Treatment of ulcerative colitis and Crohn's disease

Two biosimilar versions of infliximab are now available. Although they have demonstrated clinical comparability to the originator product, it is now recommended that infliximab should be prescribed by brand name.

NICE Guidance TA 187: Crohn’s disease – Infliximab (review) and adalimumab (review of TA 40) May 2010

Infliximab and adalimumab are recommended as treatment options for adults

• with severe active Crohn’s disease (Crohn’s Disease Activity Index score of 300 or more and a Harvey-Bradshaw Index of 8/9 or above).

and

• 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 is also recommended as a treatment option in the flowing circumstances:

• For active fistulating Crohn’s disease where the condition has not responded to conventional treatments or where patients are intolerant of or have contraindications to conventional treatments.
• In patients aged 6-17 years with severe active Crohn’s disease whose disease has not
  responded to conventional therapy or where there is intolerance or 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.

A gastroenterologist experienced in the management of Crohn’s disease should prescribe and monitor these treatments.

NICE Guidance TA 329: Infliximab, adalimumab and golimumab for treating moderately to
severely active ulcerative colitis (including a review of TA140 and TA262) Feb 2015

Infliximab, adalimumab and golimumab are recommended, within their marketing authorisations, as options for treating moderately to severely active ulcerative colitis in adults whose disease has responded inadequately to conventional therapy including corticosteroids and mercaptopurine or azathioprine, or who cannot tolerate, or have medical contraindications for, such therapies.

Infliximab is recommended, within its marketing authorisation, as an option for treating severely active ulcerative colitis in children and young people aged 6–17 years whose disease has responded inadequately to conventional therapy including corticosteroids and mercaptopurine or azathioprine, or who cannot tolerate, or have medical contraindications for, such therapies.

They should be given as a planned course of treatment until treatment fails (including the need for surgery) or until 12 months after starting treatment, whichever is shorter.

Treatment should continue only if there is clear evidence of response as determined by clinical symptoms, biological markers and investigation, including endoscopy if necessary. People who continue treatment should be reassessed at least every 12 months to determine whether ongoing treatment is still clinically appropriate.

A trial withdrawal from treatment should be considered for all patients who are in stable clinical remission. People whose disease relapses after treatment is stopped should have the option to start treatment again.

NICE Guidance TA342: Vedolizumab for treating moderately to severely active ulcerative colitis (June 2015) recommends vedolizumab as an additional treatment option under the same conditions as laid out in TA 329 (Feb 2015)

NICE Guidance TA352: Vedolizumab for treating moderately to severely active Crohn's disease after prior therapy recommends vedolizumab as an option for treating moderately to severely active Crohn's disease only if:

• a tumour necrosis factor‑alpha inhibitor has failed (that is, the disease has responded
  inadequately or has lost response to treatment) or
• a tumour necrosis factor‑alpha inhibitor cannot be tolerated or is contraindicated.

Notes:
MHRA drug safety update (April 2014): There is an increased risk of tuberculosis, or reactivation of latent tuberculosis, during treatment with tumour necrosis factor alpha (TNF-alpha) inhibitors. TNF-alpha inhibitors are contraindicated in patients with active tuberculosis or other severe infections. Patients should be screened patients for active and latent tuberculosis before starting treatment with a TNF-alpha inhibitor and monitored closely for infectious diseases including tuberculosis before, during, and after treatment.