Long-Term Benefit of Mesalamine Granules for Patients Who Achieved Corticosteroid-Induced Ulcerative Colitis Remission

Gary R. Lichtenstein, Glenn L. Gordon, Salam Zakko, Uma Murthy, Shahriar Sedghi, Ronald Pruitt, Andrew C. Barrett, Enoch Bortey, Craig Paterson, William P. Forbes

    Research output: Contribution to journalArticle

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    Abstract

    Background: Patients with ulcerative colitis (UC) who achieve remission with corticosteroids often relapse after tapering or discontinuation; alternative treatments limiting steroid exposure and UC relapse would be beneficial. It remains uncertain whether patients with corticosteroid-induced remission experience benefit with mesalamine granules (MG), a locally acting aminosalicylate extended-release capsule formulation for maintenance of UC remission in adults. Aims: Efficacy and safety of MG 1.5 g once daily was evaluated in patients with UC in corticosteroid-induced remission. Methods: Data from patients with previous corticosteroid use to achieve baseline UC remission were analyzed from two 6-month randomized, double-blind, placebo-controlled trials and a 24-month open-label extension (OLE). Six-month relapse-free rates were assessed using the revised Sutherland Disease Activity Index. UC-related adverse events (AEs) were recorded during the 30 months. Results: Included were 158 steroid-treated patients in UC remission (MG, n = 105; placebo, n = 53) and 74/105 MG-treated patients who continued MG in the OLE. A significantly larger percentage of patients remained relapse-free at 6 months with MG (77.1 %) versus placebo (54.7 %; P = 0.006), with a 55 % reduction in relapse risk (hazard ratio [HR] 0.45; 95 % CI 0.25–0.79). There was a similar (49.2 %) reduction in risk of UC-related AEs at 6 months (HR 0.51; 95 % CI 0.31–0.84; P = 0.009) that was sustained during the OLE. Conclusions: MG 1.5 g once daily administered for maintenance of corticosteroid-induced remission was associated with low risk of relapse and UC-related AEs. ClinicalTrials.gov: NCT00744016, NCT00767728, and NCT00326209.

    Original languageEnglish (US)
    Pages (from-to)221-229
    Number of pages9
    JournalDigestive Diseases and Sciences
    Volume61
    Issue number1
    DOIs
    StatePublished - Jan 1 2016

    Fingerprint

    Mesalamine
    Ulcerative Colitis
    Adrenal Cortex Hormones
    Recurrence
    Placebos
    Steroids
    Maintenance
    Risk Reduction Behavior
    Capsules
    Odds Ratio
    Safety

    All Science Journal Classification (ASJC) codes

    • Physiology
    • Gastroenterology

    Cite this

    Lichtenstein, G. R., Gordon, G. L., Zakko, S., Murthy, U., Sedghi, S., Pruitt, R., ... Forbes, W. P. (2016). Long-Term Benefit of Mesalamine Granules for Patients Who Achieved Corticosteroid-Induced Ulcerative Colitis Remission. Digestive Diseases and Sciences, 61(1), 221-229. https://doi.org/10.1007/s10620-015-3866-7

    Long-Term Benefit of Mesalamine Granules for Patients Who Achieved Corticosteroid-Induced Ulcerative Colitis Remission. / Lichtenstein, Gary R.; Gordon, Glenn L.; Zakko, Salam; Murthy, Uma; Sedghi, Shahriar; Pruitt, Ronald; Barrett, Andrew C.; Bortey, Enoch; Paterson, Craig; Forbes, William P.

    In: Digestive Diseases and Sciences, Vol. 61, No. 1, 01.01.2016, p. 221-229.

