Ulcerative Colitis Management PDF 66141712632517

Ulcerative colitis:
management
NICE guideline
Published: 3 May 2019
www.nice.org.uk/guidance/ng130
© NICE 2023. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-

conditions#notice-of-rights).
Ulcerative colitis: management (NG130)
Your responsibility
The recommendations in this guideline represent the view of NICE, arrived at after careful
consideration of the evidence available. When exercising their judgement, professionals
and practitioners are expected to take this guideline fully into account, alongside the
individual needs, preferences and values of their patients or the people using their service.
It is not mandatory to apply the recommendations, and the guideline does not override the
responsibility to make decisions appropriate to the circumstances of the individual, in
consultation with them and their families and carers or guardian.
All problems (adverse events) related to a medicine or medical device used for treatment
or in a procedure should be reported to the Medicines and Healthcare products Regulatory
Agency using the Yellow Card Scheme.
Local commissioners and providers of healthcare have a responsibility to enable the

guideline to be applied when individual professionals and people using services wish to
use it. They should do so in the context of local and national priorities for funding and
developing services, and in light of their duties to have due regard to the need to eliminate
unlawful discrimination, to advance equality of opportunity and to reduce health
inequalities. Nothing in this guideline should be interpreted in a way that would be
inconsistent with complying with those duties.
Commissioners and providers have a responsibility to promote an environmentally

sustainable health and care system and should assess and reduce the environmental
impact of implementing NICE recommendations wherever possible.
© NICE 2023. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- Page 2 of
conditions#notice-of-rights). 31
Contents
Overview ..................................................................................................................................... 4
Who is it for? .......................................................................................................................................... 4
Recommendations ...................................................................................................................... 5
1.1 Patient information and support ..................................................................................................... 5
1.2 Inducing remission in people with ulcerative colitis ..................................................................... 6
1.3 Information about treatment options for people who are considering surgery ........................ 11
1.4 Maintaining remission in people with ulcerative colitis ............................................................... 13
1.5 Pregnant women.............................................................................................................................. 15
1.6 Monitoring ........................................................................................................................................ 15
Terms used in this guideline................................................................................................................. 17
Recommendations for research ................................................................................................ 20
Key recommendations for research ................................................................................................... 20
Other recommendations for research ................................................................................................ 21
Rationale and impact.................................................................................................................. 24
Inducing remission in people with mild-to-moderate ulcerative colitis .......................................... 24
Context ........................................................................................................................................ 28
Finding more information and committee details .................................................................... 30
Update information .................................................................................................................... 31
This guideline replaces CG166 and ESNM58.
This guideline is the basis of QS81.
Overview
This guideline covers the management of ulcerative colitis in children, young people and
adults. It aims to help professionals to provide consistent high-quality care and it highlights
the importance of advice and support for people with ulcerative colitis.
We have also produced a NICE guideline on colorectal cancer prevention: colonoscopic

surveillance for adults with ulcerative colitis, Crohn's disease or adenomas.
Who is it for?
• Healthcare professionals
• Commissioners and providers
• People with ulcerative colitis and their families and carers
Recommendations
People have the right to be involved in discussions and make informed decisions
about their care, as described in NICE's information on making decisions about your
care.
Making decisions using NICE guidelines explains how we use words to show the
strength (or certainty) of our recommendations, and has information about
prescribing medicines (including off-label use), professional guidelines, standards
and laws (including on consent and mental capacity), and safeguarding.
1.1 Patient information and support

1.1.1 Discuss the disease and associated symptoms, treatment options and
monitoring:
• with the person with ulcerative colitis and their family members or carers (as
appropriate) and
• within the multidisciplinary team (the composition of which should be

appropriate for the age of the person) at every opportunity.
Apply the principles in the NICE guideline on patient experience in adult NHS
services. [2013]
1.1.2 Discuss the possible nature, frequency and severity of side effects of
drug treatment for ulcerative colitis with the person, and their family
members or carers (as appropriate). Refer to the NICE guideline on
medicines adherence. [2013]
1.1.3 Give the person, and their family members or carers (as appropriate)
information about their risk of developing colorectal cancer and about
colonoscopic surveillance, in line with the NICE guidelines on colorectal
cancer prevention: colonoscopic surveillance in adults with ulcerative
colitis, Crohn's disease or adenomas and suspected cancer: recognition
and referral. [2013]
1.2 Inducing remission in people with ulcerative

colitis
Treating mild-to-moderate ulcerative colitis
Proctitis
1.2.1 To induce remission in people with a mild-to-moderate first presentation

