Individual research recommendation details

Recommendation ID

NG130/1

Question

In a mild-to-moderate first presentation or inflammatory exacerbation of proctitis that is resistant to standard treatment, what is the effectiveness of topical immunomodulators, such as tacrolimus, in achieving clinical remission and what is the most effective formulation (suppository/ointment)?

Any explanatory notes
(if applicable)

The evidence showed that topical aminosalicylates (suppositories or enema) are the most effective
treatments for achieving remission in people with mild-to-moderate proctitis, so these were
recommended as first-line treatments. The evidence did not show any difference in effectiveness
between enema and suppository.
Topical aminosalicylates alone are recommended for up to 4 weeks because the evidence showed
that they were the most effective treatment within this timeframe. There was no direct evidence
for combining topical and oral aminosalicylates for people with proctitis. However, evidence
showed that this combination was effective for people with proctosigmoiditis, and the committee
agreed that this evidence was also applicable to people with proctitis alone. The committee chose
not to specify a dose for the oral aminosalicylate. It preferred to leave it open to clinical judgment
depending on the specific situation (for example, the clinician could give a low dose if the person
had not taken an aminosalicylate before, or a high dose if the person was already taking a low dose).
Some people will not achieve remission with topical and oral aminosalicylates. In clinical practice,
oral or topical corticosteroids are commonly added at this stage, but there was no evidence on this
combination. The committee agreed that, based on their experience, adding a topical or oral
corticosteroid should be an option at this stage.
Despite the lack of direct evidence for the effectiveness of topical or oral corticosteroids, the
committee agreed that, based on their experience, these should also be an option for people who
cannot tolerate aminosalicylates.
Some people decline topical treatment, preferring oral to topical aminosalicylates. This is more
common in children and young people, although proctitis is not common in this group. As the
evidence showed that oral aminosalicylates are not as effective at inducing remission, the
committee thought it was important to explain this to people who decline topical aminosalicylates.
There was cost-effectiveness evidence showing that using an immunomodulator as the next line of
treatment after oral or topical corticosteroids and oral aminosalicylate produced greater health
benefits at lower total costs than other strategies. However, the clinical evidence on topical
immunomodulators was limited and it was unclear how applicable it was to UK clinical practice.
Because of this, the committee recommended the sequence without this final treatment, and
recommended further research on topical immunomodulators.

Source guidance details

Comes from guidance

Ulcerative colitis: management

Number

NG130

Date issued

May 2019

Other details