Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial Infliximab for induction and maintenance therapy for ulcerative colitis. Risk Factors for Surgical Site Infection and Association With Infliximab Administration During Surgery for Crohn’s Disease The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials Infliximab induces potent anti‐inflammatory and local immunomodulatory activity but no systemic immune suppression in patients with Crohn’s disease Infliximab administration prior to surgery does not increase surgical site infections in patients with ulcerative colitis Anti-TNF Therapy Is Associated With an Increased Risk of Postoperative Morbidity After Surgery for Ileocolonic Crohn Disease: Results of a Prospective Nationwide Cohort Use of Infliximab within 3 Months of Ileocolonic Resection is Associated with Adverse Postoperative Outcomes in Crohn’s Patients Perioperative Anti-Tumor Necrosis Factor Therapy Does Not Increase the Rate of Early Postoperative Complications in Crohn’s Disease The risk of post‐operative complications associated with infliximab therapy for Crohn's disease: a controlled cohort study Effect of infliximab on short-term complications in patients undergoing operation for chronic ulcerative colitis.
BACKGROUND We did a r and omised controlled trial to assess the benefit of maintenance infliximab therapy in patients with active Crohn 's disease who respond to a single infusion of infliximab .  METHODS 573 patients with a score of at least 220 on the Crohn 's disease activity index ( CDAI ) received a 5 mg/kg intravenous infusion of infliximab at week 0 . After assessment of response at week 2 , patients were r and omly assigned repeat infusions of placebo at weeks 2 and 6 and then every 8 weeks thereafter until week 46 ( group I ) , repeat infusions of 5 mg/kg infliximab at the same timepoints ( group II ) , or 5 mg/kg infliximab at weeks 2 and 6 followed by 10 mg/kg ( group III ) . The prespecified co- primary endpoints were the proportion of patients who responded at week 2 and were in remission ( CDAI < 150 ) at week 30 and the time to loss of response up to week 54 in patients who responded . Analyses of the co- primary endpoints were by intention to treat . FINDINGS 335 ( 58 % ) patients responded to a single infusion of infliximab within 2 weeks . At week 30 , 23 of 110 ( 21 % ) group I patients were in remission , compared with 44 of 113 ( 39 % ) group II ( p=0.003 ) and 50 of 112 ( 45 % ) group III ( p=0.0002 ) patients . Thus , patients in groups II and III combined were more likely to sustain clinical remission than patients in group I ( odds ratio 2.7 , 95 % CI 1.6 - 4.6 ) . Throughout the 54-week trial , the median time to loss of response was 38 weeks ( IQR 15 to > 54 ) and more than 54 weeks ( 21 to > 54 ) for groups II and III , respectively , compared with 19 weeks ( 10 - 45 ) for group I ( p=0.002 and p=0.0002 , respectively ) .  Infliximab safety was consistent with that seen in other trials of infliximab in Crohn 's disease and rheumatoid arthritis . In particular , the incidence of serious infections was similar across treatment groups . INTERPRETATION Patients with Crohn 's disease who respond to an initial dose of infliximab are more likely to be in remission at weeks 30 and 54 , to discontinue corticosteroids , and to maintain their response for a longer period of time , if infliximab treatment is maintained every 8 weeks BACKGROUND Infliximab , a chimeric monoclonal antibody directed against tumor necrosis factor alpha , is an established treatment for Crohn 's disease but not ulcerative colitis . METHODS Two r and omized , double-blind , placebo-controlled studies --the Active Ulcerative Colitis Trials 1 and 2 ( ACT 1 and ACT 2 , respectively)--evaluated the efficacy of infliximab for induction and maintenance therapy in adults with ulcerative colitis . In each study , 364 patients with moderate-to-severe active ulcerative colitis despite treatment with concurrent medications received placebo or infliximab  ( 5 mg or 10 mg per kilogram of body weight ) intravenously at weeks 0 , 2 , and 6 and then every eight weeks through week 46 ( in ACT 1 ) or week 22 ( in ACT 2 ) . Patients were followed for 54 weeks in ACT 1 and 30 weeks in ACT 2 . RESULTS In ACT 1 , 69 percent of patients who received 5 mg of infliximab and 61 percent of those who received 10 mg had a clinical response at week 8 , as compared with 37 percent of those who received placebo ( P<0.001 for both comparisons with placebo ) . A response was defined as a decrease in the Mayo score of at least 3 points and at least 30 