or inflammatory exacerbation of proctitis, offer a topical aminosalicylate
as first-line treatment. [2019]
In May 2019, this was an off-label use of some topical aminosalicylates

for children and young people. See NICE's information on prescribing
medicines.
1.2.2 If remission is not achieved within 4 weeks, consider adding an oral

aminosalicylate. [2019]
In May 2019, this was an off-label use of some oral aminosalicylates for
children and young people. See NICE's information on prescribing
medicines.
1.2.3 If further treatment is needed, consider adding a time-limited course of a

topical or an oral corticosteroid. [2019]
In May 2019, this was an off-label use of beclometasone dipropionate in

most situations. See NICE's information on prescribing medicines.
1.2.4 For people who decline a topical aminosalicylate:
• consider an oral aminosalicylate as first-line treatment, and explain that this is

not as effective as a topical aminosalicylate
• if remission is not achieved within 4 weeks, consider adding a time-limited

course of a topical or an oral corticosteroid. [2019]
In May 2019, this was an off-label use of beclometasone dipropionate in most

situations. See NICE's information on prescribing medicines.
1.2.5 For people who cannot tolerate aminosalicylates, consider a time-limited

Proctosigmoiditis and left-sided ulcerative colitis

or inflammatory exacerbation of proctosigmoiditis or left-sided ulcerative
colitis, offer a topical aminosalicylate as first-line treatment. [2019]
1.2.7 If remission is not achieved within 4 weeks, consider:
• adding a high-dose oral aminosalicylate to the topical aminosalicylate or
• switching to a high-dose oral aminosalicylate and a time-limited course of a

topical corticosteroid. [2019]
1.2.8 If further treatment is needed, stop topical treatments and offer an oral
aminosalicylate and a time-limited course of an oral corticosteroid.
[2019]
1.2.9 For people who decline any topical treatment:
• consider a high-dose oral aminosalicylate alone, and explain that this is not as
effective as a topical aminosalicylate
• if remission is not achieved within 4 weeks, offer a time-limited course of an

oral corticosteroid in addition to the high-dose aminosalicylate. [2019]

Extensive disease
or inflammatory exacerbation of extensive ulcerative colitis, offer a

topical aminosalicylate and a high-dose oral aminosalicylate as first-line
treatment. [2019]
1.2.12 If remission is not achieved within 4 weeks, stop the topical

aminosalicylate and offer a high-dose oral aminosalicylate with a time-
limited course of an oral corticosteroid. [2019]

course of an oral corticosteroid. [2019]
Biologics and Janus kinase inhibitors for moderately to severely

active ulcerative colitis: all extents of disease
1.2.14 For guidance on biologics and Janus kinase inhibitors for treating
moderately to severely active ulcerative colitis, see the:
• NICE technology appraisal guidance on infliximab, adalimumab and golimumab

for moderately to severely active ulcerative colitis
• NICE technology appraisal guidance on vedolizumab for treating moderately to

severely active ulcerative colitis
• NICE technology appraisal guidance on tofacitinib for moderately to severely

active ulcerative colitis. [2019]
For a short explanation of why the committee made the 2019 recommendations and
how they might affect practice, see the rationale and impact section on inducing
remission in people with mild-to-moderate ulcerative colitis.
Full details of the evidence and the committee's discussion are in evidence review:
induction of remission in mild-to-moderate ulcerative colitis.
Treating acute severe ulcerative colitis: all extents of disease
The multidisciplinary team
1.2.15 For people admitted to hospital with acute severe ulcerative colitis:
• ensure that a gastroenterologist and a colorectal surgeon collaborate to

provide treatment and management
• ensure that the composition of the multidisciplinary team is appropriate for the
age of the person
• seek advice from a paediatrician with expertise in gastroenterology when

treating a child or young person
• ensure that the obstetric and gynaecology team is included when treating a
pregnant woman. [2013]
Step 1 therapy
1.2.16 For people admitted to hospital with acute severe ulcerative colitis
(either a first presentation or an inflammatory exacerbation):
• offer intravenous corticosteroids to induce remission and
• assess the likelihood that the person will need surgery (see the
recommendation on assess and document in the section on assessing
likelihood of needing surgery). [2013]
1.2.17 Consider intravenous ciclosporin or surgery for people:
• who cannot tolerate or who decline intravenous corticosteroids or
• for whom treatment with intravenous corticosteroids is contraindicated.
Take into account the person's preferences when choosing treatment. [2013]
In May 2019, this was an off-label use of ciclosporin. See NICE's information on
prescribing medicines.
Step 2 therapy
1.2.18 Consider adding intravenous ciclosporin to intravenous corticosteroids or

