Calcipotriol plus betamethasone dipropionate gel compared with its active components in the same vehicle and the vehicle alone in the treatment of psoriasis vulgaris: a randomised, parallel group, double-blind, exploratory study.

A two-compound ointment containing calcipotriol plus betamethasone dipropionate is an effective treatment for psoriasis vulgaris. The same active ingredients have now been combined in a gel formulation. Our objective was to compare the efficacy and safety of once daily treatment of the two-compound gel with the single components in the same gel vehicle and the gel vehicle alone, in patients with psoriasis vulgaris on the trunk and/or limbs. 364 patients received once daily treatment for up to 8 weeks with either the two-compound gel, the single components in the gel vehicle or the gel vehicle alone. The percentage of patients whose disease was clear or very mild and who had at least a two-step improvement in the Investigator's Global Assessment of disease severity at week 8, was significantly higher with calcipotriol plus betamethasone dipropionate (27.2%) than with betamethasone dipropionate (16.9%, p = 0.027), calcipotriol (11.4%, p = 0.006) or gel vehicle (0.0%, p < 0.001). This exploratory study showed that the two-compound gel was safe and more efficacious than its individual ingredients in the treatment of psoriasis vulgaris.

The combination of etanercept and methotrexate increases the effectiveness of treatment in active psoriasis despite inadequate effect of methotrexate therapy.

Many patients with moderate-to-severe plaque psoriasis do not respond adequately to methotrexate monotherapy. This pilot study, with a small patient population, was performed to evaluate the effectiveness and safety of etanercept and methotrexate combination in patients with plaque psoriasis and inadequate response to methotrexate. Outpatients with plaque psoriasis (Psoriasis Area and Severity Index > or = 8 and/or body surface area > 10%), despite methotrexate treatment (> or = 3 months; > or = 7.5 mg/week) were randomized to either etanercept with metho nottrexate tapered and discontinued (n = 28) or etanercept with continuous methotrexate (n = 31). Significantly more patients had a Physicians' Global Assessment of "clear"/"almost clear" in the combination group compared with etanercept/methotrexate taper (66.7 vs. 37.0%, respectively; p = 0.025). Adverse events were similar for both groups, with no cases of tuberculosis, malignancies or opportunistic infections reported. Addition of etanercept to methotrexate achieved significant improvement in psoriasis after 24 weeks.

Psoriasis patients with diabetes type 2 are at high risk of developing liver fibrosis during methotrexate treatment.

BACKGROUND/AIMS: We investigated the impact of diabetes mellitus type 2, overweight, alcohol over-consumption, and chronic hepatitis B or C as risk factors, for liver fibrosis in psoriasis patients treated with methotrexate. METHODS: One hundred and sixty-nine liver biopsies from 71 patients who underwent liver biopsies as part of the monitoring of methotrexate treatment for psoriasis were reviewed. Fibrosis, steatosis and inflammation were staged according to the NAFLD activity score. RESULTS: Twenty-six patients had one or more of the risk factors and 25 (96%) of these (median cumulative dose methotrexate 1500 mg) developed liver fibrosis. Of those without risk factor, 26 (58%) (p=0.012) developed fibrosis (median cumulative dose methotrexate 2100 mg). Ten (38%) of the patients with risk factor(s) had severe fibrosis (stage 3-4) (mean cumulative dose methotrexate 1600 mg), while four (9%) (p=0.0012) of those without risk factors had severe fibrosis (median cumulative dose methotrexate 1900 mg). CONCLUSIONS: Patients with methotrexate treated psoriasis and risk factors for liver disease, especially diabetes type 2 or overweight, are at higher risk of developing severe liver fibrosis compared to those without such risk factors, even when lower cumulative methotrexate doses are given.