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P.11.13: Bowel Ultrasound and Faecal Calprotectin as Predictors of Response to Infliximab in Ulcerative Colitis
Abstracts of the 23rd National Congress of Digestive Diseases / Digestive and Liver Disease 49S2 (2017) e73–e223
have a favorable evaluation. Preliminary data at 12 and 24 weeks shows a high rate of continue clinical response and ongoing therapy at 12 and 24 weeks.
P.11.12 PREPOUCH ILEITIS AFTER ILEAL POUCH-ANAL ANASTOMOSIS: PREVALENCE AND FEATURES C. Bezzio ∗,1 , S. Carmagnola 2 , G. Manes 1 , G. Maconi 2 , S. Saibeni 1 1 ASST
Rhodense, Rho, Italy; 2 ASST Fatebenefratelli, Sacco, Milano, Italy
Background and aim: Proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the most common operation for patients with ulcerative colitis (UC) refractory to medical therapy or with complications. While up to 50% of patients develop several forms of inflammation and complications of the pouch and/or perianal region, a subgroup of patients develop inflammation in the ileum afferent to the pouch. The pathogenic mechanisms and the clinical relevance of such a condition are not fully understood. The aim of the study was to assess the prevalence and the features of proximal ileitis in UC patients who underwent IPAA. Material and methods: 190 UC patients who underwent IPAA due to Ulcerative Colitis were retrospectively evaluated. Inflammation in the afferent ileum was defined as the presence of erythema, aftae, erosions or ulcers at endoscopy. Crohn’s disease was excluded by reviewing the histology of colectomy resection. Results: Prepouch ileitis was observed in 11/190 (5.7%) patients; in 10 pouchitis also was observed. The endoscopic findings were: in 8 pts ulcers and hyperemia, in 3 pts erosions and hyperemia. At histology, no specific alterations were observed. The mean time ± SD from surgical intervention was 30±12 months. Eight patients (4%) were symptomatic. One had increase of C-Reactive Protein (0.5%). Six patients underwent only bowel ultrasound, 5 patients underwent bowel ultrasound and entero-Magnetic Resonance. All but one patients were treated with antibiotics: 2 responded while 9 required escalation, to steroids and immunomodulators (n=3) and anti-tumor necrosis factor agents (n=6). Only in 1 patient a diagnosis of Crohn’s disease was eventually done. Conclusions: Pre-pouch ileitis rarely occurs in UC patients underwent IPAA. It appears to be a distinct entity than pouchitis or Crohn’s disease. Further studies are needed in order to understand its true clinical relevance as well as the pathogenic mechanisms.
P.11.13 BOWEL ULTRASOUND AND FAECAL CALPROTECTIN AS PREDICTORS OF RESPONSE TO INFLIXIMAB IN ULCERATIVE COLITIS C. Bezzio ∗,1 , F. Furfaro 2 , S. Carmagnola 3 , G. Maconi 3 , G. Manes 1 , S. Saibeni 1 1 ASST
Rhodense, Rho, Milano, Italy; 2 Istituto Clinico Humanitas, Milano, Italy; 3 ASST Fatebenefratelli-Sacco, Milano, Italy
Background and aim: Infliximab is used to treat ulcerative colitis, from moderate to severe, in patients refractory or intolerant to conventional therapy. It is not known what are the prognostic factors predictive of response to therapy. The of the study is to evaluate whether there are biochemical or radiological early markers of response to therapy with infliximab. Material and methods: We included prospectively in the study 40 patients (pts) with moderate to severe ulcerative colitis, candidates for treatment with infliximab. In all patients a baseline endoscopy, ultrasound and dosing of C reactive protein (CRP) and fecal calprotectin were performed. Ultrasound, CRP and calprotectin were
e207
repeated at 3, 6 and 12 months. At 12 months of the beginning of the therapy endoscopic revaluation was performed. Results: We here present data about the 16 pts who completed 12-months follow-up. At baseline endoscopy 9 pts had moderate disease activity (Mayo score 2) and 7 severe activity (Mayo score 3). The disease was extended to the rectosigmoid in 8 pts, beyond the splenic flexure in 6 and throughout the colon in 2. Intestinal ultrasound showed abnormal wall thickening in at least one colonic tract in 11/16 pts. After 12 months of treatment, 5 pts had deep (clinical and endoscopic) remission and 11 partial remission. Normalization of the wall thickness within the normal values ultrasound performed at 3 months after initiation of therapy was significantly higher in pts with deep vs. pts with partial clinical remissione (5/5 vs. 5/11; p<0.01). Similarly, also fecal calprotectin showed a significant reduction at 6 months of at least 80 mcg/g (5/5 vs. 4/11; p<0.01).CRP values did not show a significant differences. Conclusions: A reduction in wall thickness, as assessed by bowel ultrasound after 3 months of therapy, and a reduction of fecal calprotectin value after 6 months may be prognostic factors of clinical and endoscopic response to treatment with infliximab.
