E Papathanasiou , P Markopoulos , M Tzouvala , A Ioannou , E Tsironi , E Zacharopoulou , M Tzakri , E Pantelakis , G Leonidakis , G Bamias , S Michopoulos , E Zampeli

Journal of Crohn’s and Colitis, Volume 18, Issue Supplement_1, January 2024, Pages i1356–i1357, https://doi.org/10.1093/ecco-jcc/jjad212.0857

Background: Selective depletion of myeloid lineage leucocytes by adsorptive granulocyte and monocyte apheresis (GMA) with Adacolumn ^® was introduced as a nonpharmacologic treatment for ulcerative colitis (UC) in 2000. It has been reported that GMA may be effective in combination with immunosuppressive treatment in a subset of patients. Τhe purpose of our study is the evaluation of the effectiveness and safety of GMA as a complementary treatment in patients with refractory ulcerative colitis.

Methods: Prospective data collection of a patient cohort with refractory UC receiving Adacolumn ^® as an adjunct to their medical treatment. The therapeutic protocol has 2 phases: The induction phase entails two sessions per week for at least 3 weeks. The maintenance includes one weekly session for one month, one session every 15 days for one the next month, and monthly sessions thereafter. The patients’ medical treatment was maintained during the sessions. As a failure to GMA was considered the need for colectomy, the switch to a different treatment and inability to discontinue steroids. Response was evaluated after completion of at least 6 sessions of GMA.

Results: Ten patients with refractory UC were offered Adacolumn^® between February 2021 and September 2023. Mean age was 39.6 years (22-61years). All patients had failed at least one biologic treatment and two-thirds two biologics. Their treatment which was maintained during GMA was: tofacitinib 10mg bid for 4 patients, ustekinumab 90mg sc every 8 weeks for 3, vedolizumab 300 mg every 8 weeks for 2, and corticosteroids 16mg for one. The median duration of treatment was 5.1 months (2-13 months), while the median number of sessions was 16 (6-45). Clinical and endoscopic remission was achieved in two cases (20%), after 13 sessions for both (in brackets in the Table) whereas two patients (20%) responded clinically according to partial Mayo score. Treatment failure was documented for 6 patients (60%) after 6-45 sessions. Patient number 4 performed 45 sessions in different hospitals because he was reluctant to be operated. Three underwent colectomy and three discontinued due to non-response. No adverse effects were observed. The initial median of partial Mayo score was 6 (5-9) while at the end of the evaluation was 4.5 (0-9). Table 1 summarizes the results of our study.

Conclusion

1) GMA may be beneficial as an adjunct to biologics in refractory to medical treatment UC patients.

2) Interestingly, all patients on tofacitinib showed a favorable response after the addition of GMA.

This observation may help define a subset of UC patients who may benefit the most.

I. Rodríguez-Lago1, F. Cañete2, E. Guerra3, C. Herrera de Guise4, E. Iglesias-Flores5, E. Leo-Carnerero6, Y. Zabana7, M. Barreiro de Acosta8, D. Ginard Vicens9, J.L. Cabriada Nuño1

UEG journal 2023 SUPPLEMENT ABSTRACT UEG Week 2023 Poster Presentations 15 October 2023 page 1067

Introduction: Granulocyte–monocyte apheresis (GMA) selectively removes activated leukocytes and immune mediators, and it has shown to be safe and effective in treating ulcerative colitis (UC). Previous reports
have also described its combination with biologics.
Aims & Methods: The aim of our study was to evaluate the efficacy and safety of combining GMA after primary non-response (PNR) or loss of response (LOR) to tofacitinib (TOFA) in patients with UC. A retrospective, multicentre study was performed in 7 IBD Units, including all patients with refractory UC who received combined plus GMA and TOFA. The number of GMA sessions, its frequency, filtered blood volume and length of each
session were compiled, along with the clinical data. Efficacy was assessed 1 and 6 months after finishing GMA by partial Mayo score, CRP and faecal calprotectin. Data regarding TOFA intensification, need for new immunomodulators/biologics and colectomy were also compiled. Descriptive statistics and non-parametric tests were used in the statistical analysis.

