P277 Ileo-rectal anastomosis vs. ileoanal pouch in ulcerative colitis: clinical outcome in a real-life experience

Abstract Background In ulcerative colitis (UC) surgery is required in about 10–20% of patients (patients). Evidence regarding the long-term outcome of Ileo-rectal anastomosis (IRA) vs. the recently proposed ileal pouch (IPAA) are still lacking. In a real-life, retrospective, single-centre study, we aimed to assess the clinical outcome of all UC patients with IRA or IPAA. Methods In a retrospective study, clinical records of UC patients with IPAA or IRA in regular follow-up from January 2001 to September2019 were reviewed. Inclusion criteria: (1) UC diagnosis; (2) Age ≥18 years; (3) IPAA or IRA for UC;4)Detailed clinical history; (5) follow up ≥1 year after surgery. The following parameters were reported: demographic and clinical characteristics, hospitalisation, additional surgery, mortality, dysplasia/cancer of the ileum and/or rectum, number of endoscopies and outpatient visits, stool frequency and treatments. The quality of life (QoL) are being evaluated. Data were expressed as median (range), differences among groups assessed by chi-squared test or unpaired T-test. Results A total 84(4%) UC patients with IPAA (n = 47) or IRA (n = 37) were detected among 2136 UC patients. Among these 84 UC patients, in a preliminary assessment, clinical outcome was evaluated in 31 patients (16 IPAA,15 IRA) with a median follow up of 72 [12–180] months (mos) and a median time interval from surgery of 63 [1–348] mos. Considering the 16 patients with IPAA (8 M, 9 F) vs. the 15 with IRA (5 M,10 F), the median age at first assessment was 44 [range 30–56] vs. 48 [range 23–82] in patients with IPAA or IRA, respectively (p = 0.2123). The median follow up after surgery was 65 [range 12–132] vs. 79 [range 12–180] mos (p = 0.1955). The median time interval from surgery to first clinical assessment after surgery was 48 [range 1–312] vs. 78 [range 2–348] mos (p = 0.1955). Indication for surgery was refractory UC in 30 patients and endoscopic perforation in 1 pt. During the follow up, the following outcomes after surgery were recorded in patients with IPAA vs. IRA: hospitalised patients (n = 6 vs. n = 6 patients, p = 0.8864); additional intestinal surgery (n = 0 vs. n = 4 patients, p = 0.0269), mortality (n = 0 vs. n = 1 patients,p = 0.2938); occurrence of dysplasia/cancer of the ileum and/or rectum (n = 0 vs. n = 2 patients, p = 0.1310), number endoscopies after surgery (mean: 4 vs. n = 3.75, p = 0.316348), number visits after surgery (mean: 2.4/year vs. n = 1.7/year, p = 0.2429), mean stool frequency (n = 8.08 vs. n = 4.36; (p = 0.0005), need of biologics, n = 5 vs. n = 1 (p = 0.0834). Conclusion In a real-life experience, the need for intestinal surgery was significantly higher in patients with IRA vs. IPAA; the mean daily stool frequency was significantly higher in patients with IPAA vs. IRA.No statistically significant differences were found among the two groups in terms of hospitalisation, mortality, cancer/dysplasia and need for biologics.

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T04.02.23 ILEO-RECTAL ANASTOMOSIS VERSUS ILEO-ANAL POUCH IN ULCERATIVE COLITIS: CLINICAL OUTCOME IN A REAL LIFE EXPERIENCE

Digestive and Liver Disease ◽

10.1016/s1590-8658(20)30801-x ◽

2020 ◽

Vol 52 ◽

pp. S137

Author(s):

G. Sena ◽

B. Neri ◽

E. Lolli ◽

E. Calabrese ◽

G. Sica ◽

...

Keyword(s):

Ulcerative Colitis ◽

Clinical Outcome ◽

Life Experience ◽

Real Life ◽

Rectal Anastomosis

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Real-life experience with 4 years of golimumab persistence in ulcerative colitis patients

Scientific Reports ◽

10.1038/s41598-020-73577-0 ◽

2020 ◽

Vol 10 (1) ◽

Author(s):

Marisa Iborra ◽

Natalia García-Morales ◽

Saoia Rubio ◽

Federico Bertoletti ◽

Marta Calvo ◽

...

