NICE 2019 Guidelines for management of Crohn’s disease

Monotherapy

• Offer monotherapy with a conventional glucocorticosteroid (prednisolone, methylprednisolone or intravenous hydrocortisone) to induce remission in people with a first presentation or a single inflammatory exacerbation of Crohn's disease in a 12‑month period. [2012]


• Consider enteral nutrition as an alternative to a conventional glucocorticosteroid to induce remission for:

• Consider budesonide for a first presentation or a single inflammatory exacerbation in a 12‑month period for people:

• Consider aminosalicylate treatment for a first presentation or a single inflammatory exacerbation in a 12‑month period if conventional glucocorticosteroids are contraindicated, or if the person declines or cannot tolerate them. Explain that aminosalicylates are less effective than a conventional glucocorticosteroid or budesonide but may have fewer side effects than a conventional glucocorticosteroid. [2012]


• Do not offer budesonide or aminosalicylate treatment for severe presentations or exacerbations. [2012]


• Do not offer azathioprine, mercaptopurine or methotrexate as monotherapy to induce remission. [2012]

Add‑on treatment

• Consider adding azathioprine or mercaptopurine to a conventional glucocorticosteroid or budesonide to induce remission of Crohn's disease if:

• Assess thiopurine methyltransferase (TPMT) activity before offering azathioprine or mercaptopurine. Do not offer azathioprine or mercaptopurine if TPMT activity is deficient (very low or absent). Consider azathioprine or mercaptopurine at a lower dose if TPMT activity is below normal but not deficient (according to local laboratory reference values). [2012]


• Consider adding methotrexate to a conventional glucocorticosteroid or budesonide to induce remission in people who cannot tolerate azathioprine or mercaptopurine, or in whom TPMT activity is deficient, if:

• Monitor the effects of azathioprine, mercaptopurine and methotrexate as advised in the British national formulary (BNF) or British national formulary for children (BNFC). Monitor for neutropenia in people taking azathioprine or mercaptopurine even if they have normal TPMT activity. [2012]


• Ensure that there are documented local safety monitoring policies and procedures (including audit) for people receiving treatment that needs monitoring. Nominate a member of staff to act on abnormal results and communicate with GPs, people with Crohn's disease and their family members or carers (as appropriate). [2012]

Infliximab and adalimumab

• Infliximab and adalimumab, within their licensed indications, are recommended as treatment options for adults with severe active Crohn's disease whose disease has not responded to conventional therapy (including immunosuppressive and/or corticosteroid treatments), or who are intolerant of or have contraindications to conventional therapy. Infliximab or adalimumab should be given as a planned course of treatment until treatment failure (including the need for surgery), or until 12 months after the start of treatment, whichever is shorter. People should then have their disease reassessed to determine whether ongoing treatment is still clinically appropriate. [2010]


• Treatment should normally be started with the less expensive drug (taking into account drug administration costs, required dose and product price per dose). This may need to be varied for individuals because of differences in the method of administration and treatment schedules. [2010]


• When a person with Crohn's disease is starting infliximab or adalimumab discuss options of:

• Infliximab, within its licensed indication, is recommended as a treatment option for people with active fistulising Crohn's disease whose disease has not responded to conventional therapy (including antibiotics, drainage and immunosuppressive treatments), or who are intolerant of or have contraindications to conventional therapy. Infliximab should be given as a planned course of treatment until treatment failure (including the need for surgery) or until 12 months after the start of treatment, whichever is shorter. People should then have their disease reassessed to determine whether ongoing treatment is still clinically appropriate. [2010]


• Treatment with infliximab or adalimumab should only be continued if there is clear evidence of ongoing active disease as determined by clinical symptoms, biological markers and investigation, including endoscopy if necessary. Specialists should discuss the risks and benefits of continued treatment with patients and consider a trial withdrawal from treatment for all patients who are in stable clinical remission. People who continue treatment with infliximab or adalimumab should have their disease reassessed at least every 12 months to determine whether ongoing treatment is still clinically appropriate. People whose disease relapses after treatment is stopped should have the option to start treatment again. [2010]


• Infliximab, within its licensed indication, is recommended for the treatment of people aged 6 to 17 years with severe active Crohn's disease whose disease has not responded to conventional therapy (including corticosteroids, immunomodulators and primary nutrition therapy), or who are intolerant of or have contraindications to conventional therapy. The need to continue treatment should be reviewed at least every 12 months. [2010]


• For the purposes of this guidance, severe active Crohn's disease is defined as very poor general health and one or more symptoms such as weight loss, fever, severe abdominal pain and usually frequent (3 to 4 or more) diarrhoeal stools daily. People with severe active Crohn's disease may or may not develop new fistulae or have extra‑intestinal manifestations of the disease. This clinical definition normally, but not exclusively, corresponds to a Crohn's Disease Activity Index (CDAI) score of 300 or more, or a Harvey‑Bradshaw score of 8 to 9 or above. [2010]


• When using the CDAI and Harvey‑Bradshaw Index, healthcare professionals should take into account any physical, sensory or learning disabilities, or communication difficulties that could affect the scores and make any adjustments they consider appropriate. [2010]


• Treatment with infliximab or adalimumab should only be started and reviewed by clinicians with experience of TNF inhibitors and of managing Crohn's disease. [2010]

Ustekinumab and vedolizumab

• For guidance on using ustekinumab, see the NICE technology appraisal guidance on ustekinumab for moderately to severely active Crohn's disease after previous treatment. [2019]


• For guidance on using vedolizumab, see the NICE technology appraisal guidance on vedolizumab for treating moderately to severely active Crohn's disease after prior therapy. [2019]

Follow‑up during remission for people who choose not to have a maintenance treatment

• When people choose not to receive maintenance treatment:

Maintenance treatment for people who choose this option

• Offer azathioprine or mercaptopurine as monotherapy to maintain remission when previously used with a conventional glucocorticosteroid or budesonide to induce remission. [2012]


• Consider azathioprine or mercaptopurine to maintain remission in people who have not previously received these drugs (particularly people with adverse prognostic factors such as early age of onset, perianal disease, glucocorticosteroid use at presentation and severe presentations). [2012]


• Consider methotrexate to maintain remission only in people who:

• Do not offer a conventional glucocorticosteroid or budesonide to maintain remission. [2012]

5. Surgery

• Do not routinely monitor for changes in bone mineral density in children and young people. [2012]


• Consider monitoring for changes in bone mineral density in children and young people with risk factors, such as low body mass index (BMI), low trauma fracture or continued or repeated glucocorticosteroid use. [2012]

• Give information about the possible effects of Crohn's disease on pregnancy, including the potential risks and benefits of medical treatment and the possible effects of Crohn's disease on fertility. [2012]


• Ensure effective communication and information‑sharing across specialties (for example, primary care, obstetrics and gastroenterology) in the care of pregnant women with Crohn's disease. [2012]