Duration Of Infliximab Therapy Research Articles

The impact of medication belief on adherence to infliximab in patients with Crohn's disease.

Objective: Crohn's disease (CD) is an incurable chronic disease that requires long-term treatment. As an anti-tumor necrosis factor (TNF) agent, Infliximab (IFX) is widely used in the treatment of Crohn's disease, while the adherence is not high. The purpose of this study was to investigate the adherence to IFX among CD patients in China and evaluate the association between medication belief and IFX adherence. Methods: Demographic data, clinical information and patients' medication beliefs were collected using an online questionnaire and reviewing electronic medical records (EMRs). The Beliefs about Medicines Questionnaire (BMQ)-specific was used to assess medication beliefs which contains the BMQ-specific concern score and the BMQ-specific necessity score. An evaluation of adherence factors was conducted using univariate and multidimensional logistic regression analyses. Results: In all, 166 CD patients responded the online questionnaire among which 77 (46.39%) patients had high adherence. The BMQ-specific concern score in patients in low adherence was 30.00 and in high adherence patients was 27.50, and patients with lower BMQ-specific concern score had higher adherence (p = 0.013). The multiple regression analysis showed that the BMQ-specific concern score (OR = 0.940, 95% CI: 0.888-0.996) significantly affected the IFX adherence in CD patients. Otherwise, gender, marital status, time spent on the way (including the waiting time in infusion center) and accommodation to the center were also the influencing factors of adherence. Conclusion: The IFX adherence to CD in China was not high. Medicine concerns may be predictive factor of adherence. Education, the duration of IFX therapy and experience of adverse effects were not significantly associated with IFX adherence. By enhancing knowledge and relieving medicine concerns, we may increase patients' adherence to IFX.

P502 Application of an algorithm-based precision-dosing model to a real-world cohort of patients on infliximab maintenance therapy: implications for drug usage and cost

Abstract Background Infliximab is registered for use in patients with inflammatory bowel disease (IBD) at an intravenous maintenance dose of 5 mg/kg eight-weekly. Secondary loss of response during maintenance therapy occurs in up to 50% of patients. New precision dosing models, which forecast infliximab doses to achieve targeted trough levels, reduce non-response and improve patient outcomes. Aim: To compare standard 5 mg/kg eight-weekly infliximab dosing to the infliximab doses theoretically required to achieve predefined infliximab trough target levels, as determined by the iDOSE® precision dosing dashboard model. Methods IBD patients treated with eight-weekly maintenance infliximab therapy dosed at 5 mg/kg were included. A recorded infliximab dose was considered dose X if the following was available: three previous infliximab doses, albumin and C-reactive protein at time of dose X, trough infliximab level immediately preceding dose X and the patient’s weight. The Baysient LLC iDOSE® software was then used to predict dose X to maintain therapeutic infliximab trough levels of ≥ either 5-10 or 3-7 µg/ml until the next eight-weekly dose. The predicted dose X was compared to the actual dose X given. Results 174 patients (56% male) were included with 417 dose X recordings. Of those, 135 had Crohn’s disease, 31 ulcerative colitis and 8 IBD-unclassified. Median age was 36 (IQR 29-47) years with a disease duration of 5 (1-13) years. 76% of patients were receiving immunomodulators and 6% were smokers. Duration of infliximab therapy before dose X was 2 (0-4) years. Trough infliximab levels were 5.0 (2.5-7.6) µg/ml, serum albumin was 38 (35-40) g/L and C-reactive protein 3 (3-4) mg/L. Comparing actual dose X with predicted dose X, 52% and 32% of doses were subtherapeutic when aiming for trough levels of 5-10 and 3-7 µg/ml respectively. The underdosing occurred by 5.6 and 5.3 mg/kg per dose, respectively. Cost analysis showed total costs increased by 102% and 29% when aiming for trough levels 5-10 and 3-7 µg/ml. On multivariable regression analysis, significant associations with subtherapeutic infliximab levels were ulcerative colitis compared to Crohn’s disease [OR: 9.81, 95% CI: 1.28-75.40, p = 0.028] and pre-dose X infliximab trough level [OR: 0.07, 95% CI: 0.03-0.15, p < 0.001]. Conclusion More than half of maintenance infliximab drug doses given at our institution were too low to achieve therapeutic infliximab blood levels of at least 5 µg/ml. These patients would likely benefit from an increased dose or reduced dosing interval of infliximab. These findings need to be confirmed prospectively.

