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Efficacy of Ferric Carboxymaltose in Relation to Disease Activity in Inflammatory Bowel Disease
AGA Abstracts
Su1912
reduction of duodenocyte iron absorption. Experts recommend using IV iron as first line therapy for IDA in IBD patients. Little is known about efficacy of FCM in IBD patients with active inflammation. The aim of our study is to assess the differences in efficacy and safety of FCM in our iron deficient IBD cohort between those with active inflammation based on inflammatory markers versus those without active inflammation. Methods: In this retrospective chart review, we analyzed all IBD patients in our center who received FCM infusion for IDA. Data regarding patient demographics, IBD type, concomitant medications, inflammatory markers (ESR, CRP and iron indices (ferritin, hemoglobin, MCV, transferrin saturation (TSAT), TIBC, serum iron) were collected. A standard protocol of 2 infusions of iron (total 1500 mg) done 1-2 weeks apart was performed and labs were obtained prior to and after the 2 infusions. We compared changes in lab indices among patients with normal ESR/CRP versus abnormal ESR and/or CRP using two tail student T-test. Results: A total of 90 patients received 190 FCM infusions (See Table 1). The changes in hemoglobin, MCV and iron indices were statistically significant for the entire cohort. Change in TSAT and ferritin did not statistically differ between the two groups (22 vs 16 (p=0.09), 414 vs 376(p=0.3) respectively) but patients with normal ESR & CRP had a significant improvement in serum iron and changes in TIBC (62 vs 34(p=0.02), 135 vs 84 (p=0.009) respectively). There was no significant difference in improvement of hemoglobin or MCV among patients with elevated biomarkers compared to those with normal ESR and CRP (Table 2). A total of 4 patients developed adverse reactions (2 in each group) with rash (N=2) at the time of infusion which improved with administration of steroids and diphenhydramine and flu-like symptoms (N= 2) 24 hours post infusion which responded to diphenhydramine. Three continued future infusions without any complications except for one (with rash) who did not receive further infusions per patient request. Conclusions: FCM is a safe and efficacious IV iron with capability of delivering a significant dose of iron in a single formulation. Improvement of lab indices was noted in both groups with and without inflammation but notably better change of iron indices occurred in the group with no inflammation. This could be related to disease activity, but it may also be related to additional underlying factors of response to iron absorption that may need to be further elucidated. Table 1:Basedline Characteristics
COMPARATIVE PERSISTENCE OF BIOLOGICS IN THE TREATMENT OF INFLAMMATORY BOWEL DISEASE: A TRUVEN MARKETSCAN DATABASE STUDY Chao Chen, Ofor Ewelukwa, Ellen M. Zimmermann, Abraham Hartzema, Sarah C. Glover, Adi Eldar-Lissai Biologic medications are standard therapies for moderate to severe Inflammatory Bowel Disease (IBD). These medications reduce symptoms, heal mucosa and induce long-term remission. Medication persistence, defined as the time from drug initiation to discontinuation of therapy, has been suggested as a proxy for real-world therapeutic benefit and safety profile. This study seeks to compare the persistence of biologic drugs among patients with IBD using a large US administrative claims database. Methods: A retrospective study was conducted using Truven MarketScan database 2010.1-2015.9. Patients diagnosed with Crohn's disease (CD) and ulcerative colitis (UC) were identified and grouped into two mutually exclusive cohorts based on a validated algorithm using ICD-9-CM codes (555.* for CD and 556.* for UC). New IBD patients were identified by requiring a 6-months continuous health plan enrolment prior to index diagnosis, within which no prior IBD diagnosis or biologics use were allowed. Biologic medications including infliximab, adalimumab, certolizumab, golimumab and vedolizumab were identified. Study endpoint was time to discontinuation, which was defined as failing to refill the index biologic drug within a period of two times the days supply after the last refill. Switching to another biologic drug was also evaluated as secondary outcome. Kaplan-Meier curve and cumulative survival method was used to describe the persistence of use profile for each medication. Results: In total, 9,892 patients with CD and 5,378 patients with UC were included in this analysis. The study population featured slightly more female patients (51.2%), and mostly young adults with mean age of 36.6 years. Within 1 year after treatment initiation, the percentage of persistent users was 28.2% for CD patients and 31.7% for UC patients. Among all the biologic medications, infliximab had the highest 1-year persistence rate (57.0% for CD patients and 56.8% for UC patients). Overall the 1-year switching rate is 25.4% for CD patients and 27.8% for UC patients. Vedolizumab users had the lowest switching rate for both CD and UC patients, although the sample size is small (35 patients) and follow-up time might not be sufficient for this subgroup. Conclusion: The overall persistence of currently available biologic medications is relatively low. Patients on Infliximab had the highest rate of persistence consistent with relatively favorable therapeutic benefit and safety profile. Assessing medication persistence in patients with stable health insurance using a large administrative claims database may be an informative method to derive real-world medication use profiles.
