The Janssen Pharmaceutical Companies of Johnson & Johnson announced new, final five-year data from the Phase 3 IM-UNITI open-label, long-term extension (LTE) study which showed treatment of STELARA (ustekinumab) in patients with moderate to severe Crohn’s disease (CD) maintained long-term remission through five years.
These data are being presented as an oral presentation at the 28th United European Gastroenterology (UEG) Week, which is conducting its annual congress virtually.
Lead study investigator William J. Sandborn, Chief of Gastroenterology, Professor of Medicine, University of California, San Diego, who is delivering the oral presentation virtually at UEG Week. Said, “Results from the IM-UNITI study showed that patients were able to maintain response with ustekinumab treatment through five years. Notably, for those patients in clinical remission, the majority (greater than 90 per cent) who received continuous treatment with q12w or q8w ustekinumab were steroid-free at five years.”
The key findings showed more than half of the patients with moderately to severely active CD who were randomised to subcutaneous (SC) ustekinumab every eight weeks (q8w) and continued to receive this dosage in the LTE study maintained clinical response (57 per cent) and remission (55 per cent) through five years of treatment. Of these patients in clinical remission, 93 per cent were steroid-free. Patients who were randomised to SC ustekinumab every 12 weeks (q12w) and continued to receive this dosage in the LTE study also maintained clinical response (54 per cent) and remission (45 per cent) through five years of treatment. Of these patients in clinical remission, 90 per cent were steroid-free.
Additionally, among the subgroup of these patients who had never previously been exposed to anti-tumour necrosis factor-alpha (TNF-α) biologics, 40 per cent and 59 per cent were in clinical remission after five years of receiving SC ustekinumab maintenance treatment q12w and q8w, respectively. Further, among the subgroup of these patients who had previously failed (i.e. were refractory to) or who were intolerant to anti-TNF-α therapy, 41 per cent and 44 per cent were in clinical remission after five years of receiving SC ustekinumab maintenance treatment q12w and q8w, respectively. Approximately half (51 per cent, [290/567]) of all patients (randomised and assigned) who entered the LTE study completed their final dosing visit.
No new safety signals were observed and adverse events (AEs) were generally consistent with previous studies of ustekinumab and the current Summary of Product Characteristics. The most common AEs (>5%) in controlled periods of clinical studies with ustekinumab were nasopharyngitis and headache.2 Most were considered to be mild and did not necessitate discontinuation of study treatment.2
Through five years, the event rates (per one hundred patient-years) for AEs, serious AEs, and serious infections were similar among the q12w and q8w ustekinumab groups and were generally comparable with the event rates in the placebo group. Antibody to ustekinumab rates through week 272 remained low, occurring in six per cent of patients assigned to receive ustekinumab in the maintenance study and continuously receiving the approved 90 mg SC q12w or q8w regimen in the LTE.
“Crohn’s disease is a chronic, lifelong condition, so it’s important to understand the long-term outcomes of therapies in order to effectively address the disease,” said Jan Wehkamp, Vice President, Gastroenterology Disease Area Leader, Janssen Research & Development. “These results from the LTE study with ustekinumab bring us further insights into the long-term management of this chronic disease.”
Janssen is presenting a total of 16 abstracts at this year’s UEG Week congress of which seven are oral presentations.