Keyword(s):

Ulcerative Colitis ◽

Disease Duration ◽

Life Experience ◽

Real Life ◽

Efficacy And Safety ◽

Dose Intensification ◽

Factors Associated ◽

Mean Time

Abstract Golimumab has demonstrated its long-term efficacy and safety in ulcerative colitis in clinical trials, but no data of long-term persistence has been published from real world. To estimate long-term persistence of golimumab, as well as factors associated with longer persistence, in patients with ulcerative colitis in real life. Observational multicentre study including adult patients with ulcerative colitis treated with golimumab and with at least twelve months of follow-up. We included 190 patients, 105 (55.26%) naive to anti-TNF, with mean disease duration of 9.32 ± 8.09 years. Probability of persistence was 63%, 46%, 39% and 27% at 1, 2, 3 and 4 years, respectively. Persistence was lower in patients with primary failure to previous anti-TNF. Eighty-two (43.16%) patients needed dose intensification during follow-up, with a mean time until intensification of 8.03 ± 8.64 months. Dose intensification and lower disease duration predicted higher persistence with golimumab (p = 0.037 and p = 0.008, respectively). During a follow-up of 17.25 ± 15.83 months, 32 (16.5%) patients needed hospitalisation and 11 (6%) underwent colectomy. No unexpected adverse events were reported. Golimumab has demonstrated good persistence and safety profile for long treatment in ulcerative colitis patients.

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The use of anti-TNFs in inducing clinical response and remission in ulcerative colitis: a comparative analysis in the real life experience of a single referral center

10.26226/morressier.59a6b34cd462b80290b558da ◽

2017 ◽

Author(s):

Barbara Scrivo

Keyword(s):

Ulcerative Colitis ◽

Comparative Analysis ◽

Clinical Response ◽

Life Experience ◽

Real Life ◽

The Real ◽

Referral Center

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Evaluation of efficacy and comparative frequency of adverse events in patients with ulcerative colitis receiving the original infliximab and its biosimilar. One year of observation

Terapevticheskii arkhiv ◽

10.26442/00403660.2019.08.000331 ◽

2019 ◽

Vol 91 (8) ◽

pp. 41-46

Author(s):

O V Knyazev ◽

T V Shkurko ◽

A V Kagramanova ◽

A A Lishchinskaya ◽

M Yu Zvyaglova ◽

...

Keyword(s):

Ulcerative Colitis ◽

Adverse Events ◽

Real Life ◽

Fecal Calprotectin ◽

Biologic Drugs ◽

Real Life Data ◽

Bowel Diseases ◽

Significant Clinical Improvement ◽

One Year

Real - life data on the effectiveness and safety of biosimilar and biologic drugs licensed for treatment of inflammatory bowel diseases (IBD) is lacking. Aim. To investigate efficacy of original Infliximab (IFX) and its biosimilar in treating patients with ulcerative colitis (UC) and determine the frequency of adverse events during 1 year follow - up period. Materials and methods. Our cohort consisted of 98 ulcerative colitis patients, treated with original IFX and its biosimilar since December 2017 till December 2018 years. Original Infliximab was prescribed in 56 UC patients (57.1%) during 5 years and longer; 16 patients (16.3%) were switched to IFX biosimilar; 13 UC bio - naïve patients (13.3%) received original IFX, 29 (29.6%) patients - biosimilar IFX. In 14 patients (14.3%) original infliximab was rotated with biosimilar. We picked out 42 patients to assess efficacy of original IFX and biosimilar. Results and discussion. Twelve patients, received original IFX and 28 patients, treated with its biosimilar, showed significant clinical improvement by decreasing Mayo index from 9.7±0.4 and 10.2±0.2 points to 1.9±0.09 and 2.1±0.1 points, accordingly. Also we noticed positive change in laboratory markers - CRP decrease from 89.6±8.7 mg/l and 77.5±8.0 mg/l to 6.5±0.8 mg/l and 6.9±0.8 mg/l (p>0.05), albumin increase from 30.1±4.7 g/l and 29.6±3.6 g/l to 34.1±6.3 g/l and 32.8±5.9 g/l (p>0.05), increase of serum iron levels from 6.4±0.5 mcg/l and 7.1±0.65 mcg/l to 14.6±4.4 mcg/l and 15.9±5.1 mcg/l (p>0.05), hemoglobin increase from 104.7±9.8 g/l and 102.2±8.8 g/l till 124±11.3 g/l and 121±10.9 g/l (p>0.05), and fecal calprotectin decrease from 1680±134 mcg/g and 1720±126 mcg/g till 245.5±33.4 mcg/g and 230.5±29.8 mcg/g (p>0.05). During 1 year follow - up 12 UC patients, treated with original IFX and its biosimilar, developed adverse events. The majority of adverse events (n=8) were registered in patients, rotating administration of original IFX and its biosimilar. Conclusion. IFX biosimilar is effective as well as original IFX. Frequency of adverse events, occurred in patients, treated with original IFX, was comparable with adverse events frequency in patients, received biosimilar IFX. Frequency of adverse events was significantly higher in UC patients, rotating original IFX and its biosimilar.