Kaplan-Meier Curve for Persistence of Biologic Treatments among CD Patients HBI:Harvey Bradshaw Index; UCDAI- Ulcerative Colitis Disease Activity Index Table 2: Comparison of Changes in Iron Indices in IBD Patients with normal vs. elevated biomarkers
Kaplan-Meier Curve for Persistence of Biologic Treatments among UC Patients
Su1913 EFFICACY OF FERRIC CARBOXYMALTOSE IN RELATION TO DISEASE ACTIVITY IN INFLAMMATORY BOWEL DISEASE Pramoda Koduru, Malcolm Irani, Pragnesh J. Patel, Vineet Gudsoorkar, Bincy Abraham
Hb:Hemoglobin; BMI- Body Mass Index
Background: Ferric carboxymaltose (FCM) is a novel non-dextran intravenous (IV) iron which has been approved for use in patients with iron deficiency anemia (IDA) who have inadequate response to oral iron therapy. Hepcidin, a key mediator of iron homeostasis is an acute phase reactant that increases in the setting of active inflammation and cause
AGA Abstracts
S-594
Su1912
reduction of duodenocyte iron absorption. Experts recommend using IV iron as first line therapy for IDA in IBD patients. Little is known about efficacy of FCM in IBD patients with active inflammation. The aim of our study is to assess the differences in efficacy and safety of FCM in our iron deficient IBD cohort between those with active inflammation based on inflammatory markers versus those without active inflammation. Methods: In this retrospective chart review, we analyzed all IBD patients in our center who received FCM infusion for IDA. Data regarding patient demographics, IBD type, concomitant medications, inflammatory markers (ESR, CRP and iron indices (ferritin, hemoglobin, MCV, transferrin saturation (TSAT), TIBC, serum iron) were collected. A standard protocol of 2 infusions of iron (total 1500 mg) done 1-2 weeks apart was performed and labs were obtained prior to and after the 2 infusions. We compared changes in lab indices among patients with normal ESR/CRP versus abnormal ESR and/or CRP using two tail student T-test. Results: A total of 90 patients received 190 FCM infusions (See Table 1). The changes in hemoglobin, MCV and iron indices were statistically significant for the entire cohort. Change in TSAT and ferritin did not statistically differ between the two groups (22 vs 16 (p=0.09), 414 vs 376(p=0.3) respectively) but patients with normal ESR & CRP had a significant improvement in serum iron and changes in TIBC (62 vs 34(p=0.02), 135 vs 84 (p=0.009) respectively). There was no significant difference in improvement of hemoglobin or MCV among patients with elevated biomarkers compared to those with normal ESR and CRP (Table 2). A total of 4 patients developed adverse reactions (2 in each group) with rash (N=2) at the time of infusion which improved with administration of steroids and diphenhydramine and flu-like symptoms (N= 2) 24 hours post infusion which responded to diphenhydramine. Three continued future infusions without any complications except for one (with rash) who did not receive further infusions per patient request. Conclusions: FCM is a safe and efficacious IV iron with capability of delivering a significant dose of iron in a single formulation. Improvement of lab indices was noted in both groups with and without inflammation but notably better change of iron indices occurred in the group with no inflammation. This could be related to disease activity, but it may also be related to additional underlying factors of response to iron absorption that may need to be further elucidated. Table 1:Basedline Characteristics
