Interferon-β-1a for the Treatment of Steroid-Refractory Ulcerative Colitis: A Randomized, Double-Blind, Placebo-Controlled Trial

Musch, E.; Andus, T.; Kruis, Wolfgang; Raedler, Andreas; Spehlmann, Martina E.; Schreiber, Stefan; Krakamp, B; Malek, Mouhamad; Malchow, H; Závada, Filip

doi:10.1016/s1542-3565(05)00208-9

Cited by 63 publications

(43 citation statements)

References 18 publications

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“…However, several placebo-controlled follow-up trials of sargramostim in patients with active Crohn's disease failed to achieve their primary endpoint [15,16] . Likewise, controlled studies with pegylated interferonα 2a and interferonb 1a in patients with active UC failed to demonstrate clinical benefit [17,18] . In addition to the lack of efficacy in patients with IBD, immunostimulatory regimens may be potentially harmful and therefore put patients at risk to aggravate or induce other autoimmune processes.…”

Section: Discussionmentioning

confidence: 99%

Development of ulcerative colitis in a patient with multiple sclerosis following treatment with interferonβ 1a

Schott

Paul²,

Wuerfel³

et al. 2007

WJG

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To alert clinicians to a potential novel adverse drug effect of interferonb 1a, we herein report a patient with relapsing-remitting multiple sclerosis who developed ulcerative colitis following treatment with interferonb 1a. Ulcerative colitis persisted despite discontinuation o f i n t e r f e r o n b 1 a t r e a t m e n t a n d s w i t c h i n g t h e patient to glatiramer acetate. Tacrolimus (FK506), 6-mercaptopurine, and prednisolone were required to induce remission. Both ulcerative colitis and multiple sclerosis were eventually well controlled using this regimen. Our report underscores that caution should be exercised when prescribing immunostimulatory agents in patients with inflammatory bowel disease (IBD) and challenges current efforts to stimulate innate immunity as a novel therapeutic concept for IBD.

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Section: Discussionmentioning

confidence: 99%

Development of ulcerative colitis in a patient with multiple sclerosis following treatment with interferonβ 1a

Schott

Paul²,

Wuerfel³

et al. 2007

WJG

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“…62 Several case reports suggest a potential benefit of interferon-a in patients with UC. [119][120][121][122] However, a Cochrane review including three prospective studies of interferon-a in patients with UC concluded that interferon-a was not an effective option for this condition. 123 Patients with UC and concomitant HBV or HCV infection could receive interferon-a as the onset of adverse effects is less likely during the course of UC than during that of CD.…”

Section: What Is the Risk Of Exacerbation Of Ibd With Interferon?mentioning

confidence: 99%

Review article: prevention and management of hepatitis B and C infection in patients with inflammatory bowel disease

Gisbert

Chaparro

Esteve

2011

Alimentary Pharmacology &Amp; Therapeutics

105

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“…One study, reported only the mean age of 38. 24 There was no age subgroup analysis of the results in this study.…”

Section: Interferonmentioning

confidence: 79%

“…Nikolaus, Musch and Pena-Rossi studied interferon beta-1 and Tilg examined pegylated interferon alpha. 24,25,27,37 The mean age in these studies ranged was 36.9-42.2. One interferon-beta-1a study reported an age range of 32-68.…”

Section: Interferonmentioning

confidence: 98%

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Treatment of Ulcerative Colitis in the Elderly: A Systematic Review

Baggenstos

Hanson²,

Shaukat

2013

Clinical Medicine Insights: Geriatrics

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Ulcerative colitis (UC) is increasingly recognized as a disease affecting the elderly. Approximately 10%-30% of the UC population is over the age of 60 years. Additionally, younger patients with UC are aging and thus comprise a second group of elderly IBD patients. To date, there have been no clinical trials that have evaluated treatment efficacy of UC in the elderly population. The aim of our study was to conduct a systematic review of all randomized controlled trials (RCTs) addressing treatment outcome in UC; we also sought to identify the elderly population, defined as age 60 years or older, represented in these studies, to see if pooled data would lead to meaningful conclusions regarding treatment efficacy and safety profile in the elderly. A search of the MEDLINE database via PubMed and the EMBASE database via Scopus was performed to identify all RCTs evaluating medical therapy for UC in humans, published within the English language through September 2012. Studies were grouped into three categories: biological agent (BA) therapy; immunosuppressant (IS) therapy; and 5-aminosalicylic acid (5-ASA) therapy. To estimate the number of elderly patients in each study, mean age plus 1 and 2 standard deviations (SD) was calculated to find the closest approximation to age 60. Of 876 studies, 112 RCTs were included in the final analysis-20 studies for BA, 20 for IS, and 72 for 5-ASA agents. While nearly all studies reported either a mean or median age, only 38% additionally reported the SD and age range. The mean composite age was 39.2 years for the BA studies, 38.5 years for the IS studies, and 42.8 years for the 5-ASA studies, consistent with a young middle-aged patient. We estimated that no more than 16% of patients per study would have qualified as elderly, and in most cases a much smaller percentage (,8%). Additionally, there were no BA or IS RCTs that reported results by age subgroup analysis. Four studies in the 5-ASA group report age-specific analyses and showed no difference in treatment efficacy by age. None of the 112 RCTs reported age sub-analyses of safety, tolerability, adverse events, or withdrawal rates. There is insufficient evidence to evaluate efficacy of treatment and adverse events from treatment for UC in the elderly. With the rising number of elderly patients with UC, there is a need for more clinical trials that specifically address UC treatment in this unique population.

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Interferon-β-1a for the Treatment of Steroid-Refractory Ulcerative Colitis: A Randomized, Double-Blind, Placebo-Controlled Trial

Cited by 63 publications

References 18 publications

Development of ulcerative colitis in a patient with multiple sclerosis following treatment with interferonβ 1a

Development of ulcerative colitis in a patient with multiple sclerosis following treatment with interferonβ 1a

Review article: prevention and management of hepatitis B and C infection in patients with inflammatory bowel disease

Treatment of Ulcerative Colitis in the Elderly: A Systematic Review

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