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Background: HLA-G antigens are nonclassical major histocompatibility complex (MHC) class I molecules characterized by tolerogenic and antiinflammatory properties. Recently, a different expression of HLA-G antigens has been observed between intestinal biopsies of ulcerative colitis (UC) and Crohn's disease (CD) patients. These data suggested a functional role for HLA-G molecules in the diseases and proposed the HLA-G modulation as a marker for the diagnosis of UC and CD. The soluble HLA-G antigens (sHLA-G) are circulating molecules mainly produced by activated peripheral blood CD14+ monocytes., Methods: We tested, by specific enzyme-linked immunosorbent assay (ELISA), the sHLA-G molecule levels in the supernatants of unstimulated and bacterial lipopolysaccharide (LPS)-stimulated cultures of peripheral blood mononuclear cells (PBMC) from 30 healthy subjects, 10 CD, and 18 UC patients. The data were not influenced by treatment or disease activity., Results: The results confirmed a different sHLA-G expression between the diseases, with a spontaneous secretion of sHLA-G in CD patients but not in UC and healthy subjects. Moreover, a lack of sHLA-G antigens has been reported in UC patient cultures after LPS activation but not in healthy subjects and CD patients. The defective sHLA-G production was related to an impaired IL-10 secretion in UC but not in CD., Conclusions: Overall, these results confirm the presence of a different biological characteristic between CD and UC patients and suggest sHLA-G production by PBMC as a noninvasive diagnostic tool in the early phases of the diseases.

Background: Mesalazine enemas are of well proven efficacy for the topical treatment of distal ulcerative colitis. Although new rectal formulations of mesalazine are not expected to be superior in efficacy and tolerability to standard formulations, they may offer secondary advantages in terms of overall acceptability., Aim: To compare the efficacy, tolerability and overall acceptability of a new mesalazine rectal foam (Salofalk foam) with mesalazine enema in the treatment of active distal ulcerative colitis., Patients and Methods: A multicentre study was carried out in patients with active proctitis, proctosigmoiditis and left-sided ulcerative colitis as evaluated by the Clinical Activity Index (CAI > or =4) and Endoscopic Index (EI > or =6). Patients were randomly assigned to receive, in open-label fashion, either mesalazine foam 2 g twice a day or mesalazine enema (2 g/60 ml twice a day) for 3 weeks. Patients who did not achieve remission (defined as CAI <4 and EI <6) after 3 weeks continued the study receiving the alternative galenic formulation for a further 3 weeks., Results: A total of 195 patients were enrolled. Characteristics at baseline were similar except for concomitant therapy with oral 5-ASA products: during the 1st treatment phase, 41% of patients on enema received such treatment vs only 29% of those on foam. Patients with at least one post-treatment efficacy evaluation were included in the intent-to-treat analysis (n=89 foam, n=96 enema). After 3 weeks of treatment, 112 patients were in remission and only 59 patients entered the 2nd treatment phase thus providing data on acceptability. Remission was achieved after 3 weeks in 54% of patients treated with foam and in 67% of those treated with enema. The 90% confidence interval for the difference in remission rates was 0 to 24 and thus within the clinically acceptable range of therapeutic equivalence. At the end of the 2nd phase, 70% of patients switched to foam were in remission vs 65% to the enema. Two patients discontinued treatment with foam prematurely due to anal burning. No clinically important changes were seen in the laboratory tests., Conclusions: Salofalk foam and enema are equally effective for the treatment of proctitis, proctosigmoiditis and left-sided ulcerative colitis. The new foam preparation is as well tolerated and accepted as enemas and can be used as a therapeutic alternative to conventional mesalazine enema formulations.