Long-term extension study of Stelara (ustekinumab) in adults with Crohn's disease shows response maintained for up to 2 years- Janssen Biotech

Janssen Biotech announced new two-year data from the ongoing IM-UNITI long-term extension (LTE) study evaluating the efficacy and safety of subcutaneous (SC) Stelara (ustekinumab) in adult patients with moderately to severely active Crohn's disease. The results showed that treatment with ustekinumab maintained clinical response and remission for up to two years with no new safety signals observed.

Of the 1,281 patients enrolled in the maintenance study, 397 patients who achieved a response to ustekinumab at week 8 following an induction phase were randomized to receive SC ustekinumab 90mg every 8 weeks (Q8W) or every 12 weeks (Q12W), or placebo during a maintenance (0–44 week) period, before entering the LTE (44–252 week) period. A one-time dose adjustment to ustekinumab 90mg Q8W was permitted in patients in the randomized group who met loss of response criteria between weeks 8–32. Clinical efficacy data were collected every 12 weeks and safety data were collected every 4 weeks from the end of the maintenance trial (week 44) until the maintenance study was unblinded and then at Q8W or Q12W dosing visits during the LTE period; data at week 92 are reported here.

Among randomized patients who entered the LTE period and continued to receive ustekinumab through week 96, 79.2% (61/77) of patients receiving ustekinumab Q12W and 87.1% (61/70) of patients receiving ustekinumab Q8W were in remission, while 90.9% (70/77) of patients and 94.3% (66/70) of patients showed clinical response at week 92, respectively. Among all ustekinumab-treated patients who continued to receive ustekinumab through week 96, remission and response rates at week 92 were 70.7% (365/516) and 84.7% (437/516), respectively (as observed). Safety events (per hundred subject years of follow up) were similar in ustekinukab treated patients compared to placebo treated patients from week 44 through to week 96 and were similar in number to event reported in the blinded period of the maintenance trial. The data were presented at the 12th Congress of the European Crohn's and Colitis Organisation.