Crohn’s disease is an inflammatory bowel disease (IBD) characterized by the inflammation of the digestive tract, leading to abdominal pain, diarrhea, malnutrition, and cancer. Risankizumab is a humanized monoclonal that has previously been proven effective against severely active Crohn’s disease. This study aims to investigate the efficacy and safety of extended intravenous and subcutaneous maintenance therapy with risankizumab.

This open-label expansion study included a total of 108 patients with Crohn’s disease. The patients were assigned to receive open-label intravenous therapy with 600 mg risankizumab every 4 weeks for 12 weeks. Patients who were in deep remission at week 12 entered a 12-week washout phase, and patients in clinical remission at week 26 were assigned to receive open-label subcutaneous risankizumab (180 mg) every 8 weeks for 26 weeks. The primary outcome of the study was patients receiving clinical remission and response.

Of 108 initial participants, 6 were I’m deep remission and entered the 12-week washout phase. Out of 102 patients who were not in remission, 101 had received 12 weeks of 600 mg risankizumab. At 26 weeks, 53% of the patients who were not in remission were treated with 600 mg risankizumab and were in clinical remission. 

The research concluded that extended treatment of severe Crohn’s disease with open-label risankizumab was efficacious in increasing clinical response and remission rates, with good tolerance.