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Inflamm Bowel Dis. 2015 Apr 1. [Epub ahead of print]
Systematic review: sequential rescue therapy in severe ulcerative colitis: do the benefits outweigh the risks?
Narula N, Fine M, Colombel JF, et al.

BACKGROUND: The options for medical management of acute severe steroid-refractory ulcerative colitis (UC) are limited. Recent guidelines recommend against use of sequential rescue therapy in the setting of failed medical management with initial salvage therapy. A systematic review was conducted to assess outcomes of sequential rescue therapy with infliximab (IFX) and calcineurin inhibitors like cyclosporine (CsA) or tacrolimus (Tac) in patients with steroid-refractory UC.

METHODS: A literature search identified studies that investigated treatment with IFX and CsA or Tac in acute severe UC. Outcomes of interest included short-term symptomatic response to treatment, rates of remission, adverse drug reactions, serious infections, mortality, and colectomy at 3 and 12 months.

RESULTS: Overall, ten studies with 314 participants were eligible for inclusion. After sequential treatment, patients achieved short-term treatment response in 62.4% (95% confidence interval [CI], 57.0%-67.8%) of cases and remission in 38.9% (95% CI, 33.5%-44.3%). Colectomy rates were 28.3% (95% CI, 21.7%-34.5%) at 3 months and 42.3% (95% CI, 36.0%-48.6%) at 12 months. Adverse events were encountered by 23.0% (95% CI, 17.7%-28.3%) of patients, including serious infections in 6.7% (95% CI, 3.6%-9.8%) and mortality in 1% (95% CI, 0%-2.1%).

CONCLUSIONS: The risk of sequential therapy in steroid-refractory UC seems lower than initially reported. Caution must be exercised however because of very low-quality evidence. In contrast to recent guidelines, the current analysis does not support a decision for or against use of sequential rescue therapy, which should only be performed at specialized referral centers familiar with the use of calcineurin inhibition.

 


Gastroenterology.2015 Apr 6.pii: S0016-5085(15)00451-5.
Fecal microbiota transplantation induces remission in patients with active ulcerative colitis in a randomized, controlled trial.
Moayyedi P, Surette MG, Kim PT, et al.

BACKGROUND & AIMS: Ulcerative colitis (UC) is difficult to treat and standard therapy does not always induce remission. Fecal microbial transplantation (FMT) is an alternative approach that induced remission in in small series of patients with active UC. We investigated its safety and efficacy in a placebo-controlled, randomized trial.

METHODS: We performed a parallel study of patients with active UC without infectious diarrhea. Participants were examined by flexible sigmoidoscopy when the study began and then were randomly assigned to groups that received FMT (50 ml, via enema, from healthy anonymous donors; n=38) or placebo (50 ml water enema; n=37) once weekly for 6 weeks. Patients, clinicians, and investigators were blinded to the groups. The primary outcome was remission of UC, defined as a Mayo score ≤ 2 with an endoscopic Mayo score of 0, at week 7. Patients provided stool samples when the study began and during each week of FMT for microbiome analysis. The trial was stopped early for futility by the data monitoring and safety committee, but all patients already enrolled in the trial were allowed to complete the study.

RESULTS: Seventy patients completed the trial (3 dropped out from the placebo group and 2 from the FMT group). Nine patients who received FMT (24%) and 2 who received placebo (5%) were in remission at 7 weeks (a statistically significant difference in risk of 17%; 95% confidence interval, 2%-33%). There was no significant difference in adverse events between groups. Seven of the 9 patients in remission after FMT received fecal material from a single donor. Three of the 4 patients with UC ≤1 year entered remission, compared to 6/34 of those with UC > 1 year (P=.04 Fisher's exact test). Stool from patients receiving FMT had greater microbial diversity, compared with baseline, than that of patients given the placebo (P=.02, Mann Whitney U test).

CONCLUSIONS: FMT induces remission in a significantly greater percentage of patients with active UC than placebo, with no difference in adverse events. Fecal donor and time of UC appear to affect outcomes.

 


Scand J Gastroenterol. 2015 Apr 11:1-8. [Epub ahead of print]
The association of infliximab trough levels with disease activity in pediatric inflammatory bowel disease.
Hoekman DR, Brandse JF, de Meij TG, et al.

 

OBJECTIVE: Low serum trough levels (TLs) of infliximab (IFX) and antibodies to IFX (ATIs) are associated with the loss of therapeutic response in adults with inflammatory bowel disease (IBD) receiving IFX. Until now, pediatric data are scarce. Therefore, we aimed to cross-sectionally investigate the association between ATIs and IFX TLs, and clinical and biochemical disease activity in children receiving IFX for IBD.

