Janssen Pharmaceutical Companies of Johnson & Johnson have announced three-year data from the long-term extension (LTE) of the STELARA (ustekinumab) Phase 3 UNIFI study that demonstrated the majority (55.2 percent) of adult patients with moderately to severely active ulcerative colitis (UC) who initially responded to treatment with STELARA sustained symptomatic remission rates at nearly three years (week 152). Furthermore, a majority (96.4 percent) of the patients in symptomatic remission at week 152 were corticosteroid-free. These data are being presented as a digital oral presentation (DOP83) at the 16th Congress of the European Crohn's and Colitis Organisation.
STELARA is a fully human monoclonal antibody and is the first biologic treatment to selectively inhibit the interleukin (IL)-12 and IL-23 pathways. UNIFI is a Phase 3 protocol designed to evaluate the safety and efficacy of STELARA induction and maintenance dosing for the treatment of moderately to severely active UC in adults who demonstrated an inadequate response to or were unable to tolerate conventional (i.e., corticosteroids, immunomodulators) or biologic (i.e., one or more TNF blockers or vedolizumab) therapies. Both the induction and maintenance studies are randomized, double-blind, placebo-controlled, parallel group, multi-centre studies.
"Despite recent substantial therapeutic gains, many patients living with ulcerative colitis still struggle to find lasting relief from their disease symptoms, especially without the use of steroids that can be associated with debilitating side effects when used long-term," said Dr Bruce E Sands, Chief of the Dr Henry D Janowitz Division of Gastroenterology at Mount Sinai Hospital and the Dr Burrill B Crohn Professor of Medicine (Gastroenterology) at the Icahn Institute for Medicine at Mount Sinai. "The LTE of the UNIFI study underscores the importance of studying therapies long-term, with results showing ustekinumab as both an effective and enduring treatment option for patients living with moderately to severely active ulcerative colitis."
Of the 348 patients in the intent-to-treat population who had achieved clinical response at maintenance baseline and were randomised to STELARA 90 mg every eight weeks (q8w) or every 12 weeks (q12w):
- 55.2 percent of patients were in symptomatic remission at week 152.
- 96.4 percent (185/192) of patients in symptomatic remission at week 152 were not receiving corticosteroids.
- Of the 248 patients randomized to STELARA 90 mg q8w or q12w at maintenance baseline and treated in the LTE:
- 67.6 percent of patients were in symptomatic remission at week 152.
- 76.4 percent of patients in clinical remission at week 44 were in symptomatic remission at week 152.
Safety was evaluated at week 156 for all patients (n=588) who were treated in the LTE. From maintenance week 0 through week 156, combined STELARA patients and placebo patients had 1,281.6 and 425 patient-years (PYs) of follow-up, respectively. Safety events per 100 PYs of follow-up were as follows: adverse events (AEs) 235.81 for STELARA vs 204.48 for placebo; serious adverse events (SAEs) 7.73 for STELARA vs 7.53 for placebo, and serious infections 2.34 for STELARA vs 2.35 for placebo. No new safety signals were observed.
Results from a separate digital oral presentation (DOP86) on corticosteroid-sparing effects within the UNIFI LTE show 91.4 percent of STELARA patients (n=139) receiving corticosteroids at maintenance baseline were no longer receiving corticosteroids at week 152 (patients were randomized to STELARA at the start of the LTE of the study).
"Janssen is relentlessly focused on unmet patient needs and committed to improving the standard of care in ulcerative colitis," said Dr Jan Wehkamp, Vice President, Gastroenterology Disease Area Leader, Janssen Research & Development, LLC. "We are proud to share these long-term data among the gastrointestinal community, especially for patients who are still struggling to manage their disease and achieve remission."
The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA.