Frequency and predictors of loss of response to biological therapy in Crohn’s disease after one-year treatment period

2011 ◽  
Vol 152 (24) ◽  
pp. 951-957
Author(s):  
Tamás Molnár ◽  
Klaudia Farkas ◽  
Tibor Nyári ◽  
Zoltán Szepes ◽  
Ferenc Nagy ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Dose Escalation ◽  
Biological Therapy ◽  
Sustained Remission ◽  
Chi Square ◽  
Loss Of Response ◽  
Adalimumab Therapy ◽  
Frequent Event ◽  
Chi Square Test

Secondary loss of response (initial good response followed by loss of response and flare up) is a frequent event occurring during biological therapy. The aim of this study was to assess loss of efficacy in patients with Crohn’s disease treated with infliximab or adalimumab for a year. Secondary goals were to identify clinical or laboratory predictors of loss of response and to evaluate whether the frequency of dose escalation differs in patients receiving infliximab or adalimumab. Data were provided by a computerized database. Patients and methods: Sixty-one patients with Crohn’s disease achieved remission after induction therapy and received regular maintenance treatment. 35 of them were on infliximab, and 26 on adalimumab therapy. None of the patients treated with infliximab received previous biological therapy, while 10 of the adalimumab-treated patients were naïve to biological therapy. Authors compared the data of patients who relapsed with those who remained in remission and also the characteristics of infliximab-treated patients with adalimumab-naïve patients. Data were analyzed using Chi-square test. Kaplan Meier curve was used to show the time of loss of efficacy. Results: Remission was achieved in 70.5%, and response was achieved in 29.5% of the patients after induction. Loss of response occurred in 22 of the 61 patients after a year of therapy. The proportion of remission after induction was significantly lower in patients who lost response vs. those who remained in remission. More patients with sustained remission received immunosuppressive therapy before and during the biological therapy vs. those with loss of response. Loss of response was significantly more frequent and occurred earlier in adalimumab-naive patients vs. infliximab-treated patients. Conclusion: The need for dose escalation should be calculated in the budget in the majority of patients, especially in adalimumab-treated patients. Orv. Hetil., 2011, 152, 951–957.

W1106 Increased BMI Is Not Associated with Dose Escalation or Failure of Adalimumab Therapy in Crohn's Disease

2009 ◽  
Vol 136 (5) ◽  
pp. A-655 ◽  
Author(s):  
Bashar Qumseya ◽  
Amar S. Naik ◽  
Ashwin N. Ananthakrishnan ◽  
Yelena Zadvornova ◽  
Susan Skaros ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Dose Escalation ◽  
Adalimumab Therapy

scholarly journals P415 The anti-IL-23/IL-12 agent Ustekinumab is an effective and safe induction therapy in patients with Crohn’s disease refractory or intolerant to anti-TNF: a multicentre Italian study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S379-S379
Author(s):  
A Gubbiotti ◽  
B Barberio ◽  
F Zingone ◽  
R D’Incà ◽  
L Bertani ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Remission ◽  
Real Life ◽  
Previous Treatment ◽  
Categorical Variables ◽  
Biologic Agent ◽  
Chi Square ◽  
Faecal Calprotectin ◽  
Chi Square Test

Abstract Background There are limited real-life studies in medical literature evaluating the efficacy and safety of Ustekinumab, an Anti-IL-23/Anti IL-12 agent, in patients with Crohn’s disease (CD) who required treatment because of refractoriness or intolerance to previous biological treatments. Thus, the aim of this study was to assess the effectiveness and tolerability of Ustekinumab in anti-TNF refractory or intolerant CD patients. Methods All CD patients who completed induction with Ustekinumab in three Italian IBD Units (Padua, Santorso, and Pisa) were enrolled. Patients were evaluated after induction (first intravenous dose followed by a subcutaneous dose at 8 weeks) and clinical (Harvey- Bradshaw-Index) and biochemical data, including faecal calprotectin (FC) and C-reactive protein (CRP) were collected. Information on the need of optimisation (every 12 or 8 weeks) and adverse events were also collected. Continuous and categorical variables were expressed as mean with standard deviation (sd) and frequency with percentages, respectively. Comparisons between variables were conducted using paired t-test and chi-square test. Data were analysed using STATA11.1 software. Results Sixty-three patients were included (41 males, mean age 43 ± sd 13.2 years). All of them had previously been treated with at least one biologic agent and 95.2% with oral steroids. The main indications for starting therapy were: previous treatment failure (77.2%) and pharmacological intolerance (17.5%). At the time of the induction, 28.6% patients were under steroid treatment. Post induction, clinical remission was obtained in 63.5% patients, while steroid-free clinical remission in 52.4%. Moreover, a statistically significant reduction of FC (from 916 μg/l to 444 μ/l, p < 0.001) and normalisation of CRP (n = 14, 33.3%; p < 0.001) were observed. After induction, 3 adverse effects were reported, and in two treatment discontinuations was necessary (i.e. 1 case of pyelonephritis and 1 case of a re-activation of entero-cutaneous fistula). Finally, among 63 patients enrolled, 51 (80.9%) were optimised with a maintenance regimen of 8 weeks sub-cutaneous doses. Conclusion Our study shows that Ustekinumab seemed is effective in achieving clinical remission and steroid-free clinical remission after induction in the majority of CD patient despite the refractoriness to anti-TNF treatment. Moreover, the drug appeared safe and well tolerated. On the other hand, treatment optimisation to 8 weeks was adopted in most of the patients, in order to guarantee a better outcome.

