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Tacrolimus Suppositories in Therapy-Resistant Ulcerative Proctitis.

Simon U Jaeger1, Thomas Klag2, Katharina Hoeger3

  • 1Margarete Fischer Bosch Institute of Clinical Pharmacology, Stuttgart, Germany.

Inflammatory Intestinal Diseases
|March 2, 2019
PubMed
Summary
This summary is machine-generated.

Tacrolimus suppositories offer an effective treatment for refractory ulcerative proctitis. This study found that adding tacrolimus to existing therapies led to significant symptom improvement and remission in many patients, with a good safety profile.

Keywords:
Inflammatory bowel diseaseTacrolimusTherapy resistantTopical treatmentUlcerative proctitis

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Area of Science:

  • Gastroenterology
  • Clinical Pharmacology
  • Immunosuppressive Therapy

Background:

  • Ulcerative proctitis often requires advanced treatment beyond topical salicylates or steroids.
  • Some patients exhibit persistent and severe symptoms, necessitating alternative therapeutic strategies.

Purpose of the Study:

  • To evaluate the efficacy and safety of tacrolimus suppositories.
  • To assess tacrolimus as an add-on therapy for refractory ulcerative proctitis.

Main Methods:

  • Retrospective analysis of 43 patients with distal ulcerative colitis.
  • Tacrolimus suppositories (2 mg b.i.d.) were used as add-on medication.
  • Ulcerative colitis activity index (CAI), side effects, and drug levels were monitored.

Main Results:

  • A significant decrease in CAI from 8.0 to 5.5 was observed.
  • 52.3% of patients achieved clinical remission (CAI ≤4) within 50 days.
  • 60% of patients were in remission at the end of the study (median 76 days treatment duration).
  • Mean serum tacrolimus level was 5.5 ng/mL, with one case of mild acute kidney injury.

Conclusions:

  • Tacrolimus suppositories represent a safe and effective option for ulcerative proctitis.
  • This treatment is particularly beneficial for patients refractory to standard therapies like mesalazine and corticosteroids.