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P.06.11 HISTOLOGICAL INFLAMMATION IN ULCERATIVE COLITIS IN DEEP REMISSION UNDER TREATMENT WITH INFLIXIMAB
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Abstracts of the 20th National Congress of Digestive Diseases / Digestive and Liver Disease 46S (2014) S1–S144
and should become a major secondary endpoint in IBD clinical trials. The aim of our study was to evaluate the effect of anti-TNF-α treatment on fatigue and quality of life in patients with IBD, compared to a group of patients treated with azathioprine. Material and methods: A total of fifty-five patients with quiescent IBD were enrolled in the study. Twenty-six patients receiving anti-TNF-α treatment and twenty-nine patients receiving azathioprine were included. All patients were on stable treatment for at least 6 months prior to baseline measurement. Fatigue was assessed by the Italian version of the questionnaire Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT- Fatigue Scale Version 4). The quality of life was assessed by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Results: Group treated with azathioprine showed a significantly lower score to the FACIT-Fatigue Scale (therefore greater level of fatigue) compared to the group treated with biological drug (31.1±11.2 vs. 39.4±10.6; p<0.05). At the same time the score to the SIBDQ questionnaire showed that patients treated with biologic therapy have a better quality of life compared to the group that was taking azathioprine (5.71±0.88 vs. 0.94±1.5; p<0.05). Conclusions: Our data showed that patients treated with anti-TNF-α have lower levels of fatigue and better quality of life than patients treated with azathioprine. These results confirm that TNF- α could play a key role in the pathogenesis of fatigue in IBD patients.
P.06.11 HISTOLOGICAL INFLAMMATION IN ULCERATIVE COLITIS IN DEEP REMISSION UNDER TREATMENT WITH INFLIXIMAB A. Tursi ∗,1 , W. Elisei 2 , M. Picchio 3 , G. Forti 4 , A. Penna 5 , P.G. Lecca 6 , L. Di Cesare 6 , M. Di Fonzo 6 , C.D. Inchingolo 7 , R. Nenna 7 , G. Brandimarte 6 1 Gastroenterology Service, ASL BAT, Andria, Italy; 2 Division of Gastroenterology, ASL RMH, Albano Laziale (Roma), Italy; 3 Division of Surgery, “P. Colombo” Hospital, ASL RMH, Velletri (Roma), Italy; 4 Digestive Endoscopy Unit, “S. Maria Goretti” Hospital, Latina, Italy; 5 Division of Gastroenterology, “S. Paolo” Hospital, Bari, Italy; 6 Division of Gastroenterology, “Cristo Re” Hospital, Roma, Italy; 7 Department of Pathology, “Lorenzo Bonomo” Hospital, Andria, Italy
Background and aim: Mucosal healing, based on histological analysis, is an endpoint of maintenance therapy for patients with ulcerative colitis (UC). There are few data on how histological signs of inflammation develop under treatment with Infliximab (IFX). We investigated the patterns of histological features of inflammation in patients with UC in sustained clinical and endoscopic remission under IFX. Material and methods: We performed a retrospective study on 47 patients with UC in clinical and endoscopic remission and undergoing surveillance colonoscopy with biopsies while receiving maintenance therapy with IFX. Each colonic segment was evaluated based on the Mayo endoscopic subscore and the Geboes histology score (range, 0–5.4). Results: Globally, 6110 biopsy specimens were collected from 235 colonoscopies. At the beginning of the follow-up, histological features of inflammation were found in 48.9% of patients receiving maintenance IFX therapy; 25.9% of them had at least moderate inflammation based on histology scores. At the end of the follow-up, when patients were still under endoscopic and clinical remission, 40.4% of patients had at least one biopsy specimen with evidence of any histological inflammation during the follow-up, and 19.1% had biopsy specimens that met the Geboes criteria for abnormal histological inflammation. In none of the different disease locations (pancolitis, left-sided colitis, distal colitis) histological inflammation improved significantly during the follow-up. Conclusions: Patients in clinical and endoscopic remission from UC under IFX still frequently have histological features of inflammation.
