Efficacy and safety of granulocyte and monocyte apheresis (GMA) with Adacolumn® in patients with inflammatory bowel disease in real-world practice in Spain: the GRACE study.

Abstract

Background Granulocyte-monocyte apheresis (GMA) with Adacolumn® is an extracorporeal immunomodulatory therapy option that selectively depletes circulating activated granulocytes and monocytes. This approach aims to control intestinal inflammation and represents a steroid-sparing strategy for patients with inflammatory bowel disease (IBD) who are steroid-dependent, intolerant, or refractory to conventional and/or advances therapies. The GRACE study aimed to assess the efficacy, safety, and real-world use of GMA in adult patients with ulcerative colitis (UC) or Crohn’s disease (CD) in routine clinical practice in Spain.

Methods This national, multicentre, non-interventional post-marketing ongoing clinical follow-up study enrolled 148 patients with UC or CD treated with GMA (Adacolumn®). This interim analysis shows data collected at baseline and follow-up visits up to six months post-treatment. The primary endpoint of this interim analysis was the proportion of patients achieving steroid-free clinical remission six months after completion of the GMA induction, defined as a Mayo score ≤2 for UC and a Harvey–Bradshaw Index (HBI) ≤4 for CD. Secondary endpoints included the evaluation of clinical response, safety outcomes, and patterns of GMA use.

Results The study population comprised a total of 148 patients (88.5% UC and 11.5% CD) with a mean disease duration of 9.7 and 8.7 years, respectively. Most had moderate-to-severe disease activity (79,4%) and prior exposure to steroids (82.4%), immunosuppressants (50.0%), biologics (68.9%) and JAK inhibitors (19.6%). One month after completion of GMA treatment, overall steroid-free clinical remission was achieved in 33,9% of patients (33% UC, 40% CD). At 6 months, 30,5% of patients remained in steroid-free clinical remission. The highest steroid-free remission rates were observed among patients not receiving concomitant advanced therapies; with 47,1% and 56% at 1 and 6 months, respectively. GMA was well tolerated; 88.5% of adverse events were mild or moderate, and no serious adverse events were related to the device or procedure.

Conclusion In this real-world interim analysis, GMA was primarily used in complex, treatment-refractory IBD patients, mostly as an adjunct to biologic therapy. Despite the challenging clinical scenario of this population, GMA achieved clinically meaningful rates of steroid-free remission at six months, confirming its favorable safety and tolerability profile. These findings highlight the steroid-sparing effect of GMA, reinforcing its role as a valuable therapeutic option within the comprehensive management of refractory UC and CD.