MATERIAL AND METHODS: Children aged <18 years="" receiving="" ifx="" maintenance="" treatment="" for="" crohn="" s="" disease="" cd="" or="" ulcerative="" colitis="" uc="" at="" three="" dutch="" hospitals="" were="" included="" prior="" to="" two="" consecutive="" infusions="" tls="" and="" ati="" levels="" measured="" clinical="" activity="" was="" determined="" by="" pediatric="" index="" pcdai="" pucai="" respectively="" biochemical="" assessed="" serum="" c-reactive="" protein="" crp="" fecal="" calprotectin="" fc="" remission="" defined="" as="" a="" score="" of="" 10="" therapeutic="" range="" considered="" 3-7="" g="" ml="" p="">

RESULTS: Thirty-nine patients were included (31 CD; 16 females). Median age was 15 years. Median IFX TL was 3.5 μg/ml [IQR 2-7]. Subtherapeutic and supratherapeutic TLs were found in 38% and 23% of children, respectively. ATIs were detected in four patients. A correlation was found between IFX TL and CRP [rs = -0.51; p < 0.01] and FC [rs = -0.49; p < 0.01]. However, when only clinical disease activity was considered, no difference in median TL was found between remission and active disease (resp. 3.5 μg/ml [IQR 2-5] and 2.3 μg/ml [IQR 0.3-4.6]; p = 0.2).

CONCLUSIONS: IFX TLs are related to biochemical markers of disease activity. This could provide a rationale for monitoring TLs in children receiving IFX for IBD.

 


Br J Clin Pharmacol. 2015 Mar 25.
Pregnancy outcome after TNF-α inhibitor therapy during the first trimester: a prospective multicentre cohort study.
Weber-Schoendorfer C, Oppermann M, Wacker E, et al.

 

AIMS: TNF-α inhibitors are considered relatively safe in pregnancy but experience is still limited. The aim of this study was to evaluate the risk of major birth defects, spontaneous abortion, preterm birth, and reduced birth weight after first trimester exposure to TNF-α inhibitors.

METHODS: Pregnancy outcomes of women on adalimumab, infliximab, etanercept, certolizumabpegol, or golimumab were evaluated in a prospective observational cohort study and compared to outcomes of a non-exposed random sample. The samples were drawn from pregnancies identified by institutes collaborating in the European Network of Teratology Information Services.

RESULTS: In total, 495 exposed and 1532 comparison pregnancies were contributed from 9 countries. The risk of major birth defects was increased in the exposed (5.0%) compared to the non-exposed group (1.5%; ORadj 2.2; 95% CI 1.0-4.8). The risk of preterm birth was increased (17.6%; ORadj 1.69; 95% CI 1.1-2.5), but not the risk of spontaneous abortion (16.2%; HRadj 1.06; 95% CI 0.7-1.7). Birth weights adjusted for gestational age and sex were significantly lower in the exposed group compared to the non-exposed cohort (p = 0.02). As a diseased comparison group was not possible to ascertain, the influence of disease and treatment on birth weight and preterm birth could not be differentiated.

CONCLUSIONS: TNF-α inhibitors may carry a risk of adverse pregnancy outcome of moderate clinical relevance. Considering the impact of insufficiently controlled autoimmune disease on the mother and the unborn child, TNF-α inhibitors may nevertheless be a treatment option in women with severe disease refractory to established immunomodulatory drugs.

 


J Crohns Colitis. 2015 Apr 25. pii: jjv074. [Epub ahead of print]
Clinical trials in ulcerative colitis: a historical perspective.
Hindryckx P, Baert F, Hart A, et al. /

 

The clinical trial landscape in ulcerative colitis has significantly evolved over the last decades. Study endpoints have been shifting from mere clinical response to mucosal healing. It has become clear that the choice for combined clinical and endoscopic outcome criteria leads to a reduction of placebo responses, especially when central reading of the endoscopic images is performed. Accumulating evidence suggests that histological remission yields better long term outcomes for ulcerative colitis patients than mucosal healing alone and clinical trials with prolonged follow-up will have to address whether histological remission should be the ultimate treatment goal in ulcerative colitis. In recent years, there has also been increasing interest for the implementation of patient-reported outcomes (PROs) in clinical practice and research and the regulatory authorities have set up guidelines for the development of such PROs. This papers aims to provide a comprehensive review on historical aspects of clinical trials in ulcerative colitis and to discuss challenges and perspectives for clinical trials in the near future. A thorough analysis of all available "landmark" literature (both original papers and reviews) on clinical trials in UC was performed.

 


Scand J Gastroenterol. 2015 Apr 16:1-9. [Epub ahead of print]
Global mucosal and serum cytokine profile in patients with ulcerative colitis undergoing anti-TNF therapy.
Dahlén R, Magnusson MK, Bajor A, et al.

 

BACKGROUND AND OBJECTIVE: The knowledge of the effects of anti-tumour necrosis factor (TNF) treatment on the global cytokine profile in patients with ulcerative colitis (UC) is limited. A better understanding of these mechanisms could improve the ability to select patients that should undergo the therapy. Therefore, the aim was to determine the global mucosal and serum cytokine profile before and during induction therapy with anti-TNF in UC patients.

