Background: Topical corticosteroids and calcipotriol have been used separately for many years to treat psoriasis. A new combination ointment has been formulated, which contains both calcipotriol and the corticosteroid betamethasone dipropionate. Objective: To compare the combination ointment with betamethasone dipropionate ointment, calcipotriol ointment and ointment vehicle in patients with psoriasis vulgaris. Methods: 1,603 patients were randomised to one of the 4 double-blind treatments used once daily for 4 weeks. Results: Themean percentage change in the PASI at the end of treatment was –71.3 (combination), –57.2 (betamethasone), –46.1 (calcipotriol) and –22.7 (vehicle). The mean difference of combination minus betamethasone was –14.2 (95% CI: –17.6 to –10.8, p < 0.001), of combination minus calcipotriol –25.3 (95% CI: –28.7 to –21.9, p < 0.001) and of combination minus vehicle –48.3 (95% CI: –53.2 to –43.4, p < 0.001). 6.0% of patients (combination) reported local adverse reactions compared to 4.9% (betamethasone), 11.4% (calcipotriol) and 13.6% (vehicle). Conclusion: Calcipotriol/betamethasone dipropionate combination ointment used once daily is well tolerated and more effective than either active constituent used alone.
BackgroundFixed combination calcipotriol 50 μg/g (Cal) plus betamethasone 0.5 mg/g (BD) foam has been developed as a new treatment option for patients with psoriasis.MethodsThe randomized, parallel‐group, investigator‐blinded Phase III, 12‐week PSO‐ABLE study compared the efficacy and safety of Cal/BD foam with Cal/BD gel. Patients aged ≥18 years with mild‐to‐severe psoriasis were randomized 4:4:1:1 to once‐daily Cal/BD foam, Cal/BD gel, foam vehicle or gel vehicle (NCT02132936). The primary efficacy endpoint was the proportion of patients who were clear/almost clear with a ≥ 2 grade improvement according to the physician's global assessment of disease severity (i.e. treatment success) at week 4 for Cal/BD foam vs. week 8 for Cal/BD gel. Secondary efficacy endpoints included: proportion of patients achieving at least a 75% reduction in modified psoriasis area and severity index (mPASI75), and time to treatment success (TTTS). Safety was monitored throughout.ResultsA total of 463 patients were randomized: Cal/BD foam (n = 185), Cal/BD gel (n = 188), foam vehicle (n = 47), gel vehicle (n = 43); overall completion rate was 90%. Cal/BD foam achieved higher treatment success rates (38% vs. 22%; P < 0.001) and mPASI75 (52% vs. 35%; P < 0.001) by week 4 than Cal/BD gel by week 8. Median TTTS with Cal/BD foam was 6 weeks; this could not be determined for Cal/BD gel as 50% treatment success was not achieved (P < 0.001). Adverse drug reactions were reported in 14 (7.6%) Cal/BD aerosol foam patients and 7 (3.7%) Cal/BD gel patients; all were single events except for itch with Cal/BD aerosol foam (n = 5; 2.7%) and worsening psoriasis with Cal/BD gel (n = 3; 1.6%).ConclusionCal/BD aerosol foam showed significantly greater efficacy after 4 weeks, than 8 weeks of treatment with Cal/BD gel, with similar tolerability.
Findings are presented from the initial cross sectional phase of a cohort study of employees exposed to flour in bakeries or mills. Of 401 eligible workers in seven sites 344 (86%) were surveyed; symptoms assessed by self completed questionnaire, and sensitisation measured by the response to skin prick tests, were related to intensity of exposure both to total dust and to flour aeroallergen. Among 264 subjects without previous occupational exposure to flour, work related symptoms which started after first employment at the site were related to exposure intensity, especially when exposure was expressed in terms of flour aeroallergen. The relations with eyelnose and skin symptoms were independent of atopic status and cigarette smoking. Positive skin test responses to mixed flour and to a amylase were also more frequent with increasing exposure intensity, although this was confounded by atopic status. There was only a weak association between symptoms and specific sensitisation.
Findings are presented from the initial cross sectional phase of a cohort study of employees exposed to laboratory rats. Of 366 eligible workers at four sites 323 (88%) were surveyed; symptoms assessed by self completed questionnaire and sensitisation measured by the response to skin prick tests were related to intensity of exposure both to total dust and to rat urinary aeroallergen. Among 238 workers, without previous occupational expo--sure to rats, work related symptoms, which started after first employment at the site were related to exposure intensity (expressed either in terms of dust or of aeroallergen) at the time of onset of symptoms. These relations were stronger in atopic subjects but were unrelated to smoking. Positive skin tests to rat urinary extract were also more frequent with increased exposure, a relation found in both atopic subjects and in smokers. There was a strong association between work related symptoms and specific sensitisation. ( information; the current cohort study was designed to correct these deficiencies. We report findings of the initial phase. Subjects and methods SURVEY METHODSFour institutions specialising in small animal research in the United Kingdom were identified: three use a variety of animals including rats; the fourth uses almost exclusively mice and is not described in this paper. All full time employees in occupational groups where exposure to laboratory rats or mice was probable and a group of non-exposed office workers, who had started work at the site from 1 January 1986 onwards and had worked for at least one month, were invited to participate.Members of the cohort still employed at the sites have been surveyed at six-monthly intervals since 1990. We describe the findings from the initial survey. Two visits to each site were made, the second to collect information from those missed at the first visit. Of 366 eligible subjects 323 (88%) were surveyed, with no difference in response rates between the three workforces. Questionnaires were completed by 315 subjects (84%) and skin prick tests by 295
SUMMARYBackground: Heparin has anti-inflammatory and immunomodulatory activity which may be of therapeutic benefit in the treatment of ulcerative colitis. Aim: To test whether low molecular weight heparin, given subcutaneously, would provide a significant therapeutic response compared with placebo in the treatment of mild to moderate ulcerative colitis. Study design: A prospective, double-blind, randomized, placebo-controlled, multi-centre trial comparing tinzaparin 175 anti-Xa IU/kg/day (innohep, LEO Pharma) subcutaneously for 14 days followed by tinzaparin 4500 anti-Xa IU/day subcutaneously for 28 days with placebo, administered subcutaneously once daily for up to 42 days. The primary outcome measure was the mean change in colitis activity from baseline to the end of study treatment assessed by the sum of scores of stool frequency, rectal bleeding, sigmoidoscopic appearance
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