AbbVie Reports Positive Phase 3 Results for Subcutaneous SKYRIZI® in Crohn’s Disease
AbbVie (NYSE: ABBV) today announced positive topline results from the Phase 3, randomized, placebo-controlled, double-blind AFFIRM study evaluating the efficacy and safety of risankizumab (SKYRIZI®) subcutaneous (SC) induction treatment versus placebo in adult patients with moderately to severely active Crohn’s disease (CD).1
The AFFIRM study results show significantly greater proportions of patients treated with risankizumab SC induction achieved the co-primary endpoints of Crohn’s Disease Activity Index (CDAI) clinical remissiona (55% vs. 30%; p<0.0001) and endoscopic responseb (44% vs. 14%; p<0.0001) at week 12 compared to placebo.1 Among patients with clinical responsec after 12 weeks of AbbVie risankizumab SC induction treatment followed by 12 weeks of maintenance, 67% achieved CDAI clinical remission at week 24 and 57% achieved endoscopic response at week 24.1
This Phase 3 study enrolled a predominantly treatment-refractory population** (65%) with 50% of those patients having failed two or more advanced therapies and 23% having failed ustekinumab and 12% having failed a Janus kinase inhibitor (JAKi).1
“This study evaluated a difficult-to-treat Crohn’s disease patient population, including a majority with a prior failure to advanced therapy, and these data reinforce risankizumab as a leading, effective treatment for patients,” said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. “The level of endoscopic response is a particularly meaningful achievement for Crohn’s disease patients; and for AbbVie, these results underscore our continued innovation and research to raise the standard of care.”
| AFFIRM Phase 3 Co-Primary Endpoints Results at Week 12 | ||||||
| Overall Population (N=289) | Advanced Therapy Naïve* (N=100) | Prior AdvancedTherapy Failure** (N=189) | ||||
| Proportion of patients | PBO | RZB SC | PBO | RZB SC | PBO | RZB SC |
| CDAI Clinical Remissiona | 29.6 % | 55 % | 27.3 % | 73.1 % | 30.8 % | 45.2 % |
| Endoscopic Responseb | 14.3 % | 44 % | 15.2 % | 61.2 % | 13.8 % | 34.7 % |
| RZB= risankizumab; PBO=placebo | ||||||
| * | Defined as patients without prior advanced therapy failure.1 |
| ** | Defined as patients with prior failure to at least one advanced therapy for CD.1 |
| a | Defined as Crohn’s Disease Activity Index (CDAI) <150 at week 12.1 |
| b | Defined as decrease in Simple Endoscopic Score for Crohn’s disease (SES-CD) >50% from baseline or for patients with isolated ileal disease and a baseline SES-CD of 4, at least a 2-point reduction from baseline, as scored by blinded central reviewer at week 12.1 |
| c | Defined as at least a 100-point reduction from baseline in CDAI.1 |
“Crohn’s disease is a complex, often debilitating condition that affects far more than a patient’s digestive health, disrupting work, relationships and daily life,” said Millie D. Long, M.D., MPH, chief, Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, and lead investigator of the AFFIRM study. “AbbVie These high endoscopic response rates across populations, in particular among those who have not failed an advanced therapy, demonstrate the potential of subcutaneous induction risankizumab as an effective therapy for Crohn’s disease.”
During the 12-week, double-blind, AbbVie placebo-controlled period, the safety profile of risankizumab SC was consistent with the safety profile observed in Crohn’s disease with no new safety risks observed. The most common adverse events observed among patients receiving risankizumab were upper respiratory tract infection, abdominal pain and arthralgia. Serious adverse events occurred in 0.5% of patients in the risankizumab SC group compared to 3.1% in the placebo group.1
Full results will be published in an upcoming medical journal and shared at future medical congresses.
About Crohn’s Disease
Crohn’s disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, most commonly in the area between the small intestine (ileum) and the colon, causing persistent diarrhea and abdominal pain.2,3AbbVi It is a progressive disease, meaning it gets worse over time and may lead to life-threatening complications or surgery.4,5 Because the signs and symptoms of Crohn’s disease are unpredictable, it causes a significant burden on people living with the disease—not only physically but also emotionally and economically.6
About the AFFIRM Study1
AFFIRM is a global, Phase 3, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of risankizumab subcutaneous (SC) as an induction treatment in adult patients with moderately to severely active Crohn’s disease. AbbVie Co-primary endpoints were percentage of participants with CDAI Clinical Remission (CDAI < 150) and percentage of participants with endoscopic response at week 12. A total of 289 patients were randomized in a 2:1 ratio to risankizumab SC or placebo. Key demographics and baseline characteristics were generally balanced between the risankizumab SC and placebo groups; 65% had failed advanced therapies for the treatment of CD before.
The study consists of three treatment periods: a placebo-controlled Period A (baseline to week 12) to evaluate the efficacy and safety of risankizumab SC induction treatment, an extended Period B (week 12 to 24) where patients receive blinded or open-label AbbVie treatments based on their clinical response at week 12, and a 52-week open-label extension Period C where all patients receive the approved risankizumab maintenance treatment.1 More information on this trial can be found at www.clinicaltrials.gov (NCT06063967).7
About SKYRIZI® (risankizumab)
SKYRIZI is an interleukin (IL)-23 inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.8 SKYRIZI is approved by the U.S. Food and Drug Administration and the European Medicines Agency for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.8,9
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