In a poster presented during ACG, investigators show data from a long-term extension of the UNIFI trial.
Ustekinumab could be a new treatment in reducing rectal bleeding, while normalizing stool frequency in patients suffering from ulcerative colitis.
A team, led by Maria T. Abreu , MD, University of Miami Miller School of Medicine, evaluated the effect of ustekinumab maintenance therapy on stool frequency and rectal bleeding through 92 weeks in patients who were treated in the long-term extension of the UNIFI trial in data presented virtually during the annual American College of Gastroenterology (ACG) 2020 conference.
In the UNIFI randomized-withdrawal study, researchers evaluated the safety and efficacy of subcutaneous ustekinumab in patients with moderately to severely active ulcerative colitis, who had responded to intravenous ustekinumab induction. The patients who completed the 44 week maintenance study had the option of entering the long-term extension through a total of 220 weeks.
The individuals in the placebo arm of the maintenance study were discontinued from the long-term extension.
During this period, each eligible patient received dose adjustment placebo to q8w or q12w to q8w or q8w to q8w [sham dose adjustment) starting at week 56 based on investigator assessment of the patient’s ulcerative colitis disease activity.
Dose adjustment was considered part of the treatment experience and was not considered a treatment failure in the study.
The researchers also recorded the number of stools and rectal bleeding symptoms for 7 days prior to each visit. Overall, the researchers evaluated the proportion of patients with Mayo stool frequency subscores of 0 (normal number of stools) or 1 (1-2 stools more than normal) or rectal bleeding subscores of 0 (no rectal bleeding found) and summarized the absolute stool number.
Included in the final analysis of the long-term study were 141 patients who received ustekinumab 90 mg q12w and 143 participants who received ustekinumab 90 mg q8w. The absolute stool numbers in the ustekinumab q12w and q8w groups at induction baseline were 6.6 and 6.5 stools per day, respectively. These numbers ultimately decreased to 2.8 and 2.7, respectively, by maintenance baseline.
Reductions achieved at maintenance baseline were maintained at week 92 at 2.7 and 2.2 stools per day, respectively. At induction baseline, only 12.8% and 18.2% of patients, respectively, had Mayo stool frequency subscores of 0 or 1.
At maintenance baseline, 80.9% and 80.4% in the 2 treatment dosing groups had Mayo stool frequency subscores of 0 or 1. These percentages were maintained through week 92 as well at 79.4% and 86.7%, respectively. At induction baseline, there was no blood seen in the stool of 9.2% and 7.0% of the patients, respectively.
By maintenance baseline, 9.2% and 7.0% had no blood found in their stool and these percentages were maintained through week 92 (86.5% and 88.8%), respectively.
“Among patients who were treated in the long-term extension, reductions in stool frequency and rectal bleeding that had been achieved after IV ustekinumab induction were maintained through 2 years of ustekinumab SC maintenance,” the authors wrote. “These data support the durability of response to ustekinumab in ulcerative colitis.”
The study, “Effect of Ustekinumab Maintenance Therapy on Stool Frequency and Rectal Bleeding Through 2 Years in the UNIFI Phase 3 Study in Ulcerative Colitis,” was published online by ACG.