P026 Investigating Predictors of Antibodies to Infliximab Formation in Inflammatory Bowel Disease – The Importance of Immunomodulators

BACKGROUND: Anti-tumor necrosis factor (TNF)-α have revolutionized the treatment of inflammatory bowel diseases (IBD), modifying their natural history. Loss of response to anti-TNFs is a clinical challenge and has been associated with formation of antibodies. AIM: To identify predictive factors of antibodies to infliximab (ATI) formation in IBD patients. METHODS: Retrospective single-center study including all consecutive IBD patients being treated with infliximab with at least one ATI and infliximab level determination and with a minimum follow-up of six months after the first testing. Presence of ATI was considered if at least one determination was positive during the follow-up and infliximab levels at this testing were registered. Clinical and demographic data obtained included disease phenotype, surgical background, duration of infliximab therapy, use of premedication, concomitant immunomodulator therapy at the time of testing, compliance, occurrence of an infusion reaction and biochemical assessment at the time of first induction treatment. RESULTS: 104 patients were included, 56 females (53.8%) with mean age of 38.2 ± 13.1 years. The overall prevalence of detectable ATI was 28.8% (30) and the mean time to its formation was 32.8 ± 24.3 months. Most (66.7%) patients with ATI had simultaneously nontherapeutic levels of infliximab. Patients treated with concomitant immunomodulators were less likely to develop ATI (33% versus 88%, P < 0.001). Additionally, it was found that patients with Ulcerative Colitis (UC) were more likely to have detectable ATI than those with Crohn Disease (CD) (44.4% vs 23.4%, P = 0.04). However, UC patients were less treated with concomitant immunomodulators (48.1% vs 80.5%, P = 0.001). At logistic regression analysis only lack of immunomodulator use (P < 0.001; OR 13.5, CI 95%, 4.63–40.0) was independently associated with ATI formation. CONCLUSION(S): Concomitant immunomodulator therapy was the only protective factor for the ATI formation, supporting its institution to prevent loss of response to anti-TNFs.

P027 Could Fecal Calprotectin Guide the Therapeutic Regimen of Infliximab in Inflammatory Bowel Disease?

BACKGROUND: Infliximab is a monoclonal antibody against tumor necrosis factor α approved for induction and maintenance of remission in inflammatory bowel disease (IBD). Therapeutic monitoring, with determination of infliximab levels, allows to guide therapeutic decisions and helps to prevent loss of response. AIM: To identify predictive factors of non-therapeutic infliximab levels (<0.50 µg/mL) in IBD patients. METHODS: Retrospective single-center study including patients treated with infliximab with at least one determination of infliximab levels and with a minimum follow-up of six months. Clinical and demographic data obtained included disease phenotype, surgical background, duration of infliximab therapy, presence of anti-infliximab antibodies at the time of analysis, concomitant immunomodulator therapy, compliance, occurrence of an infusion reaction and biochemical assessment at the time of first induction infusion. RESULTS: 104 patients were included, 56 females (53.8%) with a mean age of 38.2 ± 13.1 years. The overall prevalence of non-therapeutic infliximab levels was 29.8%. In the majority (90.4%) of the patients, the first determination was performed during maintenance therapy. 29.0% of the patients with non-therapeutic levels had simultaneously positive antibodies, and of the remainder, 27.3% acquired antibodies in a subsequent analysis. It was found that patients with non-therapeutic levels had significantly higher fecal calprotectin values at the initiation of treatment with infliximab (1184 ± 679 vs 708 ± 621, P = 0.02). No statistically significant association was found with other analytical parameters, like haemoglobin (12.7 ± 1.7 vs 12.9 ± 1.6, P = 0.55), C-reactive protein (11.2 ± 12.2 vs 15.9 ± 20.0, P = 0.22), sedimentation rate (22.4 ± 20.7 vs 23.7 ± 19.3, P = 0.76), ferritin (138.3 ± 128.2 vs 165.5 ± 166.6, P = 0.42) or albumin (3.50 ± 0.45 vs 3.56 ± 0.47, P = 0.54). CONCLUSION(S): Patients with non-therapeutic levels of infliximab have higher values of calprotectin prior to treatment, which may be related to increased inflammatory activity. In these cases infliximab regimens with higher and/or more frequent doses may be considered.

