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P372 Effectiveness and safety of immunosuppressants for pouch disorders: results from the RESERVO Study of GETECCU

Mesonero Gismero, F.(1);Zabana, Y.(2);Fernández-Clotet, A.(3);Leo, E.(4);Caballol, B.(3);Núñez, A.(4);García, M.J.(5);Bertoletti, F.(6);Mínguez, A.(7);Suris, G.(8);Casis, B.(9);Ferreiro-Iglesias, R.(10);Calafat, M.(11);Jiménez, I.(12);Miranda-Bautista, J.(13);Lamuela, L.J.(14);Fajardo, I.(15);Torrealba, L.(16);Nájera, R.(17);Sáiz, R.M.(18);González, I.(19);Vicuña, M.(20);García-Morales, N.(21);Gutiérrez, A.(22);López-García, A.(23);Benítez, J.M.(24);Rubín de Célix, C.(25);Tejido, C.(26);Brunet, E.(27);Hernández, A.(28);Suárez, C.(29);Piqueras, M.(30);Castaño, A.(31);Ramos, L.(32);Sobrino, A.(33);Rodríguez-Grau, M.C.(34);Elosua, A.(35);Montoro, M.(36);López-Sanromán, A.(1);Barreiro-de Acosta, M.(10);

(1)Hospital Universitario Ramón y Cajal, Department of Gastroenterology, Madrid, Spain;(2)Hospital Universitari Mutua Terrassa- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas CIBERehd, Gastroenterology, Barcelona, Spain;(3)Hospital Clínic Barcelona, Gastroenterology, Barcelona, Spain;(4)Hospital Universitario Virgen del Rocío, Gastroenterology, Sevilla, Spain;(5)Hospital Universitario Marqués de Valdecilla- IDIVAL., Gastroenterology, Santander, Spain;(6)Hospital de la Santa Creu i Sant Pau, Gastroenterology, Barcelona, Spain;(7)Hospital Universitario y Politécnico La Fe, Gastroenterology, Valencia, Spain;(8)Hospital Universitari de Bellvitge, Gastroenterology, Barcelona, Spain;(9)Hospital Universitario 12 de Octubre, Gastroenterology, Madrid, Spain;(10)Hospital Clínico Universitario Santiago, Gastroenterology, Santiago de Compostela, Spain;(11)Hospital Universitari Germans Trias i Pujol, Gastroenterology, Badalona, Spain;(12)Hospital Universitario Galdakao, Gastroenterology, Bilbao, Spain;(13)Hospital Universitario Gregorio Marañón, Gastroenterology, Madrid, Spain;(14)Hospital Universitario Miguel Servet, Gastroenterology, Zaragoza, Spain;(15)Hospital Universitari Mutua Terrassa, Gastroenterology, Barcelona, Spain;(16)Hospital Universitari Doctor Josep Trueta, Gastroenterology, Girona, Spain;(17)Hospital Universitario Río Hortega, Gastroenterology, Valladolid, Spain;(18)Hospital Universitario Burgos, Gastroenterology, Burgos, Spain;(19)Hospital Universitario Puerta de Hierro Majadahonda, Gastroenterology, Madrid, Spain;(20)Complejo Hospitalario Navarra, Gastroenterology, Navarra, Spain;(21)Hospital Álvaro Cunqueiro, Gastroenterology, Vigo, Spain;(22)Hospital General Universitario Alicante- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas CIBERehd- Instituto de Investigación Sanitaria y Biomédica de Alicante ISABIAL., Gastroenterology, Alicante, Spain;(23)Hospital del Mar, Gastroenterology, Barcelona, Spain;(24)Hospital Universitario Reina Sofía, Gastroenterology, Córdoba, Spain;(25)Hospital Universitario La Princesa- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas CIBERehd- Instituto de Investigación Sanitaria Princesa IIS-IP., Gastroenterology, Madrid, Spain;(26)Complejo Hospitalario Universitario Ourense, Gastroenterology, Ourense, Spain;(27)Hospital Universitari Parc Taulí, Gastroenterology, Sabadell, Spain;(28)Hospital Universitario Nuestra Señora de Candelaria, Gastroenterology, Tenerife, Spain;(29)Hospital Universitario La Paz, Gastroenterology, Madrid, Spain;(30)Consorci Sanitari Terrassa, Gastroenterology, Barcelona, Spain;(31)Hospital Universitario Central Asturias, Gastroenterology, Oviedo, Spain;(32)Hospital Universitario de Canarias, Gastroenterology, Tenerife, Spain;(33)Hospital General Universitario Ciudad Real, Gastroenterology, Ciudad Real, Spain;(34)Hospital Universitario del Henares, Gastroenterology, Coslada, Spain;(35)Hospital García Orcoyen, Gastroenterology, Estella, Spain;(36)Hospital General Universitario San Jorge, Gastroenterology, Huesca, Spain; On behalf of the Young Group of GETECCU. RESERVO Study Group: Rodríguez Lago I Baston I Baltar R Huguet JM Hermida B Caballero-Mateos A Sánchez-Guillén L Bouhmidi A Pajares R

