- In ulcerative colitis patients with a clinical response to risankizumab induction treatment, a significantly higher proportion of patients treated with risankizumab (180 mg or 360 mg) achieved the primary endpoint of clinical remissiona (per Adapted Mayo Score) at week 52 compared to withdrawal from risankizumab treatment1
- Key secondary endpoints were met, including endoscopic improvementb, histologic endoscopic mucosal improvementc and steroid-free remissiond at one year
- Safety results in this study were consistent with the known safety profile of risankizumab, with no new safety risks observed1
- Building on AbbVie’s growing gastroenterology portfolio, risankizumab is an IL-23 inhibitor being evaluated as a treatment for adults with moderate to severe ulcerative colitis and approved for Crohn’s disease, psoriatic arthritis and psoriasis1
NORTH CHICAGO, Ill., June 15, 2023 /PRNewswire/ — AbbVie (NYSE:ABBV) today announced positive top-line results from COMMAND, its Phase 3 maintenance study, showing risankizumab (SKYRIZI®, 180 mg or 360 mg subcutaneous [SC]) achieved the primary endpoint of clinical remission (per Adapted Mayo Score) at week 52, as well as key secondary endpoints in adult patients with moderately to severely active ulcerative colitis.1 In the COMMAND maintenance study, patients from the Phase 2b/3 INSPIRE study who responded to induction treatment were re-randomized to receive risankizumab 180 mg SC, 360 mg SC or withdrawal from risankizumab treatment (risankizumab intravenous [IV] induction-only control group).1 Approximately 75% of patients previously failed at least one advanced therapy (biologics, JAK inhibitors and/or S1P receptor modulators) for ulcerative colitis.1
A significantly higher proportion of patients who received risankizumab 180 mg or 360 mg achieved clinical remission at week 52: 40% and 38%, respectively, compared to 25% in the induction-only control group (p<0.01).1
“Through important programs such as the Phase 3 COMMAND study, we continue to drive research and development to help manage the impact of serious gastroenterological conditions,” said Roopal Thakkar, M.D., senior vice president, development, regulatory affairs and chief medical officer, AbbVie. “Risankizumab is already approved in moderately to severely active Crohn’s disease, and these results demonstrate that this treatment can be a potentially effective option for ulcerative colitis as well.”
In COMMAND, 51% of patients treated with risankizumab 180 mg and 48% of patients treated with risankizumab 360 mg achieved endoscopic improvement at week 52 vs 32% of patients in the induction-only control group (p<0.001).1 Additionally, significantly more patients treated with risankizumab 180 mg and 360 mg achieved histologic endoscopic mucosal improvement at week 52 compared to those treated with induction only: 43% and 42%, respectively, vs 23% (p<0.001).1 A significantly higher proportion of patients who received risankizumab 180 mg or 360 mg achieved steroid-free clinical remission compared to the induction-only control group at week 52 (40% and 37%, respectively, vs 25%; p<0.01).1
“These positive results suggest that risankizumab is a promising therapy to help ulcerative colitis patients with challenging symptoms that disrupt their daily lives,” said Stefan Schreiber, M.D., director of department of internal medicine I, University Hospital Schleswig-Holstein, Germany, COMMAND study investigator. “Risankizumab’s achievement of a broad range of difficult-to-reach endpoints encompassing endoscopic-histologic outcomes and many others represents important progress toward addressing the need for additional treatment options for patients with ulcerative colitis.”
| Efficacy Results at Week 52*,1 | |||
|
|
Risankizumab 180 mg SC (n=179) |
Risankizumab 360 mg SC (n=186) |
Risankizumab IV induction only (control group) (n=183) |
| Clinical Remission (Adapted Mayo Score)a | 40 % | 38 % | 25 % |
| Endoscopic Improvementb | 51 % | 48 % | 32 % |
| Histologic Endoscopic Mucosal Improvement (HEMI)c | 43 % | 42 % | 23 % |
| Steroid-free Clinical Remissiond | 40 % | 37 % | 25 % |
|
*Primary endpoint was clinical remission (per Adapted Mayo Score). Endoscopic improvement, HEMI and steroid-free clinical remission were secondary endpoints. Not all secondary endpoints are shown. All primary and secondary endpoints displayed achieved statistical significance under the overall Type I error rate of 0.05 (2-sided). a Clinical remission per Adapted Mayo Score is defined as stool frequency subscore (SFS) ≤1 and not greater than baseline, rectal bleeding subscore (RBS) of 0 and endoscopic subscore ≤1 without evidence of friability. b Endoscopic improvement is defined as endoscopic subscore ≤1 without evidence of friability. c HEMI is defined as an endoscopic subscore of ≤1 without evidence of friability and Geboes score ≤3.1. d Steroid-free remission is defined as clinical remission per Adapted Mayo score at week 52 and corticosteroid free for ≥90 days prior to week 52. |
The safety profile of risankizumab in the 52-week, double-blind, placebo-controlled COMMAND study was consistent with the safety profile observed in previous studies across other indications, with no new safety risks observed.1 The most common adverse events observed in the risankizumab groups were colitis ulcerative, COVID-19, nasopharyngitis and arthralgia.1 Serious adverse events occurred in 5.2% and 5.1% of patients in the risankizumab 180 mg and 360 mg groups compared to 8.2% of patients in the control group.1 There was one death in the 360 mg group due to adenocarcinoma assessed as unrelated to study drug. There were no adjudicated major adverse cardiac events (MACE) and no adjudicated anaphylactic reaction events.
Full results from the COMMAND study will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal. Use of risankizumab in ulcerative colitis is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
About Ulcerative Colitis
Ulcerative colitis is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) of the large intestine that causes continuous mucosal inflammation extending, to a variable extent, from the rectum to the more proximal colon.2,3 The hallmark signs and symptoms of ulcerative colitis include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of pressure), urgency and fecal incontinence.3,4 The disease course of ulcerative colitis varies between patients and can range from quiescent disease to chronic refractory disease, which in some cases can lead to surgery or complications, including cancer or death.4,5 The severity of symptoms and unpredictability of disease course can lead to substantial burden and often disability among those living with the disease.6