Analysis of adverse effects of infliximab treatment in 486 patients with Crohn′s disease

Objective To assess the safety of infliximab(IFX) treatment in patients with Crohn′s disease(CD). Methods From January 2009 to May 2018, at inflammatory bowel disease (IBD) center of Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 486 CD patients received the treatment of IFX were enrolled and their clinical data were collected. Univariate and multivariate regression of binary logistic were performed for statistical analysis. Results The median follow-up duration was 31.1 months (12.0 months to 40.0 months). The median duration of IFX therapy was 13.0 months (7.0 months to 21.0 months). Among 486 patients, 98 (20.16%) patients reported adverse effects, and 12 (2.47%) patients discontinued the therapy because of adverse effects. Acute infusion reaction was the most common adverse effect in CD patients who received IFX treatment accounting for 41.84%(41/98)of all the adverse effects, and the incidence was 8.44%. Thirty-nine patients had mild and moderate infusion reaction, and all improved after symptomatic treatment (eight patients discontinued IFX therapy because of recurrent infusion reaction). Two patients developed severe infusion reaction as allergic shock, and both relieved after emergency rescue. Four patients developed late-phase allergic reactions. Among 486 patients, 39 (8.02%) patients had infections, including infections of Clostridium difficile, cytomegalovirus, herpeszoster virus, Mycobacterium tuberculosis, and other opportunistic pathogens. There was no cases of infection related death. Thirty-six patients continued with IFX treatment after infection controlled. Among 486 patients, 14(2.88%) patients had severe infection, and all the cases improved after anti-infection treatment. Twenty-seven CD patients with hepatitis B virus (HBV) infection received anti-viral treatments, no active HBV infection was observed. Colon adenocarcinoma was found in one patient under colonoscopy at 22 months after discontinuation of IFX therapy. There were six patients with the history of benign tumors, and no evidence of recurrence, progress or malignancy during treatment. In terms of other rare adverse effects in 486 patients, there were eight (1.64%) patients with liver function injury, two (0.41%) patients with anemia, one (0.21%) patient with peripheral neuropathy, and four (0.82%) patients with skin lesion. Prolonged duration of IFX therapy, without combination of immune-suppressors and with increased baseline body mass index (BMI) were the risk factors of acute infusion reactions. Prolonged duration of IFX therapy and with low baseline albumin level were the risk factors of infections. Conclusions IFX is generally safe as the treatment for CD patients, and its adverse effects can be clinically controlled. Screening before therapy and monitoring during therapy may reduce the risks of adverse effects. Key words: Crohn disease; Infection; Neoplasms; Infliximab; Adverse effects; Infusion reaction

P103 Impact of premedication and other variables on the formation of antibodies to infliximab in pediatric inflammatory bowel disease

