PBS indications for the IL-12/23 inhibitor ustekinumab (Stelara) have been expanded from September 1, 2017 to include adults with severe Crohn’s disease.
It will be available for patients with active Crohn’s disease who have failed or cannot be managed by either conventional therapy or TNF inhibitors.
Evidence comes mainly from the UNITI trials, which found a single IV dose of ustekinumab, compared to placebo, reduced disease activity scores in patients.
The IM-UNITI trial also found ongoing subcutaneous therapy every 2-3 months was effective as a maintenance therapy in about half of patients who responded to the induction therapy.
Professor Rupert Leong, director of endoscopy at Concord Hospital, told the limbic Crohn’s disease was still an area of unmet need.
He said surgical rates hadn’t declined since the introduction of biological agents.
“We’ve also found persistence with anti-TNF agents is only 50% over three years suggesting to us a loss of efficacy, complications or that patients have elected to stop treatment because of intolerance.”
He said one of the advantages of ustekinumab (Stelara) was that it already had lots of safety data from psoriasis patients to demonstrate it was quite safe, at least in the dermatology population.
“So it will not be surprising if many Crohn’s disease patients use ustekinumab over anti-TNF agents.”
He said the subcutaneous injection of ustekinumab (Stelara) every two months reduced the need for hospital utilisation seen in patients requiring infusions such as infliximab.
Ustekinumab also had less frequent dosing than adalimumab (Humira), which is given every two weeks.
Professor Leong said the PBS had been generous in providing for maintenance therapy every eight weeks instead of 12 weeks as was common in other countries.
“Patients are very lucky to be able to use this drug for a very difficult to control disease like Crohn’s disease.”
Ustekinumab (Stelara) has been available on the PBS since 2009 for severe chronic plaque psoriasis and since 2015 for severe active psoriatic arthritis.