percent , with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute rectal-bleeding subscore of 0 or 1 . In ACT 2 , 64 percent of patients who received 5 mg of infliximab and 69 percent of those who received 10 mg had a clinical response at week 8 , as compared with 29 percent of those who received placebo ( P<0.001 for both comparisons with placebo ) . In both studies , patients who received infliximab were more likely to have a clinical response at week 30 ( P < or = 0.002 for all comparisons ) . In ACT 1 , more patients who received 5 mg or 10 mg of infliximab had a clinical response at week 54 ( 45 percent and 44 percent , respectively ) than did those who received placebo ( 20 percent , P<0.001 for both comparisons ) . CONCLUSIONS Patients with moderate-to-severe active ulcerative colitis treated with infliximab at weeks 0 , 2 , and 6 and every eight weeks thereafter were more likely to have a clinical response at weeks 8 , 30 , and 54 than were those receiving placebo . ( Clinical Trials.gov numbers , NCT00036439 and NCT00096655 . BACKGROUND : Preoperative infliximab treatment may influence postoperative infectious complications in patients with Crohn ’s disease . OBJECTIVE : The aim of this study was to identify predictors of surgical site infection after surgery for Crohn ’s disease and evaluate the effects of preoperative infliximab administration . DESIGN : We performed a prospect i ve surveillance and review of surgical site infections . SETTING S : This study was conducted in the Surgical Department of Hyogo College of Medicine . PATIENTS : A total of 405 consecutive patients with Crohn ’s disease who underwent abdominal surgery between January 2008 and December 2011 were included . MAIN OUTCOME MEASURES : Infection was diagnosed by the infection control team . The possible risk factors were analyzed by using logistic regression analyses to determine their predictive significance . RESULTS : Within the patient population , 20 % of patients received infliximab , and 60 % had penetrating disease . The median duration from the last infliximab infusion to surgery was 43 days ( range , 4–80 ) . The overall incidence of surgical site infection was 27 % . The incidence of incisional surgical site infection was 18 % , and the organ/space surgical site infection rate was 8 % . In the multivariate analysis , proctectomy was the highest risk factor for all surgical site infection ( OR , 3.4–11.8 ; p < 0.01 ) . The administration of preoperative infliximab was not a risk factor for surgical site infection . By contrast , there was a significantly reduced risk of incisional surgical site infection in patients with penetrating disease who received infliximab ( OR , 0.1 ; p < 0.01 ) . LIMITATIONS : This study was a cohort study and not a r and omized trial . The data analyses were performed for surgical site infections but not for other infectious complications . CONCLUSIONS : Proctectomy was a high-risk factor for surgical site infection in patients with Crohn ’s disease . The administration of preoperative infliximab was not a risk factor for surgical site infection Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Anti‐TNFα therapy with infliximab is effective for Crohn ’s disease .  Infliximab neutralizes the biological activities of TNFα , a cytokine involved in host‐defence against certain infections Purpose The high incidence of infectious complications in ulcerative colitis ( UC ) is generally recognized to be due to several factors related to a compromised host . In our previous study , a high dose of corticosteroid was shown to be a risk factor for surgical site infection ( SSI ) . Recently , infliximab ( IFX ) has been used for refractory UC . In this study , the effect of IFX on the occurrence of infectious postoperative complications for UC was evaluated , because it remains controversial . Method A total of 196 UC patients who underwent laparotomy between January 2010 and September 2012 were included . Possible factors related to complications were analyzed to identify significant predictors . Results Twenty-two patients had IFX before surgery . The overall incidence of SSI was 47/196 ( 24.0 % ) . The incidence of infections , including SSI and other infections , was 69/196 ( 35.2 % ) . On multivariate analysis , national nosocomial infection surveillance ( NNIS ) risk index ≥2 ( p<0.01 ) and preoperative prednisolone dose ≥0.2 mg/kg/day ( p = 0.01 ) were identified as independent risk factors for overall SSI ; NNIS risk index ≥2 ( p < 0.01 ) and duration from onset of UC ≥6.3 years ( p = 0.045 ) were identified as independent