MATERIALS AND METHODS: In total, mucosal biopsies (n = 28) and serum samples (n = 42) were collected from UC patients (total n = 48) before anti-TNF therapy. At week 14 response to the therapy was evaluated and again mucosal biopsies (n = 14) and serum samples (n = 42) were collected. Quantitative real-time PCR was used to determine mucosal cytokine mRNA expression and the MSD MULTI-ARRAY assay system platform was used for analysis of cytokines in serum. The global cytokine profile was evaluated by multivariate factor analysis.

RESULTS: At baseline, the global profile of mucosal cytokine mRNA expression and serum cytokines discriminated therapy responders from non-responders. Responders had lower mucosal mRNA expression of interleukin 1β (IL-1β), IL-17A, IL-6 and interferon γ (IFN-γ) than non-responders. Fourteen weeks after therapy start mucosal IL-1β and IL-6 were down-regulated in therapy responders but not in non-responders. At week 14, serum levels of IL-6 were decreased in therapy responders whereas IFN-γ and IL-12p70 were increased in non-responders.

CONCLUSIONS: Our data suggest that patients with a therapy failure have a more severe pro-inflammatory cytokine profile before start of anti-TNF treatment, which is less well suppressed by the treatment as compared to therapy responders.

 


Eur J Gastroenterol Hepatol. 2015 Apr;27(4):436-41.
Azathioprine discontinuation earlier than 6 months in Crohn's disease patients started on anti-TNF therapy is associated with loss of response and the need for anti-TNF dose escalation.
Viazis N, Koukouratos T, Anastasiou J, et al.

 

OBJECTIVES: A high proportion of Crohn's disease (CD) patients lose response to antitumor necrosis factor (anti-TNF) and therapy needs to be intensified. We aimed to prospectively determine the predictors and frequency of anti-TNF loss of response and therefore the need for dose escalation and de-escalation in CD patients treated with infliximab or adalimumab.

METHODS: All patients were anti-TNF naive while concomitant azathioprine was administered for 6 months. In patients initially responding to anti-TNF and subsequently losing clinical response after the first 14 weeks of therapy, dose escalation was scheduled. During the follow-up period and after 1 year of intensified administration, anti-TNF was de-escalated in patients in remission.

RESULTS: A total of 161 patients were started on infliximab (n=96) or adalimumab (n=65); however, 29 patients (18.0%) did not respond to therapy and were excluded from further analysis. From the remaining 132 patients (infliximab=77, adalimumab=55), 31 (23.5%) needed a dose escalation for maintenance of remission during a median 28-month follow-up period. Factors associated with loss of response and therefore the need for anti-TNF dose escalation were azathioprine discontinuation earlier than 6 months and smoking. Most patients achieved clinical remission (n=25, 80.6%) without other interventions and among these, 16 patients (64%) were successfully de-escalated to the standard maintenance infliximab or adalimumab dose schedule after 1 year of intensified anti-TNF administration.

CONCLUSION: Azathioprine discontinuation earlier than 6 months and smoking in CD patients started on anti-TNF therapy is associated with loss of response and the need for anti-TNF dose escalation

 


J Crohns Colitis. 2015 Apr 19. pii: jjv061. [Epub ahead of print]
Combination of C-reactive protein, infliximab trough levels and stable but not transient antibodies to infliximab are associated with loss of response to infliximab in inflammatory bowel disease.
Roblin X, Marotte H, Leclerc M, et al.

 

Background Antibodies to infliximab (ATI) and trough levels to infliximab (TRI) are associated with loss of response in inflammatory bowel diseases (IBD). The best way to predict loss of response (LOR) to infliximab (IFX) is unknown. Methods We conducted a prospective observational cohort study enrolling all IBD patients who were in clinical remission at week 14 after IFX treatment initiation. TRI, ATI and C-reactive protein (CRP) level were measured at week 22 (T1) and thereafter at every other IFX infusion. Loss of clinical response was defined by a flare requiring therapeutic change (IFX dose intensification, initiation of another drug class and/or surgery). Results 93 patients (59 Crohn's disease, mean duration of follow up 17.2 months) were included. 32 patients (34.4%) lost clinical response during follow-up. Cumulative probability of LOR was 50% at 20 months. Mean TRI at T1 was significantly lower in IBD patients with stable ATI as compared to those with transient ATI or without ATI (0.052, 3.34 and 4.29 μg/mL, respectively; p=0.001 between no ATI vs. stable ATI, and p=0.005 between stable and transient ATI) (p=0.0001). Three independent factors were predictive of LOR after Cox proportional hazards modelling: TRI > 5.5 μg/mL (HR: 0.21; 95% CI: 0.05-0.89: p=0.034) at T1, CRP > 5mg/L (HR: 2.5; 95% CI: 1.16-5.26; p=0.019) at T1, and stable ATI defined by two consecutive ATI > 20ng/ml (HR: 3.77; 95% CI: 1.45-10.0: p= 0.007). Transient ATI did not influence LOR. Conclusions LOR can be predicted based on a combination of CRP, TRI and stable ATI with a high degree of accuracy.

 

 

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