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P559 Real-life experience with long-term maintenance of golimumab in ulcerative colitis patients

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjy222.683 ◽

2019 ◽

Vol 13 (Supplement_1) ◽

pp. S393-S394

Author(s):

M Iborra ◽

N García-Morales ◽

S Rubio ◽

O Nantes Castillejo ◽

F Bertoletti ◽

...

Keyword(s):

Ulcerative Colitis ◽

Life Experience ◽

Real Life ◽

Term Maintenance

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OP26 The first real-life multicentre prospective validation study of the electronic chromoendoscopy score (Paddington International Virtual ChromoendoScopy ScOre) and its outcome in ulcerative colitis

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.025 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S023-S024 ◽

Cited By ~ 2

Author(s):

M Iacucci ◽

S C Smith ◽

A Bazarova ◽

U N Shivaji ◽

P Bhandari ◽

...

Keyword(s):

Ulcerative Colitis ◽

Validation Study ◽

Real Life ◽

Mucosal Healing ◽

Vascular Changes ◽

Important Goal ◽

Kaplan Meier ◽

Virtual Chromoendoscopy

Abstract Background Mucosal healing is an important goal in the treatment of ulcerative colitis (UC). The newly published PICaSSO score characterises subtle mucosal and vascular changes and defines mucosal healing. We aimed to validate in real-life the PICaSSO score and assess its ability to predict relapse. Methods Patients with UC were prospectively recruited from 11 international centres. Participating endoscopists experienced in IBD received training on PICaSSO before starting the study. The rectum and sigmoid were examined using iScan 1,2 and 3 (Pentax, Japan) and inflammatory activity was assessed using UCEIS and PICaSSO. Biopsies were taken for the histological assessment using Robarts Histological Index (RHI) and Nancy. Follow-up was obtained at 12 months. Results A total of 278 patients were recruited (Table 1). The diagnostic performance in predicting histologic healing is shown in Table 2. When using PICaSSO score of ≤3 for mucosal and vascular architecture the AUROC to predict healing by RHI is 0.79 (95% CI 0.74–0.85) and 0.73 (95% CI 0.68–0.80) respectively and when using the Nancy score the AUROC is 0.78 (95% CI 0.72–0.84) and 0.77 (0.71–0.84). A total PICaSSO score of ≤8 and UCEIS score of ≤1 predicts remission at 12 months with an AUROC of 0.73 (0.65–0.80) and 0.71 (0.64–0.79). A Kaplan–Meier curve shows a favourable survival probability without relapse with a PICASSO score of ≤8 (Figure 1). Conclusion This real-life validation study shows the PICaSSO score can predict accurately histological healing and long-term remission and can be a useful tool in the management of UC.

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O35 Efficacy & safety of tocilizumab in GCA: a multi-centre experience of NHS clinical practice

Rheumatology ◽

10.1093/rheumatology/keaa110.034 ◽

2020 ◽

Vol 59 (Supplement_2) ◽

Author(s):

Alwin Sebastian ◽

Abdul Kayani ◽

Chavini Ranasinghe ◽

Frances Hall ◽

Colin Ransom ◽

...

Keyword(s):