risk factors for incisional SSI ; contaminated wound class ( p < 0.01 ) , preoperative hospital stay ≥6 days ( p = 0.048 ) , severe/fulminant disease activity ( p = 0.04 ) , and pancolitis ( p = 0.02 ) were identified as independent risk factors for organ/space SSI ; and contaminated wound ( p < 0.01 ) , severe/fulminant disease activity ( p = 0.02 ) , and age at surgery ≥43 years ( p = 0.047 ) were identified as independent risk factors for total infectious complications . Conclusion IFX administration was not associated with infectious complications for UC surgery Objective : To determine the risk factors of morbidity after surgery for ileocolonic Crohn disease ( CD ) . Summary Background Data : The risk factors of morbidity after surgery for CD , particularly the role of anti-TNF therapy , remain controversial and have not been evaluated in a large prospect i ve cohort study . Methods : From 2013 to 2015 , data on 592 consecutive patients who underwent surgery for CD in 19 French specialty centers were collected prospect ively . Possible relationships between anti-TNF and postoperative overall morbidity were tested by univariate and multivariate analyses . Because treatment by anti-TNF is possibly dependent on the characteristics of the patients and disease , a propensity score was calculated and introduced in the analyses using adjustment of the inverse probability of treatment-weighted method . Results : Postoperative mortality , overall and intra-abdominal septic morbidity rates in the entire cohort were 0 % , 29.7 % , and 8.4 % , respectively ; 143 ( 24.1 % ) patients had received anti-TNF <3 months prior to surgery . In the multivariate analysis , anti-TNF <3 months prior to surgery was identified as an independent risk factor of the overall postoperative morbidity ( odds-ratio [ OR ] = 1.99 ; confidence interval [ CI ] 95 % = 1.17–3.39 , P = 0.011 ) , with preoperative hemoglobin < 10 g/dL ( OR = 4.77 ; CI 95 % = 1.32–17.35 , P = 0.017 ) , operative time > 180 min ( OR = 2.71 ; CI 95 % = 1.54–4.78 , P < 0.001 ) and recurrent CD ( OR = 1.99 ; CI 95 % = 1.13–3.36 , P = 0.017 ) . After calculating the propensity score and adjustment according to the inverse probability of treatment-weighted method , anti-TNF <3 months prior to surgery remained associated with a higher risk of overall ( OR = 2.98 ; CI 95 % = 2.04–4.35 , P < 0.0001 ) and intra-abdominal septic postoperative morbidities ( OR = 2.22 ; CI 95 % = 1.22–4.04 , P = 0.009 ) . Conclusions : Preoperative anti-TNF therapy is associated with a higher risk of morbidity after surgery for ileocolonic CD . This information should be considered in the surgical management of these patients , particularly with regard to the preoperative preparation and indication of temporary defunctioning stoma Background Few studies have evaluated preoperative infliximab use and postoperative outcomes in Crohn ’s patients . Our aim was to evaluate 30-day postoperative outcomes for Crohn ’s patients treated with infliximab within 3 months prior to ileocolonic resection . Methods The study is a retrospective evaluation of data for patients undergoing ileocolonic resection after 1998 from a prospect i ve Crohn ’s disease data base .  Patient characteristics and 30-day complications were compared for patients treated with infliximab within 3 months before surgery and an infliximab naïve group . The infliximab group was also compared with  non-infliximab patients undergoing ileocolonic surgery  before 1998 . Results Sixty of 389 Crohn ’s patients undergoing ileocolonic resection received infliximab . The infliximab and non-infliximab groups had similar characteristics , preoperative risk factors , and surgical procedure . However , steroid use was higher ( p < 0.05 ) in the non-infliximab group while concurrent immunosuppressive use was higher ( p < 0.001 ) in the infliximab group . Multivariate analysis showed infliximab use to be associated with 30-day postoperative readmission ( p = 0.045 ) , sepsis ( p = 0.027 ) , and intraabdominal abscess ( p = 0.005 ) . The presence of diverting stoma ( n = 17 ) in the infliximab group was associated with lower risk of sepsis ( 0 % vs. 27.9 % , p = 0.013 ) . Similar results were noted when the infliximab group was compared to the pre-infliximab patients . Conclusions Infliximab use within 3 months before surgery is associated with increased postoperative sepsis , abscess , and readmissions in Crohn ’s patients . Diverting stoma may protect against these complications Background There have been numerous studies with conflicting results regarding the use of anti-tumor