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DOP12 Efficacy of ustekinumab for ulcerative colitis through 2 years: Results of the UNIFI maintenance study and long-term extension

R. Panaccione1, W.J. Sandborn2, B.E. Sands3, C. Marano4, C.D. O’Brien4, H. Zhang5, J. Johanns5, Y. Zhou5, L. Peyrin-Biroulet6, T. Hisamatsu7, S. Danese8, UNIFI Investigators

1University of Calgary, Inflammatory Bowel Disease Center, Calgary, Canada, 2University of California San Diego, Gastroenterology, La Jolla, USA, 3Icahn School of Medicine at Mount Sinai, Gastroenterology, New York, USA, 4Janssen Research and Development- LLC, Immunology, Spring House, USA, 5Janssen Research and Development- LLC, Clinical Biostats, Spring House, USA, 6Nancy University Hospital, Gastroenterology, Nancy, France, 7Kyorin University School of Medicine, Internal Medicine, Tokyo, Japan, 8Humanitas Research Hospital, Gastroenterology, Milan, Italy

Background

Ustekinumab (UST) is a mAb to IL-12/23p40 that is approved for moderate-to-severe ulcerative colitis (UC). The UNIFI maintenance study evaluated SC UST through 1 year in patients who responded to UST IV induction. Patients who completed the maintenance study could enter a long-term extension (LTE) through 220weeks. Here, we report the efficacy of UST through 92weeks for patients randomised in the maintenance study.

Methods

Patients who were in clinical response 8weeks after UST induction were randomised to SC PBO (n = 175), UST 90mg q12w (n = 172), or UST 90mg q8w (n = 176). All patients who completed Week 44 were eligible to enter and continue in the LTE at the investigator’s discretion. Subsequent to completion of the maintenance study at Week 44, unblinding occurred and patients who were receiving PBO were discontinued from the LTE. During the LTE, patients were eligible to receive dose adjustment (q12w to q8w or q8w to q8w [sham dose adjustment]) starting at Week 56 based on investigator assessment of their UC disease activity. Symptomatic remission (stool frequency subscore of 0 or 1 and rectal bleeding subscore of 0) and partial Mayo remission (partial Mayo score ≤2) were evaluated through Week 92. Analyses of symptomatic remission and partial Mayo over time included all patients randomised in maintenance and were performed separately, with dose adjustment as part of the treatment experience (ie, not a treatment failure) and with adjustment considered as a treatment failure.

Results

Symptomatic and partial Mayo remission were sustained through Week 92, with no clinically meaningful differences between the q12w and q8w dose groups (Figure 1 and 2). When dose adjustment was considered to be part of the treatment experience (ie, not a treatment failure), 66.1 % and 67.0% of patients randomised to q12w and q8w, respectively, were in symptomatic and partial Mayo remission at Week 92 (Figure 1). When dose adjustment was considered to be a treatment failure in the analysis, 53.2% and 54.0% of patients were in symptomatic and partial Mayo remission, respectively (Figure 2). The safety profile of UST through Week 96 was consistent with that previously reported for 1 year.

Conclusion

The efficacy of UST in patients with moderate-to-severe UC has maintained through 92weeks with q12w or q8w SC dosing when dose adjustment was considered to be part of the treatment experience.

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