Clinical Practice ◽

Life Experience ◽

Real Life ◽

Aneurysm Rupture ◽

Research Support ◽

Ischemic Disease ◽

Abdominal Aortic ◽

Relapsing Remitting ◽

Sight Loss

Abstract Background Giant cell arteritis (GCA) has a relapsing, remitting course with ischemic/vascular damage in a number of cases. Glucocorticoids (GC) remain mainstay of treatment with SAEs e.g. diabetes and fractures commonly seen. The GiACTA trial of tocilizumab (TCZ) in GCA led to NICE approval for 12 month’s therapy in relapsing/ refractory disease. We report real life experience in 51 cases. Methods Multicentre retrospective data collected through ENRAD and individual centres across England (Table 1). Outcomes were as assessed by supervising clinicians. Results Fifty-one patients were treated with TCZ (26 cranial, 13 LVV, 11 both). 11 (22.0%) had prior permanent sight loss due to AION, CRAO or both. One died prior to TCZ, from recurrent cerebral infarcts. Mean age was 71 years with 66.7% females. Ultrasound (US) was used for diagnosis in 28 (56.0%), exclusively or in combination with other tests such as biopsy, PET-CT or CTA. 70% had prior DMARD (LEF/MTX/AZT/MMF/CYC, mean duration 58 weeks). MTX was used in 50% alone or combination. Initial TCZ was given as subcutaneous or intravenous (85.4% and 14.6%). TCZ indication in 89.8% was relapsing, refractory or ischemic disease. Steroid AEs that prevented optimal GC dosing constituted 10% of TCZ indication. Mean follow up was 31 weeks, 30 (58.8%) continuing TCZ uninterrupted, 4 completed 12 months, 4 discontinued due to SAEs. Ten had brief interruptions due to minor AEs. One restarted after 12 months due to flare but died 12 weeks later from abdominal aortic aneurysm rupture. At follow up, 37(74%) were in remission with a mean GC dose of 6.97 mg (mean GC dose pre-TCZ 33.2 mg), Thirty-two (65.3%) ≤ 5mg. In 4 (8%) outcome could not be assessed as either they started TCZ recently or about to start. In 53% lipids were not checked after commencing TCZ. AEs seen were 37.0%. Conclusion In clinical practice, TCZ is efficacious and safe in relapsing/refractory/ischemic GCA. I.V. route is an option awaiting NHSE approval in refractory visual symptoms. Infections and other AEs do occur but overall safety profile is acceptable. US is excellent in identifying patients at need and is a useful disease activity monitoring tool. Disclosures A. Sebastian: None. A. Kayani: None. C. Ranasinghe: None. F. Hall: Consultancies; Sobi, S. Grants/research support; Actelion. C. Ransom: None. D. Jayne: None. V. Quick: Honoraria; Roche. M. Hughes: None. J. Stack: Member of speakers’ bureau; Roche. C. Mukhtyar: None. F. Coath: None. A. Bharadwaj: None. V. Hajela: None. S. Butler: Consultancies; Lily. M. Lwin: None. C. Edwards: Consultancies; Roche, Chugai. Grants/research support; Roche, Chugai. M. Whitlock: None. B. Dasgupta: Consultancies; Roche, Sanofi, GSK. Grants/research support; Roche.

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P663 Efficacy of tofacitinib in patients with ulcerative colitis after previous ineffective biological therapies

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.791 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S545-S546

Author(s):

M Rutka ◽

K Farkas ◽

D Pigniczki ◽

K Szántó ◽

B Anita ◽

...

Keyword(s):

Ulcerative Colitis ◽

Clinical Response ◽

Induction Therapy ◽

Dose Escalation ◽

Real Life ◽

Janus Kinase ◽

Inadequate Response ◽

Mayo Score ◽

Number Of Patients

Abstract Background Tofacitinib (TFC) is an oral, small-molecule Janus kinase inhibitor, which was recently approved for moderate to severe ulcerative colitis (UC). The aim of the current real-life study was to determine efficacy of TFC induction therapy regarding the clinical response and remission in patients with active UC. We evaluated short-term efficacy data in a Hungarian cohort with prior exposure to other biological agents such as anti-TNF drugs and vedolizumab. Methods In this single-centre retrospective study, patients with TFC introduction were included. Since January 2019, a total of 16 patients received an oral TFC induction therapy in a dose of 10 mg twice daily for 8 weeks. Endoscopic activity was evaluated by endoscopic Mayo (eMayo) score before the introduction of TFC and in case of an inadequate therapeutic response to the 5-mg-therapy to confirm therapeutic decision-making. Based on the evaluation of clinical symptoms and laboratory parameters, we either kept the dosage or reduced the dose to 5 mg according to local regulations. We also collected data from the 16. and 24. weeks of the therapy. Primary endpoints were a clinical response (as a reduction in partial Mayo Score [pMayo] by minimum 3 points) or remission (as a Mayo score of the maximum of 2 points and without blood in stool) at week 8. Results Sixteen patients had received the induction therapy (mean age: 36 years, 7 males and 9 females) in our centre. After 8 weeks, 12 (75%) patients responded to the TFC induction therapy and 6 (37.5%) of them were in remission. Four patients were primary non-responders (25%). Corticosteroid therapy (18 ± 7 mg) was required during the induction in 4 responder cases, which could be stepped down by week 8. As a continuous maintenance therapy, 4 patients have already reached the 16th week and 8 have completed the 24th week. By the end of the follow-up, 12 patients responded and 10 was in remission. During the observation period, 3 patients had to remain on 10 mg TFC dose, 6 patients required dose escalation from 5 mg to 10 mg and 5 mg was sufficient in case of only 3 patients after the introduction. Endoscopic activity showed a moderate decrease from 2.5 ± 0.5 eMayo score to 2 ± 1 (n = 7) until week 16. In respect the responder patients, CRP levels decreased from the mean of 7.23 to 5.02. No serious side-effects were observed during the follow-up. Conclusion After the 8-week TFC induction therapy, the response rate was high and only every fourth patients were non-responder. A low number of patients had adequate reactions to the 5 mg-therapy after the introduction, but TFC is effective with dose-escalation in respect of clinical response and remission in patients with UC, who have had an inadequate response to previous biological therapy.

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