The US Food and Drug Administration (FDA) has approved a new way of starting treatment with risankizumab, a biologic medicine already used for Crohn’s disease, allowing the initial doses to be given as an injection under the skin rather than through a drip into a vein. AbbVie, the company that makes the medicine under the brand name Skyrizi, said the change means some adults with moderately to severely active Crohn’s disease could begin treatment at home using a wearable injector device, continuing with the same method throughout ongoing treatment.
Background
Crohn’s disease is a long-term condition that causes inflammation in the digestive system, most often where the small intestine meets the large intestine. It can lead to persistent diarrhoea and abdominal pain, and symptoms tend to come and go unpredictably. Risankizumab works by blocking a protein in the immune system called interleukin-23, which is thought to play a part in this type of inflammation. It was already approved to treat Crohn’s disease using an intravenous infusion to start treatment, followed by injections under the skin for ongoing maintenance doses.
What the trial found
The approval was based on results from a phase 3 clinical trial called AFFIRM, which compared the injectable starting doses of risankizumab against a placebo, or dummy treatment, in adults with moderately to severely active Crohn’s disease. The researchers looked at two main measures at twelve weeks: clinical remission, meaning symptoms such as pain and diarrhoea were well controlled, and endoscopic response, meaning a camera examination showed meaningfully less visible inflammation in the gut.
Across the full group studied, more people taking risankizumab reached clinical remission and showed endoscopic response than those given placebo. The difference was particularly marked among people who had not previously tried, or had not failed, other advanced therapies such as biologic medicines. In this group, around three in four reached clinical remission compared with roughly one in four on placebo, and three in five showed endoscopic response compared with about one in six on placebo. People who had already tried and not responded to other advanced therapies also had higher response rates on risankizumab than on placebo, though the differences were smaller. According to AbbVie, the safety profile seen with this injectable starting regimen was broadly similar to what has already been reported for risankizumab in Crohn’s disease, with no new safety concerns identified.
The FDA also approved a change to the medicine’s safety information that applies across all its approved uses. Previously, tuberculosis testing was recommended as a standard step before starting treatment. The updated information allows healthcare providers to use their own clinical judgement when deciding whether testing is needed, rather than following a fixed requirement.
Why this matters
For people living with Crohn’s disease, starting treatment can involve hospital visits for infusions, which some find difficult to fit around work, family, or travel. Having the option to begin treatment with injections at home, using the same device used for ongoing maintenance treatment, may offer more flexibility for some patients, although this will depend on individual circumstances and a doctor’s advice.
What to keep in mind
These findings come from one clinical trial, and treatment decisions should always be made with a gastroenterologist, taking into account a person’s full medical history. Symptom improvement does not always mean that underlying gut inflammation has fully settled, which is why doctors often use examinations alongside symptom reviews. Further research and real-world experience will help confirm how this new injectable starting option performs over time.
Reference
ClinicalTrials.gov. A Study to Evaluate Efficacy and Safety of Risankizumab Subcutaneous Induction in Participants With Moderately to Severely Active Crohn’s Disease (AFFIRM). NCT06063967. Available at: https://clinicaltrials.gov/study/NCT06063967
AbbVie. U.S. FDA Approves Subcutaneous Induction Regimen for Skyrizi (risankizumab-rzaa) for Crohn’s Disease. Press release, 23 October 2026.
This article is a journalistic summary for informational purposes only. It does not constitute clinical advice or a recommendation to alter treatment decisions.