1.5.3 Drugs affecting the immune response

This guidance relates only to the use of infliximab within its marketing authorisation, for the treatment of acute exacerbations of severely active ulcerative colitis. It relates to an induction course of three doses of infliximab.

1.1 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.

1.2 In people who do not meet the criterion in 1.1, infliximab should only be used for the treatment of acute exacerbations of severely active ulcerative colitis in clinical trials.

https://www.nice.org.uk/Guidance/ta163

1.1 Infliximab and adalimumab, within their licensed indications, are recommended as treatment options for adults with severe active Crohn's disease (see 1.6) 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 (see 1.4) to determine whether ongoing treatment is still clinically appropriate.

1.2 Treatment as described in 1.1 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 individual patients because of differences in the method of administration and treatment schedules.

1.3 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 (see 1.4) to determine whether ongoing treatment is still clinically appropriate.

1.4 Treatment with infliximab or adalimumab (see 1.1 and 1.3) 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.

1.5 Infliximab, within its licensed indication, is recommended for the treatment of people aged 6–17 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.

1.6 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 (3–4 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.

1.7 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.

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

https://www.nice.org.uk/guidance/ta187

This guidance relates only to the use of infliximab for subacute manifestations of moderately to severely active ulcerative colitis. The guidance does not cover the use of infliximab for acute manifestations of moderately to severely active ulcerative colitis.

1.1 Infliximab is not recommended for the treatment of subacute manifestations of moderately to severely active ulcerative colitis.

1.2 For the purposes of this guidance, a subacute manifestation of moderately to severely active ulcerative colitis is defined as disease that would normally be managed in an outpatient setting and that does not require hospitalisation or the consideration of urgent surgical intervention.

https://www.nice.org.uk/guidance/ta140?unlid=99534170120163335214

1.1 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.

Golimumab is recommended only if the company provides the 100 mg dose of golimumab at the same cost as the 50 mg dose, as agreed in the patient access scheme.

1.2 The choice of treatment between infliximab, adalimumab or golimumab should be made on an individual basis after discussion between the responsible clinician and the patient about the advantages and disadvantages of the treatments available. This should take into consideration therapeutic need and whether or not the patient is likely to adhere to treatment. If more than 1 treatment is suitable, the least expensive should be chosen (taking into account administration costs, dosage and price per dose).

1.3 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.

1.4 Infliximab, adalimumab or golimumab 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. Specialists should then discuss the risks and benefits of continued treatment with the patient, and their parent or carer if appropriate:

• They should continue treatment 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.

• They should consider a trial withdrawal from treatment 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.

https://www.nice.org.uk/guidance/ta329

1.1 Vedolizumab is recommended, within its marketing authorisation, as an option for treating moderately to severely active ulcerative colitis in adults only if the company provides vedolizumab with the discount agreed in the patient access scheme.

1.2 Vedolizumab should be given until it stops working or surgery is needed. At 12 months after the start of treatment, people should be reassessed to see whether treatment should continue. Treatment should only continue if there is clear evidence of ongoing clinical benefit. For people in complete remission at 12 months, consider stopping vedolizumab, resuming treatment if there is a relapse. People who continue vedolizumab should be reassessed at least every 12 months to see whether continued treatment is justified.

http://www.nice.org.uk/guidance/ta342

1.1 Vedolizumab is recommended 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.
  
  Vedolizumab is recommended only if the company provides it with the discount agreed in the patient access scheme.

1.2 Vedolizumab should be given as a planned course of treatment until it stops working or surgery is needed, or until 12 months after the start of treatment, whichever is shorter. At 12 months, people should be reassessed to determine whether treatment should continue. Treatment should only continue if there is clear evidence of ongoing clinical benefit. For people in complete remission at 12 months, consider stopping vedolizumab, resuming treatment if there is a relapse. People who continue vedolizumab should be reassessed at least every 12 months to decide whether continued treatment is justified.

1.3 People whose treatment with vedolizumab is not recommended in this NICE guidance, but was started within the NHS before this guidance was published, should be able to continue treatment until they and their NHS clinician consider it appropriate to stop.

http://www.nice.org.uk/guidance/ta352

Recommendations

1.1 Tofacitinib is recommended, within its marketing authorisation, as an option for treating moderately to severely active ulcerative colitis in adults when conventional therapy or a biological agent cannot be tolerated or the disease has responded inadequately or lost response to treatment. It is recommended only if the company provides tofacitinib with the discount agreed in the commercial arrangement.

Why the committee made these recommendations

Clinical trial evidence shows that tofacitinib is more effective than placebo for treating moderately to severely active ulcerative colitis. An indirect comparison suggests that for people who have not had a TNF-alpha inhibitor, tofacitinib is more effective than adalimumab and golimumab as maintenance treatment. For people who have had a TNF-alpha inhibitor, tofacitinib is more effective than adalimumab as induction treatment. No other statistically significant differences between tofacitinib and biological therapies were identified.

Based on the health-related benefits and costs compared with conventional therapy and biologicals, tofacitinib is recommended as a cost-effective treatment for moderately to severely active ulcerative colitis in adults whose disease has responded inadequately to, or who cannot tolerate, conventional or biological therapy.

https://www.nice.org.uk/guidance/ta547