P.06.12 GRANULO-MONOCYTOAPHERESIS IS MORE EFFECTIVE IN INDUCING AND MAINTAINING CLINICAL RESPONSE IN MILD ULCERATIVE COLITIS THAN IN MODERATE TO SEVERE DISEASE C. De Cassan ∗ , E.V. Savarino, P. Marson, G. Hatem, G.C. Sturniolo, R. D’Incà Università studi di Padova, Padova, Italy Background and aim: Granulo-monocytoapheresis (GMA) consists on extracorporeal removal of granulocytes and monocytes from the peripheral blood. It has been used in patients with mild to severe disease active ulcerative colitis (UC) in order to modulate intestinal inflammation with conflicting results. Aim of this study was to evaluate whether GMA effectiveness varies according to severity of UC. Material and methods: This study is designed as a retrospective review of prospectively collected data of patients undergoing GMA at our center, with a median follow-up period of 6 months. Demographics, clinical and laboratory data were extracted from the patients’ charts and electronic records. Severity of UC was measured according to Modified Truelove Witts Severity Index (MTWSI). Clinical response was defined as a decrease from baseline in MTWSI of ≥2 points or a value of MTWSI ≤2 points. Results: A total of 41 [24M/17F; mean age 47] patients were included. At 1-month follow-up period after GMA, 75% (n=21) of mild UC underwent clinical response compared to 53% (n=7) of patients with moderate to severe disease (p=0.27). At 6-months, 50% (n=14) of mild UC maintained clinical response compared to 15% (n=2) of patients with moderate to severe disease (p=0.04). Conclusions: Our data show that patients with mild disease benefit of GMA more than patients with moderate to severe disease. Thus, in patients with mild disease, GMA can be considered as a valid and alternative therapeutic approach, particularly in case of contraindications to immunosuppressors/corticosteroids or biologics.
P.06.13 MAINTENANCE GRANULO-MONOCYTOAPHERESIS IS EFFECTIVE IN INDUCING AND MAINTAINING CLINICAL RESPONSE IN MILD ULCERATIVE COLITIS C. De Cassan ∗ , E.V. Savarino, T. Tison, G. Hatem, G.C. Sturniolo, R. D’Incà Azienda ospedaliera universitaria Padova, Padova, Italy Background and aim: Granulo-monocytoapheresis (GMA) has been used in patients with active ulcerative colitis (UC) with beneficial effects in terms of clinical steroid free remission rates. Results on GMA use as maintenance therapy are limited. Aim of this study was to evaluate whether one session of GMA performed every month for 5 months (maintenance GMA) after an induction cycle increases the rate of steroid free response at 6 months of follow-up. Material and methods: Eight patients with mild disease, with steroids and/or immunosuppressants intolerance/contraindication and ineligible for anti TNF alfa, were offered maintenance GMA after successful GMA induction. Outcome and clinical data were compared with those observed in 13 consecutive patients who responded to induction GMA and did not undergo maintenance GMA. Median follow-up period was 6 months. Demographics, clinical and laboratory data were extracted from the patients’ charts and electronic records. Severity of UC was evaluated according to the Modified Truelove Witts Severity Index (MTWSI). Clinical response was defined as a decrease from baseline in MTWSI of ≥2 or a value of MTWSI ≤2 points. Results: A total of 21 [10M/11F; mean age 53 (19-73); mean MTWSI 6 (4-8)] patients were included. At the end of induction cycle (week 5), according to MTWSI, all patients underwent clinical response. At 6-month follow-up period, all patients in maintenance GMA (n=8) had clinical response compared to 46% (n=6/13) of patients who received only induction GMA (p=0.01). Conclusions: Our data show that maintenance GMA is helpful in maintaining clinical response in patients with mild UC and could represent a successful opportunity for patients with contraindications to traditional treatment.