BACKGROUND: Infliximab is a chimeric monoclonal antibody against tumor necrosis factor α approved for induction and maintenance of remission in inflammatory bowel disease (IBD). Loss of response to infliximab is a clinical challenge and has been associated with drug immunogenicity and formation of antibodies to infliximab (ATI). The role of premedication with corticosteroids in preventing ATI formation is controversial and poorly studied in children. The aim of this cross sectional study is to investigate the effect of corticosteroid premedication on the prevalence of ATI, as well as to identify other variables that may affect ATI formation and infliximab level. METHODS: The study cohort included pediatric IBD patients treated with infliximab at our institution and had first ATI testing between 1/1/2003 and 6/30/2018. Clinical data obtained included routine premedication, duration of infliximab therapy, infliximab level, age, sex, BMI percentile, albumin, CRP, fecal calprotectin, occurrence of an infusion reaction (IR), and concomitant use of immunomodulator at the time of testing. The above variables were compared between the premedicated and non-premedicated groups, ATI positive and negative groups, and detectable and undetectable infliximab level groups and analyzed with descriptive statistics. Continuous variables were assessed by t-test and categorical variables by chi-square contingency analysis. P value &lt;0.05 indicates statistical significance. This study was approved by the Institutional Review Board. RESULTS: We identified a total of 289 patients, 171 males and 118 females with mean age of 14.6 ± 3.2 years. Reasons for ATI testing were therapeutic drug monitoring (59%), flare (33%), abnormal labs (7%), or IR (1%). The overall prevalence of detectable ATI was 35% (101/289). When we compared the premedicated group (n = 213) to the nonpremedicated group (n = 76), we found no significant difference in ATI prevalence (38% vs 28%, P = 0.113). The premedicated group had significantly longer infliximab therapy duration prior to the first ATI testing (491 ± 605 vs 161 ± 247 days, P &lt; 0.001), and higher BMI percentile (60.5 ± 29.8 vs 48.3 ± 30.6, P = 0.002). No significant differences were found in other variables. Next, we observed that patients with detectable ATI were on infliximab therapy longer (550 ± 634 days vs 321 ± 487 days, P ≤ 0.001) and were less likely to be treated with concomitant immunomodulators (11% vs 23%, P = 0.011) compared to the undetectable ATI group. None of the other variables were significantly different. In addition, we found that detectable infliximab correlated significantly with normal CRP and albumin (P = 0.004 and P ≤ 0.001). Patients with undetectable infliximab were more likely to have an IR (10.4%) than patients with detectable infliximab (1.3%) (P &lt; 0.001). Interestingly, concomitant immunomodulator use did not influence the likelihood of having detectable infliximab (19% vs 19%, P = 0.983). CONCLUSION(S): Our data suggests that premedication does not appear to decrease the prevalence of ATI formation. Our study confirms that concomitant immunomodulator therapy does lead to less ATI formation; however, immunomodulator therapy did not correlate with detectable infliximab. Detectable infliximab was the only variable that correlated with improved clinical parameters (CRP and albumin). Having undetectable infliximab, but not the lack of premedication or presence of ATI, increased the likelihood of IR.

Safety of Short 30 Minutes Infliximab Infusion: A Pilot Study

BACKGROUND: Infliximab (IFX), a TNF-α inhibitor, plays a major role in the treatment of inflammatory bowel disease (IBD). It's typically infused over 2 hours, progressively increasing the infusion rate to a maximum rate of 160ml/hr. This slow infusion was adopted because of concerns for infusion reactions. However, this strategy increases both direct cost (cost per hour of infusion, facility fee, nurse time) and indirect costs (patient time away from work and family). Our pilot study aimed to assess the safety of a shortened 30 min. infusion protocol of IFX. METHODS: Patients followed at MedStar Georgetown University, who were on a stable maintenance dose of IFX and who had no history of infusion reaction to standard 2hrs IFX infusion were offered to change their infusion time to 30min. We assessed the occurrence of adverse reactions during the infusion and up to 30 days after IFX infusions. Reactions were further classified as drug related or infusion related. We present the data of our 6 months experience with short infusion (i.e. after an average of 3-4 infusions per patient) RESULTS: Of 121 IBD patients receiving IFX at our institution during the last year, 46 (38%) received 30 min. short infusions and 75 (62%) received standard infusions. Maintenance dose of IFX ranged from 5 mg/kg (69% of patients) to 7.5-10mg/kg (31%). Adverse reactions were reported in a total of 10 patients (8.3%), 4 of which in the short infusion group. A total of 5 patients, 3 of which had short infusion, had drug induced paradoxical psoriasis. Five patients had an infusion reactions: 3 had cardiovascular events (high blood pressure, tachycardia) of which 1 had received a short infusion, and 2 had self limited skin rash. None of these infusion reactions were deemed severe and none lead to a change in the subsequent infusion rate. Correlation studies were performed and no correlation was found between the incidence of adverse events and IFX infusion rate, IFX dose, and duration of IFX therapy before the reaction occurred (n=0.893). CONCLUSION(S): Short 30 minute IFX infusions in selected patients who are on a stable dose of IFX and have no history of infusion reaction during standard 2hrs infusions were well tolerated and were not associated with an increased incidence of adverse reactions. Further studies on a larger group of patients and for a longer period are needed to confirm these findings. Reduction of infusion time will decrease direct and indirect cost of therapy and improve patient experience.