consider surgery for people:
• who have little or no improvement within 72 hours of starting intravenous

corticosteroids or
• whose symptoms worsen at any time despite corticosteroid treatment.
Take into account the person's preferences when choosing treatment. [2013]
In May 2019, this was an off-label use of ciclosporin. See NICE's information on
prescribing medicines
1.2.19 Infliximab is recommended as an option for the treatment of acute

exacerbations of severely active ulcerative colitis only in patients in
whom ciclosporin is contraindicated or clinically inappropriate, based on
a careful assessment of the risks and benefits of treatment in the
individual patient. [2008]
[This recommendation is from NICE technology appraisal guidance on

infliximab for acute exacerbations of ulcerative colitis]
1.2.20 In people who do not meet the criterion in the recommendation above on
the use of infliximab in patients in whom ciclosporin is contraindicated or
clinically inappropriate, infliximab should only be used for the treatment
of acute exacerbations of severely active ulcerative colitis in clinical
trials. [2008]
[This recommendation is from NICE technology appraisal guidance on

infliximab for acute exacerbations of ulcerative colitis]
Monitoring treatment
1.2.21 Ensure that there are documented local safety monitoring policies and
procedures (including audit) for adults, children and young people
receiving treatment that needs monitoring (aminosalicylates, tacrolimus,
ciclosporin, infliximab, azathioprine and mercaptopurine). Nominate a
© NICE 2023. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- Page 10
conditions#notice-of-rights). of 31
member of staff to act on abnormal results and communicate with GPs

and people with ulcerative colitis and their family members or carers (as
appropriate). [2013]
Assessing likelihood of needing surgery

1.2.22 Assess and document on admission, and then daily, the likelihood of
needing surgery for people admitted to hospital with acute severe
ulcerative colitis. [2013]
1.2.23 Be aware that there may be an increased likelihood of needing surgery

for people with any of the following:
• stool frequency more than 8 per day
• pyrexia
• tachycardia
• an abdominal X-ray showing colonic dilatation
• low albumin, low haemoglobin, high platelet count or C-reactive protein above
45 mg/litre (bear in mind that normal values may be different in pregnant
women). [2013]
1.3 Information about treatment options for

people who are considering surgery
These recommendations apply to anyone with ulcerative colitis considering elective
surgery. The principles can also be applied to people requiring emergency surgery.
Information when considering surgery

1.3.1 For people with ulcerative colitis who are considering surgery, ensure
that a specialist (such as a gastroenterologist or a nurse specialist) gives
the person and their family members or carers (as appropriate)
information about all available treatment options, and discusses this with
them. Information should include the benefits and risks of the different
treatments and the potential consequences of no treatment. [2013]
1.3.2 Ensure that the person and their family members or carers (as
appropriate) have sufficient time and opportunities to think about the
options and the implications of the different treatments. [2013]
1.3.3 Ensure that a colorectal surgeon gives any person who is considering
surgery and their family members or carers (as appropriate) specific
information about what they can expect in the short and long term after
surgery, and discusses this with them. [2013]
1.3.4 Ensure that a specialist (such as a colorectal surgeon, a

gastroenterologist, an inflammatory bowel disease nurse specialist or a
stoma nurse) gives any person who is considering surgery and their
family members or carers (as appropriate) information about:
• diet
• sensitive topics such as sexual function
• effects on lifestyle
• psychological wellbeing
• the type of surgery, the possibility of needing a stoma and stoma care. [2013]
1.3.5 Ensure that a specialist who is knowledgeable about stomas (such as a

stoma nurse or a colorectal surgeon) gives any person who is having
surgery and their family members or carers (as appropriate) specific
information about the siting, care and management of stomas. [2013]
Information after surgery

1.3.6 After surgery, ensure that a specialist who is knowledgeable about
stomas (such as a stoma nurse or a colorectal surgeon) gives the person
and their family members or carers (as appropriate) information about
managing the effects on bowel function. This should be specific to the
type of surgery performed (ileostomy or ileoanal pouch) and could
include the following:
• strategies to deal with the impact on their physical, psychological and social
wellbeing
• where to go for help if symptoms occur
• sources of support and advice. [2013]
1.4 Maintaining remission in people with

ulcerative colitis
Proctitis and proctosigmoiditis

1.4.1 To maintain remission after a mild-to-moderate inflammatory
exacerbation of proctitis or proctosigmoiditis, consider the following
options, taking into account the person's preferences:
• a topical aminosalicylate alone (daily or intermittent) or
• an oral aminosalicylate plus a topical aminosalicylate (daily or intermittent) or
• an oral aminosalicylate alone, explaining that this may not be as effective as

combined treatment or an intermittent topical aminosalicylate alone. [2013]
In May 2019, note that this was an off-label use of some aminosalicylates for
children and young people. See NICE's information on prescribing medicines
Left-sided and extensive ulcerative colitis