Results: Twelve patients with UC were included (median 46 years [IQR, 37-58]; 67% female; 67% E3; 75% non-smokers). Patients were receiving TOFA10 mg bid (75%), 5 mg bid (16%), or 15 mg bid (8%), with 33% receiving
steroids at baseline. All patients had prior exposure to anti-TNF agents, 42% to vedolizumab and 8% ustekinumab. Median baseline Mayo score was 7 (IQR, 5-7), median CRP of 11 mg/L (IQR, 5-32) and faecal calprotectin 800 mg/kg (IQ, 715-2,094). GMA was started mostly after PNR (73%), and the median number of GMA sessions was 11 (IQR, 3-20) and 50% received maintenance GMA. Partial Mayo score significantly decreased 1 month after the last GMA session (p=0.027). Four patients (36%) were switched to a new therapy and no patient required colectomy during follow-up. All patients under steroids at baseline were able to stop them. No patient reported adverse events related to the combination therapy.

Conclusion: Combination of GMA with TOFA can be an effective and safe therapy in selected cases of UC after PNR or LOR to this drug.

N.D. Salazar Parada1, M. Algara San Nicolas1,A. Suárez-Saro Fernández1, A. Masedo1, C. Yela San Bernardino1,C. Begoña1, P. Martínez Montiel1, I. Fernández Vázquez1

UEG journal 2023 SUPPLEMENT ABSTRACT UEG Week 2023 Poster Presentations 15 October 2023 page 1047

Introduction: Despite the importance of granulocytoapheresis (GCA) in the treatment of inflammatory bowel disease (IBD), its effectiveness in steroid-dependent and steroid-refractory IBD has not been widely evaluated, the approaches are heterogeneous and data on efficacy and safety remain limited in our population.
Aims & Methods: This study aims to assess the effectiveness of GCA for induction of remission and maintenance in patients with steroid-dependent and steroid-refractory IBD in the real-world practice.
Retrospective cohort of patients with steroid-dependent and steroid-refractory colonic IBD, in which GCA was used as induction of remission and maintenance treatment between January-2015 to January-2023. We
analyze demographics, disease characteristics, prior exposure including biologic agents. The success of GCA was defined on a decrease of at least 3 points in the True-love score for Ulcerative Colitis (UC) and a decrease of
at least 100 points in the CDAI for Crohn Disease (CD). To analyze predictive factors of treatment success we performed a univariate and multivariable analysis.
Results: 49 patients were included. 5 cycles of apheresis were performed in the first 3 weeks as induction and at least 10 cycles of apheresis as maintenance in the next 6 months.

75 % (37 / 49) had UC, 86.4 % (32 / 37) were steroid-refractory while 13.6 % (5 / 37) steroid-dependent, 54 % (20 / 37) male; median age 60 ± 10.5 years with a mean of 10.5 years from diagnosis. 67.7 % (25 / 37) had received at least 1 biological treatment in the past, 43.5 % (17 / 39) ≥ 2 biological. After induction, 75 % (28 / 37) responded to treatment, 62 % (23 / 37) continued with maintenance therapy of which 67 % (15 / 23) responding. Mean PCR and calprotectin were 3,16 mg / dl and 2038 mg / dl before treatment, 1.45mg / dl and 1025 mg / dl after induction, 1.15 mg / dl and 900 mg / dl after maintenance, respectively.

25 % (12 / 49) had CD, 50 % (6/12) male; median age 62 ± 9.8 years, 75% (9 / 12) steroid-refractory and 25 % (3 / 12) steroid-dependent, with a mean of 9 years from diagnosis, 67.7 % had received at least one biological
treatment in the past. After induction, 58 % (7 / 12) responded, 80 % (10 /12) continued with maintenance with 50 % (5 / 10) responding. Mean CRP and calprotectin were 3.16 mg / dl and 3645 mg / dl before treatment, 1.7
mg / dl and 2473 mg / dl after induction, 1.14 mg / dl and 623 mg / dl after maintenance.
Factors such as smoking, extent of disease, longer disease course and lack of response to previous treatments, were not significantly related to response in either induction or maintenance.
No patient had major adverse events recorded.
Conclusion: GCA appears to be safe and effective for inducing and maintaining clinical remission in patients with IBD, especially in patients with UC. No significant differences were found in disease extension, duration or
lack of response to previous treatments.