scholarly journals A56 CLINICAL AND BIOCHEMICAL EFFICACY ARE NOT AFFECTED BY SWITCH FROM INFLIXIMAB ORIGINATOR TO RENFLEXIS IN PEDIATRIC INFLAMMATORY BOWEL DISEASE PATIENTS.

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 13-14
Author(s):  
K Rosborough ◽  
G Yu ◽  
C Barker ◽  
K Jacobson ◽  
S Lawrence
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Fecal Calprotectin ◽  
Growth Data ◽  
Pediatric Inflammatory Bowel Disease ◽  
Drug Expenditures ◽  
Inflammatory Bowel ◽  
Significant Change ◽  
Prospective Longitudinal ◽  
Pediatric Ibd

Abstract Background Increased infliximab (IFX) utilization has generated higher drug expenditures and cost burden to the healthcare system. The expiration of the IFX originator Remicade patent led to the addition of biosimilar agents to the drug market that may reduce drug expenditures. In British Columbia, Pharmacare’s 2019 biosimilar initiative mandated all pediatric inflammatory bowel disease (IBD) patients on Remicade to switch to the biosimilar Renflexis. To date, there is limited pediatric IBD data demonstrating that switching from IFX originator to IFX biosimilar CT-P13 is safe and effective, and no data on switching to Renflexis. Aims To determine the proportion of patients remaining on Renflexis 6 months after switch from originator IFX. The secondary aims are to determine the proportion of patients remaining in clinical and biochemical remission after switch. Methods In this prospective, longitudinal observation single-center study, all children with Crohn’s disease and ulcerative colitis receiving maintenance IFX originator therapy were switched to Renflexis by May 15th 2020. Baseline demographics, concomitant therapy, clinical disease indices (wPCDAI, PUCAI), growth data, blood work, fecal calprotectin and IFX drug levels were collected at baseline and prospectively from 6 months after the switch. All data are presented as median and interquartile range. Results A total of 139 children (110 CD, 25 UC and 4 IBDU; Median age 16.2 (3.7) years) with a median IFX originator duration of 42.7 (35.1) months before switching to Renflexis were included. 137/139 (99%) of patients remained on Renflexis at study end. The proportion of children in clinical remission from baseline to 6 months post switch was unchanged (133/139 (95.7%) vs. 130/132 (98.5%), p=0.17). There was no significant change pre and post switch in median CRP (<5 (0) mg/L vs <5 (0) mg/L, p=0.26) or fecal calprotectin (72.5 (144.2) ug/g vs. 65.5 (140.0) ug/g, p=0.87). There was no significant change pre and post switch in the proportion of patients with normal CRP (<5 mg/L) (89/103 (86.4%) vs 89/98 (90.8%), p=0.33) or normal fecal calprotectin (<250 ug/g)(91/112 (81.2%) vs 51/63 (80.9%), p=0.60). There was no significant change pre and post switch in IFX trough level (15.5 (12.3) ug/mL vs 17.5 (12.9) ug/mL, p=0.42). 2 patients had antibodies to IFX after switching. Safety profile is improved with adverse events in 38/139 (27.3%) children on IFX originator vs. 11/139 (7.91%) children on Renflexis for 6 months. Conclusions Pediatric IBD patients can be successfully switched from IFX originator to biosimilar Renflexis during maintenance without affecting efficacy, immunogenicity or safety in the short term. Funding Agencies None

scholarly journals Comparison of Fecal Calprotectin Methods for Predicting Relapse of Pediatric Inflammatory Bowel Disease

2017 ◽  
Vol 2017 ◽  
pp. 1-10 ◽  
Author(s):  
Saranya Kittanakom ◽  
Md. Sharif Shajib ◽  
Kristine Garvie ◽  
Joceline Turner ◽  
Dan Brooks ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Clinical Performance ◽  
Fecal Calprotectin ◽  
Analytical Performance ◽  
Medical Decision ◽  
Specific Marker ◽  
Pediatric Inflammatory Bowel Disease ◽  
Inflammatory Bowel ◽  
Pediatric Ibd

