Letter to NICE regarding Crohn's Disease management update CG152
Dear Sir / Madam,
As a group of patients with Crohn’s Disease, close family members and friends or doctors with an interest in Inflammatory Bowel Disease, we would like to request that your current review of the guidelines for post-surgical Crohn’s disease management include discussion of the option of anti-MAP antibiotic therapy (AMAT) for the treatment of Crohn’s. AMAT is a treatment combining the antibiotics Clarithromycin, Rifabutin and Clofazimine to target Mycobacterium avium subspecies paratuberculosis (MAP). The rationale for this treatment is based on increasing evidence supporting the hypothesis that Crohn’s disease is caused by MAP in susceptible patients.
In particular, we would request that the panel review the recent data from the phase III randomised controlled trial ‘Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease’ (MAPUS) led by Redhill Biopharma (https://tinyurl.com/RedhillRHB104) and consider whether AMAT should be included as an additional treatment option in the updated guidelines. These recent trial data suggest both safety and efficacy of this treatment over standard care including corticosteroids, immunosuppressants, oral 5-ASA compounds and biologics (infliximab or adalimumab). Of note, AMAT does not carry the rare but life-threatening risks associated with biologics (e.g. lymphoma) nor the risks associated with long-term immunosuppression. At a cost of £4660 for a 12-month course, the treatment compares favourably to current therapies in terms of cost-effectiveness.
Given these data are in the public domain, it seems likely that many patients will seek information and guidance on this new treatment option. It is therefore important that national recommendations provide guidance for doctors making difficult decisions together with patients who may have exhausted all other treatment options.
We thank you in advance for your consideration and look forward to your response.