Abstracts of the 20th National Congress of Digestive Diseases / Digestive and Liver Disease 46S (2014) S1–S144
and should become a major secondary endpoint in IBD clinical trials. The aim of our study was to evaluate the effect of anti-TNF-α treatment on fatigue and quality of life in patients with IBD, compared to a group of patients treated with azathioprine. Material and methods: A total of fifty-five patients with quiescent IBD were enrolled in the study. Twenty-six patients receiving anti-TNF-α treatment and twenty-nine patients receiving azathioprine were included. All patients were on stable treatment for at least 6 months prior to baseline measurement. Fatigue was assessed by the Italian version of the questionnaire Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT- Fatigue Scale Version 4). The quality of life was assessed by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Results: Group treated with azathioprine showed a significantly lower score to the FACIT-Fatigue Scale (therefore greater level of fatigue) compared to the group treated with biological drug (31.1±11.2 vs. 39.4±10.6; p<0.05). At the same time the score to the SIBDQ questionnaire showed that patients treated with biologic therapy have a better quality of life compared to the group that was taking azathioprine (5.71±0.88 vs. 0.94±1.5; p<0.05). Conclusions: Our data showed that patients treated with anti-TNF-α have lower levels of fatigue and better quality of life than patients treated with azathioprine. These results confirm that TNF- α could play a key role in the pathogenesis of fatigue in IBD patients.
P.06.11 HISTOLOGICAL INFLAMMATION IN ULCERATIVE COLITIS IN DEEP REMISSION UNDER TREATMENT WITH INFLIXIMAB A. Tursi ∗,1 , W. Elisei 2 , M. Picchio 3 , G. Forti 4 , A. Penna 5 , P.G. Lecca 6 , L. Di Cesare 6 , M. Di Fonzo 6 , C.D. Inchingolo 7 , R. Nenna 7 , G. Brandimarte 6 1 Gastroenterology Service, ASL BAT, Andria, Italy; 2 Division of Gastroenterology, ASL RMH, Albano Laziale (Roma), Italy; 3 Division of Surgery, “P. Colombo” Hospital, ASL RMH, Velletri (Roma), Italy; 4 Digestive Endoscopy Unit, “S. Maria Goretti” Hospital, Latina, Italy; 5 Division of Gastroenterology, “S. Paolo” Hospital, Bari, Italy; 6 Division of Gastroenterology, “Cristo Re” Hospital, Roma, Italy; 7 Department of Pathology, “Lorenzo Bonomo” Hospital, Andria, Italy
Background and aim: Mucosal healing, based on histological analysis, is an endpoint of maintenance therapy for patients with ulcerative colitis (UC). There are few data on how histological signs of inflammation develop under treatment with Infliximab (IFX). We investigated the patterns of histological features of inflammation in patients with UC in sustained clinical and endoscopic remission under IFX. Material and methods: We performed a retrospective study on 47 patients with UC in clinical and endoscopic remission and undergoing surveillance colonoscopy with biopsies while receiving maintenance therapy with IFX. Each colonic segment was evaluated based on the Mayo endoscopic subscore and the Geboes histology score (range, 0–5.4). Results: Globally, 6110 biopsy specimens were collected from 235 colonoscopies. At the beginning of the follow-up, histological features of inflammation were found in 48.9% of patients receiving maintenance IFX therapy; 25.9% of them had at least moderate inflammation based on histology scores. At the end of the follow-up, when patients were still under endoscopic and clinical remission, 40.4% of patients had at least one biopsy specimen with evidence of any histological inflammation during the follow-up, and 19.1% had biopsy specimens that met the Geboes criteria for abnormal histological inflammation. In none of the different disease locations (pancolitis, left-sided colitis, distal colitis) histological inflammation improved significantly during the follow-up. Conclusions: Patients in clinical and endoscopic remission from UC under IFX still frequently have histological features of inflammation.
