Area Editoriale
La discrepanza è in ogni caso in parte spiegabile considerando la differenza fra i pazienti valutati nei due studi. Il primo è una rianalisi dei dati di un trial terapeutico e conferma che nella maggior parte dei pazienti con CU che raggiungono una remissione clinica al termine di una terapia di fase acuta è riscontrabile anche una remissione endoscopica. Il secondo è uno studio trasversale su pazienti sottoposti ad una colonscopia di sorveglianza e considerati in una fase di remissione clinica (ma eterogenei riguardo terapie in atto, compliance alla terapia di mantenimento, durata della remissione clinica etc) e dimostra che una elevata percentuale di questi presenta in realtà segni endoscopici di attività Can endoscopy be avoided in the assessment of ulcerative colitis in clinical trials?Dhanda AD, Creed TJ, Greenwood R, Sands BE, Probert CS. Inflamm Bowel Dis. 2012;18:2056-62
BACKGROUND: There is no gold standard index in the measurement of ulcerative colitis (UC) disease activity in clinical trials. Mucosal healing has been described as an important clinical endpoint requiring endoscopic assessment, which is unpleasant for the patient and may hamper recruitment to trials. The aim of this study was to determine whether endoscopy is necessary in the assessment of UC disease activity and whether a noninvasive disease activity index (partial Mayo score) could be used to predict the Mayo score.
METHODS: In all, 149 subjects with moderate to severe UC enrolled in a clinical trial were assessed using total and partial Mayo scores. Histologic assessment of biopsies was performed. A regression model was constructed to predict total Mayo score from the partial Mayo score and histology score from the Mayo score. A Bland-Altman test of agreement was performed.
RESULTS: The partial Mayo score correlated closely with the total Mayo score at week 4 (rho = 0.97) and week 8 (rho = 0.98). The model to predict total from partial Mayo score showed excellent correlation (rho = 0.97) and good agreement with the total Mayo score at week 4 and the week 8 validation set (rho = 0.97) and accurately classified disease severity (kappa = 0.82). The model to predict histology score from the Mayo score correlated only moderately with the actual histology score at week 4 (rho = 0.59) and week 8 (rho = 0.36).
CONCLUSIONS: The Mayo score can be accurately predicted from the partial Mayo score. A noninvasive index can replace the Mayo score in future clinical trials. Majority of patients with inflammatory bowel disease in clinical remission have mucosal inflammation.Baars JE, Nuij VJ, Oldenburg B, Kuipers EJ, van der Woude CJ. Inflamm Bowel Dis. 2012;18:1634-40
BACKGROUND: Management of inflammatory bowel disease (IBD) is increasingly focused on mucosal remission. We assessed the prevalence of mucosal inflammation during clinical remission, the clinical consequences, and the impact on disease course. METHODS: IBD patients from two referral centers who underwent a surveillance colonoscopy while clinically in remission between January 2001 and December 2003 were included. Follow-up ended May 1, 2009. Clinical data were collected from patient charts. Statistical analysis was performed using independent t-tests and nonparametric tests. RESULTS: In total, 152 IBD patients were included (98 [65%] ulcerative colitis, 46 [30%] Crohn's disease; 85 [56%] males). Median follow-up was 6.8 years (interquartile range [IQR] 6-8). Forty-seven (31%) patients had no signs of inflammation during endoscopy (group A). Of the remaining 105 (68%) patients, 51 (49%) had both endoscopic and histological inflammation (group B), 51 (49%) histological inflammation only (group C), two (2%) endoscopic lesions only (group D). Two years later, 29% of all patients had endoscopic inflammation and another 27% had only microscopic inflammation. In 39% the inflammation had resolved spontaneously. Inflammation was more often found in group B+C (n = 62/102; 61%) than in group A (n = 17/47; 36%; P = 0.21). Inflammation was not associated with more frequent clinical relapses nor with stricture formation, nor with the need for surgery.
CONCLUSIONS: A large proportion of IBD patients have mucosal inflammation without clinical symptoms. Although one-third recover spontaneously, mucosal inflammation in patients who are clinically in remission is associated with more severe mucosal disease activity, but not with more complications or symptomatic flares during follow-up.