1.4.2 To maintain remission in adults after a mild-to-moderate inflammatory
exacerbation of left-sided or extensive ulcerative colitis:
• offer a low maintenance dose of an oral aminosalicylate
• when deciding which oral aminosalicylate to use, take into account the
person's preferences, side effects and cost. [2013]
1.4.3 To maintain remission in children and young people after a mild-to-

moderate inflammatory exacerbation of left-sided or extensive ulcerative
colitis:
• offer an oral aminosalicylate (dosing requirements for children should be

calculated by body weight, as described in the BNF)
• when deciding which oral aminosalicylate to use, take into account the
person's preferences (and those of their parents or carers as appropriate), side
effects and cost. [2013]
In May 2019, this was an off-label use of some oral aminosalicylates for
children and young people. See NICE's information on prescribing medicines.
All extents of disease

1.4.4 Consider oral azathioprine or oral mercaptopurine to maintain remission:
• after 2 or more inflammatory exacerbations in 12 months that require treatment

with systemic corticosteroids or
• if remission is not maintained by aminosalicylates. [2013]
In May 2019, this was an off-label use of some brands of azathioprine and
mercaptopurine. See NICE's information on prescribing medicines.
1.4.5 To maintain remission after a single episode of acute severe ulcerative

colitis:
• consider oral azathioprine or oral mercaptopurine
• consider oral aminosalicylates if azathioprine and/or mercaptopurine are

contraindicated or the person cannot tolerate them. [2013]
In May 2019, this was an off-label use of some brands of azathioprine and
mercaptopurine. See NICE's information on prescribing medicines.
Dosing regimen for oral aminosalicylates

1.4.6 Consider a once-daily dosing regimen for oral aminosalicylates when
used for maintaining remission. Take into account the person's
preferences, and explain that once-daily dosing can be more effective,
but may result in more side effects. [2013]
In May 2019, this was an off-label use of some oral aminosalicylates. See
NICE's information on prescribing medicines.
1.5 Pregnant women

1.5.1 When caring for a pregnant woman with ulcerative colitis:
• Ensure effective communication and information-sharing across specialties (for

example, primary care, obstetrics and gynaecology, and gastroenterology).
• Give her information about the potential risks and benefits of medical
treatment to induce or maintain remission and of not having treatment, and
discuss this with her. Include information relevant to a potential admission for
an acute severe inflammatory exacerbation. [2013]
1.6 Monitoring
Monitoring bone health
Adults
1.6.1 For recommendations on assessing the risk of fragility fracture in adults,

refer to the NICE guideline on osteoporosis: assessing the risk of fragility
fracture. [2013]
Children and young people
1.6.2 Consider monitoring bone health in children and young people with
ulcerative colitis in the following circumstances:
• during chronic active disease
• after treatment with systemic corticosteroids
• after recurrent active disease. [2013]
Monitoring growth and pubertal development in children and

young people
1.6.3 Monitor the height and body weight of children and young people with
ulcerative colitis against expected values on centile charts (and/or
z scores) at the following intervals according to disease activity:
• every 3 to 6 months:
－ if they have an inflammatory exacerbation and are approaching or

undergoing puberty or
－ if there is chronic active disease or
－ if they are being treated with systemic corticosteroids
• every 6 months during pubertal growth if the disease is inactive
• every 12 months if none of the criteria above are met. [2013]
1.6.4 Monitor pubertal development in young people with ulcerative colitis

using the principles of Tanner staging, by asking screening questions
and/or carrying out a formal examination. [2013]
1.6.5 Consider referral to a secondary care paediatrician for pubertal

assessment and investigation of the underlying cause if a young person
with ulcerative colitis:
• has slow pubertal progress or
• has not developed pubertal features appropriate for their age. [2013]
1.6.6 Monitoring of growth and pubertal development:
• can be done in a range of locations (for example, at routine appointments,

acute admissions or urgent appointments in primary care, community services
or secondary care)
• should be carried out by appropriately trained healthcare professionals as part

of the overall clinical assessment (including disease activity) to help inform the
need for timely investigation, referral and/or interventions, particularly during
pubertal growth.
If the young person prefers self-assessment for monitoring pubertal

development, this should be allowed if possible and they should be instructed
on how to do this. [2013]
1.6.7 Ensure that relevant information about monitoring of growth and pubertal
development and about disease activity is shared across services (for
example, community, primary, secondary and specialist services). Apply
the principles in the NICE guideline on patient experience in adult NHS
services in relation to continuity of care. [2013]
Terms used in this guideline
Mild, moderate and severe ulcerative colitis

