Rectal tacrolimus in the treatment of resistant ulcerative proctitis

Summary 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...

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Bibliographic Details
Published in:Alimentary pharmacology & therapeutics 2008-11, Vol.28 (10), p.1214-1220
Main Authors: LAWRANCE, I. C., COPELAND, T.‐S.
Format: Article
Language:English
Subjects:
Adult
Biological and medical sciences
Colitis, Ulcerative - drug therapy
Digestive system
Female
Gastroenterology. Liver. Pancreas. Abdomen
Humans
Immunosuppressive Agents - administration & dosage
Male
Medical sciences
Middle Aged
Ointments
Other diseases. Semiology
Pharmacology. Drug treatments
Pilot Projects
Proctitis - drug therapy
Prospective Studies
Rectum
Severity of Illness Index
Stomach. Duodenum. Small intestine. Colon. Rectum. Anus
Tacrolimus - administration & dosage
Treatment Outcome
Western Australia
Young Adult
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Summary:Summary 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.
ISSN:0269-2813
1365-2036
DOI:10.1111/j.1365-2036.2008.03841.x