New biologic option for Crohn's disease

Stelara, which suppresses the effects of interleukin (IL)-12 and IL-23, is approved as an option for adults who have had an inadequate response to, lost response to, or are intolerant of either conventional therapy or a tumour necrosis factor (TNF) antagonist, or in whom such therapies are contraindicated.

New vial presentation

A new vial presentation of the monoclonal antibody containing 130mg concentrate for solution for infusion has been launched to support initial intravenous induction dosing in Crohn's disease. Subsequent doses are administered subcutaneously using the existing 45mg and 90mg presentations available as vials and pre-filled syringes.

Clinical response

Researchers conducted two 8-week intravenous induction studies of ustekinumab, UNITI-1 and UNITI-2, in adults with moderately to severely active Crohn's disease (n=1369).

The rate of clinical response at 6 weeks (defined as a reduction in Crohn's Disease Activity Index [CDAI] score of ≥100 points) was significantly higher for patients who received ustekinumab 6mg/kg than for patients given placebo, among both those who had failed anti-TNF therapy (33.7% vs 21.5%; p=0.003) and those who had failed conventional therapy (55.5% vs 28.7%; p<0.001).

Patients who had achieved a clinical response after 8 weeks of induction therapy continued into a maintenance study (n=397). After 44 weeks of subcutaneous maintenance treatment, remission was maintained in 53.1% of patients receiving ustekinumab 8-weekly and 48.8% of those receiving ustekinumab 12-weekly, compared with 35.9% of patients on placebo (p=0.005 and p=0.040, respectively).

Stelara is also approved for the treatment of psoriasis and psoriatic arthritis.