In this guideline, the categories of mild, moderate and severe are used to describe
ulcerative colitis:
• In adults these categories are based on the Truelove and Witts' severity index (see
table 1). This table is adapted from the Truelove and Witts' criteria.
• In children and young people these categories are based on the Paediatric Ulcerative
Colitis Activity Index (PUCAI; see table 2).
Table 1: Truelove and Witts' severity index
– Mild Moderate Severe
6 or more plus at least 1 of the

Bowel movements
Fewer than 4 4–6 features of systemic upset (marked
(number per day)
with * below)
No more than Between

Blood in stools small amounts mild and Visible blood
of blood severe
– Mild Moderate Severe
Pyrexia
(temperature
No No Yes
greater than
37.8°C) *
Pulse rate greater

No No Yes
than 90 bpm *
Anaemia * No No Yes
Erythrocyte
30 or
sedimentation rate 30 or below Above 30
below
(mm/hour) *
© Copyright British Medical Journal, 29 October 1955. Reproduced with permission.
Disease severity in table 2 is defined by the following scores:
• severe: 65 or above
• moderate: 35–64
• mild: 10–34
• remission (disease not active): below 10.
Table 2: Paediatric Ulcerative Colitis Activity Index (PUCAI)
Item Points
1. Abdominal pain _
No pain 0
Pain can be ignored 5
Pain cannot be ignored 10
2. Rectal bleeding _
None 0
Small amount only, in less than 50% of stools 10
Small amount with most stools 20
Large amount (50% of the stool content) 30
3. Stool consistency of most stools _
Formed 0
Partially formed 5
Completely unformed 10
4. Number of stools per 24 hours _
0–2 0
3–5 5
6–8 10
>8 15
5. Nocturnal stools (any episode causing wakening) _
No 0
Yes 10
6. Activity level _
No limitation of activity 0
Occasional limitation of activity 5
Severe restricted activity 10
Sum of PUCAI (0–85) _
© Copyright The Hospital for Sick Children, Toronto, Canada, 2006. Reproduced with
permission.
Time-limited course of oral corticosteroids

A course of corticosteroids used to treat active disease, normally given for 4 to 8 weeks
(depending on the steroid).
Recommendations for research

The guideline committee has made the following recommendations for research. As part of
the 2019 update, the guideline committee made an additional 3 research
recommendations on inducing remission in mild-to-moderate ulcerative colitis.
Key recommendations for research
1 The effectiveness of immunomodulators in inducing remission

in proctitis
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)?
For a short explanation of why the committee made the recommendation for research,
see the rationale on proctitis.
2 The effectiveness of immunomodulators in unresponsive

ulcerative colitis
What is the effectiveness of oral tacrolimus and systemic (intramuscular/subcutaneous/
oral) methotrexate in the induction of remission in mild-to-moderate ulcerative colitis
unresponsive to aminosalicylates?
see the rationale on extensive ulcerative colitis.
3 The relative effectiveness of corticosteroids for inducing

remission in ulcerative colitis
What is the clinical and cost effectiveness of prednisolone, budesonide, and
beclometasone in addition to aminosalicylates compared with each other and with
aminosalicylate monotherapy for the induction of remission for people with mild-to-
moderate ulcerative colitis?
see the rationale on all extents of disease.
Other recommendations for research
From the 2019 update
Induction of remission for people with moderate ulcerative colitis:

prednisolone compared with aminosalicylates
What is the clinical and cost effectiveness of prednisolone compared with aminosalicylates
for the induction of remission for people with moderate ulcerative colitis?
Induction of remission for people with moderate ulcerative colitis:

prednisolone compared with beclometasone
What is the clinical and cost effectiveness of prednisolone plus an aminosalicylate
compared with beclometasone plus an aminosalicylate for induction of remission for

people with moderate ulcerative colitis?
Induction of remission for people with subacute ulcerative colitis that is

refractory to systemic corticosteroids
What are the benefits, risks and cost effectiveness of methotrexate, ciclosporin,
tacrolimus, adalimumab and infliximab compared with each other and with placebo for
induction of remission for people with subacute ulcerative colitis that is refractory to
systemic corticosteroids?
From the 2013 guideline

