Two-year data from the long-term extension of the PIII UNIFI study (n=399) demonstrated majority of patients who achieved symptomatic remission with ustekinumab were able to sustain remission through week 92 (69% on 8-weekly and 80% on 12 weekly regimen) .
Further positive results from PIII UNIFI study ustekinumab as maintenance therapy in adults with moderate to severe UC announced at conference. More patients on ustekinumab achieved complete remission at week 52 vs placebo (44% of adults receiving ustekinumab every 8 weeks and 38% receiving ustekinumab every 12 weeks vs 24% of patients on placebo (both p<0.001) .
Positive 8-week induction data announced from PIII UNIFI study in pts with severe Ulcerative Colitis (UC). At wk 8, 15.6% of pts receiving ustekinumab 130 mg and 15.5% of pts receiving ~6 mg/kg ustekinumab achieved clinical remission vs. 5.3% of pts receiving placebo (p11. Endoscopic healing (endoscopy subscore of 0 or 1) occured in 26.3% and 27.0% receiving ustekinumab 130mg and 6 mg/kg respcteivly vs. 13.8% receiving placebo (p<0.001). Clinical response (decrease of ≥30% in Mayo score and ≥3 points + decrease in rectal bleeding subscore ≥1 or a rectal bleeding subscore of 0 or 11) occurred in 51.3% and 61.8% of pts receiving ustekinumab 130mg and 6mg/kg respectively vs. achieved 31.3% receiving placebo (p<0.001). Similar improvements were seen in mucosal healing and symptom scores (secondary endpoints). Adverse were of similar proportions across ustekinumab and placebo gps. No malignancies, opportunistic infections or tuberculosis infections were reported through Week 8. One death from oesophageal varices haemorrhage was reported for a pt with no known history of cirrhosis or portal hypertension in the ~6 mg/kg dose group prior to wk 8.
PIII UNIFI is still recruiting pts .
PIII UNIFI study (NCT02407236) to evaluate the efficacy and safety of ustekinumab as intravenous infusion in an induction study in participants with moderately to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration in a maintenance study in participants with moderately to severely active UC who have demonstrated a clinical response to Induction treatment with IV ustekinumab. . 951 adults will be recruited from sites globally, inlcuidng US & EU (plus UK). Primary outcome in the Induction Study is number of participants With clinical remission at week 8 (The global definition of Clinical remission is defined as Mayo score less than or equal to () 1, for countries outside the United States (US). For the US, Clinical remission is defined as absolute stool number <=3, a rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0 or 1. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy and physician´s global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity). In the Maintenance Study primary outcome is number of participants with clinical remission among participants in clinical response to IV Ustekinumab Induction Treatment at week 44. Collection of these data should complete Apr 18 .