COMPARATIVE PERSISTENCE OF BIOLOGICS IN THE TREATMENT OF INFLAMMATORY BOWEL DISEASE: A TRUVEN MARKETSCAN DATABASE STUDY Chao Chen, Ofor Ewelukwa, Ellen M. Zimmermann, Abraham Hartzema, Sarah C. Glover, Adi Eldar-Lissai Biologic medications are standard therapies for moderate to severe Inflammatory Bowel Disease (IBD). These medications reduce symptoms, heal mucosa and induce long-term remission. Medication persistence, defined as the time from drug initiation to discontinuation of therapy, has been suggested as a proxy for real-world therapeutic benefit and safety profile. This study seeks to compare the persistence of biologic drugs among patients with IBD using a large US administrative claims database. Methods: A retrospective study was conducted using Truven MarketScan database 2010.1-2015.9. Patients diagnosed with Crohn's disease (CD) and ulcerative colitis (UC) were identified and grouped into two mutually exclusive cohorts based on a validated algorithm using ICD-9-CM codes (555.* for CD and 556.* for UC). New IBD patients were identified by requiring a 6-months continuous health plan enrolment prior to index diagnosis, within which no prior IBD diagnosis or biologics use were allowed. Biologic medications including infliximab, adalimumab, certolizumab, golimumab and vedolizumab were identified. Study endpoint was time to discontinuation, which was defined as failing to refill the index biologic drug within a period of two times the days supply after the last refill. Switching to another biologic drug was also evaluated as secondary outcome. Kaplan-Meier curve and cumulative survival method was used to describe the persistence of use profile for each medication. Results: In total, 9,892 patients with CD and 5,378 patients with UC were included in this analysis. The study population featured slightly more female patients (51.2%), and mostly young adults with mean age of 36.6 years. Within 1 year after treatment initiation, the percentage of persistent users was 28.2% for CD patients and 31.7% for UC patients. Among all the biologic medications, infliximab had the highest 1-year persistence rate (57.0% for CD patients and 56.8% for UC patients). Overall the 1-year switching rate is 25.4% for CD patients and 27.8% for UC patients. Vedolizumab users had the lowest switching rate for both CD and UC patients, although the sample size is small (35 patients) and follow-up time might not be sufficient for this subgroup. Conclusion: The overall persistence of currently available biologic medications is relatively low. Patients on Infliximab had the highest rate of persistence consistent with relatively favorable therapeutic benefit and safety profile. Assessing medication persistence in patients with stable health insurance using a large administrative claims database may be an informative method to derive real-world medication use profiles.
Kaplan-Meier Curve for Persistence of Biologic Treatments among CD Patients HBI:Harvey Bradshaw Index; UCDAI- Ulcerative Colitis Disease Activity Index Table 2: Comparison of Changes in Iron Indices in IBD Patients with normal vs. elevated biomarkers
Kaplan-Meier Curve for Persistence of Biologic Treatments among UC Patients
Su1913 EFFICACY OF FERRIC CARBOXYMALTOSE IN RELATION TO DISEASE ACTIVITY IN INFLAMMATORY BOWEL DISEASE Pramoda Koduru, Malcolm Irani, Pragnesh J. Patel, Vineet Gudsoorkar, Bincy Abraham
Hb:Hemoglobin; BMI- Body Mass Index
Background: Ferric carboxymaltose (FCM) is a novel non-dextran intravenous (IV) iron which has been approved for use in patients with iron deficiency anemia (IDA) who have inadequate response to oral iron therapy. Hepcidin, a key mediator of iron homeostasis is an acute phase reactant that increases in the setting of active inflammation and cause
AGA Abstracts
S-594