Randomized Multicentre Clinical Trial

Abstract: In a randomized trial, the addition of 7 weekly sessions of GMA to a conventional course of oral prednisone did not increase the proportion of steroid-free remissions in patients with active steroid-dependent UC, though it delayed clinical relapse.

Cited by 11 publications

References 21 publications

Granulocyte and monocyte apheresis as an adjunctive therapy to induce and maintain clinical remission in ulcerative colitis: a systematic review and meta-analysis

Granulocyte and monocyte apheresis as an adjunctive therapy to induce and maintain clinical remission in ulcerative colitis: a systematic review and meta-analysis

Oral Corticosteroids Impair Mucin Production and Alter the Posttransplantation Microbiota in the Gut

Leukocytapheresis in patients with inflammatory bowel diseases

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