2
S252 Poster presentations colectomy rate were 18.6% (95% CI 11.8%-26.9%) and 25.6% (95%CI 17.9%-34.7%) respectively. High CRP values and severe endoscopic lesions were associated with the risk of colectomy: Risk Ratio (RR) = 2.15 (95% CI 1.05 4.36), and RR = 5.13 (95% CI 1.55 16.96), respectively. In patients escaping early colectomy, the probability of a colectomy-free course at 12, 24, 36 and 60 months was 91%, 85%, 81% and 73%, respectively. Endoscopic severity was the only predictor of long term colectomy (RR = 7.0; 95% CI 1.09 44.7). Adverse events occurred in 16 patients (14%); there was one death (0.88%) due to pulmonary abscess. Conclusions: Infliximab is an effective and safe rescue therapy for severe corticosteroid-refractory ulcerative colitis. A three- dose induction regimen seems to be the treatment of choice for preventing early colectomy. Severe endoscopic lesions appears to be predictor of short- and long-term colectomy. P446 Infliximab is an effective induction therapy in children with perianal fistulizing Crohn’s disease A. Wegner, M. Dadalski *, J. Kierkus*. Children’s Memorial Health Institute, Gastroenterology, Hepatology and Feeding Disorders, Warsaw, Poland Background: Infliximab is applied in the treatment of Crohn’s Disease (CD) in pediatric patients, who do not respond to conventional therapy or/and in case of perianal fistulizing CD. Overall efficacy of induction therapy with infliximab in children with CD is up to 80%, whereas in adult subgroup with perianal fistulizing CD induction therapy is successful in about 60% cases. The aim of this study was to assess the efficacy of induction therapy with infliximab in children with perianal fistulizing Crohn’s disease. Methods: This is a subanalysis of CIMIT study. The subgroup of 25 patients (19M, 6F; age 14.2±3.1 years; CD duration 1.8±1.8 years; PCDAI 48.4±12 [mean±SD]) with PCDAI >30 and perianal fistula present were involved to the study and received induction therapy with infliximab 5 mg/kg at weeks 0, 2, and 6. Clinical (PCDAI score) response (decrease of PCDAI greater or equal than 15 and total PCDAI smaller than 30) and remission (PCDAI smaller or equal than 10) were assessed at Week 10 as well as fistulas’ healing. Results: 1 patient had induction therapy stopped due to VZV infection. 21 out of 25 (84%) pts had clinical response, and 16 out of them (64%) had clinical remission at the end of induction therapy. Fistula closure was found in 16 of 25 patients (64%) at 10 weeks study. 3 out of 4 patients with no response still had active fistulas at Week 10 and among 9 patients with active fistulas at Week 10, 4 had clinical remission (fistula was the only symptom of CD) and 7 had clinical response. Conclusions: Infliximab is an effective induction therapy in children with perianal fistulizing Crohn’s Disease with successful fistulas closure in 64% cases. The majority of patients with no fistula healing had also clinical benefit with such a therapy. P447 Infliximab in the treatment of moderate-to-severe ulcerative colitis: Results of a large multicenter Italian survey M. Cappello 1 *, M. Mazza 1 , G. Costantino 2 , W. Fries 2 , A.C. Privitera 3 , M. Mastronardi 4 , F. Bossa 5 , A. Rispo 6 , F. Castiglione 6 , A. Lauria 7 , N. Buccianti 8 , R. Marasco 9 , L. Grossi 10 , M.B. Principi 11 . 