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S503 social functioning; Work Productivity and Activity Impairment questionnaire (WPAI) for work productivity; State-Trait Anxiety Inventory (STAI 1,2), for psychological assessment. IBD activity was measured by Partial Mayo score. Student's t test or Wilcoxon rank sum test were used to compare continuous variables between subgroups and chi-square test to compare categorical variables. Univariate and multi-variate linear regression were used, respectively, to assess the relationship between psychosocial and disease characteristics and to compare outcomes with determinant associated results in univariate regression. Results: Univariate analysis showed a statistically significant correlation of the overall QFS score with both the level of education (0.6; 95% CI = 0.1-1.2; p = 0.028) and the unemployed status (-4.5; 95% CI =-8.9-0.1; p = 0.044). Moreover, the impairment of WPAI was greater in subjects with ulcerative colitis with severe endoscopic activity according with Partial Mayo score (15.5; 95% CI = 1.0-30.0; p = 0.038). Overall impairment in subjects with stable employment correlated with age (-0.5; 95% CI =-0.9-0.1; p = 0.010) and was greater in subjects who underwent at least one surgical operation (15.8; 95% CI = 3.0-28.6; p = 0.016). Psychological evaluation showed that state and trait anxiety correlated significantly with Partial Mayo score (re-spectively 1.8; 95% CI = 0.6-2.7; p = 0.004 and 1.3; 95% CI = 0.1-2.5; p = 0.042) and age (respectively-0.2; 95% CI =-0.3-0.1; p = 0.028 and-0.3; 95% CI =-0.5-0.1; p = 0.037). State anxiety increased in case of long-standing illness (-0.3; 95% CI =-0.5-0.1; p = 0.037), while the non-worker status correlated with trait anxiety when compared to paid employment (-7.0; 95% CI =-0.9-13.1; p = 0.026). Conclusion: Social functioning was correlated to the employment status and to the level of education. Work productivity was lower in UC patients with severe activity and who undergone at least one surgery related to IBD. The state of anxiety was related with age, duration and activity of illness, while the trait of anxiety was major in non-worker patients. Background: Vedolizumab (VDZ) has demonstrated remission in ul-cerative colitis (UC) and Crohn's disease (CD), but its impact on patient (pt) fatigue is not well understood. Herein we report interim fatigue analysis data from a Belgian registry of VDZ-treated pts. Methods: Ad-hoc analysis from the prospective observational Belgian VDZ registry (started, November 2016; data cutoff, February 2019), a sub-study of the European VDZ post-authorization safety study (ENcePP EUPAS6469) included pts aged ≥18 years with UC or CD with ongoing VDZ intravenous therapy (≥2 weeks) at recruitment. At baseline (recruitment) and every 6 months, physicians collected data (follow-up was 3 years or 1 year after last dose if VDZ was discontinued [whichever occurred first] and pts completed the 13-Item Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale. Clinical remission was defined as Harvey-Bradshaw Index (HBI) score 1 for UC. This analysis explored the association (using generalized estimating equations) between all available FACIT-F total scores and baseline demographic, clinical, and treatment characteristics in the treatment analysis set (TAS; pts had ≥1 VDZ dose and ≥1 year of follow-up records). Results: The registry enrolled 202 VDZ-treated UC and CD pts from 19 Belgian centres. TAS included 141 pts (UC 47, CD 94); median follow-up was 537 days; 140/141 pts had ≥1 FACIT-F score. In the UC and CD groups, respectively, 68% and 42% of pts were male; median (IQR) age at index date was 51 (37-59) and 40 (29-52); and baseline median (IQR) FACIT-F total score was 39 (32-46) and 32 (24-40). Lower FACIT-F score (more fatigue) was associated with higher pMS in UC (p

The efficacy of ustekinumab, an antagonist of the p40 subunit of interleukin-12 and interleukin-23, as induction and maintenance therapy in patients with ulcerative colitis is unknown.We evaluated ustekinumab as 8-week induction therapy and 44-week maintenance therapy in patients with moderate-to-severe ulcerative colitis. A total of 961 patients were randomly assigned to receive an intravenous induction dose of ustekinumab (either 130 mg [320 patients] or a weight-range-based dose that approximated 6 mg per kilogram of body weight [322]) or placebo (319). Patients who had a response to induction therapy 8 weeks after administration of intravenous ustekinumab were randomly assigned again to receive subcutaneous maintenance injections of 90 mg of ustekinumab (either every 12 weeks [172 patients] or every 8 weeks [176]) or placebo (175). The primary end point in the induction trial (week 8) and the maintenance trial (week 44) was clinical remission (defined as a total score of ≤2 on the Mayo scale [range, 0 to 12, with higher scores indicating more severe disease] and no subscore1 [range, 0 to 3] on any of the four Mayo scale components).The percentage of patients who had clinical remission at week 8 among patients who received intravenous ustekinumab at a dose of 130 mg (15.6%) or 6 mg per kilogram (15.5%) was significantly higher than that among patients who received placebo (5.3%) (P0.001 for both comparisons). Among patients who had a response to induction therapy with ustekinumab and underwent a second randomization, the percentage of patients who had clinical remission at week 44 was significantly higher among patients assigned to 90 mg of subcutaneous ustekinumab every 12 weeks (38.4%) or every 8 weeks (43.8%) than among those assigned to placebo (24.0%) (P = 0.002 and P0.001, respectively). The incidence of serious adverse events with ustekinumab was similar to that with placebo. Through 52 weeks of exposure, there were two deaths (one each from acute respiratory distress syndrome and hemorrhage from esophageal varices) and seven cases of cancer (one each of prostate, colon, renal papillary, and rectal cancer and three nonmelanoma skin cancers) among 825 patients who received ustekinumab and no deaths and one case of cancer (testicular cancer) among 319 patients who received placebo.Ustekinumab was more effective than placebo for inducing and maintaining remission in patients with moderate-to-severe ulcerative colitis. (Funded by Janssen Research and Development; UNIFI ClinicalTrials.gov number, NCT02407236.).