Comparison of efficacy, pharmacokinetics, and immunogenicity between infliximab mono- versus combination therapy in ulcerative colitis.

The association of concomitant immunosuppressant use with infliximab (IFX) and therapeutic outcomes in correlation with pharmacokinetic properties in ulcerative colitis (UC) remains unclear. To assess the effect of concomitant immunosuppressant use on the duration of IFX therapy, and the pharmacokinetic properties of IFX in patients with UC. A retrospective analysis of UC patients treated with IFX. Duration of efficacious IFX therapy, and serum IFX and antibody-to-IFX (ATI) levels were compared between those receiving IFX as monotherapy and in combination with an immunosuppressant. Among the 85 UC patients who received IFX, 46 (54.1%) received concomitant immunosuppressants, and 38 (45.9%) received IFX monotherapy. Concomitant immunosuppressant use was associated with increased duration of IFX therapy as 90% of patients receiving immunosuppressants remained on therapy at 1 year versus 61% of patients on monotherapy (Log-rank, P = 0.016). Concomitant immunosuppressant use, as compared with monotherapy, was associated with greater IFX levels (20.4 mg/L vs 10.5 mg/L, P = 0.025) and less frequent ATI formation (4.5% vs 33.3%, P = 0.031). Patients receiving greater than 2.0 mg/kg of azathioprine had greater IFX lev l than those receiving less than 2.0 mg/kg (26.0 vs 10.6 mcg/mL, P = 0.03) and those receiving IFX monotherapy (26.0 vs 11.2 mcg/mL, P = 0.03). The duration of IFX therapy among patients receiving less than 2.0 mg/kg azathioprine was indistinguishable from patients on IFX monotherapy (Log-rank, P = 0.95). Concomitant immunosuppressant therapy with IFX improves outcomes in UC as shown by increased duration of therapy, decreased immunogenicity against IFX, and increased blood levels of IFX. Our data suggest that this benefit may be dependent on the dose of concomitant immunosuppression.

A5: Detectable Anti‐Infliximab Antibodies in Children Treated with Infliximab for Rheumatic Diseases

Background/Purpose:Infliximab (IFX) is a monoclonal TNF‐alpha inhibiting antibody which is frequently used to treat children with refractory arthritis and uveitis. The most frequent and limiting adverse events are infusion reactions associated with the presence of anti‐drug antibodies.Objectives:To describe the incidence of detectable anti‐IFX antibodies and the correlation with infusion reactions and patient characteristics.Methods:Blood samples were collected before infusion between Aug 2009 and April 2013 every 6 months in all patients treated with IFX at our department. Patients' charts were retrospectively reviewed for IFX infusion reactions. Factors such as IFX dosage, infusion interval, co‐medication and time until first occurrence of an infusion reaction were collected and statistical analysis performed in search for possible correlation. Anti‐IFX antibody testing was performed using a Radio Immuno Assay developed by Sanquin laboratories (www.sanquin.nl).Results:A total of 288 samples from 64 patients (70% females) were tested. Diagnosis was JIA in 37/64 (58%), JIA with uveitis in 17/64 (27%) and 10/64 (16%) had isolated uveitis. The indication for IFX treatment was arthritis in 38 (59%) patients and uveitis in 25 (39%) patients. In one patient an associated Crohn's disease was the indication for IFX treatment. Anti‐IFX antibodies resulted positive in 53/288 (18%) samples of 15/64 (23%) patients after a mean IFX treatment time of 1065 days (range 42–3498 days). Titers of anti‐IFX antibodies varied between 12–120,000 AU/ml with a median of 160 AU/ml. Seven patients with positive antibodies (47%) also had ≥1 infusion reaction (median antibody titer 290 AU/ml, range 13–120,000). The median antibody concentration among patients without infusion reactions was 36 AU/ml (range 12–430). Among the 49 patients without detectable antibodies, 3 (6%) had a history of infusion reactions (p = 0.005 Chi square). In 3/15 (20%) patients the occurrence of anti‐IFX antibodies was associated with a disease flare, two of them experienced simultaneously an infusion reaction. Presence of anti‐IFX antibodies increased with the duration of IFX treatment (p = 0.0002) and was more commonly found in patients with arthritis as the treatment indication p = 0.005), in girls (p = 0.03), in children with a younger age at IFX start (p = 0.02) and was less common in patients who had received systemic steroids at some point during IFX treatment (p = 0.05). A multivariate analysis was performed with all factors positive in the univariate analysis using a stepwise regression model. The age at IFX start was the most significant factor (p = 0.003), followed by arthritis as treatment indication (p = 0.008) and systemic steroid treatment (p = 0.05), while the total duration of IFX therapy (p = 0.07) and gender (p = 0.19) were not significantly associated with anti‐IFX antibodies.Conclusion:In our cohort 15/64 (23%) patients developed detectable anti‐IFX antibodies with infusion reactions occurring in 47% of them. A younger age at start of IFX treatment was associated with the development of antibodies while uveitis as a treatment indication and co‐medication with systemic steroids at some point during IFX therapy were associated with a lower antibody frequency.

