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. Conflict of interest: Dr. Rodríguez-Lago, Iago: Financial support for traveling and educational activities from or has served as an advisory board member for Abbvie, Adacyte, Alfasigma, Biogen, Chiesi, Faes Farma, Ferring, Fresenius Kabi, Galapagos, Johnson & Johnson, Eli Lilly, Mirum Pharmaceuticals, Merck, Pfizer, Roche, Takeda, and Tillotts Pharma. Research support from AbbVie. Supported by a research grant from Gobierno Vasco-Eusko Jaurlaritza (Grant No 2020111061 and 2023222006). Cabriada Nuno, José Luis: No conflict of interest Vicuña Arregui, Miren: No conflict of interest Leo, Eduardo: The author declares receiving grants or fees for scientific activities, presentations, or as a scientific advisor for MSD, Pfizer, Abbvie, Takeda, Janssen, Tillotts Pharma, Shire Pharmaceuticals, Ferring, Dr. Falk Pharma, Lilly, Adacyte, and Otsuka Pharmaceutical. Iglesias Flores, Eva: has served as a speaker, consultant and advisory member for or has received research funding from AbbVie, Janssen, Takeda, Gillead, Celgene, Pfizer, Lilly, Ferring, Faes Farma, Dr. Falk Pharma, Chiesi, and Adacyte, Domènech Moral, Eugeni: Personal Fees: I have served as a speaker, or has received research or education funding or advisory fees from AbbVie, Adacyte Therapeutics, Biogen, Celltrion, Gilead, Janssen, Kern Pharma, MSD, Pfizer, Roche, Samsung, Takeda, Tillots. Other: I have served as a speaker, or has received research or education funding or advisory fees from AbbVie, Adacyte Therapeutics, Alfasigma/Galapagos Biogen, Celltrion, Ferring, Gilead, GoodGut, Imidomics, Janssen, Kern Pharma, Lilly, MSD, Pfizer, Roche, Takeda, Tillots. Moraleja-Yudego, Irene: The author declares receiving financial support for traveling and educational activities from or has served as an advisory board member for Adacyte. Boscá Watts, Marta Maia: The author declares to have paticipated in presentations / advisory boards / research promoted by: MSD, Ferring, Abbvie, Janssen, Biogen, Pfizer, Galápagos, Otsuka, Kernpharma and Takeda. Calvo Iñiguez, María: The authors declares receiving support for educational purposes from Abbvie, Takeda, Adacyte, Janssen, Lilly and Kern Pharma. Abanades Tercero, María: Abbvie, Adacyte, Ferring. Todos ellos para financiación de congresos/cursos. Moralejo Lozano, Óscar: I have received educational funding from Abbvie, Johnson & Johnson, Takeda, Kern Pharma, Alfasigma, Pfizer, Lilly, Sandoz, Dr. Falk Pharma, Ferring, and Tillotts. I have also served as a speaker for Abbvie, Takeda, Alfasigma, and Lilly. Rancel Medina, Francisco Jose: No conflict of interest Bastida Paz, Guillermo: I declare that I have received fees for lectures, consulting, research, or other collaborations from the following laboratories: Abbvie, J & J, Kern, Lilly, and GALAPAGOS. Herrera De Guise, Claudia Maria: No conflict of interest Hernández Ramirez, Vicente: Vicent Hernandez has served as consultant, has served as speaker, has received travel support or research funding from MSD, AbbVie, Ferring, Dr. Falk Pharma, Tillotts Pharma, Pfizer, Takeda, Janssen, KernPharma Biologics, Adacyte, Sandoz, FAES Farma, Galapagos, Lilly and Casen-Recordati Sánchez, Damián: The author confirms receiving assistance for attending conferences and training sessions from Adacyte, Abbvie, Janssen, and Takeda, and personal fees for training talks from Abbvie and Janssen. Viejo Almazor, Alejandro: No conflict of interest Fradejas Salazar, Paola María: No conflict of interest Suarez Ferrer, Cristina Julia: The author declares receiving speaker or researcher fee from: Ferring, FAES, Abbvie, Jannsen, Pfizer, Takeda, Thillots, Kher, Chiesi, Aldacyte, Lilly. Blasco Comenarejo, Maria del Mar: The author declares receiving Falk funding for conference. Ceballos Santos, Daniel: No conflict of interest Quílez Pérez, Lucía: No conflict of interest Rull Murillo, Nuria: No conflict of interest Muñoz, Margarita: No conflict of interest Arribas Del Campo, Sonia: The author declares receiving fees from Abbvie, Galápagos, Tillots. Madero Velázquez, Lucía: None Huguet, José María: The auhtor has participated in educational activities, research projects, scientific meetings or advisory boards sponsored by Abbvie, Biogen, Faes Farma, Ferring, Janssen, Kern Pharma, Merck Sharp Dohme (MSD), Sandoz, Takeda, and Vifor Pharma Fernández Pérez, Francisco Jose: The author received speaker fees from: Adacyte, Abbvie, Ferring, Shire. The author had courses organized with the collaboration of: Johnson & Johnson, Abbvie, Lilly, Pfizeer, Ferring. Soria López, Estela: No conflict of interest Reygosa, María Cristina: Cristina Reygosa has served as a speaker, or has received education funding from Abbvie, Takeda, Pfizer, Janssen and Ferring Hernandez Camba, Alejandro: I have served as a speaker or has received research or education funding or advisory fees from Lilly, Takeda, J and J, FAES Pharma, Falk, Abbvie, Adacyte Therapeutics, Tyllots, Ferring, Kern Pharma, Alfasigma and Chiesi. Zapico Fernandez, Pablo: P.Z. is a full-time employee od Adacyte Therapeutics. Ginard Vicens, Daniel: No conflicts
Rodríguez-Lago et al. (Thu,) studied this question.