necrosis factor ( TNF ) therapy and its relationship to postoperative outcome in Crohn disease . The aim of our study was to examine the rate of postoperative morbidity in patients receiving anti TNF therapy in the perioperative period . Methods All patients undergoing surgery for Crohn disease from 2005 till 2008 were abstract ed from a prospect i ve data base . Patients undergoing surgery which included a suture or staple line at risk for leaking were selected for the study . A retrospective review of medical records was performed . The study group comprised patients treated with perioperative anti TNF therapy ( defined as treatment within 8 weeks preoperatively or up to 30 days postoperatively ) . The remainder of the patients did not receive perioperative anti TNF therapy .  Patient characteristics , disease severity , medication use , operative intervention and 30-day complication were compared between the two groups . Results Three hundred and seventy patients were selected for analysis in this study , of which 119 received perioperative anti TNF therapy and 251 did not . The groups were similar in baseline characteristics , perioperative risk factors and procedures . The group who received perioperative anti TNF therapy had a more severe disease overall as measured by the American College of Gastroenterology ( ACG ) categories of disease ( 50 % severe fulminant disease in the perioperative anti-TNF therapy group versus 18 % in the group that did not receive perioperative anti-TNF therapy , p < 0.001 ) . There was no significant association of perioperative anti TNF therapy and any postoperative complications ( 27.9 % in anti-TNF group versus 30.1 % in no anti-TNF group , p = 0.63 ) nor intra-abdominal infectious complications ( 5.0 % in anti-TNF group versus 7.2 % in no anti-TNF group , p = 0.44 ) . Univariate analysis showed that the only factors associated with an increase in postoperative intra-abdominal infections were age and penetrating disease . Conclusions The use of anti-TNF therapy in the perioperative period is safe and is not associated with an increase in overall or infectious complications in Crohn disease patients undergoing surgery Background : By temporarily suppressing the immune response , the anti‐tumour necrosis factor agent , infliximab , may increase the risk of peri‐operative complications BACKGROUND Total proctocolectomy and ileal pouch anal anastomosis ( IPAA ) is the preferred operation for patients with chronic ulcerative colitis ( CUC ) refractory to medical therapy .  Infliximab ( IFX ) , an antitumor necrosis factor-alpha antibody , has demonstrated efficacy in medical management of CUC . The aim of this study is to determine if IFX before IPAA impacts short-term outcomes . STUDY DESIGN A prospect i ve institutional data base was retrospectively review ed for short-term complications after IPAA for CUC . Postoperative outcomes were compared between patients who received pre-IPAA IFX  and those who did not . RESULTS Between 2002 and 2005 , 47 patients received IFX before IPAA , and 254 patients received none . There were no gender ( p = 0.16 ) or body mass index ( p = 0.07 ) differences between groups . IFX patients were younger than non-IFX patients ( mean age 28.1 to 39.3 years ) ( p < 0.001 ) . In IFX patients , 70 % were receiving preoperative IFX , azathioprine , and corticosteroids .  Mortality was nil . Overall surgical morbidity was similar : 61.7 % and 48.8 % , IFX and non-IFX , respectively ( p = 0.10 ) . Anastomotic leaks ( p = 0.02 ) , pouch-specific ( p = 0.01 ) and infectious ( p < 0.01 ) complications were more common in IFX patients . Multivariable analysis revealed IFX as the only factor independently associated with infectious complications ( odds ratio [ OR ] = 3.5 ; CI , 1.6 - 7.5 ) . In a separate analysis , incorporating age , high-dose corticosteroids , azathioprine , and severity of colitis , IFX remained significantly associated with infectious complications ( OR = 2.7 ; CI , 1.1 - 6.7 ) . CONCLUSIONS CUC patients treated with IFX before IPAA have substantially increased the odds of postoperative pouch-related and infectious complications . Additional prospect i ve studies are required to determine if IFX alone or other factors contribute to the observed increases in infectious complications
Tumor necrosis factor-alpha inhibitor ( TNFi ) treatment is effective for ulcerative colitis ( UC ) and Crohn ’s disease ( CD ) .
Although several meta-analyses have been performed to evaluate the association between TNFi treatment and surgical morbidity , the results are controversial .