Search

Background Patients with inflammatory bowel disease (IBD) are often classified as ulcerative colitis (UC) and Crohn’s disease (CD). However, in some cases this categorization is not possible and these patients are labelled as inflammatory bowel disease unclassified (IBDU) -or indeterminate colitis if histologic analysis of surgical specimens is possible-.The aims of this study were to compare the prognosis and therapeutic requirements in patients with IBDU and UC, and to identify potential predictive factors of reclassification as UC or CD. Methods Retrospective, observational, multicenter and case-control study of Spanish ENEIDA registry promoted by GETECCU. IBDU patients were identified from 18 centers. Every case of IBDU was matched with 2 patients of ulcerative colitis of the same hospital by sex, age at diagnosis and disease extent (in the patchy colitis subgroup, every case was matched with 1 extensive colitis and 1 left colitis). Results 231 IBDU patients and 469 UC patients were included. Only 15 IBDU patients met current criteria of indeterminate colitis. In the IBDU group 59.7% patients were males and the mean of age at diagnosis was 43.3 years. Disease extent was distributed in 14 proctitis, 59 left-sided colitis, 87 extensive colitis and 53 patchy colitis. 13.9% had rectal sparing and 31.9% presented ileitis. Thirteen percent were smokers at diagnosis, 5.6% had perianal disease and 15.9% had extraintestinal manifestations. Table 1: baseline characteristics of IBDU and UC group. When comparing IBDU to UC patients, there were no statistical differences between proportion of patients that needed immunosuppressants (35.7% vs 37.7%, p=0.558) and biological therapy (27.3% vs 24.3%, p=0.415). Regarding surgery for medically refractory disease, UC patients had higher surgical rates, although these differences did not reach statistical significance (2.6% vs 0.5%, p= 0.062). Figure 1: immunosuppressants, biological and surgery rates. Overall mortality rates were similar in both groups (5.1% in IBDU vs 2.6% in UC); with only one case related to IBD in IBDU group. During follow-up, 67 IBDU patients (31%) were reclassified (32 UC, 34 CD, 1 indeterminate colitis). 25% of patients were reclassified within 46 months of follow-up (Figure 2: Kaplan-Meier curve of reclassification). Neither clinical, biochemical (C- reactive protein, albumin, hemoglobin) nor endoscopic variable (rectal sparing, ileitis) was associated with change in diagnosis. Conclusion In clinical practice, there were no statistical differences in prognosis, therapeutic requirements and surgical treatment between IBDU and UC patients. Two thirds of patients remained classified as IBDU during the follow-up. No predictive factors of reclassification have been identified.

Background Recently, a subcutaneous formulation of biosimilar infliximab (CT-P13) (SC-IFX) has been approved for inflammatory bowel disease (IBD). The aims of this study were to evaluate efficacy, safety, pharmacokinetics and patient experience following a switching to SC-IFX in patients who are in clinical remission on IV-IFX maintenance treatment. Methods Multicentre, descriptive, and observational study including Crohn’s disease (CD) and ulcerative colitis (UC) patients who were going to be changed from IV-IFX to SC-IFX on the ENEIDA registry (a large, prospectively maintained database of the Spanish Working Group in IBD–GETECCU). All patients were on clinical and biological remission at least 24 weeks before changing. Demographic and disease data, clinical activity (Harvey-Bradshaw index for CD and mayo index for UC), analytical data (C reactive protein (CRP) and fecal calprotectin (FC), as well as trough levels were collected at baseline, at 12 and 24 weeks. Results One hundred and fifty-five patients were included: 54 UC (35%) and 91 (65%) CD; 44% women and 56% men; age 45.5 years (32-55). IV-IFX was mainly administered due to active disease (72%) and perianal disease (7%) and during 32 months [range 14-56]. Pre-switch, 78 (50.3%) were on 8-weekly dosing of IV-IFX, 77 (49.7%) were with intensification dose and the half (50.3%) were on concomitant immunomodulatory therapy. SC-IFX was mainly switching by COVID-19 pandemic (60%), to increase through levels (15%) or patient request (25%). The majority of patients (140, 90%) remained with standard dose, 8 (5%) required dose intensification (120 mg weekly in 4 and 240 mg every 2 weeks in 4) and 7 (4.5%) had successful de-escalation (120 mg every 3 weeks in 4 and 120 mg every 4 weeks in 3). Clinical indices, CRP levels and FC remained unchanged (Figure). Median SC-IFX levels significantly increased from baseline of 4.5 μg/dl [range 2.6-9.2] to 14 μg/dl [range 9.5-16.2] at week 12 and 13.2 μg/dl [range 10.4-19.7] at week 24. No factors (immunossupresor, body mass index, disease location) were associated with the increase of IFX trough levels. During 24 weeks of follow-up, 16 of the 78 patients (20.5%) stopped immunosuppressant treatment. The adverse events were recorded in 9 patients (5.8%), 4 (2.6%) were hospitalized and 4 (2.6%) had surgery (one of them for perianal disease). Nine patients (5.8%) stopped SC-IFX (1 primary failure, 2 loss of response, 4 adverse events, 1 voluntarily, and 1 surgery). Conclusion The switch from IV to SC IFX maintains clinical remission safely in IBD patients, offers higher drug levels and a good patient acceptance. However, the significance of higher drug levels with SC-IFX requires further exploration.

Background A new formulation of biosimilar infliximab (IFX) has recently been approved for subcutaneous administration (SC) that may offer pharmacokinetic advantages resulting in higher drug exposure. Our purpose was to evaluate the efficacy, safety, pharmacokinetic changes and patients’ acceptability after switching from intravenous (IV) to SC IFX in a cohort of patients with Inflammatory Bowel Disease (IBD) in clinical practice. Methods Observational, prospective and single-center study including patients with IBD in sustained (≥6 months) clinical remission under IV IFX that were switched to SC IFX 120 mg every 2 weeks. Prospective monitoring was performed with clinical and laboratory data including IFX trough levels prior to the last IV infusion (W-IV), prior to the first SC administration (W-0), and after 16 weeks (W-16) and 52 weeks (W-52) of SC treatment. Patients’ satisfaction has been evaluated at W-52. A descriptive analysis of the data has been carried out with the R Studio statistical program using means and Wilcoxon signed rank test. Results Sixty patients have been included, all have achieved W-16 and twelve W-52. Thirty-five (58,3%) are men with a median age of 42,5 (20-71) years. Thirty-eight (63,3%) have Crohn’s disease and twenty-two (36,7%) ulcerative colitis, with a median disease duration of 11,3 years. They have been receiving IV IFX (5mg/kg/8 weeks in 95% of cases) for 5,7 (0,6-21,1) years, at a stable dose (≥6 months). Twenty-seven (45%) received concomitant immunomodulatory treatment and IFX was the first biological in 75% of patients. None of the patients presented clinical relapse during follow-up (Table 1). Median trough IFX levels under IV treatment were 3,9 µg/dl (W-IV) and 4,3 µg/dl (W-0). Compared to W-0, IFX trough levels were significantly higher both in W-16 [17,05 µg/dl (5,59–57,60), p Conclusion Switching from IV to SC IFX is safe, effective, and well accepted by patients with stable IBD. A significant increase in IFX trough levels is observed with the SC formulation.