Injected Risankizumab Improves Crohn's Remission in Phase III Trial
Injected risankizumab improved symptoms and bowel inflammation versus placebo, potentially offering an alternative to infusion-based induction.
Summary
Injected risankizumab helped adults with moderate to severe Crohn's disease achieve symptom remission and reduce bowel inflammation in a phase III trial. Among 289 participants, 55% receiving the drug achieved symptom remission after 12 weeks, compared with 29.6% receiving placebo. Bowel examinations showed improvement in 44% versus 14.3%. Many participants had previously tried other advanced treatments without adequate success. Risankizumab already has an approved treatment schedule that begins with intravenous infusions before switching to injections; this study tested injections as the starting treatment. The manufacturer has applied for FDA approval of that approach. However, the trial did not directly compare injections with infusions. The supplied conference report is also incomplete and lacks detailed safety results, so patients should discuss established options with their gastroenterologist rather than change treatment themselves.
Detailed Summary
Subcutaneous risankizumab could offer adults with moderate to severe Crohn's disease another way to start treatment without intravenous infusions. Crohn's causes persistent digestive tract inflammation that can disrupt nutrition and daily life. The drug blocks an immune signal called interleukin 23. Its established treatment approach starts with intravenous doses before switching to injections under the skin.
In the phase III AFFIRM trial, 289 adults were randomly assigned to injected risankizumab or placebo. After 12 weeks, 55% receiving risankizumab achieved symptom remission, compared with 29.6% receiving placebo. Improvement seen during bowel examinations occurred in 44% versus 14.3%, respectively. Both differences were statistically significant. These findings suggest benefits extended beyond symptom relief to measurable improvements in intestinal inflammation.
Other examination results supported the main findings: 27.7% achieved endoscopic remission versus 10.2% with placebo, while 26.2% had examinations showing no ulcers versus 10.2%. Benefits appeared in participants who had never received advanced therapies and those whose previous treatments had failed or caused intolerance. This matters because many participants had already tried other potent immune therapies.
For clinical practice, an injectable starting regimen could offer greater flexibility than infusion appointments. The article reports that AbbVie submitted an application seeking FDA approval for this use. Patients should discuss available options with their gastroenterologist rather than change treatment independently. Importantly, the trial compared injections with placebo, not intravenous risankizumab, so it cannot establish that injections outperform infusions.
These results come from conference coverage rather than a complete published trial report. The supplied article is truncated during discussion of maintenance treatment and provides no detailed safety findings. Longer follow-up, full adverse event data, and direct comparisons with intravenous induction are needed to assess durability and tradeoffs. This study addresses Crohn's disease control, not lifespan extension or benefits for healthy adults without a confirmed inflammatory bowel disease diagnosis.
Key Findings
- At 12 weeks, symptom remission occurred in 55% receiving injected risankizumab versus 29.6% receiving placebo.
- Bowel examinations showed improvement in 44% receiving risankizumab versus 14.3% receiving placebo.
- Endoscopic remission occurred in 27.7% receiving risankizumab versus 10.2% receiving placebo.
- The trial did not compare injected induction directly with intravenous induction, so superiority over infusions remains unproven.
- Discuss treatment options with a gastroenterologist; the article reports an approval application, not approval, for injected induction.
Methodology
MedPage Today provides medical news coverage of findings presented at the American College of Gastroenterology annual meeting. The evidence comes from AFFIRM, a double-blind phase III trial that randomized 289 adults 2:1 to subcutaneous risankizumab or placebo, with primary outcomes assessed at 12 weeks.
Study Limitations
The supplied article ends during maintenance results and does not provide detailed adverse event data or complete longer-term outcomes. Conference reporting should be checked against the full trial publication and regulatory documents, and the placebo comparison cannot establish equivalence or superiority to intravenous induction.
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