Background.Pediatric inflammatory bowel disease (IBD) is on the rise worldwide. Endoscopies are necessary for IBD assessment but are invasive, expensive, and inconvenient. Recently, fecal calprotectin (FCal) was proposed as a noninvasive and specific marker of gut inflammation. We evaluated the analytical performance of three FCal assays and their clinical performance in predicting relapse in pediatric IBD.Methods.This study used 40 pediatric IBD and 40 random non-IBD patients’ fecal samples. Two automated ELISAs (Bühlmann and PhiCal® Calprotectin-EIA) and an EliA (Phadia 250 EliA-Calprotectin) were used to evaluate the analytical performance. The clinical performance was assessed by PhiCal Calprotectin-EIA, EliA-Calprotectin, and Bühlmann immunochromatographic point-of-care test (POCT).Results.All assays displayed acceptable analytical performance below and above the medical decision cut-off [imprecision (CV < 10% intra-assay; <15% interassay); linearity (overall mean % deviation < 16.5%)]. The agreement with PhiCal Calprotectin-EIA was 100% and 78.6% for Bühlmann (95% CI, 87.5–100; Kappa: 1) and EliA-Calprotectin (95% CI, 60.5–89.8; Kappa: 0.32), respectively, and 63.6% between Bühlmann and EliA-Calprotectin (95% CI, 46.6–77.8; Kappa: 0.16). All assays evaluated had similar clinical performance [AUC: 0.84 (EliA-Calprotectin); 0.83 (POCT and PhiCal Calprotectin-EIA)].Conclusion.FCal levels determined using the same method and assay together with clinical history would be a noninvasive and useful tool in monitoring pediatric IBD.

Phenotypic Features and Longterm Outcomes of Pediatric Inflammatory Bowel Disease Patients with Arthritis and Arthralgia

2017 ◽  
Vol 44 (11) ◽  
pp. 1636-1643 ◽  
Author(s):  
Osnat Nir ◽  
Firas Rinawi ◽  
Gil Amarilyo ◽  
Liora Harel ◽  
Raanan Shamir ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Medical Records ◽  
Biologic Therapy ◽  
Joint Involvement ◽  
Pediatric Inflammatory Bowel Disease ◽  
History Of ◽  
Inflammatory Bowel ◽  
Phenotypic Features ◽  
Pediatric Ibd

Objective.The natural history of pediatric inflammatory bowel disease (IBD) patients with joint involvement has not been clearly described. Thus, we aimed to investigate phenotypic features and clinical outcomes of this distinct association.Methods.The medical records of patients with pediatric IBD diagnosed from 2000 to 2016 were reviewed retrospectively. Main outcome measures included time to first flare, hospitalization, surgery, and biologic therapy.Results.Of 301 patients with Crohn disease (median age 14.2 yrs), 37 (12.3%) had arthritis while 44 (14.6%) had arthralgia at diagnosis. Arthritis and arthralgia were more common in women (p = 0.028). Patients with arthritis and arthralgia demonstrated lower rates of perianal disease (2.7% and 4.5% vs 16.9%, p = 0.013), whereas patients with arthritis were more likely to be treated with biologic therapy (HR 2.05, 95% CI 1.27–3.33, p = 0.009). Of 129 patients with ulcerative colitis (UC; median age 13.7 yrs), 3 (2.3%) had arthritis and 16 (12.4%) had arthralgia at diagnosis. Patients with arthralgia were treated more often with corticosteroids (p = 0.03) or immunomodulator therapies (p = 0.003) compared with those without joint involvement. The likelihood to undergo colectomy was significantly higher in patients with arthralgia (HR 2.9, 95% CI 1.1–7.4, p = 0.04). During followup (median 9.0 yrs), 13 patients developed arthritis (3.3%). Arthralgia at diagnosis was a significant predictor for the development of arthritis during followup (HR 9.0, 95% CI 2.86–28.5, p < 0.001).Conclusion.Pediatric IBD patients with arthritis have distinct phenotypic features. Arthralgia at diagnosis is a predictor for colectomy in UC and a risk factor for the development of arthritis during followup.

