A Double-blind, Placebo-controlled, Randomized Study of Infliximab in Primary Sclerosing Cholangitis

Hommes, Daan W.; Erkelens, Willemien; Ponsioen, Cyriel Y.; Stokkers, Pieter; Rauws, E.A.J.; Spek, Mirjam van der; Kate, Fiebo Ten; Deventer, Sander J. van

doi:10.1097/mcg.0b013e3181662426

Cited by 112 publications

(72 citation statements)

References 31 publications

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“…Autoimmunity has a strong association for PSC with IBD [1,30] . Various IAs such as corticosteroid [31,32] , infliximab [16] , natalizumab [33] , tacrolimus [34] , mycophenolate mofetil [15,35] , budesonide, and prednisolone [12,36,37] had been investigated. However, the clinical benefit and risk associated with the administration of IAs in PSC patients remain inconclusive.…”

Section: Discussionmentioning

confidence: 99%

“…Six trials reported the dropout numbers in the treatment (29 patients) and the control (6 patients) group [3,4,[13][14][15][16] . One study did not report the exact dropout rate [12] .…”

Section: Methodological Quality Of Included Studiesmentioning

confidence: 99%

“…1 ). Five RCTs compared penicillamine [13] , colchicine [14] , infliximab [16] , MTX [4] , mycophenolate mofetil plus UDCA [15] with UDCA. Two retrospective comparative studies compared MTX plus UDCA with UDCA [3] , colchicine plus prednisone with placebo [12] .…”

Section: Characteristics Of Included Trailsmentioning

confidence: 99%

“…A subgroup analysis was performed according to IAs monotherapy or co-administration therapy. IAs monotherapy included 4 RCTs with no significant influence of primary outcome (RR 0.94, 95% CI 0.58-1.53, p = 0.80) [4,13,14,16] . Co-administration therapy included 3 trials; 2 were MTX and mycophenolate mofetil combined with UDCA respectively [3,15] and one was a combination of prednisone and colchicine [12] .…”

Section: Risk Of Bias In Included Studiesmentioning

confidence: 99%

“…An uncontrolled study in 12 patients with co-administration of prednisone and colchicine reported a significant improvement in liver function test at 6 and 12 months [12] . In addition, penicillamine, colchicine, MTX, and mycophenolate mofetil (MMF) have been explored in randomized controlled trials (RCTs) or retrospective comparative studies [3,4,[12][13][14][15][16] . However, the benefit of IAs to PSC patients is still uncertain.…”

mentioning

confidence: 99%

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Immunosuppressive Agents for the Treatment of Primary Sclerosing Cholangitis: A Systematic Review and Meta-Analysis

Peng

Luo²,

Hou³

et al. 2017

Dig Dis

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Objectives: Currently, there are no effective therapeutic agents for patients with primary sclerosing cholangitis (PSC). This study aimed to evaluate the safety and efficiency of immunosuppressive agents (IAs) for the treatment of PSC. Methods: The literatures were searched using the following keywords singly or in combination: PSC, treatments, IAs. The primary outcome was defined as the need for liver transplantation or mortality. Results: Two hundred sixty six patients from 7 eligible studies were analyzed. IAs had no remarkable effects on the rate of mortality or liver transplantation (relative risk, RR 1.02, 95% CI 0.58-1.62, p = 0.92). Subgroup analyses showed no significant effect of IAs co-administration therapy (IAs co-administered with ursodeoxycholic acid, IA co-administered with IA; RR 1.41, 95% CI 0.40-4.95, p = 0.60). IAs caused adverse events (AEs) such as diarrhea, abdominal pain, and pruritus (RR 1.81, 95% CI 1.07-3.07, p = 0.03). IAs therapy did not significantly improve markers of liver function except for aspartate transaminase (weighted mean difference -9.76, 95% CI -12.92 to -6.6, p < 0.001). Conclusion: IAs administrated as either monotherapy or combination therapy do not reduce the risk of mortality or liver transplantation. IAs monotherapy is associated with AEs.

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Section: Discussionmentioning

confidence: 99%

“…Six trials reported the dropout numbers in the treatment (29 patients) and the control (6 patients) group [3,4,[13][14][15][16] . One study did not report the exact dropout rate [12] .…”

Section: Methodological Quality Of Included Studiesmentioning

confidence: 99%

Section: Characteristics Of Included Trailsmentioning

confidence: 99%

Section: Risk Of Bias In Included Studiesmentioning

confidence: 99%

mentioning

confidence: 99%

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Immunosuppressive Agents for the Treatment of Primary Sclerosing Cholangitis: A Systematic Review and Meta-Analysis

Peng

Luo²,

Hou³

et al. 2017

Dig Dis

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Pharmacological interventions for primary sclerosing cholangitis

Saffioti

Gurusamy

Hawkins

et al. 2017

Cochrane Database of Systematic Reviews

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Evidence is currently insufficient to show differences in effectiveness measures such as mortality, health-related quality of life, cirrhosis, or liver transplantation between any active pharmacological intervention and no intervention. However, trials were at high risk of bias and included small numbers of participants, had short follow-up periods, and reported few clinical outcomes. An urgent need exists to identify an effective medical treatment for primary sclerosing cholangitis through well-designed RCTs with adequate follow-up that aim to identify differences in outcomes important to people with primary sclerosing cholangitis.

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Primary Sclerosing Cholangitis

Vesterhus

Karlsen

2019

Evidence‐based Gastroenterology and Hepatology 4e

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A Double-blind, Placebo-controlled, Randomized Study of Infliximab in Primary Sclerosing Cholangitis

Abstract: Study findings failed to demonstrate efficacy of infliximab in this small group of patients with established primary sclerosing cholangitis.

Cited by 112 publications

References 31 publications

Immunosuppressive Agents for the Treatment of Primary Sclerosing Cholangitis: A Systematic Review and Meta-Analysis

Immunosuppressive Agents for the Treatment of Primary Sclerosing Cholangitis: A Systematic Review and Meta-Analysis

Pharmacological interventions for primary sclerosing cholangitis

Primary Sclerosing Cholangitis

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