P.11.14 GOLIMUMAB IN ULCERATIVE COLITIS: A “REAL LIFE” OBSERVATIONAL STUDY E. Capoferro ∗ Ospedale Sacro Cuore Don Calabria, Negrar (VR), Italy Background and aim: Ulcerative colitis (UC) is an inflammatory bowel disease (IBD), characterized by diffuse mucosal inflammation and diarrhea mixed with blood. The 2 PURSUIT studies demonstrated that Golimumab (Glm) is effective and safe to treat moderate to severe UC refractory to conventional therapy. Our aim was to investigated real life results after Glm entry in our available drugs for IBD treatment. Material and methods: Observational study of effectiveness and safety of Glm in pt (patients) with UC treated in our IBD Unit. All pt received standard induction regimen (200 mg week 0, 100 mg week 2 and then 100 mg or 50 mg every 4 weeks in relation to weight greater or lower than 80 kg). Results: We observed 25 pt referred to our IBD Unit since May 2015 until October 2016 (9 male, 16 female; mean age 47 years old, range 26–74), treated with Glm. Of these, 11 were naïve and 14 switching from another antiTNFalpha (for secondary failure or intolerance to previous antiTNFalpha).The average treatment time with Glm was 34 weeks (range 6–70). In agree with Montreal classification, 18 pt had left side UC (E2), 4 had pancolitis (E3) and 2 pt had proctitis (E1); 21 had endoscopic severe disease, 4 moderate disease. 8 pt had history of disease less than 5 years, 10 pt between 5 and 10 years, 7 more than 10 years. Subanalysis of therapy outcome at 6 months was performed in 19 pt (6 had follow-up less than 24 weeks) observing clinical answer (decrease in Mayo score of 30% and no need for steroids) in 10/19, primary failure in 2/19 (1 underwent proctocolectomy), secondary failure in 7/19. Subanalysis of therapy outcome at 12 months was possible only in 8 pt observing clinical answer in 2/8 pt (confirmed by endoscopy) and secondary failure in 6/8. After 15 months of experience with Glm, 10 pt ended therapy (6 pt underwent proctocolectomy, 3 pt switched therapy for secondary failure and 1 pt experienced a significant pustular psoriasis). The pt continuing Glm therapy are above all naïve (9/15). Conclusions: From this preliminary analysis of our data, the predictors of effectiveness of Glm seem to be: pt naïve or with previous
have a favorable evaluation. Preliminary data at 12 and 24 weeks shows a high rate of continue clinical response and ongoing therapy at 12 and 24 weeks.
P.11.12 PREPOUCH ILEITIS AFTER ILEAL POUCH-ANAL ANASTOMOSIS: PREVALENCE AND FEATURES C. Bezzio ∗,1 , S. Carmagnola 2 , G. Manes 1 , G. Maconi 2 , S. Saibeni 1 1 ASST
Rhodense, Rho, Italy; 2 ASST Fatebenefratelli, Sacco, Milano, Italy
Background and aim: Proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the most common operation for patients with ulcerative colitis (UC) refractory to medical therapy or with complications. While up to 50% of patients develop several forms of inflammation and complications of the pouch and/or perianal region, a subgroup of patients develop inflammation in the ileum afferent to the pouch. The pathogenic mechanisms and the clinical relevance of such a condition are not fully understood. The aim of the study was to assess the prevalence and the features of proximal ileitis in UC patients who underwent IPAA. Material and methods: 190 UC patients who underwent IPAA due to Ulcerative Colitis were retrospectively evaluated. Inflammation in the afferent ileum was defined as the presence of erythema, aftae, erosions or ulcers at endoscopy. Crohn’s disease was excluded by reviewing the histology of colectomy resection. Results: Prepouch ileitis was observed in 11/190 (5.7%) patients; in 10 pouchitis also was observed. The endoscopic findings were: in 8 pts ulcers and hyperemia, in 3 pts erosions and hyperemia. At histology, no specific alterations were observed. The mean time ± SD from surgical intervention was 30±12 months. Eight patients (4%) were symptomatic. One had increase of C-Reactive Protein (0.5%). Six patients underwent only bowel ultrasound, 5 patients underwent bowel ultrasound and entero-Magnetic Resonance. All but one patients were treated with antibiotics: 2 responded while 9 required escalation, to steroids and immunomodulators (n=3) and anti-tumor necrosis factor agents (n=6). Only in 1 patient a diagnosis of Crohn’s disease was eventually done. Conclusions: Pre-pouch ileitis rarely occurs in UC patients underwent IPAA. It appears to be a distinct entity than pouchitis or Crohn’s disease. Further studies are needed in order to understand its true clinical relevance as well as the pathogenic mechanisms.