1 University of Palermo, Gastroenterology Section, DiBiMis, Palermo, Italy, 2 University of Messina, Dipartimento di Medicina Interna e Terapia Medica, Messina, Italy, 3 Ospedale Cannizzaro, Catania, Azienda Ospedaliera per l’Emergenza, Catania, Italy, 4 IRCCS, Castellana Grotte (BA), UOC Gastroenterologia ed Endoscopia Digestiva, Castellana Grotte (BA), Italy, 5 Casa Sollievo della Sofferenza, S. Giovanni Rotondo, Gastroenterologia, S. Giovanni Rotondo (FG), Italy, 6 Universit` a Federico II, Napoli, Gastroenterologia, Napoli, Italy, 7 A. O. Bianchi-Melacrino- Morelli, Reggio Calabria, Gastroenterologia e Endoscopia Digestiva, Reggio Calabria, Italy, 8 A.O.S. Carlo, Potenza, U.O.C. di Medicina Interna, Potenza, Italy, 9 Policlinico Catanzaro, UOC Gastroenterologia, Catanzaro, Italy, 10 Ospedale Spirito Santo, Pescara, Fisiopatologia Digestiva, Pescara, Italy, 11 Policlinico, Bari, Gastroenterologia, Bari, Italy Background: Infliximab (IFX) has been proven effectivein RCTs both for induction of remission and maintenance in moderate- to-severe ulcerative colitis (UC). The aim of this study is to provide data on IFX efficacy in UC in everyday clinical practice. Methods: Eleven referral and non-referral centers from Southern Italy participated in the study. All patients with UC who received at least one infusion of IFX from January 2008 to June 2012 were recruited. Clinico-demographic characteristics, IFX indications, concomitant therapy anddisease activity were registered. Outcomes evaluated were clinical and endoscopic responses at week 14 and 52, steroid-free remission, colectomy rate. Results: 319 patients (60.2% males, mean age 35.4) were enrolled. Extent of disease was pancolitis in 67.1%, left-sided colitis in 24.8%, proctosigmoiditis in 8.2%. Median duration of disease was 51 months. Median follow-up was 23 months. Indication to IFX were steroid dependence in 75.3%, steroid- resistance in 16.9%, extra-intestinal complications in 2.2%, rescue therapy for severe refractory UC in 5.6%. Patients received a median of 10 (range 5 16) infusions. Mayo score was 8.3 at enrolment, 4.3 at 14 weeks and 3.2 at 52 weeks (p < 0.001). Steroids were used in 93.5% at baseline, 44.4% at week 14 and 26% at week 52. Mucosal healing was obtained in 77.3%. Colectomy rate was 8.3%. Median time to colectomy was 5 months. Results were compared in steroid dependent versus steroid-resistantpatients, IFX monotherapyversus combo and long-lasting versus recent disease. Colectomy rate was signifi- cantly higher in steroid-resistant (p = 0.0003) patients; steroid- free remission was less common in long-lasting disease. Conclusions: Infliximab is effective in inducing short and long- term clinical response, mucosal healing, steroids sparing and in reducing colectomy rate in moderate-to-severe UC. Steroid- dependent disease is the most frequent indication in the “real- life” with favourable outcomes and a lower rate of colectomy. P448 Inflammatory and cancerous skin lesions in inflammatory bowel disease patients treated with anti-TNF therapy A. Ocepek, C. Pernat Drobez*. UMC Maribor, Gastroenterology, Maribor, Slovenia Background: Skin lesions are most frequently observed adverse reactions to anti-TNF therapy. In inflammatory bowel disease (IBD) patients their incidence is 20 25%. Most common skin side effects of anti-TNF are injection site reactions, cutaneous manifestations of infusion reactions, cutaneous infections, non-