scholarly journals Effect of elemental diet combined with infliximab dose escalation in patients with Crohn's disease with loss of response to infliximab: CERISIER trial

2018 ◽  
Vol 16 (3) ◽  
pp. 494 ◽  
Author(s):  
Tadakazu Hisamatsu ◽  
Reiko Kunisaki ◽  
Shiro Nakamura ◽  
Tomoyuki Tsujikawa ◽  
Fumihito Hirai ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Dose Escalation ◽  
Elemental Diet ◽  
Loss Of Response

scholarly journals Long-Term Clinical Remission in Biologically Naïve Crohn’s Disease Patients with Adalimumab Therapy, Including Analyses of Switch from Adalimumab to Infliximab

2016 ◽  
Vol 10 (2) ◽  
pp. 283-291 ◽  
Author(s):  
Tsutomu Mizoshita ◽  
Satoshi Tanida ◽  
Keiji Ozeki ◽  
Takahito Katano ◽  
Takaya Shimura ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Dose Escalation ◽  
Clinical Remission ◽  
Therapeutic Option ◽  
Serious Adverse Events ◽  
Adalimumab Therapy ◽  
Treatment Naïve ◽  
Trough Levels

There is little evidence regarding the maintenance of long-term clinical remission by adalimumab (ADA) therapy in Crohn’s disease (CD) patients naïve to anti-tumor necrosis factor treatment (naïve CD patients), since most CD patients are treated with ADA after infliximab (IFX) therapy. The long-term clinical response to ADA was retrospectively analyzed in 17 naïve CD patients for at least 24 months, and the serum trough IFX levels were evaluated in patients switching from ADA to IFX. Of the 17 naïve CD patients, 14 (82.4%) maintained long-term clinical remission with ADA therapy for at least 24 months, without serious adverse events. The clinical condition of 7 patients was observed for more than 36 months, and 3, 1, 1, and 2 cases maintained remission at months 42, 48, 54, and 60 after ADA therapy, respectively. Three patients (17.6%) switched from ADA to IFX less than 24 months after the start of ADA therapy, and they had remission, retaining trough levels of IFX higher than 1 μg/ml, occasionally by dose escalation. In conclusion, maintenance ADA therapy achieves long-term clinical remission in naïve CD patients. Switching from ADA to IFX is an important therapeutic option in CD patients showing loss of response to ADA, occasionally with dose escalation, based on the analysis of serum IFX trough levels.

scholarly journals Sarcopenia is associated with Postoperative Outcome in Patients with Crohn’s Disease Undergoing Bowel Resection

2019 ◽  
Vol 1 (1) ◽  
pp. 201-209 ◽  
Author(s):  
Diogo Carvalho ◽  
Charlene Viana ◽  
Isabel Marques ◽  
Catarina Costa ◽  
Sandra F. Martins
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Postoperative Outcome ◽  
Mean Value ◽  
Chi Square ◽  
Muscle Area ◽  
Skeletal Muscle Index ◽  
Exact Test ◽  
Chi Square Test ◽  
Inflammatory Bowel

Sarcopenia is as an important prognostic factor in inflammatory bowel disease. In patients with Crohn’s disease (CD), sarcopenia has impact on morbidity after surgical resection. Aim: Evaluate sarcopenia impact on prognosis of patients with CD and assess CD sarcopenia prevalence. An retrospective study of 58 CD patients diagnosed histologically and imagiologically at the Hospital de Braga between 1 January 2009 and 31 December 2017. In order to obtain the Skeletal Muscle Index (SMI), it was calculated the muscle area at L3 level, from computed tomography. The t-test was used for independent samples, Mann-Whitney test, chi-square test and Fisher’s exact test for comparison between groups with and without sarcopenia. Sarcopenia prevalence was 41.4% (24 patients). Patients with sarcopenia presented a muscle area with a mean value of 119.88 cm2 (±28.10), significantly lower than that of the group of patients without sarcopenia (t(56) = 2.191, p = 0.033, d = 0.60), and values of SMI with median 42.86 cm2/m2, significantly lower than patients without sarcopenia (t(56) = 2.815, p = 0.007, d = 0.08). Regarding postoperative complications, significant differences were observed between the two groups (p = 0.000). In this study, sarcopenia was significantly associated with postoperative morbidity, as reported in the literature.

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