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AIMTo evaluate the real-world effectiveness of golimumab in ulcerative colitis (UC) and to identify predictors of response.METHODSWe conducted an observational, prospective and multi-center study in UC patients treated with golimumab, from September 2014 to September 2015. Clinical activity was assessed at week 0 and 14 with the physician’s global clinical assessment (PGA) and the partial Mayo score. Colonoscopies and blood tests were performed, following daily-practice clinical criteria, and the results were recorded in an SPSS database.RESULTSThirty-three consecutive patients with moderately to severely active UC were included. Among them, 54.5% were female and 42 years was the average age. Thirty percent had left-sided UC (E2) and 70% had extensive UC (E3). All patients had an endoscopic Mayo score of 2 or 3 at baseline. Twenty-seven point three percent were anti-tumor necrosis factor (TNF) treatment naïve, whereas 72.7% had previously received infliximab and/or adalimumab. Sixty-nine point seven percent showed clinical response and were steroid-free at week 14 (a decrease from baseline in the partial Mayo score of at least 3 points). Based on PGA, the clinical remission and clinical response rates were 24% and 55% respectively. Withdrawal of corticosteroids was observed in 70.8% of steroid-dependent patients at the end of the study. Three out of 10 clinical non-responders needed a colectomy. Mean fecal calprotectin value at baseline was 300 μg/g, and 170.5 μg/g at week 14. Being anti-TNF treatment naïve was a protection factor, which was related to better chances of reaching clinical remission. Twenty-seven point three percent of the patients required treatment intensification at 14 wk of follow-up. Only three adverse effects (AEs) were observed during the study; all were mild and golimumab was not interrupted.CONCLUSIONThis real-life practice study endorses golimumab’s promising results, demonstrating its short-term effectiveness and confirming it as a safe drug during the induction phase.

OBJECTIVES We aimed at evaluating bacterial DNA (bactDNA) presence in blood of Crohn's disease (CD) patients in remission as an independent risk factor of flare at 6 months. METHODS This is a prospective, multicenter study on CD patients with Crohn's disease activity index (CDAI)<150. The primary end point was time-to-relapse as evaluated by CDAI>150 in the following 6 months. BactDNA in blood, the nucleotide-binding oligomerization domain containing 2 (NOD2) genotype, and serum cytokine levels were determined at baseline. RESULTS A total of 288 patients were included. BactDNA was detected in 98 patients (34.0%). A variant-NOD2 genotype was identified in 114 patients (39.6%). Forty patients (14%) relapsed during follow-up. Multivariate survival analysis identified bactDNA as an independent risk factor of flare (hazard ratio (HR) 8.75 (4.02-19.06) 95% confidence interval (CI)). Hospitalization, surgery, switch of treatment, initiation and escalation of anti-tumor necrosis factor (TNF) therapy, steroids initiation, and increased fecal calprotectin levels at 6 months were associated with bactDNA at baseline. A logistic regression analysis showed bactDNA as an independent and significant predictive factor of hospitalization (odds ratio (OR) 11.9 (3.4-42.3); P<0.001), steroids startup (OR 8.5 (2.7-27.1); P<0.001), and switch of treatment (OR 3.5 (1.6-7.7); P=0.002) at 6 months. No relationship was observed between bactDNA and mucosal lesions in patients with colonoscopy at admission. Serum pro-inflammatory cytokines were significantly increased in patients with bactDNA or a variant-NOD2 genotype. The combination of both factors induced decreased anti-TNF-levels and a higher percentage of patients on intensified anti-TNF therapy. CONCLUSIONS BactDNA is an independent risk factor of relapse at 6 months in CD patients. BactDNA is also independently associated with an increased risk of hospitalization, switch of treatment, and steroids initiation. Originally published at: Gutiérrez, Ana; Zapater, Pedro; Juanola, Oriol; Sempere, Laura; García, Marifé; Laveda, Raquel; Martínez, Antonio; Scharl, Michael; González-Navajas, José M; Such, José; Wiest, Reiner; Rogler, Gerhard; Francés, Rubén (2016). Gut bacterial DNA translocation is an independent risk factor of flare at short term in patients with crohn's disease. American Journal of Gastroenterology, 111(4):529-540. DOI: https://doi.org/10.1038/ajg.2016.8 Title:Gut bacterial DNA translocation is an independent risk factor of flare at short--term in patients with Crohn's Disease. Short title:Crohn's disease and bacterial DNA Authors:Ana Gutiérrez 1 , Pedro Zapater 2 , Oriol Juanola 2 , Laura Sempere 1 , Marifé García 3 , Raquel Grant support:This work has been supported by Abbvie (ADATHEC study), and co--funded by the FEDER program (EU).

The Migraine-ACT questionnaire is a simple but sensitive and specific tool to predict improvements at 3 months resulting from changes in migraine treatment and can be used to detect patients with suboptimal migraine management and to monitor treatment effectiveness.

These results suggest that the Migraine-ACT questionnaire can be used more reliably than the MIDAS questionnaire for detecting improvements in treatment of new and follow-up patients with migraine.