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Page 1: P448 Inflammatory and cancerous skin lesions in inflammatory bowel disease patients treated with anti-TNF therapy

S252 Poster presentations

colectomy rate were 18.6% (95% CI 11.8%-26.9%) and 25.6%(95% CI 17.9%-34.7%) respectively. High CRP values and severeendoscopic lesions were associated with the risk of colectomy:Risk Ratio (RR) = 2.15 (95% CI 1.05 4.36), and RR = 5.13 (95% CI1.55 16.96), respectively. In patients escaping early colectomy,the probability of a colectomy-free course at 12, 24, 36 and60 months was 91%, 85%, 81% and 73%, respectively. Endoscopicseverity was the only predictor of long term colectomy(RR = 7.0; 95% CI 1.09 44.7). Adverse events occurred in 16patients (14%); there was one death (0.88%) due to pulmonaryabscess.Conclusions: Infliximab is an effective and safe rescue therapyfor severe corticosteroid-refractory ulcerative colitis. A three-dose induction regimen seems to be the treatment of choice forpreventing early colectomy. Severe endoscopic lesions appearsto be predictor of short- and long-term colectomy.

P446Infliximab is an effective induction therapy in childrenwith perianal fistulizing Crohn’s diseaseA. Wegner, M. Dadalski *, J. Kierkus *. Children’s MemorialHealth Institute, Gastroenterology, Hepatology and FeedingDisorders, Warsaw, Poland

Background: Infliximab is applied in the treatment of Crohn’sDisease (CD) in pediatric patients, who do not respond toconventional therapy or/and in case of perianal fistulizing CD.Overall efficacy of induction therapy with infliximab in childrenwith CD is up to 80%, whereas in adult subgroup with perianalfistulizing CD induction therapy is successful in about 60% cases.The aim of this study was to assess the efficacy of inductiontherapy with infliximab in children with perianal fistulizingCrohn’s disease.Methods: This is a subanalysis of CIMIT study. The subgroupof 25 patients (19M, 6F; age 14.2±3.1 years; CD duration1.8±1.8 years; PCDAI 48.4±12 [mean±SD]) with PCDAI >30 andperianal fistula present were involved to the study and receivedinduction therapy with infliximab 5 mg/kg at weeks 0, 2, and 6.Clinical (PCDAI score) response (decrease of PCDAI greater orequal than 15 and total PCDAI smaller than 30) and remission(PCDAI smaller or equal than 10) were assessed at Week 10 aswell as fistulas’ healing.Results: 1 patient had induction therapy stopped due to VZVinfection. 21 out of 25 (84%) pts had clinical response, and 16out of them (64%) had clinical remission at the end of inductiontherapy. Fistula closure was found in 16 of 25 patients (64%) at10 weeks study. 3 out of 4 patients with no response still hadactive fistulas at Week 10 and among 9 patients with activefistulas at Week 10, 4 had clinical remission (fistula was theonly symptom of CD) and 7 had clinical response.Conclusions: Infliximab is an effective induction therapy inchildren with perianal fistulizing Crohn’s Disease with successfulfistulas closure in 64% cases. The majority of patients with nofistula healing had also clinical benefit with such a therapy.

P447Infliximab in the treatment of moderate-to-severeulcerative colitis: Results of a large multicenter Italiansurvey

M. Cappello1 *, M. Mazza1, G. Costantino2, W. Fries2,A.C. Privitera3, M. Mastronardi4, F. Bossa5, A. Rispo6,F. Castiglione6, A. Lauria7, N. Buccianti8, R. Marasco9,L. Grossi10, M.B. Principi11. 1University of Palermo,Gastroenterology Section, DiBiMis, Palermo, Italy, 2Universityof Messina, Dipartimento di Medicina Interna e TerapiaMedica, Messina, Italy, 3Ospedale Cannizzaro, Catania,Azienda Ospedaliera per l’Emergenza, Catania, Italy, 4IRCCS,Castellana Grotte (BA), UOC Gastroenterologia ed EndoscopiaDigestiva, Castellana Grotte (BA), Italy, 5Casa Sollievo dellaSofferenza, S. Giovanni Rotondo, Gastroenterologia, S.Giovanni Rotondo (FG), Italy, 6Universita Federico II, Napoli,Gastroenterologia, Napoli, Italy, 7A. O. Bianchi-Melacrino-Morelli, Reggio Calabria, Gastroenterologia e EndoscopiaDigestiva, Reggio Calabria, Italy, 8A.O.S. Carlo, Potenza,U.O.C. di Medicina Interna, Potenza, Italy, 9PoliclinicoCatanzaro, UOC Gastroenterologia, Catanzaro, Italy,10Ospedale Spirito Santo, Pescara, Fisiopatologia Digestiva,Pescara, Italy, 11Policlinico, Bari, Gastroenterologia, Bari,ItalyBackground: Infliximab (IFX) has been proven effectivein RCTsboth for induction of remission and maintenance in moderate-to-severe ulcerative colitis (UC). The aim of this study is toprovide data on IFX efficacy in UC in everyday clinical practice.Methods: Eleven referral and non-referral centers fromSouthern Italy participated in the study. All patients with UCwho received at least one infusion of IFX from January 2008 toJune 2012 were recruited. Clinico-demographic characteristics,IFX indications, concomitant therapy anddisease activity wereregistered. Outcomes evaluated were clinical and endoscopicresponses at week 14 and 52, steroid-free remission,colectomy rate.Results: 319 patients (60.2% males, mean age 35.4) wereenrolled. Extent of disease was pancolitis in 67.1%, left-sidedcolitis in 24.8%, proctosigmoiditis in 8.2%. Median durationof disease was 51 months. Median follow-up was 23 months.Indication to IFX were steroid dependence in 75.3%, steroid-resistance in 16.9%, extra-intestinal complications in 2.2%,rescue therapy for severe refractory UC in 5.6%. Patientsreceived a median of 10 (range 5 16) infusions. Mayo scorewas 8.3 at enrolment, 4.3 at 14 weeks and 3.2 at 52 weeks(p < 0.001). Steroids were used in 93.5% at baseline, 44.4% atweek 14 and 26% at week 52. Mucosal healing was obtained in77.3%. Colectomy rate was 8.3%. Median time to colectomy was5 months. Results were compared in steroid dependent versussteroid-resistantpatients, IFX monotherapyversus combo andlong-lasting versus recent disease. Colectomy rate was signifi-cantly higher in steroid-resistant (p = 0.0003) patients; steroid-free remission was less common in long-lasting disease.Conclusions: Infliximab is effective in inducing short and long-term clinical response, mucosal healing, steroids sparing andin reducing colectomy rate in moderate-to-severe UC. Steroid-dependent disease is the most frequent indication in the “real-life” with favourable outcomes and a lower rate of colectomy.

