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In the phase III AFFIRM trial, 55% of patients given subcutaneous risankizumab achieved clinical remission at 12 weeks, compared with 29.6% on placebo. AbbVie has applied to the FDA to use the injection as Crohn’s disease induction therapy; the regulator’s decision and full trial publication remain pending.
Subcutaneous risankizumab produced higher 12-week clinical remission and endoscopic response rates than placebo in adults with moderately to severely active Crohn’s disease, according to results from the phase III AFFIRM trial presented at the American College of Gastroenterology annual meeting. AbbVie has submitted an application to the FDA seeking approval for the injection as induction therapy, which could add a non-intravenous option for starting treatment.
At week 12, 55% of participants assigned to risankizumab 720 mg achieved Crohn’s Disease Activity Index (CDAI)-defined clinical remission, compared with 29.6% on placebo. Endoscopic response was seen in 44% of the risankizumab group and 14.3% of the placebo group. Both comparisons had P values below 0.0001, researcher Millie D. Long, MD, MPH, of the University of North Carolina at Chapel Hill, reported.
The trial also found higher rates of endoscopic remission at week 12: 27.7% with risankizumab and 10.2% with placebo. Ulcer-free endoscopy rates were 26.2% and 10.2%, respectively. Long said the primary endpoint results were also higher among participants who had not previously received advanced therapy and among those who had not tolerated or had responded inadequately to previous advanced treatments.
A maintenance phase followed the induction period. Among 134 people who responded to risankizumab induction and continued subcutaneous risankizumab 360 mg at weeks 12 and 20, 67.2% were in clinical remission through week 24. The corresponding figure was 29.6% among placebo induction responders who continued placebo. Endoscopic response was 57.5% versus 11.4%; endoscopic remission, 35.8% versus 9.1%; and ulcer-free endoscopy, 36.6% versus 9.1%. These maintenance comparisons are between selected induction responders, not all trial participants.
A New Route for Crohn’s Induction
The application concerns the induction phase—the initial treatment period intended to bring active disease under control. Risankizumab is already FDA-approved for moderately to severely active Crohn’s disease as intravenous induction followed by subcutaneous maintenance. If the FDA approves the new use, patients and clinicians could have an injection-based route for induction rather than beginning with an infusion.
The findings may be relevant to patients with prior treatment difficulties. Long described the study population as medically refractory: roughly two-thirds had prior anti-TNF exposure, while some had failed ustekinumab or JAK inhibitors. However, the reported results do not establish that the treatment will work for every patient or that it is better than other active therapies; the main comparison presented was against placebo.
Crohn's disease subcutaneous risankizumab injection
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How AFFIRM Tested the Injection
AFFIRM was a double-blind phase III trial of 289 adults diagnosed with Crohn’s disease at least three months earlier. Participants had moderate to severe disease based on CDAI and endoscopic criteria, and had previously been intolerant of or responded inadequately to conventional and/or advanced therapies. They were randomized in a 2:1 ratio to receive subcutaneous risankizumab 720 mg or placebo.
Risankizumab is an interleukin-23 inhibitor. The FDA approved it for Crohn’s disease in 2022, with intravenous induction followed by subcutaneous maintenance. AFFIRM evaluated whether subcutaneous dosing could also be used for induction. The reported results came from a presentation at the American College of Gastroenterology meeting; the supplied report does not provide a full peer-reviewed paper.
“In my clinical practice I do plan — once this is available — to move predominantly to subcutaneous risankizumab.”
— Millie D. Long, MD, MPH
Crohn’s disease induction therapy injection
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FDA Review and Safety Details
The FDA has not yet approved subcutaneous risankizumab for Crohn’s induction, and the source report gives no review timetable. It is also not clear from the reported presentation when the agency will act or whether it will request additional information. The results reported at the meeting do not by themselves establish the regulator’s conclusion about the application.
Safety findings were described in broad terms: treatment-emergent adverse events were reported at lower rates in the risankizumab group, serious adverse events were low in both groups, and the one discontinuation due to an adverse event occurred in the placebo group. The report does not give the specific event counts or a detailed breakdown, so the relative safety profile cannot be fully assessed from these figures alone. Longer-term outcomes beyond the reported 24-week period also remain unclear.
subcutaneous biologic injections for Crohn’s disease
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FDA Decision and Full Trial Data
The next regulatory milestone is the FDA’s review of AbbVie’s application for subcutaneous risankizumab induction. No decision date is stated in the report. Further details, including a complete safety analysis and longer-term results, would help clinicians judge how the injection compares with existing induction approaches and which patients may benefit most.
Crohn’s disease endoscopic response treatment
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Key Questions
What did the AFFIRM trial find at 12 weeks?
Clinical remission was reported in 55% of participants receiving subcutaneous risankizumab and 29.6% receiving placebo. Endoscopic response rates were 44% and 14.3%, respectively.
Is subcutaneous risankizumab approved for Crohn’s disease induction?
Not according to the report. Risankizumab is approved for Crohn’s disease with intravenous induction followed by subcutaneous maintenance. AbbVie has applied to the FDA for approval of subcutaneous induction, and the decision is pending.
Who took part in the trial?
AFFIRM enrolled 289 adults with moderately to severely active Crohn’s disease and a history of intolerance or inadequate response to conventional and/or advanced therapies.
What safety information was reported?
The meeting report said treatment-emergent adverse events were less frequent with risankizumab, serious adverse events were low in both groups, and one adverse-event-related discontinuation occurred in the placebo group. It did not provide detailed event counts in the supplied summary.
Source: rss
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