P0967 Clinical long-term follow-up of randomized, double blinded sham-controlled granulocyte monocyte apheresis treatment in ulcerative colitis.

Abstract Background Ulcerative colitis (UC) is a chronic inflammatory bowel disease that is upheld by complex immune dysregulation. Despite the development of new drugs many patients suffer from recurring flairs due to loss of drug response. One alternative approach is apheresis by granulocyte monocyte apheresis (GMA). Several trials have published different outcomes (1), but few studies investigated long-term outcomes. Methods Between 2014 and 2020 38 individuals were included in a prospective double-blinded sham-controlled study, of which 25 received 8 cycles of GMA treatment. Endoscopic and clinical activity index (EAI, CAI Rachmilewitz), clinical and patient-reported outcomes were collected. In May 2022 participants were contacted again with questionnaire telephone interview, collecting information on the further UC course. Time span until the next flair, treatment changes and further medication regimes, laboratory parameters and patient reported outcomes (inflammatory bowel disease questionnaire, IBDQ) as well as their subjective opinion on GMA treatment were recorded. Results Numeric endoscopic response and remission rates and clinical response rates did not improve during treatment. CAI improved from 11 to 7 (verum) and from 10.0 to 6.5 (sham) (n.s.). IBD-Q was 106.0 before and 126.5 after (verum) and 111.0 before and 134.5 after (sham) 8 cycles of GMA (n.s.). In the long-term follow-up 27 of the initially 38 participants responded, of which 19 % were female (median age 40 years). Time until follow-up interviews ranged from 2 - 8 years. Time span after GMA until initiation of treatment change was 9.7 (SD 10.7) months. In three individuals therapy had to be changed immediately; in two cases treatment was not changed until follow-up. 92 % (24/26) showed relevant active inflammation in the next endoscopy after GMA treatment. Two participants underwent proctocolectomy. 69 % (18/26) subjectively reported positive effects after GMA lasting a median time of 12.5 months. Mean CAI was 3.8 (SD 2.9) points at the time of follow-up (9.6 before GMA and 5.7 directly after GMA treatment). Mean IBD-Q was 176.7 (SD 27.2) points at follow-up. In 85 % (22/26) individuals, personal assessment of GMA treatment correlated with CAI. 73 % (19/26) were willing to undergo GMA again, of these 68 % (13/19) even for unlimited time period. Conclusion Randomized sham-controlled GMA treatment for UC has shown insufficient endoscopic improvement of UC. The follow-up interview highlighted that most individuals required therapy escalation. Despite the negative results, acceptance for GMA was high. GMA is ineffective as monotherapy but might be used in combination with other therapies to increase response rates as published previously (2). References: 1. Sands B, Hanauer S. A randomized, double-blind, sham-controlled study of granulocyte/monocyte apheresis for active ulcerative colitis. Gastroenterology . 2008 Aug;135(2):400-9. 2. Kiss S, Alizadeh H. Granulocyte and monocyte apheresis as an adjunctive therapy to induce and maintain clinical remission in ulcerative colitis: a systematic review and meta-analysis. BMJ Open. 2021 May 19;11(5):e042374. Conflict of interest: Meyer, Sophie: No conflict of interest Dr. Weidlich, Simon: Honoraria from Abbvie, bms, Falk, Johnson&Johnson, Lilly, Sanofi, Takeda, Tillotts. Sebastian, Noe: No conflict of interest Giavoni, Selene: No conflict of interest Roland M., Schmid: No conflict of interest Treiber, Matthias: J&J: advisory activity, speaker, travelling fees. Galapagos: travelling fees. Falk foundation: speaker.