BACKGROUND In patients with Crohn's disease, the efficacy of ustekinumab, a human monoclonal antibody against interleukin-12 and interleukin-23, is unknown. METHODS We evaluated ustekinumab in adults with moderate-to-severe Crohn's disease that was resistant to anti-tumor necrosis factor (TNF) treatment. During induction, 526 patients were randomly assigned to receive intravenous ustekinumab (at a dose of 1, 3, or 6 mg per kilogram of body weight) or placebo at week 0. During the maintenance phase, 145 patients who had a response to ustekinumab at 6 weeks underwent a second randomization to receive subcutaneous injections of ustekinumab (90 mg) or placebo at weeks 8 and 16. The primary end point was a clinical response at 6 weeks. RESULTS The proportions of patients who reached the primary end point were 36.6%, 34.1%, and 39.7% for 1, 3, and 6 mg of ustekinumab per kilogram, respectively, as compared with 23.5% for placebo (P = 0.005 for the comparison with the 6-mg group). The rate of clinical remission with the 6-mg dose did not differ significantly from the rate with placebo at 6 weeks. Maintenance therapy with ustekinumab, as compared with placebo, resulted in significantly increased rates of clinical remission (41.7% vs. 27.4%, P = 0.03) and response (69.4% vs. 42.5%, P < 0.001) at 22 weeks. Serious infections occurred in 7 patients (6 receiving ustekinumab) during induction and 11 patients (4 receiving ustekinumab) during maintenance. Basal-cell carcinoma developed in 1 patient receiving ustekinumab. CONCLUSIONS Patients with moderate-to-severe Crohn's disease that was resistant to TNF antagonists had an increased rate of response to induction with ustekinumab, as compared with placebo. Patients with an initial response to ustekinumab had significantly increased rates of response and remission with ustekinumab as maintenance therapy. (Funded by Janssen Research and Development; CERTIFI ClinicalTrials.gov number, NCT00771667.)

Background/Aims : A large multicenter trial to compare the efficacy of peginterferon alfa-2a with interferon alfa-2a, in combination with ribavirin, in chronic hepatitis C patients. Efficacy data for prior relapsers are reported because treatment recommendations for this patient population are not well defined. Patients and methods : This study was a multicenter, prospective, randomized clinical trial. The primary efficacy endpoint was sustained virologic response in naive patients (n = 348) and relapsers (n = 95). Results : Sustained virologic response rates were similar in naive patients and relapsers, both for non-pegylated and pegylated interferon (respectively 27 and 26% and 54 and 43%). Pegylated interferon given for 48 weeks did not improved the relapse rate : 15.9 and 27.3% for non-pegylated and 16.7 and 30.4% for pegylated interferon, naive vs relapsers respectively. Stepwise logistic regression analysis revealed a significant association between slow response (detectable HCV RNA at week 12 and undetectable at week 24) and relapse in patients with an end-of-treatment response (55% versus 13% respectively; p = 0.02; odds ratio = 6.07). Conclusions : This trial confirms the value of using peginterferon alfa-2a in both naive and relapsed patients and provides support for a more tailored approach to treatment for relapsers and particulary for patients with a slow viral response. (Acta gastroenterol. belg., 2010, 73, 223-228).

ispartof: Tijdschrift voor Geneeskunde vol:64 issue:17 pages:856-860 status: published

A 23-year-old female developed a necrotising wound after a caesarean section. In this case we were however confronted with an abrupt deterioration of the clinical evolution despite a broad-spectrum antibiotic therapy. After the diagnosis of pyoderma gangrenosum and the initiation of a ciclosporine therapy, a quick recovery did fortunately occur. ispartof: Tijdschrift voor Geneeskunde vol:64 issue:10 pages:537-540 status: published

Infection with the hepatitis C virus (HCV) represents an important public health problem and is a leading cause of chronic hepatitis, cirrhosis and hepatocellular carcinoma. Chronic hepatitis C is a heterogeneous disease. Many patients have mild disease at presentation but not all of them will develop advanced liver disease. However, the identification of these patients with mild hepatitis C who will show progressive disease is difficult and is based on histological criteria and the assessment of co-factors (age, alcohol intake, steatosis). In addition, serum transaminases that are persistently normal on several occasions during 18 months may point to a more benign course. Patients with mild hepatitis C should not be excluded "a priori" from the possibility of being treated, as treatment with pegylated interferon and ribavirin is safe and effective in this group. Overall, the decision to initiate therapy should be individualized and based on the severity of the disease by liver biopsy, the potential of serious side effects, the probability of response and the motivation of the patient