Rectal tacrolimus in the treatment of resistant ulcerative proctitis

Aliment Pharmacol Ther. 2008 Nov 15;28(10):1214-20. doi: 10.1111/j.1365-2036.2008.03841.x. Epub 2008 Aug 30.


Background: Resistant ulcerative proctitis can be extremely difficult to manage. Oral tacrolimus can be effective, but may have numerous adverse effects. Topically administered tacrolimus, however, may also be effective in proctitis. Aim To undertake a pilot study to assess a potential role for topical tacrolimus in the management of resistant ulcerative proctitis.

Methods: Patients with resistant ulcerative proctitis were assessed prospectively by the colitis activity index (CAI) and Modified Mayo score. Topical rectal tacrolimus ointment was commenced at 0.3 mg/mL 3 mL b.d. and increased depending on clinical response. CAI and modified Mayo scores were assessed at 0 and 8 weeks, as were steroid usage and adverse effects.

Results: Eight patients (five male/three female) with inflammation to a maximum of 30 cm from the anus were included. All patients had failed disease control with 5-aminosalicylic acids, steroids, immunosuppressants and infliximab therapy. The mean initial CAI was 12.1 (range 9-16) and the mean modified Mayo score was 8.0 (range 6-9). After 8 weeks, six of eight patients achieved remission with steroids reduced or ceased in five of six. There were no significant adverse effects.

Conclusions: This prospective pilot study demonstrated that topical rectal tacrolimus ointment can be effective in ulcerative proctitis. The preparation was well tolerated with no significant adverse effects. Further controlled studies are required.

MeSH terms

  • Adult
  • Colitis, Ulcerative / drug therapy*
  • Female
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Male
  • Middle Aged
  • Ointments
  • Pilot Projects
  • Proctitis / drug therapy*
  • Prospective Studies
  • Rectum
  • Severity of Illness Index
  • Tacrolimus / administration & dosage*
  • Treatment Outcome
  • Western Australia
  • Young Adult


  • Immunosuppressive Agents
  • Ointments
  • Tacrolimus