AbbVie said 40.5% of patients receiving its experimental Crohn’s disease treatment ABBV-466 reached endoscopic remission after 24 weeks, above the rates reported for either component drug in a 300-patient study.
At Week 24, AbbVie reported remission in 22.4% of patients taking risankizumab alone and 20.0% taking trosunilimab alone. At Week 12, the study’s primary assessment, the rates were 30.2% for ABBV-466, 21.3% for risankizumab and 18.0% for trosunilimab.
The Phase 2a TARGET-CD trial randomized patients with moderate to severe Crohn’s disease to 24 weeks of open-label treatment. It assigned 106 patients to ABBV-466, 94 to risankizumab and 100 to trosunilimab. AbbVie said 75% had previously failed at least one advanced therapy, while 25% had received no biologic treatment.
The trial used a measure of bowel inflammation assessed during colonoscopy. To count as endoscopic remission, a patient needed a Simple Endoscopic Score for Crohn’s Disease of 4 or less, with no individual variable scored above 1.
ABBV-466 pairs risankizumab, which targets IL-23 p19, with trosunilimab, which targets integrin α4β7. AbbVie said it combined the drugs after research suggested that inflammation linked to α4β7 could persist during risankizumab treatment.
Through Week 24, serious adverse events were reported in 10.4% of patients receiving the combination, 9.6% of those taking risankizumab and 9.0% of those taking trosunilimab. AbbVie’s announcement did not include confidence intervals or statistical test results for the remission comparisons. The public trial record has no posted results.
Remo Panaccione, professor of medicine and director of the Inflammatory Bowel Disease Unit at the University of Calgary, said “ongoing inflammation can drive disease progression over time.” ABBV-466 is still being studied, and regulatory authorities have made no finding on its safety or effectiveness.
AbbVie has also reported long-term results for a different Crohn’s treatment, upadacitinib, covered in an earlier EconoTimes report on Crohn’s remission data. The separate studies do not directly compare the treatments.
AbbVie listed the ABBV-466 findings for a late-breaking presentation on Oct. 19 at United European Gastroenterology Week in Barcelona. The meeting runs through Oct. 20.
