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Journal of Crohn's and Colitis: 10 (10)

Editor-in-Chief

Laurence J. Egan, Ireland

Associate Editors

Shomron Ben-Horin, IsraelSilvio Danese, ItalyPeter Lakatos, HungaryMiles Parkes, UKJesús Rivera-Nieves, USABritta Siegmund, GermanyGijs van den Brink, NLSéverine Vermeire, Belgium

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Published on behalf of

“One more time” 5-ASA retrial after a glucocorticosteroid induced remission in moderate to severe ulcerative colitis: A prospective community practice experience

Seth Lipka, Seymour Katz, Navroop Kaur
DOI: http://dx.doi.org/10.1016/j.crohns.2012.07.018 342-343 First published online: 1 May 2013

Dear Sir,

The role for re-trial of 5-Aminosalycilic acid (5-ASA) after a glucocorticosteroid (GCS) induced remission in moderate to severe UC remains unchartered.1,2

34 of our patients with moderate or severe active UC (Fig. 1) were given the option to restart oral 5-ASA 4.8 g (pH 6.8 formulation) once steroids were tapered to 20 mg and in clinical remission (Table 1).

View this table:
Table 1

ACG classification of UC severity.1

ClassificationFeatures
Mild< 4 stools/d + − blood, normal ESR, no sign of toxicity
Moderate≥ 4 stools/d + − blood, minimal signs of toxicity
Severe> 6 stools/day + blood, evidence of toxicity (fever, tachycardia, anemia, or elevated ESR)
Fulminant> 10 stools/d, continuous bleeding, toxicity, abdominal tenderness and distension, transfusion requirement, colonic dilation on X-ray
  • ESR = erythrocyte sedimentation rate.

Of the 34 patients who met inclusion criteria, 25 did not wish to retry 5-ASA: 8 could not be tapered to 20 mg oral prednisone and 17 chose immunomodulator and/or biologic therapy, or surgery. Of 17 participating, 2 were non-compliant with medications and 2 were lost to follow up. In the remaining 13, 4 failed 5-ASA therapy in less than 2 weeks. Of those 4 who failed therapy 3 were salvaged on infliximab, and 1 required colectomy. However, 9 of the 13 successfully maintained a response with oral 5-ASA 4.8 g after steroids were discontinued 20 weeks from the last observed visit (range 14–44 weeks) (Table 2).

View this table:
Table 2

General characteristics of the 13 oral 5-ASA retrial.

Age (years)18–75 years old
M/F7/6
Localization of disease in failed3 left sided colitis; 1 pancolitis
Localization of disease in successful therapy4 left sided colitis; 5 pancolitis
Duration of disease (years)1–19 years
Remained in remission on oral 4.8 g 5-ASA9/13 (median 20 weeks)

Although no data on the retrial of oral 5-ASA 4.8 g after steroid induced remission exists for moderate to severe UC one study of 18 UC patients with moderate to severe disease given oral 5-ASA (2.4–3.2 g/day) and topical (4 g/day) mesalazine enemas showed a reduction in clinical recurrence.3 An open label trial of oral 5-ASA 3.2 g/day versus Azathioprine (AZA) 2 mg/kg/day for 6 months in steroid refractory patients with moderate-to-severe UC found that more patients in the AZA group had clinical and endoscopic remission.4 Two uncontrolled studies demonstrated higher doses of 5-ASA (2.5 to 4.4 g/daily) to be effective as adjunctive treatment in 50% of steroid dependent patients.5,6 Bello et al1 retrospectively studied 143 mild-to-moderate UC patients naïve to immunosuppressive therapy agents that were treated for the first time with oral corticosteroids after a flare. Mesalazine (minimum dose of 2.5 g/day) was started in 35 patients. 13 out of 35 patients (37%) were still in remission on mesalazine after a 1 year follow up. In the ASCEND trials moderate UC patients previously treated with corticosteroids benefited from 4.8 g/day delayed-released mesalamine over 2.4 g/day in achieving treatment complete remission (p = 0.05).7

Using the step-up or top-down philosophy a clinician may feel pressured to use biologic and immunomodulator therapy after steroid induced remission. A more conservative approach may be beneficial in patients with preexisting comorbidities where immunomodulators or biologic therapy may precipitate adverse effects i.e. infections and preexisting malignancy. 5-ASA may be overshadowed by the success of immunomodulator and biologic therapy in moderate to severe disease, but certainly should not be forgotten.

Conflict of interest statement

The authors certify that they have no conflicts of interest to declare.

Acknowledgment

This study was supported by a grant from Shire Inc. The authors report no conflicts of interest and have followed the ethical adherence guidelines. All authors have made substantial contributions to the conception and design of the study, drafting of the article, and approve of its final version. This manuscript has not been published and is not under consideration elsewhere. Dr. Seymour Katz consults for Abbott and UCB and gives lectures for Abbott, UCB, Warner-Chilcott.

References

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