Background

Pouchitis and other inflammatory disorders of the pouch (IDP), such as Crohn´s-like disease of the pouch (CDP), are frequent in patients operated for a previous diagnosis of ulcerative colitis. Many different therapies have been used, but the effectiveness of immunosupresants (IMM) has been poorly explored in this setting. Our aim was to evaluate the use, efficacy and safety of IMM in patients with pouchitis or another IDP.

Methods

Retrospective and multicentric study of a Spanish cohort of pouch-carrying patients with previous diagnosis of ulcerative colitis, and subsequent diagnosis of IDP, following ECCO diagnostic criteria. Patients who used IMM to treat these conditions were selected. Clinical effectiveness was evaluated at long-term. We defined clinical remission as returning to the previous stool frequency, no pain or defecatory urgency, clinical response as the improvement in these parameters without the achievement of remission, and non-response as no improvement or worsening symptoms. Endoscopic response was evaluated when possible using modified pouchitis disease activity index (PDAI) endoscopic subscore. Adverse events were collected. We used descriptive statistics.

Results

In the overall cohort of 338 patients with IDP, 93 (27%) were treated with IMM. Of those, 57% males, median age 40 (20-71) ys, and 72% non-smokers. Colectomy was performed at a median age of 31 (18-63) ys and IPD was diagnosed 25 (1-235) months after ileostomy closure. IMM used were thiopurines (n=86), methotrexate (n=4), cyclosporine (n=2) and tacrolimus (n=1). IMM were used as monotherapy in 66 (71%) cases and were indicated as treatment of pouchitis (n=60, 65%), CDP (n=32, 34.4%) and cuffitis (n=1, 1%). Effectiveness was evaluated only for thiopurine monotherapy (n=62). After a median follow-up of 23 (1-234) months, clinical remission was achieved in 31%, clinical response in 31% and non-response in 38% (Figure 1). There were no differences in effectiveness between pouchitis and CDP (63.9% vs 57.7%, p= 0.62). Endoscopic response was evaluated in 19 (30.6%) cases. After a median of 9 months of follow-up median PDAI endoscopic subscore dropped from 3 (range 2-4) to 1 (range 0-3), (Figure 2). Adverse events related with treatment appeared in 28 patients (45%). Thiopurines were discontinued in 39 cases (63%) due to failure (17), toxicity (16) and long remission (6 cases).

Figure 1. Effectiveness of thiopurines in pouchitis and other inflammatory pouch disorders

Conclusion

In our cohort, thiopurines were used in 27% of patients with IDP, with long-term benefit (remission or response) in around two-thirds of them. This therapy could be one more option to manage these disorders.

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