What are the benefits, risks and cost effectiveness of methotrexate, ciclosporin,
tacrolimus, adalimumab and infliximab compared with each other and with placebo for
induction of remission for people with subacute ulcerative colitis that is refractory to
systemic corticosteroids?
What is the clinical and cost effectiveness of regular maintenance treatment compared
with no regular treatment (but rapid standard treatment if a relapse occurs) in specific
populations with mild to moderate ulcerative colitis?
To develop and validate a risk tool that predicts the likelihood of needing surgery for adults
admitted to hospital with acute severe ulcerative colitis.
In children and young people with ulcerative colitis receiving steroid treatment, what are
the clinical benefits of routine monitoring of bone density, what tests should be done and
how frequently?
A registry to collect data to answer 'What are the potential harms or benefits of drug
treatments in pregnant women with ulcerative colitis?'
What are the information needs of people with ulcerative colitis when they are considering
surgery?
What is the clinical and cost effectiveness of sulphasalazine compared to high-dose

branded mesalazine for induction of remission for people with mild moderate ulcerative
colitis?
What is the validity, reliability and accuracy of available adult risk tools as a predictor for
the need for surgery in people admitted into hospital with acute severe ulcerative colitis?
What is the validity, reliability and accuracy of the paediatric ulcerative colitis activity index
(PUCAI) as a predictor for surgery for children and young people admitted to hospital with
acute severe colitis?
In people with mild to moderate ulcerative colitis, what are the best second-line treatment
strategies for induction of remission after people have failed to respond to ASA mono or
combination therapies?
In people with subacute ulcerative colitis, what are the best second-line treatment
strategies for induction of remission after people have failed to respond to oral
prednisolone?
In people with mild to moderate ulcerative colitis, what are the best strategies for the
induction of remission after people have failed to respond to tacrolimus?
Establish a national registry to identify the incidence of growth failure and/or pubertal
delay in ulcerative colitis and the relationship with treatment (to record treatment
[steroids, ASA, immunomodulators] and growth [z scores]).
Rationale and impact

This section briefly explains why the committee made the recommendations and how they
might affect practice. It links to details of the evidence and a full description of the
committee's discussion.
Inducing remission in people with mild-to-

moderate ulcerative colitis
Recommendations 1.2.1 to 1.2.14
Why the committee made the recommendations
Proctitis
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 made a research recommendation on topical
immunomodulators.
Proctosigmoiditis or left-sided ulcerative colitis
There is evidence that topical aminosalicylates are effective for achieving remission in
people with mild-to-moderate proctosigmoiditis or left-sided ulcerative colitis. In the
committee's experience topical aminosalicylates also work faster and more effectively
than topical corticosteroids. Topical aminosalicylates alone are recommended for up to
4 weeks because the evidence showed that they were effective within this timeframe.
Cost-effectiveness evidence also showed that treatment sequences starting with topical
aminosalicylates produced greater health benefits and incurred lower total costs than
other strategies.
There is no direct evidence for the effectiveness of high-dose oral aminosalicylates

combined with either topical aminosalicylates or topical corticosteroids. However, there is
evidence that topical treatments or high-dose oral aminosalicylates individually provide
some benefit. Therefore, the committee agreed it was reasonable to recommend
combinations of these if remission is not achieved. While there was limited evidence for
oral corticosteroids, in the committee's experience an oral corticosteroid may benefit
people with proctosigmoiditis or left-sided disease if further treatment is needed. As a
result, they recommended oral corticosteroids with oral aminosalicylates instead of topical
treatment for these people. This reflects current practice for people who do not achieve
remission with topical treatments and high-dose oral aminosalicylates.
Extensive ulcerative colitis
The evidence showed that people with mild-to-moderate extensive ulcerative colitis would
benefit most from a combination of high-dose oral aminosalicylates with topical
aminosalicylates as first-line treatment. High-dose oral aminosalicylates combined with
topical aminosalicylates are recommended for up to 4 weeks, because in the committee's
experience they are the most effective treatment within this timeframe. There is evidence
that an oral corticosteroid combined with a high-dose oral aminosalicylate is also
effective, so the committee recommended this combination if remission is not achieved
with aminosalicylates alone. In people who cannot tolerate aminosalicylates, oral
corticosteroids are recommended as they are also an effective treatment option.
The sequence of drugs recommended was more effective than starting with a high-dose
oral aminosalicylate alone. There was some uncertainty around the cost effectiveness of
this sequence. The data on the effectiveness of high-dose oral aminosalicylates combined
with topical aminosalicylates was from an 8-week clinical trial. The committee believed
that in practice, people whose disease did not respond to treatment within 4 weeks would
switch to another treatment. When the cost-effectiveness analysis allowed for early
switching, the combination of a high-dose oral aminosalicylate and topical aminosalicylate
was not cost effective. However, if it was assumed that everyone continued treatment as
described in the trial, the combination of a high-dose oral aminosalicylate and topical
aminosalicylate was more likely to be cost effective. The committee took the uncertainty
about the cost-effectiveness results in the different scenarios into account in
recommending the combination as first-line treatment.
There was some evidence on methotrexate for inducing remission, but it did not show a
clear benefit, and there was no evidence on oral tacrolimus. To address these gaps in the
evidence, the committee made a research recommendation on the effectiveness of
immunomodulators in unresponsive ulcerative colitis.
All extents of disease
Most of the evidence was for adults. However, the committee agreed to generalise the
recommendations to all people with a mild-to-moderate exacerbation or first presentation
of ulcerative colitis.
There is limited evidence on oral corticosteroids. In addition, the committee agreed that
the use of oral corticosteroids is generally reserved for later lines of treatment because of
concerns about side effects. It is not clear which corticosteroid is most effective for each
extent of disease. There is also limited evidence on immunomodulators, specifically oral
tacrolimus and systemic methotrexate for each extent of disease. The committee made a
research recommendation on corticosteroids for the induction of remission in mild-to-
moderate ulcerative colitis to address these uncertainties.
How the recommendations might affect practice