P.06.12 GRANULO-MONOCYTOAPHERESIS IS MORE EFFECTIVE IN INDUCING AND MAINTAINING CLINICAL RESPONSE IN MILD ULCERATIVE COLITIS THAN IN MODERATE TO SEVERE DISEASE C. De Cassan ∗ , E.V. Savarino, P. Marson, G. Hatem, G.C. Sturniolo, R. D’Incà Università studi di Padova, Padova, Italy Background and aim: Granulo-monocytoapheresis (GMA) consists on extracorporeal removal of granulocytes and monocytes from the peripheral blood. It has been used in patients with mild to severe disease active ulcerative colitis (UC) in order to modulate intestinal inflammation with conflicting results. Aim of this study was to evaluate whether GMA effectiveness varies according to severity of UC. Material and methods: This study is designed as a retrospective review of prospectively collected data of patients undergoing GMA at our center, with a median follow-up period of 6 months. Demographics, clinical and laboratory data were extracted from the patients’ charts and electronic records. Severity of UC was measured according to Modified Truelove Witts Severity Index (MTWSI). Clinical response was defined as a decrease from baseline in MTWSI of ≥2 points or a value of MTWSI ≤2 points. Results: A total of 41 [24M/17F; mean age 47] patients were included. At 1-month follow-up period after GMA, 75% (n=21) of mild UC underwent clinical response compared to 53% (n=7) of patients with moderate to severe disease (p=0.27). At 6-months, 50% (n=14) of mild UC maintained clinical response compared to 15% (n=2) of patients with moderate to severe disease (p=0.04). Conclusions: Our data show that patients with mild disease benefit of GMA more than patients with moderate to severe disease. Thus, in patients with mild disease, GMA can be considered as a valid and alternative therapeutic approach, particularly in case of contraindications to immunosuppressors/corticosteroids or biologics.
P.06.13 MAINTENANCE GRANULO-MONOCYTOAPHERESIS IS EFFECTIVE IN INDUCING AND MAINTAINING CLINICAL RESPONSE IN MILD ULCERATIVE COLITIS C. De Cassan ∗ , E.V. Savarino, T. Tison, G. Hatem, G.C. Sturniolo, R. D’Incà Azienda ospedaliera universitaria Padova, Padova, Italy Background and aim: Granulo-monocytoapheresis (GMA) has been used in patients with active ulcerative colitis (UC) with beneficial effects in terms of clinical steroid free remission rates. Results on GMA use as maintenance therapy are limited. Aim of this study was to evaluate whether one session of GMA performed every month for 5 months (maintenance GMA) after an induction cycle increases the rate of steroid free response at 6 months of follow-up. Material and methods: Eight patients with mild disease, with steroids and/or immunosuppressants intolerance/contraindication and ineligible for anti TNF alfa, were offered maintenance GMA after successful GMA induction. Outcome and clinical data were compared with those observed in 13 consecutive patients who responded to induction GMA and did not undergo maintenance GMA. Median follow-up period was 6 months. Demographics, clinical and laboratory data were extracted from the patients’ charts and electronic records. Severity of UC was evaluated according to the Modified Truelove Witts Severity Index (MTWSI). Clinical response was defined as a decrease from baseline in MTWSI of ≥2 or a value of MTWSI ≤2 points. Results: A total of 21 [10M/11F; mean age 53 (19-73); mean MTWSI 6 (4-8)] patients were included. At the end of induction cycle (week 5), according to MTWSI, all patients underwent clinical response. At 6-month follow-up period, all patients in maintenance GMA (n=8) had clinical response compared to 46% (n=6/13) of patients who received only induction GMA (p=0.01). Conclusions: Our data show that maintenance GMA is helpful in maintaining clinical response in patients with mild UC and could represent a successful opportunity for patients with contraindications to traditional treatment.