Moderately to severely active ulcerative colitis: adalimumab
This is information from a NICE 'Evidence summary: new medicines', and is not NICE guidance. The complete commentary is available at http://publications.nice.org.uk/esnm6
Adalimumab is an inhibitor of tumour necrosis factor (TNF) alpha. It is licensed for treating moderately to severely active ulcerative colitis in adults whose condition has responded inadequately to conventional therapy including corticosteroids and mercaptopurine or azathioprine, or when such therapies are contraindicated or not tolerated.
Current UK clinical practice in the use of TNF inhibitors in ulcerative colitis is based on Infliximab for acute exacerbations of ulcerative colitis (NICE technology appraisal guidance 163) and Infliximab for subacute manifestations of ulcerative colitis (NICE technology appraisal guidance 140). Infliximab has the same licensed indication in ulcerative colitis as adalimumab. NICE recommends infliximab as an option for treating acute exacerbations of severely active ulcerative colitis in certain circumstances, but it is not recommended for treating subacute manifestations of moderately to severely active ulcerative colitis that would normally be managed in an outpatient setting.
Adalimumab has been compared with placebo in 2 clinical trials of outpatients whose ulcerative colitis was moderately to severely active despite concurrent and stable treatment with oral corticosteroids, mercaptopurine or azathioprine. In these studies about 7 to 9 people per 100 treated with adalimumab obtained remission at 8 weeks over and above the response seen with placebo. In the long-term follow up of 1 of these studies, about half of these people remained in remission for a full year.
Like other TNF inhibitors, adalimumab is associated with a range of adverse reactions. Some of these are very common (frequency of more than 1 in 10), such as upper respiratory tract infections, injection site reactions, headache and musculoskeletal pain. Serious but uncommon (frequency at least 1 in 1000 but less than 1 in 100) or rare (frequency at least 1 in 10,000 but less than 1 in 1000) adverse reactions include lymphoma, leukaemia, solid organ malignancies, and fatal or life-threatening infections.
Induction treatment with adalimumab costs £2112.84 and the usual annual cost of maintenance therapy is £9155.64 (adalimumab given once every 2 weeks). Some people may benefit from an increase in dosing frequency to 40 mg every week, which would increase the annual cost of maintenance therapy to £18,311.28. (Costs exclude VAT and are taken from MIMS, October 2012).
People with ulcerative colitis, clinicians and commissioners will need to consider this evidence when making decisions about using adalimumab. The likely benefits of its use will need to be balanced against the possible risks of adalimumab and alternative treatments, the administration routes of adalimumab and alternative treatments, and their different costs.
Reinisch W, Sandborn W, Hommes D et al. (2011) Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial. Gut 60: 780–7 (ULTRA 1)
Sandborn W, Van Assche G, Reinisch W et al. (2012) Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology 142: 257–65 (ULTRA 2)
'Evidence summaries: new medicines' provide summaries of key evidence for selected new medicines, or for existing medicines with new indications or formulations, that are considered to be of significance to the NHS. The strengths and weaknesses of the relevant evidence are critically reviewed within this summary to provide useful information for those working on the managed entry of new medicines for the NHS, but this summary is not NICE guidance.