The new recommendations classify the extents of ulcerative colitis differently. This more
closely reflects current practice, so will be clearer and more informative for people with
mild-to-moderate ulcerative colitis and healthcare professionals.
The recommendations in the 2013 guideline referred to specific corticosteroids. To better

reflect the available evidence, the updated recommendations refer to aminosalicylates and
corticosteroids as a class rather than recommending individual treatments. This allows
healthcare professionals and people with mild-to-moderate ulcerative colitis to choose the
most appropriate corticosteroid or aminosalicylate, depending on patient preference,
availability and acquisition cost.
The new recommendations specify that courses of oral corticosteroids should be time-
limited. This should address varying practice in prescribing for some corticosteroids.
Return to recommendations
Context
Ulcerative colitis is the most common type of inflammatory bowel disease. There are
around 146,000 people in the UK with a diagnosis of ulcerative colitis (Crohn's & Colitis
UK). The cause of ulcerative colitis is unknown. It can develop at any age, but peak
incidence is between the ages of 15 and 25 years, with a second, smaller peak between
55 and 65 years (although this second peak has not been universally demonstrated).
Ulcerative colitis usually affects the rectum, and a variable extent of the colon proximal to
the rectum. The inflammation is continuous in extent. Inflammation of the rectum is
referred to as proctitis, and inflammation of the rectum and sigmoid as proctosigmoiditis.
Left-sided colitis refers to disease involving the colon distal to the splenic flexure.
Extensive colitis affects the colon proximal to the splenic flexure, and includes pan-colitis,
where the whole colon is involved.
Symptoms of active disease or relapse include bloody diarrhoea, an urgent need to

defecate and abdominal pain.
Ulcerative colitis is a lifelong disease that is associated with significant morbidity. It can
also affect a person's social and psychological wellbeing, particularly if poorly controlled.
Typically, it has a relapsing-remitting pattern.
Current medical approaches focus on treating active disease to address symptoms, to

improve quality of life, and thereafter to maintain remission. The long-term benefits of
achieving mucosal healing remain unclear. The treatment chosen for active disease is likely
to depend on clinical severity, extent of disease and the person's preference, and may
include the use of aminosalicylates, corticosteroids or biological drugs. These drugs can
be oral or topical (into the rectum), and corticosteroids may be administered intravenously
in people with acute severe disease. Surgery may be considered as emergency treatment
for severe ulcerative colitis that does not respond to drug treatment. People may also
choose to have elective surgery for unresponsive or frequently relapsing disease that is
affecting their quality of life.
Advice and support for people with ulcerative colitis is important, in terms of discussing
the effects of the condition and its course, medical treatment options, the effects of
medication and the monitoring required. Around 10% of inpatients with inflammatory bowel
disease reported a lack of information about drug side effects on discharge from hospital.
Information to support decisions about surgery is also essential, both for clinicians and for
people facing the possibility of surgery. This includes recognising adverse prognostic
factors for people admitted with acute severe colitis to enable timely decisions about
escalating medical therapy or predicting the need for surgery. It is also very important to
provide relevant information to support people considering elective surgery.
The wide choice of drug preparations and dosing regimens, the judgement required in
determining the optimum timing for surgery (both electively and as an emergency) and the
importance of support and information may lead to variation in practice across the UK.
This guideline aims to address this variation, and to help healthcare professionals to
provide consistent high-quality care. Managing ulcerative colitis in adults and children
overlaps in many regards, so the guideline incorporates advice that is applicable to
children and young people, which again should help to address potential inconsistencies in
practice.
Finding more information and committee