Validation and evaluation of fecal calprotectin assays in pediatric inflammatory bowel disease

2014 ◽  
Vol 47 (12) ◽  
pp. 1141
Author(s):  
Saranya Kittanakom ◽  
Md. Sharif Shajib ◽  
Celynne Hinzmann ◽  
Kristine Garvie ◽  
Joceline Turner ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Fecal Calprotectin ◽  
Pediatric Inflammatory Bowel Disease ◽  
Inflammatory Bowel

scholarly journals Trends in Early Outpatient Drug Therapy in Pediatric Inflammatory Bowel Disease in Finland: A Nationwide Register-Based Study in 1999–2009

2012 ◽  
Vol 2012 ◽  
pp. 1-7 ◽  
Author(s):  
Lauri J. Virta ◽  
Kaija-Leena Kolho
Keyword(s):  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Drug Therapy ◽  
Crohn's Disease ◽  
Bowel Disease ◽  
Early Years ◽  
Aminosalicylic Acid ◽  
Pediatric Inflammatory Bowel Disease ◽  
Inflammatory Bowel ◽  
Pediatric Ibd

Objective. There are limited data on the changes of treatment strategies of disease-modifying drugs used to treat pediatric inflammatory bowel disease (IBD). Methods. We utilized data from two national registers: the Drug Reimbursement Register for drug costs (for identifying children with IBD) and the Drug Purchase Register (for exposure to drugs), both of which are maintained by the Social Insurance Institution of Finland. The frequencies and trends of drug therapy strategies during the first year of pediatric IBD were evaluated between 1999 and 2009. Results. A total of 481 children diagnosed with IBD were identified. During the first six months, 68% of the patients purchased systemic corticosteroids; these combined with 5-aminosalicylic acid in almost all cases. The use of corticosteroids was stable from the early years compared with the end of the study period. In Crohn's disease, there was a trend towards more active use of azathioprine: the therapy was introduced earlier and proportion of pediatric patients purchasing azathioprine increased by up to 51% (P<0.05). Conclusions. In pediatric IBD, the majority of patients purchased corticosteroid within the first six months, reflecting moderate-to-severe disease. During recent years in pediatric Crohn's disease, the therapeutic strategies of oral medication have changed towards more active immunosuppression with azathioprine.

scholarly journals Incidence and Prevalence Trends of Pediatric Inflammatory Bowel Disease in the Daegu-Kyungpook Province From 2017 to 2020

2022 ◽  
Vol 9 ◽  
Author(s):  
Jae Young Choe ◽  
Sujin Choi ◽  
Ki Hwan Song ◽  
Hyo-Jeong Jang ◽  
Kwang-Hae Choi ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Children And Adolescents ◽  
Bowel Disease ◽  
Population Based ◽  
Annual Number ◽  
Number Of Children ◽  
Pediatric Inflammatory Bowel Disease ◽  
Prevalence Trends ◽  
Inflammatory Bowel ◽  
Pediatric Ibd

Background and Aim: There is paucity of data regarding the epidemiology of pediatric IBD in Asia compared to that of Western countries. We aimed to investigate the incidence and prevalence trends of pediatric inflammatory bowel disease (IBD) in the Daegu-Kyungpook province of South Korea from 2017 to 2020.Methods: This study was a multicenter, retrospective study conducted in eight IBD referral centers located in the Daegu-Kyungpook province. Children and adolescents of ≤18 years who were initially diagnosed with IBD between 2017 and 2020 were included. The annual number of children and adolescents newly diagnosed with IBD and the annual resident population of children and adolescents ≤18 years of age in the Daegu-Kyungpook province were investigated to calculate the annual incidence and prevalence in the region.Results: A total 304 children and adolescents that had been diagnosed with IBD were included in this study. Among these patients, 71.4% had been diagnosed with Crohn's disease (CD), and 28.6% with ulcerative colitis (UC). The population based annual incidences of IBD from 2017 to 2020 were each 7.24, 6.82, 10.27, and 13.33 per 100,000, respectively (P for trend &lt;0.001), 4.48, 5.26, 7.39, and 9.8 per 100,000, respectively, for CD (P for trend &lt;0.001), and 2.76, 1.56, 2.88, and 3.53 per 100,000, respectively, for UC (P for trend = 0.174).Conclusion: Pediatric IBD, especially CD has significantly increased recently in the Daegu-Kyungpook province. Epidemiology studies from other regions of Asia are required to better elucidate this trend of increase in Asia.

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