P404 Real-life experience with golimumab in ulcerative colitis patients according to prior anti-TNF use
C. Taxonera*1, F. Bertoletti2, C. Rodriguez3, I. Marin4, J. Arribas5, P. Martinez-Montiel6, M. Sierra7, L. Arias8, M. Rivero9, A. Juan10, E. Iglesias11, N. Manceñido12, J.L. Perez-Calle13, A. Algaba14, M. Barreiro-de Acosta15, A. Gutierrez16, F. Argüelles17, D. Busquets18, M. Chaparro19, C. Alba1, D. Olivares1, M. Calvo20, J.P. Gisbert19
1Hospital Clinico San Carlos, IBD Unit, Madrid, Spain, 2Hospital Santa Creu i Sant Pau, Barcelona, Spain, 3Hospital de Navarra A, Department of Gastroenterology, Pamplona, Spain, 4Hospital Gregorio Marañón, Madrid, Spain, 5Hospital Ramón y Cajal, Department of Gastroenterology, Madrid, Spain, 6University Hospital 12 De Octubre, Department of Gastroenterology, Madrid, Spain, 7Hospital de León, Gastroenterology, León, Spain, 8Hospital de Burgos, Burgos, Spain, 9University Hospital Marques de Valdecilla - HUMV, Department of Gastroenterology, Santander, Spain, 10Hospital Germans Trias i Pujol, Barcelona, Spain, 11Hospital Reina Sofía, Gastroenterology, Córdoba, Spain, 12Hospital Infanta Sofía, Gastroenterology, Madrid, Spain, 13Hospital Universitario Fundación Alcorcón, Gastroenterology, Madrid, Spain, 14Hospital de Fuenlabrada, Gastroenterology, Madrid, Spain, 15Hospital Clínico de Santiago, Gastroenterology, Santiago de Compostela, Spain, 16Hospital Universitario de Alicante, Alicante, Spain, 17Hospital Universitario Virgen Macarena, Sevilla, Spain, 18Hospital Universitari Dr Trueta, Girona, Spain, 19Hospital La Princesa, IP and CIBERehd, Gastroenterology, Madrid, Spain, 20Hospital Puerta de Hierro, Gastroenterology, Madrid, Spain
Golimumab is effective in anti-TNF naïve patients with moderate-to-severe ulcerative colitis (UC). There are no data regarding the efficacy of golimumab in anti-TNF experienced UC patients. The aim of this study was to assess the short- and long-term outcomes of golimumab in UC patients according to prior anti-TNF use.
Retrospective multicentre cohort study evaluating all UC patients who received at least 2 golimumab induction doses at weeks 0 and 2. We compared the outcomes of the cohorts of anti-TNF experienced patients vs anti-TNF naïve patients. Post-induction short-term clinical response and remission were evaluated based on a partial Mayo score (PMS). In the long-term, the response and remission rates and the cumulative probabilities of golimumab failure-free survival and colectomy-free survival were calculated.
From September 2012 to August 2015, 142 UC patients were evaluated. Of these, 85 (60%) had previous anti-TNF use (28 infliximab, 5 adalimumab and 52 both). Ninety-seven (68%) achieved short-term clinical response, of these 45 (32%) entered into remission. Mean PMS was 6 (range 3–9; standard deviation [SD] 1) at baseline and 3 (range 0–9; SD 3) at week 8 (p < 0.001). Clinical response and remission rates were significantly lower in the anti-TNF experienced patients compared with anti-TNF naïve patients (p = 0.03 and p = 0.01, respectively). After a median follow-up of 10 months (IQR 6–14), 67 patients (47%) maintained clinical response. Of these, 49 (35%) were in corticosteroid-free remission. Further, 33 anti-TNF experienced patients (39%) vs 34 anti-TNF naïve patients (60%) maintained response (p = 0.15). At last follow-up, 60 patients (42%) had golimumab failure. Anti-TNF experienced patients had a numerically higher adjusted rate of golimumab failure compared with anti-TNF-naïve patients (HR 1.4; 95% CI 0.82–.5; p = 0.22). Fifteen patients (11%) needed colectomy. Median time to colectomy was 4 months (IQR 29–). Anti-TNF experienced patients had a significantly higher adjusted rate of colectomy (HR 7.6; 95%CI 1.1–58.7; p = 0.02). Thirty-three patients (23%) required golimumab dose escalation. The median time to escalation was 5 months (IQR 3–9). Short-term response was identified as a predictor of golimumab failure-free survival (HR 0.2; 95% CI 0.12–0.34; p < 0.001) and colectomy-free survival (HR 0.16; 95% CI 0.05–.051; p = 0.002).
In this real-life cohort of UC patients treated with golimumab, 47% of patients maintained clinical response, and 89% of patients avoided colectomy. Although anti-TNF naïve patients had better outcomes, golimumab was also effective in anti-TNF experienced patients, with 62% having short-term clinical response, 39% maintaining clinical response, and 84% avoiding colectomy.