P625 Randomized controlled trial on the effect of megaboluses of intravenous corticosteroids added to oral corticosteroids in the treatment of moderately active ulcerative colitis
Llaó, J.(1);Martín-Arranz, E.(2);Zabana, Y.(3);Navarro-Llavat, M.(4);Garcia-Planella, E.(5);Busquets, D.(6);Monfort, D.(7);Pineda, J.R.(8);Gutiérrez, A.(9);Villoria, A.(10);Menchén, L.(11);Bastida, G.(12);García-Alonso, F.J.(13);Rivero, M.(14);Chaparro, M.(15);Riestra, S.(16);Merino, O.(17);Rodríguez-Lago, I.(18);Barreiro-de-Acosta, M.(19);Domènech MoralPhD, E.(20)*;
(1)Xarxa Assistencial Althaia, Gastroenterology, Manresa, Spain;(2)H..U.La Paz, Gastroenterology, Madrid, Spain;(3)H.U.Mútua Terrassa & CIBEREHD, Gastroenterology, Terrassa, Spain;(4)H.Moisès Broggi, Gastroenterology, Sant Joan Despí, Spain;(5)H.. de la Santa Creu i Sant Pau, Gastroenterology, Barcelona, Spain;(6)H.U. Josep Trueta, Gastroenterology, Girona, Spain;(7)Consorci Sanitari de Terrassa, Gastroenterology, Terrassa, Spain;(8)H. Álvaro Cunqueiro, Gastroenterology, Vigo, Spain;(9)H. .G.U. Dr Balmis & ISABIAL, Gastroenterology, Alicante, Spain;(10)Consorci Sanitari Parc Taulí & CIBEREHD, Gastroenterology, Sabadell, Spain;(11)H.U. Gregorio Marañón & CIBEREHD, Gastroentrology, Madrid, Spain;(12).Universitari i Politècnic La Fe, Gastroenterology, Valencia, Spain;(13)H.U.Río Hortega, Gastroenterology, Valladolid, Spain;(14)H.U. Marqués de Valdecilla & IDIVAL, Gastroenterology, Santander, Spain;(15)H.U.La Princesa & CIBEREHD, Gastroenterology, Madrid, Spain;(16)H.U. Central Asturias, Gastroenterology, Oviedo, Spain;(17)H.Cruces, Gastroenteorology, Bilbao, Spain;(18)H. Galdakao, Gastroenterology, Galdakao, Spain;(19)Complejo hospitalario de Santiago, Gastroenterology, Santiago de Compostela, Spain;(20)Hospital Universitario Germans Trias i Pujol and CIBEREHD, Gastroenterology, Badalona, Spain;
Oral corticosteroids remain as the first-line treatment for moderately active ulcerative colitis (UC). In controlled studies, they achieved clinical remission in 30-60% of patients at 30 days. In severe systemic diseases, intravenous bolus administration of methyl-prednisolone accelerates the clinical response and increases the therapeutic efficacy of corticosteroids.
Aims: To assess the additive effect of IV boluses of methyl-prednisolone in an outpatient Schedule on the remission rate of moderately active UC.
Randomized, controlled, open study. Inclusion criteria: 1) moderately active (complete May 6-10) distal or extensive UC; 2) never exposed to immunosuppressants or biologicals; 3) without corticosteroid therapy within the last 6 months. Randomization to oral prednisone 60mg/day (ORAL arm) or the same regimen preceded by intravenous boluses of 500mg methyl-prednisolone for 3 days (BOLUS arm). Primary endpoint: clinical and endoscopic remission at week 8 as defined by a complete Mayo score <3 with no subscore >1. Results are expressed in frequencies, medians and interquartile range.
75 patients (39 ORAL, 36 BOLUS) were included, 24% at diesease onset, 49% extensive UC, 68% were on maintenance with oral 5ASA, and 31% had ever received systemic corticosteroids. At baseline, complete Mayo score was 9 (7-9), with C-reactive protein 9.25 mg/L (3.85-20.17) and fecal calprotectin 1430 ug/g (501-2702), with no differences in the baseline clinical-epidemiological characteristics between both treatment arms. At 8 weeks, 37% of patients achieved clinical-endoscopic remission (47% BOLUS vs 28% ORAL; p=0.089), 52% mucosal healing -Mayo endoscopic subscore <2- (61% BOLUS vs 44% ORAL; p=0.129), 24% endoscopic remission -Mayo endoscopic=0- (31% BOLUS vs 18% ORAL; p=0.202) and 55% clinical remission - partial Mayo score <2- (61% BOLUS vs 49% ORAL; p=0.281). No associated factors with clinical-endoscopic remission were identified.
The addition of three intravenous megaboluses at the beginning of a conventional regimen of oral prednisone achieves a non-significant increase in clinical-endoscopic remission rates at the end of corticosteroid treatment in patients with moderately active UC.