P448Inflammatory and cancerous skin lesions in inflammatorybowel disease patients treated with anti-TNF therapyA. Ocepek, C. Pernat Drobez*. UMC Maribor, Gastroenterology,Maribor, SloveniaBackground: Skin lesions are most frequently observed adversereactions to anti-TNF therapy. In inflammatory bowel disease(IBD) patients their incidence is 20 25%. Most common skinside effects of anti-TNF are injection site reactions, cutaneousmanifestations of infusion reactions, cutaneous infections, non-

Page 2: P448 Inflammatory and cancerous skin lesions in inflammatory bowel disease patients treated with anti-TNF therapy

Clinical: Therapy & observation S253

melanoma skin cancer, and psoriasis. Rare lesions includelupus-like syndrome, Stevens-Johnson syndrome, erythemamultiforme and toxic epidermal necrolysis. We present ourgroup of IBD patients treated with anti-TNF therapy whodeveloped skin lesions.Methods: Medical charts of all IBD patients treated withanti-TNF therapy from January 2007 to February 2013 wereretrospectively reviwed, in search of inflammatory or cancerousskin lesions as side effects of therapy.Results: 125 IBD patients were included, 65 male and 60female, average age was 42.2 years. 18 patients (14.4%),developed skin side effects. 11 patients (61.1%) were treatedfor Crohn’s disease and 7 (38.9%) for ulcerative colitis. In16 patients (12.8%) inflammatory skin lesions were found,psoriasiform lesions in 7 (38.9%), eczematiform lesions in3 (16.7%), undefined lesions in 3 (16.7%) and other lesions(alopecia, hyperkeratosis, bullous pemphigoid) in 3 (16.7%)patients. Most frequently skin lesions affected arms and legs(in 9 patients or 56%), only trunk was affected in 3 patients(19%), trunk, arms and legs were affected in 1 patient (6%),only face in 1 patient (6%) and scalp in 2 patients (13%). 3 casesof basocellulare carcinoma (BCC) were discovered in 2 patients(1.6%), in a male patient on infliximab and in a female patienton adalimumab. 12 patients with skin side effects (77.8%) weretreated with infliximab, 4 patients (22.2%) with adalimumaband 2 patients (11.1%) with both drugs consecutively. Skinlesions developed after a median time of 14.9 months (2to 39 months) after initiating anti-TNF therapy. All patientswere refered to a dermatologist, both patients with BCC wereoperated by a plastic surgeon, and all 3 lesions were removedwith a clean safety margin. In a patient (5.5%) with bullouspemphigoid anti-TNF therapy was stopped, in all other patientstherapy was continued, and skin lesions were alleviated bytopical dermatological therapy.Conclusions: Skin side effects are frequent in patients treatedwith anti-TNF agents. In our group of IBD patients inflammatoryand cancerous skin lesions developed in 14.4% of patients. Onlyin one patient (5.5%) anti-TNF therapy was stopped, in all otherpatients topical dermatological therapy was sufficient. Bothpatients with BCC were treated surgicaly and are continuingwith anti-TNF therapy under surgical surveillance.

