The National Institute for Health and Care Excellence (NICE) recommends tofacitinib (Xeljanz) as a treatment option for previously treated active ulcerative colitis.
Tofacitinib is recommended for the treatment of adults with moderately to severely active ulcerative colitis who were either intolerant or had an inadequate response or loss of response to conventional therapy or a biological agent.
Recommended dose for tofacitinib is:
- Induction: 10 mg orally twice daily x 8 weeks;
- Maintenance: 5 mg taken twice daily.
If the induction dose fails to provide benefit at 8 weeks, it may be continued for a further 8 weeks. Therapy should not be continued beyond 16 weeks if there is no therapeutic benefit. If the response decreases on the maintenance dose, it should be increased to 10 mg twice daily. For patients with inadequate response to tumour necrosis factor (TNF) antagonist therapy, a 10-mg twice-daily maintenance dose is recommended. When there is an inadequate response to tofacitinib, corticosteroids may be lowered or discontinued as per standard care.
The trial evidence showed that tofacitinib was superior to placebo in treating moderately to severely active ulcerative colitis. An indirect comparison showed better efficacy of tofacitinib than adalimumab and golimumab as maintenance treatment in patients not treated with a TNF-alpha inhibitor earlier. In those previously treated with a TNF-alpha inhibitor, tofacitinib had better efficacy than adalimumab as induction treatment.
The drug is to be used only when provided by the company in agreement with the commercial arrangement.