The temporal evolution of antidrug antibodies in patients with inflammatory bowel disease treated with infliximab

ObjectiveTo characterise the temporal evolution of antibodies to infliximab (ATI).DesignProspective observational study of infliximab-treated patients with inflammatory bowel disease between 2009 and 2012.InterventionsTrough levels of infliximab and ATI were measured...

WITHDRAWAL OF MAINTAINENCE INFLIXIMAB THERAPY

Aims/BackgroundInfliximab (IFX) is a chimeric monoclonal antibody effective for inducing and maintaining remission in Crohn's disease (CD) and ulcerative colitis (UC). Long term therapy is efficacious for maintaining clinical remission;...

Su1250 Inflammatory Bowel Disease and Selective Immunoglobulin a Deficiency

Introduction: The pathogenesis of inflammatory bowel disease (IBD) is related to an unchecked inflammatory response in the gut mediated by tumor necrosis factor alpha (TNFa). Infliximab, an anti-TNFa chimeric IgGmonoclonal antibody, is a staple therapy for moderateto-severe IBD. Recent literature describes obesity as a low-grade inflammatory state as adipose tissue releases cytokines including TNFa. The purpose of this study was to determine if there is greater failure rate of infliximab therapy in obese IBD patients given theoretical increased TNFa activity. Methods: A retrospective study was performed. 103 patients who received infliximab from 2006-2012 were identified. Patient were grouped based on BMI (group 1 BMI , 18.5, group 2 BMI 18.5-25, group 3 BMI 25-30, group 4 BMI . 40). Logistic regression was performed on outcomes of the impact of weight and body mass index on surgery and loss of clinical response within one year of initiation of infliximab. Linear regression was performed on the impact of weight and body mass index on length of time of durable response of infliximab. Results: 52 women and 51 men were evaluated. The average age of the patient population when diagnosed with IBD was 26.38 years old (STD +/12.9). The average age of initiation of infliximab therapy was 33.7 years old (STD +/-13.1) with mean disease duration of 11 years (STD +/-10.79). Average BMI was 23.76lbs/ in2 (STD +/-4.44) with average weight of 155.6lbs (STD +/-38.6lbs). Average duration of infliximab therapy was 17 months (STD +/-13.67). There were no patients in group 4 (BMI . 30) that required surgery or hospitalization for complications of IBD within 1 year of initiating infliximab. Among all groups, there was no statistical significance in surgical requirements for IBD complications at 1 year. There was no significant relationship between BMI and duration of infliximab treatment, though there was a trend towards shorter duration in patients with normal BMI. Finally, there was no significant difference in ESR and CRP at 1 month into infliximab treatment across all BMI groups. Conclusions: IBD and obesity are two separate inflammatory states with shared elevated TNFa activity. This study demonstrated no statistical difference in failure rates within anti-TNFa treatment with infliximab in patients with different BMIs as measured by hospitalization and surgery secondary to complications of IBD at 1 year of therapy initiation. This study would benefit from an increase the sample size to determine if there is significance in these outcomes.