P449Inflammatory bowel disease patients’ partnerhow important is their support?A. Lahat *, S. Neuman, R. Eliakim, S. Ben-Horin. Chaim ShebaMedical Center, Gastroenterology, Ramat Gan, Israel

Background: Chronic inflammatory disease of the bowel causessignificant distress to the patient and his family. Data assessingthe need of these patients for support and sharing with theirpartners is scares.Our aim was assess patients’ view regarding information sharingwith their partners.Methods: All IBD patients treated at the Sheba Medical centerbetween 1.2011 1.2013 were asked to fill an anonymousquestionnaire. Patients that had a stable partner and thatcompleted more than 95% of the questionnaire were included.Results: One hundred thirty-four patients filled out thequestionnaire, of them 101 were included. 53 were men.Mean age: 45±15. 50% had academic education. Only 42%of patients reported that their partner accompanies themto the doctor. 93% of patients share health problems withtheir partner. 64% would like their partner to receive moremedical information, and 70% would like their partner to bemore involved. 88% of patients believe that more partners’involvement can help them deal better with the disease.70% think that support group for partners should be established.No association was found between patients’ demographicdata to their answers. Patients that felt that their partner’s

involvement can help them dealing with the disease tended toshare with them medical information and wanted them to bemore involved in health decisions (p < 0.001).Conclusions: Most IBD patients want their partner to be moreinvolved with their health problems, and believe that greaterinvolvement can help them deal better with their disease.Therefore, more attention should be attributed towards bettercooperation with patients’ families.

P450Inflammatory bowel disease patients’ satisfaction withhospital care a novel evaluation model

B. Moreira Goncalves1 *, A. Sofia Marinho1, F. Dalia1, A. CeliaCaetano1, S. Costa1, F. Magro2, R. Goncalves1, J.B. Soares1.1Hospital Braga, Gastroenterology Department, Braga,Portugal, 2Centro Hospitalar Sao Joao, GastroenterologyDepartment, Porto, Portugal

Background: Satisfaction of patients has gained increasingimportance in the evaluation of health care quality. Thereis no data regarding the satisfaction of Inflammatory BowelDisease (IBD) patients with hospital care in Portugal. Thepurpose of this study was to evaluate the satisfaction of IBDpatients with hospital care in Portugal and its determinants.Methods: We used a structural approach that included3 steps: (1) Specification of a patient satisfaction modelbased on European Customer Satisfaction Index (ECSI) thatwas composed by the following dimensions: Expectations,Facilities, Admission Process, Auxiliary Personnel, Nurses,Doctors, Medical Treatment, Inpatient Care, Outpatient Care,Image, Global Quality, Global Satisfaction and Loyalty;(2) sample survey from 2000 patients, members of thePortuguese Association of the Inflammatory Bowel Disease(APDI); (3) estimation of patient satisfaction model based onsurvey’s data, through the method of partial least squares(XLSTAT-PLSPM®).Results: We received 423 (21%) valid questionnaires, from273 (65%) patients with Crohn’s disease and 140 (33%) withulcerative colitis, with a mean age of 43±13 years andmainly (57%) of the female genre. The mean index ofGlobal Satisfaction was 73±20 (scale of 0 100). The maindeterminants of Global Satisfaction (Figure 1 and Figure 2) werethe variables Image (b = 0.42), Inpatient Care (b = 0.20) andOutpatient Care (b = 0.19), whose mean indices were 81±19,59±18 and 73±22, respectively. The satisfaction model usedallowed to explain 85% of the Global Satisfaction variance(R2 = 0.85). Differences in Global Satisfaction degree have alsobeen observed, depending on patient’s age, disease’s activity,number of crises in the previous year, type of medication andthe act of complaint.

Figure 1. Summary of the structural model. b coefficient vector;R2 coefficient of determination.