Crohn’s disease remains one of the most challenging inflammatory bowel diseases (IBD) to manage. Patients with refractory—or treatment-resistant—Crohn’s often face a frustrating cycle, experiencing minimal improvement after trying multiple medications or showing temporary progress only to relapse. Even biologics, the advanced targeted therapies that serve as the backbone of modern treatment, frequently lose efficacy over time.
However, new real-world clinical data offers significant hope for this difficult patient population. A recent study reveals that more than half of these refractory patients achieved clinical remission—meaning their symptoms stabilized without the use of steroids—following treatment with risankizumab. While remission does not imply a complete cure, it marks a state where disease activity is safely quieted. The findings suggest that risankizumab could fill a critical treatment gap for patients who have exhausted existing options.
Conducted by researchers at Santiago de Compostela University Hospital and a health research foundation in Spain, the study analyzed the real-world effectiveness and safety of the drug. The findings were published online on June 10, 2026, in the journal Alimentary Pharmacology and Therapeutics.
Overcoming Biologic Failure and Steroid Dependence
Risankizumab, marketed by AbbVie under the brand name Skyrizi, is a biologic that selectively inhibits interleukin-23 (IL-23). IL-23 is a specific cytokine protein that drives inflammatory responses in immune cells; when this signaling pathway becomes overactive, chronic intestinal inflammation persists. By blocking this pathway, the drug effectively cools the inflammatory response.
Crohn’s disease causes chronic inflammation that can strike anywhere along the digestive tract, from the mouth to the anus, triggering recurrent abdominal pain, severe diarrhea, weight loss, and bloody stools. In severe cases, it leads to strictures (narrowing of the intestine) or fistulas (abnormal passages between organs), frequently requiring surgical intervention.
To combat this, modern IBD care prioritizes "steroid-free remission." While corticosteroids can rapidly suppress acute flare-ups, long-term reliance on them carries severe side effects, including heightened infection risks, osteoporosis, diabetes, hypertension, and weight gain. Consequently, clinicians emphasize strategies that minimize steroid dependence while securing long-term disease stability.
High Remission Rates in Real-World Clinical Practice
The Spanish research team utilized data from the country's national IBD patient registry to conduct a large-scale observational analysis. Unlike tightly controlled clinical trials, real-world observational studies reflect routine, everyday medical practices, offering a clearer picture of how a drug performs across diverse and complex patient profiles.
The study evaluated 857 adult patients with hard-to-treat Crohn’s disease who initiated risankizumab treatment across 60 Spanish hospitals. The cohort had a mean age of 50.3 years, and 59.6% were men. The vast majority of these individuals had a long history of treatment failure; roughly half had already cycled through three or more advanced therapies. Specifically, 89.6% had previously used anti-tumor necrosis factor (anti-TNF) agents, and 69.3% had tried ustekinumab—two of the primary biological classes traditionally used to manage Crohn's.
The treatment regimen followed standard clinical protocols: an induction phase of 600 mg administered via intravenous (IV) infusion at weeks 0, 4, and 8, followed by a maintenance phase of 360 mg via subcutaneous injection every eight weeks starting at week 12.
The primary goal was achieving steroid-free clinical remission, defined as a Harvey-Bradshaw Index (HBI) score of 4 or less without systemic corticosteroid use. The HBI measures disease activity by tracking factors like abdominal pain, daily liquid stools, and general well-being.
The analysis revealed that 56.4% of these highly resistant patients achieved steroid-free clinical remission within the first 8 to 12 weeks of starting risankizumab. By the final follow-up evaluation, that success rate rose to 61.2%. Given that the registry comprised individuals who had failed multiple prior lines of biologic therapy, these outcomes are highly encouraging.
The data also showed that while the likelihood of remission tended to decrease slightly with older age, prior experience with ustekinumab showed no negative association with achieving steroid-free clinical remission at the final follow-up. This indicates that risankizumab remains an effective follow-on option even for patients who did not find success with ustekinumab.
Furthermore, the drug's safety profile proved favorable. Adverse events were reported in only 7.9% of all patients, and those who had to discontinue treatment due to side effects accounted for just 1.4% of the total cohort.
While the researchers noted that observational data has inherent limitations in establishing direct causality compared to randomized controlled trials, the study successfully confirmed the drug's effectiveness in a broad, routine practice setting. The research team concluded that while risankizumab serves as a powerful tool later in the care timeline, introducing it earlier in the treatment sequence could potentially yield even greater clinical benefits for Crohn's patients.
