Safety and efficacy of Profermin® to induce remission in ulcerative colitis

AIM: To test the efficacy and safety of Profermin^® in inducing remission in patients with active ulcerative colitis (UC).METHODS: The study included 39 patients with mild to moderate UC defined as a Simple Clinical Colitis Activity Index (SCCAI) > 4 and < 12 (median: 7.5), who were treated open-label with Profermin^® twice daily for 24 wk. Daily SCCAI was reported observer blinded via the Internet.RESULTS: In an intention to treat (ITT) analysis, the mean reduction in SCCAI score was 56.5%. Of the 39 patients, 24 (62%) reached the primary endpoint, which was proportion of patients with ≥ 50% reduction in SCCAI. Our secondary endpoint, the proportion of patients in remission defined as SCCAI ≤ 2.5, was in ITT analysis reached in 18 of the 39 patients (46%). In a repeated-measure regression analysis, the estimated mean reduction in score was 5.0 points (95% CI: 4.1-5.9, P < 0.001) and the estimated mean time taken to obtain half the reduction in score was 28 d (95% CI: 26-30). There were no serious adverse events (AEs) or withdrawals due to AEs. Profermin^® was generally well tolerated.CONCLUSION: Profermin^® is safe and may be effective in inducing remission of active UC.     

Holter monitoring: are two days better than one?

The optimal duration of Holter monitoring (HM) to minimize costs and maximize yield is unknown. In a retrospective review of 164 patients referred to a tertiary care center for evaluation with 2 days of HM, we found that 48 hours was not cost effective when compared with the traditional 24-hour period.     

Adalimumab treatment of anti-TNF-naïve patients with ulcerative colitis: Deep remission and response factors

BackgroundAdalimumab is the second tumour necrosis factor antagonist (anti-TNF) adopted for the treatment of ulcerative colitis. Clinical data from naïve patients are scarce.AimExamine the response to adalimumab in TNF-antagonist-naïve patients.MethodsThis multicentre, observational, prospective study was conducted using a cohort of consecutive patients with ulcerative colitis. Clinical remission, mucosal healing and deep remission were examined employing the Mayo Score and Mayo Endoscopic Score. Clinical response was assessed using the Partial Mayo Score.ResultsOf 53 individuals included in this study, 49.1% of patients were in clinical remission at week 8 and 60.3%, at week 52. Clinical response was observed in 84.9% and 69.8%, respectively. Mucosal healing was found in 62.3% and 67.9% of the patients, and 43.4% and 58.4% showed deep remission at week 8 and 52, respectively. After a year, 71.7% of the patients continued the adalimumab treatment. Adverse effects were observed in 28.3% of patients. Multivariate analysis showed that the long-term factor predictive of response at week 52 was the response in week 8 (expressed as Mayo Score; OR 0.66; 95% IC 0.1–0.67, p < 0.006).ConclusionsAdalimumab treatment of ulcerative colitis is effective; the results are better in clinical practice and in patients naïve to anti-TNF.