    Research output: Contribution to journalArticle

    Lichtenstein, GR, Gordon, GL, Zakko, S, Murthy, U, Sedghi, S, Pruitt, R, Barrett, AC, Bortey, E, Paterson, C & Forbes, WP 2016, 'Long-Term Benefit of Mesalamine Granules for Patients Who Achieved Corticosteroid-Induced Ulcerative Colitis Remission', Digestive Diseases and Sciences, vol. 61, no. 1, pp. 221-229. https://doi.org/10.1007/s10620-015-3866-7
    Lichtenstein, Gary R. ; Gordon, Glenn L. ; Zakko, Salam ; Murthy, Uma ; Sedghi, Shahriar ; Pruitt, Ronald ; Barrett, Andrew C. ; Bortey, Enoch ; Paterson, Craig ; Forbes, William P. / Long-Term Benefit of Mesalamine Granules for Patients Who Achieved Corticosteroid-Induced Ulcerative Colitis Remission. In: Digestive Diseases and Sciences. 2016 ; Vol. 61, No. 1. pp. 221-229.
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    abstract = "Background: Patients with ulcerative colitis (UC) who achieve remission with corticosteroids often relapse after tapering or discontinuation; alternative treatments limiting steroid exposure and UC relapse would be beneficial. It remains uncertain whether patients with corticosteroid-induced remission experience benefit with mesalamine granules (MG), a locally acting aminosalicylate extended-release capsule formulation for maintenance of UC remission in adults. Aims: Efficacy and safety of MG 1.5 g once daily was evaluated in patients with UC in corticosteroid-induced remission. Methods: Data from patients with previous corticosteroid use to achieve baseline UC remission were analyzed from two 6-month randomized, double-blind, placebo-controlled trials and a 24-month open-label extension (OLE). Six-month relapse-free rates were assessed using the revised Sutherland Disease Activity Index. UC-related adverse events (AEs) were recorded during the 30 months. Results: Included were 158 steroid-treated patients in UC remission (MG, n = 105; placebo, n = 53) and 74/105 MG-treated patients who continued MG in the OLE. A significantly larger percentage of patients remained relapse-free at 6 months with MG (77.1 {\%}) versus placebo (54.7 {\%}; P = 0.006), with a 55 {\%} reduction in relapse risk (hazard ratio [HR] 0.45; 95 {\%} CI 0.25–0.79). There was a similar (49.2 {\%}) reduction in risk of UC-related AEs at 6 months (HR 0.51; 95 {\%} CI 0.31–0.84; P = 0.009) that was sustained during the OLE. Conclusions: MG 1.5 g once daily administered for maintenance of corticosteroid-induced remission was associated with low risk of relapse and UC-related AEs. ClinicalTrials.gov: NCT00744016, NCT00767728, and NCT00326209.",
    author = "Lichtenstein, {Gary R.} and Gordon, {Glenn L.} and Salam Zakko and Uma Murthy and Shahriar Sedghi and Ronald Pruitt and Barrett, {Andrew C.} and Enoch Bortey and Craig Paterson and Forbes, {William P.}",
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    AU - Gordon, Glenn L.

    AU - Zakko, Salam

    AU - Murthy, Uma

    AU - Sedghi, Shahriar

    AU - Pruitt, Ronald

    AU - Barrett, Andrew C.

    AU - Bortey, Enoch

    AU - Paterson, Craig

    AU - Forbes, William P.

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    N2 - Background: Patients with ulcerative colitis (UC) who achieve remission with corticosteroids often relapse after tapering or discontinuation; alternative treatments limiting steroid exposure and UC relapse would be beneficial. It remains uncertain whether patients with corticosteroid-induced remission experience benefit with mesalamine granules (MG), a locally acting aminosalicylate extended-release capsule formulation for maintenance of UC remission in adults. Aims: Efficacy and safety of MG 1.5 g once daily was evaluated in patients with UC in corticosteroid-induced remission. Methods: Data from patients with previous corticosteroid use to achieve baseline UC remission were analyzed from two 6-month randomized, double-blind, placebo-controlled trials and a 24-month open-label extension (OLE). Six-month relapse-free rates were assessed using the revised Sutherland Disease Activity Index. UC-related adverse events (AEs) were recorded during the 30 months. Results: Included were 158 steroid-treated patients in UC remission (MG, n = 105; placebo, n = 53) and 74/105 MG-treated patients who continued MG in the OLE. A significantly larger percentage of patients remained relapse-free at 6 months with MG (77.1 %) versus placebo (54.7 %; P = 0.006), with a 55 % reduction in relapse risk (hazard ratio [HR] 0.45; 95 % CI 0.25–0.79). There was a similar (49.2 %) reduction in risk of UC-related AEs at 6 months (HR 0.51; 95 % CI 0.31–0.84; P = 0.009) that was sustained during the OLE. Conclusions: MG 1.5 g once daily administered for maintenance of corticosteroid-induced remission was associated with low risk of relapse and UC-related AEs. ClinicalTrials.gov: NCT00744016, NCT00767728, and NCT00326209.

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