details
You can see everything NICE says on this topic in the NICE Pathway on ulcerative colitis.
To find NICE guidance on related topics, including guidance in development, see the NICE
web page on inflammatory bowel disease.
For full details of the evidence and the guideline committee's discussions, see the
evidence reviews. You can also find information about how the guideline was developed,
including details of the committee.
NICE has produced tools and resources to help you put this guideline into practice. For
general help and advice on putting NICE guidelines into practice see practical steps to
improving the quality of care and services using NICE guidance.
Update information
May 2019: This guideline is an update of NICE guideline CG166 (published June 2013) and
replaces it.
We have reviewed the evidence on inducing remission for people with mild-to-moderate
ulcerative colitis. These recommendations are marked [2019].
Recommendations marked [2008] or [2013] last had an evidence review in 2008 or 2013.
In some cases minor changes have been made to the wording to bring the language and
style up to date, without changing the meaning.
Minor changes since publication
July 2019: The research recommendations from the 2013 guideline were added.
ISBN: 978-1-4731-3392-1
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Ulcerative colitis:

© NICE 2023. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-

Local commissioners and providers of healthcare have a responsibility to enable the

Commissioners and providers have a responsibility to promote an environmentally

Who is it for? .......................................................................................................................................... 4

1.1 Patient information and support ..................................................................................................... 5

1.2 Inducing remission in people with ulcerative colitis ..................................................................... 6

1.4 Maintaining remission in people with ulcerative colitis ............................................................... 13

1.5 Pregnant women.............................................................................................................................. 15

1.6 Monitoring ........................................................................................................................................ 15

Terms used in this guideline................................................................................................................. 17

Recommendations for research ................................................................................................ 20

Key recommendations for research ................................................................................................... 20

Other recommendations for research ................................................................................................ 21

Rationale and impact.................................................................................................................. 24

Inducing remission in people with mild-to-moderate ulcerative colitis .......................................... 24

Finding more information and committee details .................................................................... 30

Update information .................................................................................................................... 31

This guideline replaces CG166 and ESNM58.

This guideline is the basis of QS81.

We have also produced a NICE guideline on colorectal cancer prevention: colonoscopic

• Commissioners and providers

• People with ulcerative colitis and their families and carers

1.1 Patient information and support

• within the multidisciplinary team (the composition of which should be

and referral. [2013]

1.2 Inducing remission in people with ulcerative

Treating mild-to-moderate ulcerative colitis

1.2.1 To induce remission in people with a mild-to-moderate first presentation

In May 2019, this was an off-label use of some topical aminosalicylates

1.2.2 If remission is not achieved within 4 weeks, consider adding an oral

1.2.3 If further treatment is needed, consider adding a time-limited course of a

In May 2019, this was an off-label use of beclometasone dipropionate in

1.2.4 For people who decline a topical aminosalicylate:

• consider an oral aminosalicylate as first-line treatment, and explain that this is

• if remission is not achieved within 4 weeks, consider adding a time-limited

In May 2019, this was an off-label use of beclometasone dipropionate in most

1.2.5 For people who cannot tolerate aminosalicylates, consider a time-limited

Proctosigmoiditis and left-sided ulcerative colitis

1.2.6 To induce remission in people with a mild-to-moderate first presentation

1.2.7 If remission is not achieved within 4 weeks, consider:

• adding a high-dose oral aminosalicylate to the topical aminosalicylate or

• switching to a high-dose oral aminosalicylate and a time-limited course of a

1.2.9 For people who decline any topical treatment:

• if remission is not achieved within 4 weeks, offer a time-limited course of an

1.2.10 For people who cannot tolerate aminosalicylates, consider a time-limited

1.2.11 To induce remission in people with a mild-to-moderate first presentation

or inflammatory exacerbation of extensive ulcerative colitis, offer a

1.2.12 If remission is not achieved within 4 weeks, stop the topical

1.2.13 For people who cannot tolerate aminosalicylates, consider a time-limited

Biologics and Janus kinase inhibitors for moderately to severely

• NICE technology appraisal guidance on infliximab, adalimumab and golimumab

• NICE technology appraisal guidance on vedolizumab for treating moderately to

• NICE technology appraisal guidance on tofacitinib for moderately to severely

Treating acute severe ulcerative colitis: all extents of disease

The multidisciplinary team

• ensure that a gastroenterologist and a colorectal surgeon collaborate to

• seek advice from a paediatrician with expertise in gastroenterology when