P.11.13 BOWEL ULTRASOUND AND FAECAL CALPROTECTIN AS PREDICTORS OF RESPONSE TO INFLIXIMAB IN ULCERATIVE COLITIS C. Bezzio ∗,1 , F. Furfaro 2 , S. Carmagnola 3 , G. Maconi 3 , G. Manes 1 , S. Saibeni 1 1 ASST
Rhodense, Rho, Milano, Italy; 2 Istituto Clinico Humanitas, Milano, Italy; 3 ASST Fatebenefratelli-Sacco, Milano, Italy
Background and aim: Infliximab is used to treat ulcerative colitis, from moderate to severe, in patients refractory or intolerant to conventional therapy. It is not known what are the prognostic factors predictive of response to therapy. The of the study is to evaluate whether there are biochemical or radiological early markers of response to therapy with infliximab. Material and methods: We included prospectively in the study 40 patients (pts) with moderate to severe ulcerative colitis, candidates for treatment with infliximab. In all patients a baseline endoscopy, ultrasound and dosing of C reactive protein (CRP) and fecal calprotectin were performed. Ultrasound, CRP and calprotectin were
e207
repeated at 3, 6 and 12 months. At 12 months of the beginning of the therapy endoscopic revaluation was performed. Results: We here present data about the 16 pts who completed 12-months follow-up. At baseline endoscopy 9 pts had moderate disease activity (Mayo score 2) and 7 severe activity (Mayo score 3). The disease was extended to the rectosigmoid in 8 pts, beyond the splenic flexure in 6 and throughout the colon in 2. Intestinal ultrasound showed abnormal wall thickening in at least one colonic tract in 11/16 pts. After 12 months of treatment, 5 pts had deep (clinical and endoscopic) remission and 11 partial remission. Normalization of the wall thickness within the normal values ultrasound performed at 3 months after initiation of therapy was significantly higher in pts with deep vs. pts with partial clinical remissione (5/5 vs. 5/11; p<0.01). Similarly, also fecal calprotectin showed a significant reduction at 6 months of at least 80 mcg/g (5/5 vs. 4/11; p<0.01).CRP values did not show a significant differences. Conclusions: A reduction in wall thickness, as assessed by bowel ultrasound after 3 months of therapy, and a reduction of fecal calprotectin value after 6 months may be prognostic factors of clinical and endoscopic response to treatment with infliximab.
P.11.14 GOLIMUMAB IN ULCERATIVE COLITIS: A “REAL LIFE” OBSERVATIONAL STUDY E. Capoferro ∗ Ospedale Sacro Cuore Don Calabria, Negrar (VR), Italy Background and aim: Ulcerative colitis (UC) is an inflammatory bowel disease (IBD), characterized by diffuse mucosal inflammation and diarrhea mixed with blood. The 2 PURSUIT studies demonstrated that Golimumab (Glm) is effective and safe to treat moderate to severe UC refractory to conventional therapy. Our aim was to investigated real life results after Glm entry in our available drugs for IBD treatment. Material and methods: Observational study of effectiveness and safety of Glm in pt (patients) with UC treated in our IBD Unit. All pt received standard induction regimen (200 mg week 0, 100 mg week 2 and then 100 mg or 50 mg every 4 weeks in relation to weight greater or lower than 80 kg). Results: We observed 25 pt referred to our IBD Unit since May 2015 until October 2016 (9 male, 16 female; mean age 47 years old, range 26–74), treated with Glm. Of these, 11 were naïve and 14 switching from another antiTNFalpha (for secondary failure or intolerance to previous antiTNFalpha).The average treatment time with Glm was 34 weeks (range 6–70). In agree with Montreal classification, 18 pt had left side UC (E2), 4 had pancolitis (E3) and 2 pt had proctitis (E1); 21 had endoscopic severe disease, 4 moderate disease. 8 pt had history of disease less than 5 years, 10 pt between 5 and 10 years, 7 more than 10 years. Subanalysis of therapy outcome at 6 months was performed in 19 pt (6 had follow-up less than 24 weeks) observing clinical answer (decrease in Mayo score of 30% and no need for steroids) in 10/19, primary failure in 2/19 (1 underwent proctocolectomy), secondary failure in 7/19. Subanalysis of therapy outcome at 12 months was possible only in 8 pt observing clinical answer in 2/8 pt (confirmed by endoscopy) and secondary failure in 6/8. After 15 months of experience with Glm, 10 pt ended therapy (6 pt underwent proctocolectomy, 3 pt switched therapy for secondary failure and 1 pt experienced a significant pustular psoriasis). The pt continuing Glm therapy are above all naïve (9/15). Conclusions: From this preliminary analysis of our data, the predictors of effectiveness of Glm seem to be: pt naïve or with previous