Su1249 The Association Between Increased Body Mass Index and Failure of Infliximab Treatment for Inflammatory Bowel Disease

Introduction: The pathogenesis of inflammatory bowel disease (IBD) is related to an unchecked inflammatory response in the gut mediated by tumor necrosis factor alpha (TNFa). Infliximab, an anti-TNFa chimeric IgGmonoclonal antibody, is a staple therapy for moderateto-severe IBD. Recent literature describes obesity as a low-grade inflammatory state as adipose tissue releases cytokines including TNFa. The purpose of this study was to determine if there is greater failure rate of infliximab therapy in obese IBD patients given theoretical increased TNFa activity. Methods: A retrospective study was performed. 103 patients who received infliximab from 2006-2012 were identified. Patient were grouped based on BMI (group 1 BMI , 18.5, group 2 BMI 18.5-25, group 3 BMI 25-30, group 4 BMI . 40). Logistic regression was performed on outcomes of the impact of weight and body mass index on surgery and loss of clinical response within one year of initiation of infliximab. Linear regression was performed on the impact of weight and body mass index on length of time of durable response of infliximab. Results: 52 women and 51 men were evaluated. The average age of the patient population when diagnosed with IBD was 26.38 years old (STD +/12.9). The average age of initiation of infliximab therapy was 33.7 years old (STD +/-13.1) with mean disease duration of 11 years (STD +/-10.79). Average BMI was 23.76lbs/ in2 (STD +/-4.44) with average weight of 155.6lbs (STD +/-38.6lbs). Average duration of infliximab therapy was 17 months (STD +/-13.67). There were no patients in group 4 (BMI . 30) that required surgery or hospitalization for complications of IBD within 1 year of initiating infliximab. Among all groups, there was no statistical significance in surgical requirements for IBD complications at 1 year. There was no significant relationship between BMI and duration of infliximab treatment, though there was a trend towards shorter duration in patients with normal BMI. Finally, there was no significant difference in ESR and CRP at 1 month into infliximab treatment across all BMI groups. Conclusions: IBD and obesity are two separate inflammatory states with shared elevated TNFa activity. This study demonstrated no statistical difference in failure rates within anti-TNFa treatment with infliximab in patients with different BMIs as measured by hospitalization and surgery secondary to complications of IBD at 1 year of therapy initiation. This study would benefit from an increase the sample size to determine if there is significance in these outcomes.

Infliximab et sarcoïdose chronique. L’expérience française à propos de 31 cas

The management of chronic forms of sarcoidosis can be a difficult therapeutic problem. The purpose of this observational study was to analyze the effectiveness and tolerance of infliximab in chronic sarcoidosis. This multicentre retrospective study involved 31 cases of chronic, systemic, and/or pulmonary sarcoidosis treated by infliximab. Disease had been present for 9 years and involved a mean of four organs. Patients had received several immunosuppressive drugs and 30/31 were treated with corticosteroids (19 ± 16 mg prednisone/day) with the addition in 17 cases, of one or more other immunosuppressive agents. The duration of infliximab therapy was 13 ± 12 months. A beneficial response to infliximab was observed in 62% of the cases across all organs involved: 65% for lung involvement, 67% for skin lesions and 50% for central nervous system lesions. For other organs, responses were disparate. The corticosteroid sparing effect was small (2.8 ± 9.7 mg/day). Effectiveness was more frequent in patients who were treated with additional immunosuppressive agents. Thirteen (41.9%) patients developed side effects; in seven out of 13, side effects were severe, sometimes requiring infliximab to be stopped. Our study supports the continuing interest in the use of infliximab for the treatment of chronic sarcoidosis, but also highlights the frequency and severity of side effects. Indications are difficult to specify, and currently, its use should be restricted to clinical trials.